Biobanks As A Resource

Biobanks
as resources for health

Mats G. Hansson & Marianne Levin (eds.)
j~ dK e~
Marianne Levin
(Eds.)

_~ as Rosourcos lor HoalLh

Rosoarch Irogran ILhics in Bionodicino

Biolanls as Rosourcos Ior HoalLh
MaLs G. Hansson & Marianno Lovin (ods.}

ISBN 91-506-1659-6

IirsL rinL
IirsL odiLion 200J
Rosoarch Irogran ILhics in Bionodicino
IrinLod ly: InivorsiLoLsLryclorioL, Isala
Covor: Jacquos Ioshaios INA Ianily viLh Colls", Acrylic on canvas
TyosoLLing & layouL: Josoino Iornov

^

Tho rosoarch rojocLs roorLod in Lhis lool havo loon linancod ly Lho Svodish
IoundaLion lor SLraLogic Rosoarch (Lhrough Lho ILSA rogranno}, Lho Svodish
Agoncy lor InnovaLion SysLons (\INNC\A}, Lho IodoraLion ol CounLy Councils,
Lho NaLional Board ol HoalLh and \ollaro and Lho KnuL and Alico \allonlorg
IoundaLion (Lhrough Lho SvoGono Biolanl Irogranno and \allonlorg
ConsorLiun NorLh}.

Social Lhanls Lo Josoino Iornov lor co-ordinaLing Lho naling ol Lhis roorL and Lo
Rogor Tannor lor languago rovision.

`

1. Biobanks as resources for health
V

j~ dK e~ C j~~ i

1. InLroducLion 9

2. Biolanling is noL a nov honononon 12

J. A groaL varioLy ol rosoarch rojocLs lor roalising Lho oLonLial ol
liolanls
1J

4. IarLnorshi lor Lho lonoliL ol aLionLs 14

5. Svodish lav rocognisos loLh rosoarch inLorosLs and Lho inLorosLs ol
inLogriLy
15

6. Tho nov logislaLion oons Lho vay Lo ragnaLic soluLions and
nininisos Lho risl ol arliLrarinoss
15

. A Svodish sLandard lor inlornaLion and consonL rocoduros 1

8. Tho inorLanco ol agroononLs on disosiLion loLh ovor Lho
liolanls and liological naLorial
18

2. Clinical data a necessary requirement for realising the potential of
biobanks
ON

_ p i

1. InLroducLion 21

2. Biolanls in Clinical Iraxis 22

J. Basic scionco and LranslaLional rosoarch 2J

4. \haL lind ol clinical inlornaLion is noodod 24

5. Ixanlos ol disoasos and Lho nood lor clinical and rolaLod daLa 26

6. Iharnaco-gonoLics J0

. Gono Lhoray J0

8. \haL is Lho Lasl ol Lho hysician J0

3. Examples from Swedish biobank research
PP

j~ h~

1. InLroducLion JJ

2. CollocLion ol Svodish liolanl naLorial JJ

J. Ixanlos J4

4. Clinical genomics companies and biobanks The use of biosamples
in commercial research on the genetics of common diseases
RN

g i~~Je~

1. InLroducLion 51

2. Tho clinical gononics conany: sono loaLuros 52

J. Tho connorcial uso ol liolanls: inorLanL issuos 5

4. Tho noLhodology ol Lho sLudy 62

5. doCodo GonoLics 62

6. Cxagon 65

. InanGononics 68

8. ConaraLivo analysis 0

9. Concluding ronarls 8
5. Public law aspects on the use of biobank samples
Privacy versus the interests of research
VN

b~ o

1. InLroducLion 91

2. Sono righLs and inLorosLs Lo considor 92

J. RoconL logal dovolononLs 96

4. Hunan liological naLorial a carrior ol orsonal daLa 99

5. IarLs ol Lho hunan lody as rav naLorial 10J

6. Ising Svodish liolanl naLorials in rosoarch 105

. Conclusions 115

8. Closing ronarls 121

6. Focusing on personal integrity violation legal guidelines for ethical
practice
NOV

r b

1. InLroducLion 129

2. Tho ILhical Roviov AcL 1J0

J. Accoss Lo rosoarch naLorial 1J6

4. Roviov ly Lho Boards lor Rosoarch ILhics 140

7. A Swedish standard for information and consent procedures in
biobank research
NQV

d e

1 InLroducLion 149

2. Biolanls and inlornaLion on individuals 149

J. Inlornod consonL 151

4. \aluos aL sLalo 152

5. Gonoral and socilic inlornaLion 15J

6. ConsonL 155

. Iiscussion 159

8. Mapping the debate on informed consent
NSR

p~ b

1. InLroducLion 165

2. ShorL ovorviov ol Lho dolaLo loading u Lo Lho Biolanls AcL 166

J. Sono Loics dolaLod during Lho logislaLion rocoss 12

9. Public and patient perception of biobanks and informed consent
NVT

i~ o C ~ h i~

1. InLroducLion 19

2. Inirical rosoarch on Lho viovs ol Lho gonoral ullic and aLionLs
rogarding rosoarch on liolanl naLorial and inlornod consonL
rocoduros an inLornaLional orsocLivo
198

J. Tho Svodish ullic`s orcoLions ol rosoarch using liolanls and
inlornod consonL rocoduros a iloL sLudy
201

10. Intellectual property and biobanks
OMT

~ e~I p~~ t C o~ t~

1. InLroducLion 20

2. Tho liolanl, Lho narloL and Lho lav 209

J. Ixclusivo righLs Lo liolanls 212

4. \ho ovns Lho liolanl 220

5. Sunnary 22J

11. Gifts and donations
OOT

^~ e m

1. GilLs and donaLions 22

2. Torninology 228

J. \ho donaLos hunan liological naLorial 2J0

4. \ho rocoivos hunan liological naLorial 2JJ

5. GilLs 2J4

6. CljocL ol gilLs 2J6

. IonaLions 2J9

8. CljocL ol donaLions 242

9. Conarison loLvoon gilLs and donaLions 242

10. A conaraLivo analysis ol doods ol gilL and donors` lorns 24J

11. Malors ol gilLs and donors 245

12. RociionLs ol gilLs and donoos 246

1J. Conclusions 248

12. Commercial engagement and public research in the biomedical area
ORR

r~ _~

13. Agreements concerning human biological material
ORT

r~ m~ C o~ c

1. Baclground 25

2. Gonoral ovorviov agroononLs and scoo ol arLiclo 25

J. Koy clausos 260

4. Conclusion 26

14. Publications and activities
OSV

1. IrojocL roorLs 269

2. ScionLilic ullicaLions 20

J. Ioular scionco/roviovs 21

4. Conloronco and soninar conLriluLions 21

5. IrojocL acLiviLios 26

Liobanls as resources jor health

1

Biobanks as resources for health

Associate rojessor Mats C. Hansson
1
& rojessor Marianne Levin
?

1
Research rogram thics in Liomedicine, Uppsala University
2
Department oj Lau, Stoclholm University

The potential benejits oj biomedicine and biotechnology are considerable, but this is also
an area oj science and medicine that is sometimes jound controversial. Decisions made by
scientists, by health care projessionals and by policymalers must be uell injormed and
based on lnouledge and sound research. Legal experts concerned uith public lau and
intellectual property rights, philosophers and social pharmacists have been collaborating
uith geneticists, pathologists and doctors in several research projects in order to seel the
lind oj biobanl management that uould satisjy the interests oj both the research
community and the general public as regards neu medicines and jorms oj treatment,
uhilst protecting the integrity oj the individual. A summary oj that research is presented
in this bool, and in the present chapter ue provide a short overvieu.

1. Introduction

Tho oLonLial lonoliLs ol lionodicino and lioLochnology aro considorallo, luL Lhis is
also an aroa ol scionco and nodicino LhaL is sonoLinos lound conLrovorsial. \aluo
sLudios loLh in Svodon and alroad rovoal vidosroad scoLicisn anong Lho gonoral
ullic alouL luLuro dovolononLs in Lhis shoro. Tho raidiLy ol dovolononL loLh
aLLracLs and rools. IsLallishing rolaLionshis ol LrusL is viLally inorLanL. A nininal
roquirononL lor Lho osLallishnonL ol LrusL is LhaL Lho docisions nado ly scionLisLs, ly
hoalLh caro rolossionals and ly olicynalors aro voll inlornod and lasod on
lnovlodgo and sound rosoarch. This is Lruo noL only lor lioLochnology and nodicino,
luL also lor oLhics and social olicy-naling. In 1998 Lho \ico-Chancollor ol Isala
InivorsiLy iniLiaLod Lho rosoarch rogran thics in Liomedicine Rosoarch Irogranno
in ordor Lo onallo a discilinod ovaluaLion ol oLhical valuos, roviding sound rosoarch
and scholarshi. IsychologisLs and oLhics rosoarchors aro collaloraLing viLh clinical
gonoLicisLs, oncologisLs and surgoons Lo doLornino hov aLionLs and rolaLivos roacL
vhon Lold LhaL Lhoy aro gonoLically disosod Lo cancor. In rojocLs alouL liolanling,
logal oxorLs concornod viLh ullic lav and inLollocLual roorLy righLs,
hilosohors and social harnacisLs havo loon collaloraLing viLh gonoLicisLs,
aLhologisLs and docLors in sooling Lho lind ol liolanl nanagononL LhaL vould
saLisly Lho inLorosLs ol loLh Lho rosoarch connuniLy and Lho gonoral ullic as
rogards nov nodicinos and lorns ol LroaLnonL, vhilsL roLocLing Lho inLogriLy ol Lho
individual. This lool is a roorL lron Lho rojocLs on liolanling. All ullicaLions
and acLiviLios onanaLing lron Lho rojocL aro lisLod in Lho concluding chaLor.
9
Mats C. Hansson & Marianne Levin

Tho rosoarch rogran thics in Liomedicine Rosoarch Irogranno has Lho lonoliL ol a
sizoallo grou ol scholars in-houso luL doonds lor iLs succoss on good rolaLionshis
viLh oLhor doarLnonLs, loLh aL Isala InivorsiLy and aL oLhor univorsiLios. Tho
IoarLnonL ol Lav aL SLoclholn InivorsiLy has loon an inorLanL collaloraLor lor
nany yoars, viLh iLs oxorLiso in dilloronL aroas ol rivaLo lav and ullic lav. Tho
Chalnors InivorsiLy ol Tochnology is anoLhor arLnor ol inorLanco. In Lho rojocLs
on liolanling, closo conLacL viLh naLural scionLisLs, loLh aL acadonic insLiLuLions
and aL harnacouLical conanios, has loon ossonLial in ordor Lo goL Lho lacLs sLraighL
and acquiro lirsL-hand lnovlodgo alouL Lho uso ol liolanls lor rosoarch urosos.
1

Tho lolloving scholars and scionLisLs havo loon involvod in Lho rojocLs on
liolanling as arLnors or as consulLanLs:

Associate rojessor Mats C. Hansson, B.A., ThI, (IrojocL Loador}, Rosoarch
Irogran ILhics in Bionodicino, Isala InivorsiLy.

rojessor Maria Anvret, IhI, AsLraZonoca AB.

Ulla Ljrlman, LLM, Sonior LocLuror, IoarLnonL ol Lav, Isala
InivorsiLy.

1acob Dahl Rendtorjj, IhI., IoarLnonL ol Ihilosohy, Roslildo InivorsiLy.

Associate rojessor Lengt Domeij, LLI, IndusLrial Icononics and
ManagononL, Royal InsLiLuLo ol Tochnology, SLoclholn

Stejan rilsson, ThI, Rosoarch Irogran ILhics in Bionodicino, Isala
InivorsiLy.

Ulril von ssen, LLI, IoarLnonL ol Lav, SLoclholn InivorsiLy.

Rebecla risl, LLM, Bird & Bird.

Cert Helgesson, IhI, Rosoarch Irogran ILhics in Bionodicino, Isala
InivorsiLy.

Asa Hellstadius, IocLoral CandidaLo, LLM, IoarLnonL ol Lav, SLoclholn
InivorsiLy

Lena 1onsson, IhI, Anorshan Bioscioncos.

Magnus Kaijser, IhI, IoarLnonL ol Modical Iidoniology, Karolinsla
InsLiLuLoL.

Asa KettisLindblad, IhI, IoarLnonL ol Iharnacy, Isala InivorsiLy.

1
Ior an oarlior roorL soo: Hansson, M.G., (od.}, The Use oj Human Liobanls. thical, Social,
conomical and Legal Aspects, RoorL 1, Isala InivorsiLy 2001, ISBN 91-506-142-X, 9J .
10
Associate rojessor 1ens LaageHellman, IhI, InsLiLuLo lor ManagononL ol
InnovaLion and Tochnology, Chalnors InivorsiLy ol Tochnology, GLolorg.

rojessor Ulj Landegren, MI, IhI, IoarLnonL ol GonoLics and IaLhology,
Isala InivorsiLy.

rojessor Marianne Levin, LLI, IoarLnonL ol Lav, SLoclholn InivorsiLy.

Lo Lindberg, MI, IhI, Iornor Modical IirocLor, Aladonisla sjulhusoL
(Isala InivorsiLy HosiLal}.

Lena Ring, IhI, IoarLnonL ol Iharnacy, Isala InivorsiLy.

Urban aulsson, AdvocaLo, Bird & Bird, Monlor ol Lho Svodish Bar
AssociaLion

Associate rojessor Annina ersson, LLI, IoarLnonL ol Lav, SLoclholn
InivorsiLy.

Associate rojessor lisabeth Rynning, LLI, IoarLnonL ol Lav, Isala
InivorsiLy.

Associate rojessor Christer Sundstrm, MI, IhI, IoarLnonL ol GonoLics
and IaLhology, Isala InivorsiLy.

Richard Wessman, LLI, IoarLnonL ol Lav, SLoclholn InivorsiLy.

Li Westerlund, LLI, IoarLnonL ol Lav, SLoclholn InivorsiLy.

Associate rojessor Kerstin Westermarl, Modical IroducLs Agoncy, Isala

Sanna Woll, IocLoral candidaLo, LLM, IoarLnonL ol Lav, SLoclholn
InivorsiLy.

As can lo soon lron Lho lasL chaLor ol Lhis roorL, Lho auLhors havo ullishod in
scionLilic journals viLhin Lhoir ovn acadonic liolds. Sono LiLlos aro lorLhconing
during 200J. This roorL rorosonLs a sunnary ol Lho rosulLs. Through Lho rosoarch
rojocLs a nulLi-discilinary lasis has loon laid lor Lho inlononLaLion ol oLhical
and logal raxis rogarding liolanling. Thanls Lo an iniLiaLivo Lalon ly Lho Svodish
IodoraLion ol CounLy Councils in January 200J a unilorn raxis is dovoloing
anong Svodish hoalLh caro rovidors rogarding inlornaLion and consonL rocoduros
lor collocLion and sLorago ol hunan liological socinon. Sovoral quosLions ronain Lo
lo solvod. Thoro is a nood lor closor collaloraLion ovor naLional lordors and Lhoro
nusL lo sLandards ol qualiLy and saloLy LhaL aro connon Lo dilloronL arLnors
collaloraLing in diagnosis and rosoarch. Tho nov II IirocLivo (2001/8J/IC} soLLing
sLandards ol qualiLy and saloLy lor Lho collocLion, LosLing, rocossing, sLorago and
disLriluLion ol hunan llood and llood conononLs vill sLinulaLo coordinaLion and
collaloraLion loLvoon Lho nonlor sLaLos ol Lho Iurooan Inion lor Lho lonoliL ol
11
aLionL saloLy. A nov dirocLivo rogarding harnacogononics lron Tho Iurooan
Agoncy lor Lho IvaluaLion ol Modicinal IroducLs (IMIA}, docidod in Ioconlor
2002 (IMIA/cn/J00/01}vill laciliLaLo collaloraLion Lhrough osLallishing
unilorn criLoria lor gonoLic LosLs and coding ol gonoLic inlornaLion. Cl groaL and
olvious concorn lor Lho inlononLaLion ol a Iurooan raxis is also Lo lollov
closoly Lho rogross ol Lho nov roosal lor a II IirocLivo (2002/0128(CCI} on
soLLing sLandards ol qualiLy and saloLy lor Lho donaLion, rocurononL, LosLing,
rocossing, sLorago and disLriluLion ol hunan Lissuos and colls.

2. Biobanking is not a new phenomenon

Issuos rolaLod Lo sanling ol hunan liological naLorial havo cono Lo lo inLonsivoly
discussod during Lho roconL livo yoars. Svodon has had nov logislaLion in ollocL sinco
1sL January 200J and logislaLion is oxocLod in oLhor counLrios as voll. HoalLh caro
rolossionals, scionLisLs and oliLicians aro involvod in discussions rolaLod Lo dilloronL
asocLs ol liolanling. In Lhis conLoxL iL is inorLanL Lo rononlor LhaL Lho Laling ol
llood and Lissuo sanlos has loon a arL ol rouLino clinical racLico lor nany yoars.
Iron Lho orsocLivo ol ordinary hoalLh caro, liolanling is noL a nov honononon.
IL is nornal rocoduro in ordor Lo orlorn diagnosis or ascorLain Lho ollocLs ol
nodical LroaLnonL. Bo Lindlorg`s accounL ol liolanling (ch. 2} as a arL ol clinical
racLico is a ronindor ol Lhis lacL. In nany disoasos an oxacL diagnosis is nocossary
loloro LroaLnonL sLarLs, and liosios nusL lo sLorod in ordor Lo diagnoso rolasos ol a
disoaso or lor Lho salo ol aLionL saloLy. Suly ol salo llood roducLs is a
roroquisiLo lor nosL surgical rocoduros Loday. IL is inorLanL also Lo aclnovlodgo
LhaL viLhin Lho conLoxL ol ordinary hoalLh caro Lhoso asocLs ol nodical LroaLnonL
havo loon guidod ly connon and voll-accoLod codos ol rolossional conducL, such
as giving Lho aLionLs aroriaLo inlornaLion and rosocLing Lhoir soll-
doLorninaLion. This racLico, vhich has long loon codiliod in Svodish hoalLh caro
logislaLion, is an inLrinsic olononL ol clinical oLhics.
Hovovor, ovon il liolanling as such is noL a nov honononon in clinical
racLico, iL is also inorLanL Lo aclnovlodgo LhaL nov scionLilic lnovlodgo, o.g.
gonoLic rosoarch, has Lurnod Lho sanlos ol llood and Lissuo inLo viLal noans lor
rosoarch. Il succosslul, Lhis rosoarch vill onallo Lho dovolononL ol nov nodical
LroaLnonLs. Lindlorg has oinLod Lo Lho inorLanco ol voll-nanagod and accuraLo
clinical daLa lor roalising Lho oLonLial ol Lho clinical liolanls. Roliallo clinical daLa,
including a conrohonsivo and sLrucLurod anannosis and lanily hisLory, Lho rosulLs
lron clinical oxaninaLions and laloraLory invosLigaLions, aro nocossary Lools il Lhoso
rosourcos ol hoalLh aro Lo lo roalisod. Rosoarch using hunan liolanls has so lar
loon doninaLod ly nolocular oidoniologisLs using largo cohorLs nunloring
hundrods or Lhousands ol aLionLs. \iLh Lho rogross nov loing nado in luncLional
gononics Lhoro is groving inLorosL in having accoss Lo clinical daLa vhoro aLionLs aro
voll-characLorisod loLh aL Lho nolocular lovol and viLh rogard Lo lanily hisLory and
lilo-sLylo lacLors. A lov voll-characLorisod aLionLs nay lo noro advanLagoous lor
sono rosoarch urosos in luncLional gononics Lhan accoss Lo Lhousands ol aLionLs
characLorisod only in ono or Lvo asocLs. Good clinical racLico and closo
collaloraLion loLvoon scionLisLs and docLors aro ossonLial in ordor Lo sorvo Lho
inLorosLs ol aLionL vollaro in loLh Lho shorL- and in Lho long-Lorn orsocLivo.
12
3. A great variety of research projects for realising the potential of biobanks

Thoro aro nany linds ol liolanls organisod lor nany dilloronL urosos, ranging
lron snall collocLions ol liological socinon assonllod lron socilic aLionL grous
Lo largo liolanls viLh hundrods ol Lhousands ol sanlos assonllod viLhin Lho
lranovorl ol dilloronL scrooning rogrannos. Magnus Kaijsor (ch. J} has suggosLod
a caLogorisaLion ol Lhoso dilloronL liolanls disLinguishing loLvoon (i} naLorial
collocLod lor diagnosis, (ii} naLorial collocLod lor luLuro clinical and diagnosLic uso,
(iii} naLorial lor naing ol aLionLs viLh dilloronL characLorisLics such as oLonLial
lono narrov donors and (iv} naLorial collocLod oxclusivoly lor rosoarch. \haLovor
Lho nain uroso ol collocLion, all Lhoso liolanls havo rovod Lo lo invaluallo Lools
lor lionodical rosoarch. Kaijsor rovos Lhis oinL viLh oighLoon illusLraLivo oxanlos
ol dilloronL rosoarch rojocLs carriod ouL roconLly. His collocLion ol oxanlos shovs
LhaL a groaL varioLy ol rosoarch quosLions can lo addrossod Lhrough Lho uso ol
liolanls. Iach scionLilic rosulL adds inorLanL lnovlodgo LhaL, succosslully collaLod,
nay lo ol groaL lonoliL lor Lho vollaro ol aLionLs. Cno inorLanL losson lron Lhis
survoy is LhaL in ordor Lo lully roaliso Lho oLonLial ol liolanls, liological
inlornaLion lron Lho liological socinon noods Lo lo conlinod viLh ovory lind ol
nodical and orsonal inlornaLion availallo. Tho uso ol liolanls lor rosoarch Lhon
inlios lull accoss Lo inlornaLion availallo in dilloronL linds ol nodical rogisLors,
accoss Lo clinical daLa lor oach individual and also accoss Lo oidoniologically
signilicanL inlornaLion availallo in dilloronL linds ol ullic rocords and scionLilic
daLalasos. Cno lurLhor inlicaLion, as vill lo discussod laLor, is LhaL all Lhis
inlornaLion nusL lo saloly handlod so LhaL no harn is dono Lo sanlo donors,
aLionLs or oLhor inlornanLs ol rogisLors and rocords.
Sono ol Lho concroLo oxanlos ol rosoarch rojocLs also illusLraLo Lho
ossililiLy ol a dirocL loss ol scionLilic valuo il oxliciL and socilic inlornod consonL
is Lho rulo viLhouL oxcoLion vhon using roviously collocLod sanlos lor addrossing
nov rosoarch quosLions. Sono quosLions nay noL lo aslod, and Lhoro is a cosL rolaLod
Lo a sLudy`s dro-ouL raLo. Tho scionLilic valuo ol Lho sLudy dininishos and viLh iL
Lho valuo ol Lho lnovlodgo lor undorsLanding and curing disoasos. Thoro vill alvays
lo a dro-ouL vhon Lhoro is a sLricL roquirononL ol olLaining lrosh inlornod consonL
lron a sanlo donor. BoLvoon 20-40' ol Lho inlornanLs vill noL roly, no naLLor
hov nany ronindors aro sonL ouL. IL is inossillo lor Lho scionLisLs Lo lnov il Lhoso
noL rosonding lolong Lo a grou ol arLicular inLorosL lor Lho sLudy or vhy Lhoy
don`L rosond. Il groaL risls ol harn aro associaLod viLh arLiciaLing in Lho sLudy,
Lhis nay lo an oLhical rico LhaL has Lo lo accoLod. BuL il Lho risls aro slighL ono
assunos a groaL noral rosonsililiLy vhon arguing lor inlornod consonL viLhouL
oxcoLion, sinco Lho ossililiLy ol nooLing Lho noods rolaLod Lo aLionL vollaro aro
drasLically roducod. Hov Lhis lalanco loLvoon aLionL inLorosLs lor nov nodically
inorLanL lnovlodgo vorsus donors` inLorosLs ol soll-doLorninaLion nay lo achiovod
is a loy concorn in Lho nov Svodish Biolanls AcL and is discussod ly sovoral ol Lho
auLhors in Lhis roorL.
2
Tho Biolanls AcL assigns Lho Lasl ol lalancing valuos aL sLalo
Lo Lho rosoarch oLhics conniLLoos and iL should lo noLod LhaL Lho rolovanL rovision
ol Lho Biolanls AcL doos noL inoso any sLaLuLory rosLricLions on Lho discroLion ol
Lho rosoarch oLhics conniLLoos. Hovovor, as shovn ly Ilril von Isson (ch. 6} and

2
Soo also Hansson, M.G, Balancing Lho qualiLy ol consonL, 1ournal oj Medical thics, and Hansson,
M.G, Conlining ollicioncy and concorns alouL inLogriLy in Lho uso ol hunan liolanls, lorLhconing.
13
GorL Holgosson (ch. }, a nov Svodish lav rogulaLing oLhical roviov ol rosoarch vill
inlluonco Lho raxis ol rosoarch oLhics conniLLoos (GovornnonL Bill 2002/0J:50}.
This lav is oxocLod Lo cono inLo ollocL as ol January 2004.

4. Partnership for the benefit of patients

In ordor Lo roaliso Lho oLonLial ol hunan liological naLorial and addiLional nodical
and orsonal inlornaLion inLo nov nodical roducLs and LroaLnonL oorLuniLios,
ullic and rivaLo arLnors nusL collaloraLo. IocLors and scionLisLs aL ullic
univorsiLios and hosiLals do noL havo Lho linancial noans or Lho conoLonco Lo
assuno rosonsililiLy lor Lurning lasic scionLilic lnovlodgo inLo nov nodical
roducLs and LroaLnonLs. IilloronL arLios in Lhoso collaloraLions nay havo dilloronL
inLorosLs LhaL nay noL lo oasily soLLlod in a connon vonLuro. Connorcial arLios
lilo harnacouLical and gononic conanios havo logiLinaLo connorcial inLorosLs.
ScionLisLs vanL Lo ullish Lhoir rosulLs oonly and Lho rino duLy ol docLors is Lo
Lhoir aLionLs. CollaloraLion viLh connorcial arLnors is noLhing nov Lo
univorsiLios, nor is iL uniquo Lo liolanl rosoarch. IL is sonoLhing LhaL has loon
sLinulaLod viLh Lho aid ol loLh local and naLional iniLiaLivos lor Lho Lranslor ol
lnovlodgo and Lochnology loLvoon univorsiLios and indusLry. \iLhin Lho conLoxL ol
liolanl rosoarch a nunlor ol iniLiaLivos havo loon Lalon ly harnacouLical and
diagnosLic conanios in ordor Lo soarch lor disoaso-associaLod gonos and rolaLod
LargoLs lor drug and narlor dovolononL. IirocL collaloraLion loLvoon indusLrial
lirns and acadonic scionLisLs has loon lroquonL loLh in dilloronL linds ol clinical
Lrials and in liolanl rosoarch. AnoLhor oLion lor acadonia is collaloraLion viLh
social gononic conanios as inLornodiarios. Jons Laago-Hollnan has sLudiod Lhroo
such connorcialisaLion vonLuros: doCodo GonoLics in Icoland, Cxagon in Lho IK
and InanGononics in Svodon (ch. 4}. Cno inorLanL conclusion lor conanios
inLorosLod in Lhis liold is LhaL a connorcialisaLion vonLuro is dilliculL Lo organiso" in
Lho ordinary sonso ol LhaL vord. Tho organisaLion and Lho rosulLing orlornanco
onorgo raLhor as a rosulL ol a conlox inLorlay anong nany acLors, oach ol vhich
nay havo dilloronL inLorosLs. Laago-Hollnan noLos as ono inlicaLion ol Lhis LhaL an
acLor`s aliliLy Lo inLoracL viLh oLhors and luild LrusLvorLhy rolaLionshis is crucial Lo
his ovn succoss as voll as lor Lho rogross ol Lho vholo vonLuro. A losson Lo lo
dravn lron Lho Svodish caso in Ino is LhaL all arLios concornod nusL lo includod
in a arLnorshi and agroononLs nusL lo nado loLh viLh Lho univorsiLios and viLh
Lho individual scionLisLs. This is also sLrossod ly Irlan Iaulsson and Rolocla Irisl
(ch. 1J}. Cxagon has solocLod a noro ronising aroach in Lhis rosocL, viLh a
sonso ol arLnorshi vhoro Lhoy can Lalo advanLago ol Lho conoLonco and Lho
rosourcos ossossod ly acadonic insLiLuLions in a largo noLvorl, vhilo sLill
nainLaining a connorcially ollicionL nodo. Thoro is noLhing Lo suggosL LhaL ullic
ovnorshi per se vould load Lo a loLLor and noro ollicionL uso ol liolanls. Tho
Ino caso il anyLhing illusLraLos Lho conLrary. \iLh rogard Lo oLhical and logal rulos,
Lho Biolanls AcL only rogulaLos liolanls soL u viLhin Lho rolossional acLiviLios ol
a hoalLh caro rovidor. Hovovor, Lho nov Svodish lav on oLhical roviov vill includo
all rosoarch viLh liological naLorial. IL is Lhoroloro roconnondod LhaL rivaLo
conanios alroady nov adjusL Lhoir raxis Lo Lho rovisions ol Lho Biolanls AcL.
14
5. Swedish law recognises both research interests and the interests of integrity

IlisaloLh Rynning aclnovlodgos in hor roorL on ullic lav asocLs (ch. 5} LhaL
loLh aLionLs and socioLy havo an inLorosL in guaranLooing rosoarchors and indusLry a
lavourallo clinaLo viLh roady accoss Lo rosoarch naLorial and noL Loo nany
cunlorsono rosLricLions. Ixcossivoly onorous roquirononLs nay rovonL Lho
dovolononL ol loLLor LroaLnonL noLhods lor luLuro aLionLs. Rynning also
undorlinos Lho inorLanL oinL LhaL Lho rosorvaLion ol ullic LrusL is oqually
inorLanL lor Lho dovolononL ol scionco and good hoalLh caro. IroLocLing Lho
inLogriLy ol Lho donors and gonoLically rolaLod individuals is doliniLoly in Lho long-
Lorn inLorosL ol loLh scionco and socioLy. Tho nood Lo lalanco rosoarch inLorosLs viLh
inLogriLy concorns is a conLral oinL in Lho Biolanls AcL as voll as oLhor logislaLion.
Rynning rovidos a doLailod accounL ol Lhoir rolovanco Lo hunan Lissuo sanling and
liolanl rosoarch. Sho and oLhors aro criLical ol Lho AcL lor loing conronisod ly
inconsisLoncios, gonoral olscuriLios and oLhor shorLconings, and Lho Biolanls AcL
vill noL lo Lho ond ol a rogulaLory rocoss rogarding Lho uso ol liolanls. Nov
logislaLion vill havo Lo lo inLroducod shorLly on Lho lanling ol sanlos lron
inconoLonL adulLs. Tho lacl ol rogulaLion is oLhically rollonaLic, sinco iL inlios
discrininaLion ol inconoLonL orsons in loLh hoalLh caro and rosoarch. Hovovor,
conarod viLh Lho hiLhorLo unrogulaLod racLico vhich has allovod roon lor
rivaLo soluLions and arliLrarinoss, vo aro nov on noro socuro ground and
ovonLually racLiLionors vill lind LhaL Lho nov lav is loLh ragnaLic and sullicionL
lor nooLing Lhoir noods ol lorosooaliliLy and socuriLy in logal rolaLions as voll as in
rosoarch vonLuros. Tho nov lav on oLhical roviov vill lurLhor rovo Lhis oinL.

6. The new legislation opens the way to pragmatic solutions and minimises the
risk of arbitrariness

Tho hoalLh caro rovidors aro assignod Lho Lasl ol aroving and rogisLoring all
liolanls soL u. IL should lo olsorvod LhaL, aarL lron gonoral roquirononLs ol
qualiLy, LracoaliliLy and rovisions rogarding sharing ol sanlos, Lho Biolanls AcL
doos noL say hov liolanls aro Lo lo goograhically organisod. This is an
adninisLraLivo quosLion rolaLod Lo racLical concorns and rosoarch inLorosLs. Cno and
Lho sano liolanl nay lo locaLod aL dilloronL laciliLios. Tho hoalLh caro rovidor is
lroo Lo docido LhaL anoLhor organisaLion, o.g. a rosoarch insLiLuLion or a rivaLo
conany, shall adninisLraLo Lho liolanl. Hovovor, Lho lornal rosonsililiLy lor
rogisLraLion sLill ronains viLh Lho hoalLh caro rovidor.
\hon Lho uroso ol osLallishing a liolanl is rosoarch or vhon sanlos
alroady collocLod and sLorod vill lo usod lor rosoarch urosos, Lho rosoarch oLhics
conniLLoo nusL arovo Lho sanling and Lho rosoarch rojocL. Hov dilloronL
inLorosLs rolaLod Lo Lhis rosoarch should lo lalancod and vhaL lind ol inlornaLion
and consonL rocoduros aro aroriaLo havo loon nuch dolaLod issuos. SLolan
Irilsson (ch. 8} rovidos an inLorosLing ovorviov ol Lho ullic dolaLo LhaL rocodod
Lho Svodish logislaLion on liolanling and a lroad rosonLaLion ol sLandoinLs and
argunonLs roosod in Lho inLornaLional scholarly dolaLo rolaLod Lo inlornod
consonL. IrivaLo oinions, acadonic osiLions rosonLod in scholarly journals and
olicy roosals lron various oLhical conniLLoos and lodios aro rosonLod. Ior a
doLailod accounL ol Lho dolaLos vo rolor Lo Irilsson`s chaLor. Ior a docLor, a
15
scionLisL, a nonlor ol Lho rosoarch oLhics conniLLoo or a layorson iL nay lo vory
dilliculL Lo soL Lhings righL on Lho lasis ol Lhis dolaLo. IL conos as no surriso il Lhoy
oxorionco a sonso ol arliLrarinoss in Lhoso oLhical advicos. Hovovor, ovon il Lho
Biolanls AcL doos noL inoso any sLaLuLory rosLricLions on Lho discroLion ol Lho
oLhics conniLLoos, rulings ly Lho conniLLoos Lhonsolvos vill noL lo arliLrary. As
Ilril von Isson doscrilos in his chaLor on logal guidolinos lor oLhical racLico (ch.
6}, undor Lho nov ILhical Roviov AcL (GovornnonL Bill 2002/0J:50} oxaninaLion
ly Lho nov Boards lor Rosoarch ILhics vill consLiLuLo a Lasl involving oxorciso ol
ullic auLhoriLy and rogulaLod ly sLaLuLo.
Cno gonoral and inorLanL guidolino is Lho 1996 Iurooan ConvonLion on
Bionodicino and Hunan RighLs. As sLaLod in Lho travaux preparatoires ol Lho ILhical
Roviov AcL, Lhis convonLion has loon a loacon Lo Lho logislaLors. ArLiclo 22 ol Lho
convonLion lays dovn LhaL: \hon in Lho courso ol an inLorvonLion any arL ol a
hunan lody is ronovod, iL nay lo sLorod and usod lor a uroso oLhor Lhan LhaL lor
vhich iL vas ronovod, only il Lhis is dono in conlorniLy viLh aroriaLo
inlornaLion and consonL rocoduros". Tho quosLion sLill ronains, ol courso, vhaL aro
appropriate inlornaLion and consonL rocoduros Sono guidanco is olLainallo lron
Lho oxlanaLory roorL Lo Lho ConvonLion, vhoro iL is oxlainod concorning ArLiclo
22 (connonL 1J}: Tho inlornaLion and consonL arrangononLs nay vary according
Lo Lho circunsLancos, Lhus alloving lor lloxililiLy sinco Lho oxross consonL ol an
individual Lo Lho uso ol arLs ol his lody is noL sysLonaLically noodod. Thus,
sonoLinos, iL vill noL lo ossillo, or vory dilliculL, Lo lind Lho orsons concornod
again in ordor Lo asl lor Lhoir consonL. In sono casos, iL vill lo sullicionL lor a
aLionL or his or hor rorosonLaLivo, vho havo loon duly inlornod (lor insLanco, ly
noans ol loalloLs handod Lo Lho orsons concornod aL Lho hosiLal}, noL Lo oxross
Lhoir oosiLion. In oLhor casos, doonding on Lho naLuro ol Lho uso Lo vhich Lho
ronovod arLs aro Lo lo uL, oxross and socilic consonL vill lo nocossary, in
arLicular vhoro sonsiLivo inlornaLion is collocLod alouL idonLiliallo individuals."
Tho locus in Lho oxlanaLory roorL Lo ArLiclo 22 is on risls ol danago and
Lho handling ol sonsiLivo inlornaLion. Ilril von Isson has doscrilod Lho ronisos on
vhich Lho oLhical roviov shall lo lasod, and Lho locus is sinilar Lo Lho oxlanaLory
roorL ol Lho ConvonLion. Tho conLral ruling ol Lho ILhical Roviov AcL is LhaL a
rosoarch rojocL nay lo arovod only il Lho risls onLailod ly iL Lo Lho rosoarch
suljocL`s hoalLh, socuriLy and orsonal inLogriLy aro counLorlalancod ly iLs scionLilic
valuo. Tho Board lor Rosoarch ILhics vill lirsL considor Lho rosoarch on Lho liological
naLorial and Lhon, soaraLoly, oxanino danago risls rolaLod Lo Lho handling ol
orsonal daLa. Rogarding rosoarch on Lho liological naLorial, a risl ol harn vill only
ariso in oxLronoly oxcoLional casos. Tho only lind ol harn is violaLion ol orsonal
inLogriLy, and sinco Lho sanlos vill as a rulo lo codod, Lhis risl is nininal.
Hovovor, as von Isson olsorvos, il Lho sanlos aro noL codod or il Lho codo nay lo
lrolon aL a laLor nononL, Lho Board lor Rosoarch ILhics vill also carry ouL an
oLhical roviov ol Lho rojocL including any rocossing ol sonsiLivo daLa. \hon
doLornining Lho risl, Lho loard vill assoss Lho socuriLy in Lho rocossing ol daLa and
Lhon aclnovlodgo LhaL il Lho rincial invosLigaLor is a ullic rorosonLaLivo, o.g. a
univorsiLy scionLisL, socrocy vill aly Lo orsonal inlornaLion alouL individuals. Tho
dogroo ol Lho risl ol violaLion ol orsonal inLogriLy nay Lhon lo considorod lov and
Lho counLorlalancing loLvoon risl ol inLogriLy violaLion and scionLilic valuo nay
nornally load Lo aroval ol Lho rosoarch rojocL.
16
7. A Swedish standard for information and consent procedures

Tho loy issuo in Lho oLhical roviov ol liolanl rosoarch concorns socuriLy in
connocLion viLh Lho rocossing ol daLa, and ullic conlidonco in liolanl rosoarch
nay Lo a signilicanL oxLonL doond on undorsLanding LhaL sonsiLivo inlornaLion vill
noL lo assod on Lo insuranco conanios, onloyors, Lho olico or oLhor ullic
auLhoriLios, or rivaLo conanios noL involvod in Lho rosoarch rojocL. InlornaLion
rogarding Lhis lind ol rosoarch should nalo cloar LhaL daLa vill only lo rocossod lor
rosoarch urosos. As sovoral auLhors in Lho roorL nonLion, rosoarch suljocLs havo a
osiLivo aLLiLudo Lo lionodical rosoarch and aro olLon alLruisLically noLivaLod Lo Lalo
arL in rosoarch lor Lho advancononL ol lnovlodgo. Lona Ring and Asa KoLLis
Lindllad doscrilo in doLail Lvo largo survoys, ono ol a rorosonLaLivo sanlo ol Lho
gonoral ullic conrising 6,000 individuals and ono ol a grou ol 2,000 dialoLos
aLionLs (ch. 9}. In Lhoir iloL sLudy Lhoy shovod LhaL 89 ' ol Lho rosondonLs
vould consonL Lo donaLo an oxLra llood sanlo lor rosoarch urosos and a najoriLy
ol Lho rosondonLs had a osiLivo aLLiLudo Lovards gonoLic nodical rosoarch. \iLh all
Lhis and Lho rovisions ol Lho ILhical Roviov AcL in nind, sono conclusions nay
also lo dravn rogarding aroriaLo inlornaLion and consonL rocoduros.
\iLhin Lho LradiLions ol clinical oLhics and rosoarch oLhics sinco Lho
Nuronlorg Lrials, risl-oxosuro is a conLral olononL jusLilying Lho rulos ol inlornod
consonL. Tho rosoarch suljocL has a righL noL Lo lo oxosod Lo risls ho has noL
accoLod. In clinical Lrials Lho invosLigaLor is olligod Lo chocl lor acLual and oLonLial
shorL- and long-Lorn risls Lo Lho rosoarch suljocL. AlLor having dono Lhis roorly
and Lhon oxlainod Lho uroso ol Lho rojocL and carolully inlornod Lho rosoarch
suljocL ol any ronaining risl, Lho invosLigaLor asls hin il ho is villing Lo assuno Lhis
risl and arLiciaLo in Lho rojocL. \hon Lho risls aro slighL, an inlornaLion and
consonL rocoduro lasod on an oL-ouL, or inlornod rolusal nodol nay lo
aroriaLo. \hon Lho risls aro groaL and Lino is liniLod Lhoro is a voll-osLallishod
raxis in clinical LroaLnonL ol rosuning consonL. Irosunod consonL is also usod lor
rosoarch roLocols viLh ninor risls involvod. Risl-oxosuro is a loy concorn ol Lho
oLhical roviov.
J

\iLh rogard Lo rosoarch using hunan liological naLorial, Lho only
signilicanL oLonLial risls aro Lhoso rolaLod Lo violaLion ol inLogriLy and Lho oLonLial
sroad ol orsonally sonsiLivo inlornaLion. Il Lhoso risls can lo conLrollod, dilloronL
vorsions ol oL-ouL nodols ol inlornod consonL nay lo sullicionL in nosL casos. GorL
Holgosson (ch. } has oxaninod and discussod Lho argunonLs rogarding inlornaLion
and consonL rocoduros. Ho suggosLs a Svodish sLandard lasod on Lho nov lavs viLh
gonoral inlornaLion availallo alouL liolanling and rosoarch using liolanls. Thoro
vill lo lour dilloronL consonL lorns: (i} consonL Lo sLoring liological sanlos lor
diagnosLic and LroaLnonL urosos (Lho docLor vorilios Lho consonL viLh a signaLuro},
(ii} consonL Lo sLoring sanlos lor luLuro clinical uso or lor naing urosos, o.g.
Lho Tolias rogisLry or sLoring ol ova and onlryos in connocLion viLh I\I-LroaLnonL,
(Lho donor signs Lho consonL lorn}, (iii} consonL Lo sLoring and using sanlos lor
socilic rosoarch urosos (Lho donor signs Lho consonL lorn} and (iv} consonL Lo
using oxisLing sanlos lor rosoarch vhoro Lhoro is no rovious consonL (Lho donor
signs Lho consonL lorn}. In all casos iL is suggosLod LhaL Lho donor nay consonL Lo
luLuro lionodical rosoarch viLh or viLhouL sociliod oxcoLions. Il sanlos Lalon as

J
Ilid.
17
arL ol rouLino caro includo a consonL Lo lionodical rosoarch Lho Board lor Rosoarch
ILhics vill nornally noL nood Lo asl lor ronovod consonL laLor on. Having rogard Lo
such socuriLy noasuros as sLaLod in Lho Svodish Socrocy AcL a lroad uroso such as
lionodical rosoarch" is suggosLod as an accoLallo rosulL ol counLorlalancing lov
risl-oxosuro againsL Lho scionLilic valuo ol Lho rosoarch.

8. The importance of agreements on disposition both over the biobanks and
biological material

In Lho conLoxL ol liolanls and oLhor organ and Lissuo LranslanLs vo soal ol
donors" and rociionLs". Tho acL ol loLLing a hosiLal Lalo sanlos or donaLing
Lissuo or organs is in iLsoll lasod on a osiLivo orsonal docision or assivo accoLanco
ly Lho involvod individual, or his or hor closo rolaLivos. Tho orson involvod has Lho
righL Lo docido ovor Lho lody or arLs Lhorool. This loads us Lo Lhinl in Lorns ol
ovnorshi and disosiLion righLs. Tho innodiaLo quosLion a lavyor Lhon osos is
vhoLhor conclusions lor Lhoso Lyos ol donaLions could lo dravn lron Lho
Lorninological sinilariLios and dilloroncos loLvoon Lho GilLs AcL, including oLhor
rivaLo lav rulos on gilLs, and Lho TranslanL Surgory AcL. Tho TranslanL Surgory
AcL dolinos Lho condiLions undor vhich organs nay lo ronovod lron Lho lody ol a
living or docoasod orson lor LranslanL or oLhor nodical urosos. Hovovor, Lho
AcL doos noL rogulaLo Lho logal rolaLionshi loLvoon Lho donor and Lho donoo. Tho
GilLs AcL rogulaLos Lho validiLy ol various Lyos ol gilLs in Lho rivaLo shoro, and
Annina H. Iorsson (ch. 11} locusos hor sLudy on vhoLhor such rivaLo lav rulos
could lo aliod in rogard ol such donaLions ol hunan liological naLorial LhaL aro
noL govornod ly Lho TranslanL Surgory AcL or oLhor ullic lav logislaLion. Is Lho
naling ol a gilL an acLivo giving and LhaL ol a donaLion a assivo giving, and vhaL aro
Lho sinilariLios and dilloronco loLvoon a donor ol a gilL in Lhis gonoral conLoxL and
sonoono vho donaLos hunan liological naLorial Tho nain conclusion roachod is
LhaL Lho GilLs AcL and oLhor gonoral civil lav rulos on gilLs, oLc. aro noL roally
suiLallo Lo lo aliod Lo Lho donaLion ol liological naLorial. NoLviLhsLanding LhaL
Lhoro aro corLain sinilariLios loLvoon Lho gonoral gilLs and donaLions ol liological
naLorial Lalon lron living orsons, Lho dilloroncos aro novorLholoss signilicanL, noL
loasL as rogards vho can lo Lho nalor ol a gilL. Nor aro Lho sinilariLios loLvoon a
donoo ol hunan liological naLorial and Lho rociionL ol a gonoral gilL arLicularly
sLriling. Tho conclusion ol Lhis in-doLh sLudy is Lhoroloro LhaL Lho GilLs AcL cannoL
lo aliod Lo oaquo logal quosLions rogarding Lho donaLion ol liological naLorial.
This loavos us viLh an unrogulaLod rolaLionshi loLvoon Lho donor and Lho donoo,
vhich nalos Lho logal locus on Lho inlornaLion and consonL rocoduros all Lho noro
inorLanL.
\hon iL conos Lo rolaLions loLvoon nodical conanios and holdors ol liological
naLorial, such as rosoarchors aL univorsiLios and Lho lilo, Lho Biolanls AcL has Lo a
corLain oxLonL clariliod Lho logal siLuaLion. Ior Lho orsocLivo ol connorcial uso ol
Lho liolanl naLorial, iL is oxocLod LhaL Lho nunlor ol collaloraLions loLvoon
conanios and acadonia in rosocL ol Lho liolanls vill incroaso. BuL in ordor lor
collaloraLion Lo lo succosslul and unconLosLod a nunlor ol rollons havo Lo lo
Lalon inLo accounL, nanoly: Lho rohiliLion undor Lho TranslanL Surgory AcL and
Lho Biolanls AcL ol doriving roliL lron handling donaLod hunan liological
18
naLorial, Lho rulos concorning oLhical aroval, Lho roquirononL ol aLionL consonL
and Lho ollocL ol viLhdraval ol consonL. Ixorionco on such issuos is Lo a groaL
oxLonL lacling, and guidolinos aro olviously noodod. So iL is osocially volcono LhaL
sono ol Lho nosL inorLanL, criLical logal issuos ol Lhis lind havo loon analysod ly
Irlan Iaulson and Rolocla Irisl (ch. 1J}. Thoir sLudy covors loLh racLical and
LhooroLical asocLs, including discussions ol and roosals lor Lho dralLing ol loy
clausos. Thoir conclusion is LhaL, in arLicular, such loy clausos doaling viLh righLs
ol uso and LiLlo Lo Langillo rosoarch rosulLs, and sLrucLuro ol aynonLs undor Lho
agroononL, nay nov lo dralLod viLh a highor dogroo ol logal corLainLy Lhan in Lho
asL. BuL iL nusL aL Lho sano Lino lo onhasisod LhaL Lho logislaLion inosos hoavy
roquirononLs on Lho rudonL and lnovlodgoallo nogoLiaLing and dralLing ol
connorcial agroononLs lor valid accoss Lo and rosoarch on hunan liological naLorial
sLorod in liolanls.
Also in rolaLion Lo quosLions ol ovnorshi ol and disosiLion ovor liolanls,
Lho dralLing ol agroononLs has rovod Lo lo viLally inorLanL. Cno sLriling oxanlo
is Lho alovo nonLionod caso ol Inan Gononics and Lho nogoLiaLions viLh Ino
InivorsiLy and Lho Ino CounLy Council. \ho ovns Lho liolanl is oLhorviso a
quosLion LhaL has so lar loon liLLlo discussod. Tho ansvor nay in nany casos lo
unoxocLod, and orhas noL vhaL Lho holdor ol Lho liolanl had largainod lor (Soo
Illa Bjrlnan`s sunnary in ch. 12}. A sLarLing oinL is LhaL Lho croaLion ol a
liolanl is a vorl ol Lho nind, and nany such vorls onjoy roLocLion undor
inLollocLual roorLy lav. In Lho inLollocLual roorLy conLoxL, liolanls aro rogardod
as roLocLallo conilaLions, i.o. daLalasos. Honco, Lho croaLor or nalor ol liolanls
nay lo roLocLod ly oxclusivo roorLy righLs in Lho lorn ol coyrighL or sui generis
roLocLion, rosocLivoly. Tho oxLonL and Lho racLical ollocLs ol such roLocLion ol
liolanls aro ol inorLanco Lo rorioLors and usors ol liolanls, rosoarchors,
aLionLs and oLhors, sinco Lho righLs holdor nay rovonL corLain acLs involving Lho
sanlos conLainod in Lho liolanl. Tho ovnorshi ol inLollocLual roorLy in
liolanls and rolaLod naLorials rosulLing lron scionLilic rosoarch is Lhoroloro ol
social inLorosL and has lornod Lho suljocL ol a social sLudy (ch. 10} ly Asa
HollsLadius, Richard \ossnan and Sanna \oll. NoL loasL Lho inLollocLual roorLy
righLs ol rosoarchors onloyod aL Svodish univorsiLios, govornod as Lhoy aro ly Lho
so-callod Toachor IxcoLion, roquiro social aLLonLion. IL is Lhoroloro roconnondod
LhaL Lho inLollocLual roorLy righLs lo roorly rogulaLod ly conLracLs in advanco,
jusL as rogulaLion is noodod concorning any oLhor righL Lo Lho naLorial (righL ol
disosiLion, uso oLc.} in a liolanl.

19
References

Hansson, M.G., (1998} Balancing Lho ualiLy ol ConsonL, 1ournal oj Medical thics, \ol. 24,
No J, Juno 1998, 182-18.

Hansson, M.G., (2002} Conlining ollicioncy and concorns alouL inLogriLy vhon using
hunan liolanls, sulniLLod Ioc. 2002

Hansson, M.G., (Id.}, (2001} The Use oj Human Liobanls. thical, Social, conomical and
Legal Aspects, RoorL 1, Isala InivorsiLy 2001, ISBN 91-506-142-X, 9J agos.

Regeringens proposition ?00?/0J.0 om lag om etilprvning av jorslning som avser mannislor
(2002} SLoclholn.

20
`~ ~~ ~ ~ ~ ~ ~

O

Clinical data a necessary requirement for
realising the potential of biobanks

_ p iI jaI maI ~

^~~ Er~~ r e~F

^~ ~ ~ ~ ~ ~
I ~ ~ ~ ~ ~K _~ ~~ ~ ~
~ ~ ~
~ ~ ~ K o~ ~ ~~ ~
~~ ~ ~ I ~ ~ ~~ ~ ~~
~ ~ ~ ~ ~K ^
~ ~ ~ J~ ~
~~ ~ K q ~ ~ ~ ~ ~
~ ~
~ ~K

1. Introduction

RighL on inLo Lho niddlo ol Lho 19Lh conLury Lho dogna ol hunoral aLhology lron
ancionL Linos sLaLod LhaL disoasos voro duo Lo an inlalanco loLvoon Lho lour lody
lluids: llood, yollov lilo, llacl lilo and nucus. Cno ol Lho loundors ol nodorn
nodicino, Lho Gornan hysician Rudoll \irchov
1
, conLosLod LhaL viov in a lanous
ullicaLion on collular aLhology ullishod in 1858.
\irchov sLaLod LhaL all disoasos sLarL in Lho colls, and Lhis sLaLononL has had
a rovoluLionary inlluonco on nodicino ovor sinco. \irchov, a aLhologisL, usod
sovoral sLaining Lochniquos vhich onallod hin Lo sLudy hunan Lissuos in hoalLh and
disoaso. IaLhologisLs voro Lho lirsL, ~~ ~ I Lo osLallish liolanls.
Iov discovorios havo had such a rovoluLionary inlluonco on ovoryday
nodicino as \irchov`s collular aLhology during Lho 19Lh conLury. Tho olucidaLion
ol Lho nolocular sLrucLuro ol INA
2
and Lho conloLo soquoncing ol Lho hunan
gonono aro Lvo ol Lho nosL inorLanL achiovononLs sinco Lhon. IilLy yoars alLor
\aLson and Cricl`s doscriLion ol Lho sLrucLuro ol INA, Lho hunan gonono vas
docodod. Tho gonoLic laclground ol disoasos has consoquonLly loon in locus during
Lho lasL docados, and Lho inorLanco ol liolanls has grovn corrosondingly.

1
\irchov, R. 1858.
2
\aLson, J., Cricl, I. 195J
21
_ p i
2. Biobanks in clinical praxis

Biolanls ol rolovanco Lo aLionLs nay lo caLogorisod as dorivod lron llood and lron
oLhor Lissuos.

2.1 Blood
Sinco 1901, vhon Karl LandsLoinor lirsL roorLod on Lho ABC llood grous,
J
sovoral
hundrod llood grous havo loon doscrilod and Lho anLigons involvod characLorisod.
CLhor llood conononLs such as loucocyLos and laLoloLs, as voll as various lracLions
ol lasna, havo also loon soaraLod and sLorod in llood lanls. IrosorvaLion
Lochniquos nalo iL ossillo Lo sLoro llood roducLs lor a long Lino. Suly ol salo
llood roducLs is a roroquisiLo lor nosL surgical rocoduros Loday. Ior salo
Lranslusion, Lho llood grous nusL lo accuraLoly caLogorisod. In raro casos, only a
lov ossillo donors in Lho vorld aro lnovn, luL Lhanls Lo an inLornaLional co-
ooraLion, Lhoir llood can lo LransorLod and givon Lo Lho rociionL anyvhoro.
Blood roducLs can also lo usod lor oLhor urosos Lhan surgory. Loulaonia
(lirsL doscrilod ly \irchov in 1845} and sono Lunours sonoLinos call lor lono
narrov LranslanLs. Tho Tolias RogisLry, Lho naLional rogisLry ol volunLary lono
narrov donors in Svodon, vas launchod in 1992. This is ono ol nany vorldvido
and Lhoro aro noro Lhan sovon nillion Lissuo-Lyod/HLA-Lyod oLonLial donors in
Lhoso rogisLors. So lar, around J00 nonlors ol Lho Tolias RogisLry havo donaLod
lono narrov conLaining haonaLological sLon colls.
Long-Lorn rosorvaLion(>15 yoars} ol sLon colls in llood dravn lron Lho
unlilical cord aL lirLh is a nov lorn ol liolanls. Such llood can lo saloly usod ly
Lho donor nuch laLor in lilo. Nino rivaLo lanls dovoLod Lo Lho sLorago ol unlilical
llood havo loon loundod Loday.
Analysos ol anLi-nucloar anLilodios in sorun aro usod in Lho diagnosis ol
rhounaLic disoasos and anLi-nouLrohil cyLolasnaLic anLilodios in vascular injurios,
including glonorulonohriLis and vaculiLis. CLhor narlors aro ol valuo, o.g. in Lho
diagnosis ol cardio-vascular and gasLro-inLosLinal disoasos, and in ondocrinoaLhios.
Sanlos nusL Lhon lo sLorod lor ro-oxaninaLion lor conarison in ordor Lo ascorLain
Lho ollocL ol LroaLnonL and Lo diagnoso rolasos ol Lho disoaso. Sanlos nay also lo
usod Lo doLocL nov sorun lacLors ossilly associaLod viLh Lho disoaso.
A osiLivo anLilody LiLro nay indicaLo asL or curronL viral inlocLion. Sora
dravn viLhin Lho lirsL Lvo vools alLor onsoL aro varially nogaLivo lor IgG anLilodios
and should noL lo usod Lo oxcludo an inlocLion. Tho losL ovidonco lor inlocLion is a
signilicanL chango in LiLros on Lvo aroriaLoly Linod socinons, vhoro loLh LosLs
aro dono in Lho sano laloraLory aL Lho sano Lino. In rognancy iL is inorLanL Lo
oxcludo an inlocLion aL corLain gosLaLional vools vhoro Lho risl ol looLal
nallornaLions is high. IL is Lhon arLicularly inorLanL Lo havo sLorod sora in ordor
Lo orlorn Lho analysis on airod sanlos.

2. 2 Other tissues
In nany disoasos an oxacL diagnosis is nocossary loloro LroaLnonL sLarLs. Biosios aro
oxaninod viLh Lochniquos vhich havo ovolvod onornously sinco \irchov`s Lino. AL
doarLnonLs ol aLhology all ovor Lho vorld, nillions ol Lissuo sanlos aro sLorod

J
LandsLoinor, K. 1901

22
`~ ~~ ~ ~ ~ ~ ~
alLor Lho diagnosLic rocoduros aro conloLod. This sLorago is nocossary nainly lor
Lho saloLy ol Lho aLionL: a diagnosis nay lo quosLionod and a nov analysis ol Lho
original sanlo nay lo orlornod, orhas viLh a nov Lochniquo or ly anoLhor
aLhologisL. Nov disoaso onLiLios nay also lo doLocLod in sLorod sanlos.
A aLionL vho has loon LroaLod lor a Lunour nay dovolo a nov ono. IL is
Lhon inorLanL Lo osLallish il Lho original Lunour has rocurrod or il Lhoro is a nov
disoaso. This disLincLion nay lo ol viLal inorLanco lor Lho aLionL. Tho socinons
nusL Lhon lo sLorod lor a vory long Lino.
\iLh nodorn Lochniquos INA sanlos can lo roarod lron hisLological
naLorial, a ossililiLy LhaL can lurLhor incroaso Lho valuo ol Lho socinon.

3. Basic science and translational research

3.1 Genomic and proteomic studies in the diagnostics of diseases
Many disoasos havo loon shovn Lo havo gonoLic causos, Lhough Lhoso doondonL on
a singlo gono aro lov in nunlor and concorn a rolaLivoly snall nunlor ol aLionLs.
\hon Lho gonoLyos ol aLionLs viLh a arLicular disoaso aro analysod, sovoral
sulLyos ol Lho disoaso nay ovolvo. This inhonogonoiLy ol Lho aLionL naLorial
nighL lo ono oxlanaLion lor Lho succoss or lacl ol succoss ol LroaLnonL in sono
casos. GonoLical and onvironnonLal lacLors lroquonLly inLoracL. Conlox changos
viLhin Lho gononic onvironnonL as voll as Lho oxLornal onvironnonL lay a rolo. Ior
disoasos viLh laLo onsoL, ovon randon liological changos nay lo ol inorLanco. IL
vill lo inorLanL in Lho luLuro Lo rovolo gono oxrossion, in ordor Lo lind vhich
gonos aro Lurnod on in dilloronL hoalLh and disoaso siLuaLions. Sinlo rovocaLion
could includo dioL, drugs and/or oxorciso. Tho rosonso could oasily lo doLorninod
ly INA nicroarray-lasod Lochniquos, vhich allov Lhousands ol gonos Lo lo
doLocLod aL onco on a singlo nicroarray.
Gononic sLudios during Lho lasL lov yoars havo givon riso Lo a dolugo ol
inlornaLion vhich havo nocossiLaLod Lho carolul sLorago, organisaLion and indoxing
ol soquonco inlornaLion. InlornaLion scionco as aliod Lo liology (lioinlornaLics
and conuLaLional liology} involvos Lho lolloving:
Iinding Lho gonos in Lho INA soquoncos.

Iovoloing noLhods Lo rodicL Lho sLrucLuro and luncLion ol Lho oncodod
roLoins (roLoonics}.
ClusLoring roLoin soquoncos inLo lanilios ol rolaLod soquoncos and Lho
dovolononL ol roLoin nodols.

3.2 Translational research
TranslaLional rosoarch can lo dolinod as alying lnovlodgo gainod lron lasic
scionco Lo clinically rolovanL rollons. AlLhough roconL yoars havo soon an oxlosion
ol lundanonLal insighLs inLo Lho nochanisns ol disoaso, Lranslor ol Lhis lnovlodgo
inLo racLical advancos in hoalLh caro has novod noro slovly. TranslaLion also
noans Lho convoyanco ol clinical insighLs inLo hyoLhosos vhich can lo validaLod in
Lho laloraLory. Gononic sLudios nay clarily nunorous nov roLoin sLrucLuros, luL
Lho luncLion ol Lhoso roLoins lor disoaso dovolononL has Lo lo conlirnod and
osLallishod ly sLudios on aLionLs. Roliallo clinical daLa aro Lhus a nocossary
roquirononL lor roalising Lho oLonLial ol Lho liolanls.

23
_ p i
3.3 Clinical trials
A clinical Lrial is a rosoarch sLudy Lo lind loLLor vays ol rovonLing and LroaLing
disoasos. Clinical Lrials aro usually classiliod in ono ol Lhroo hasos. Ihaso I ovaluaLos
a nov Lhoray lor saloLy, vhon lound salo, Ihaso II Lrials doLornino il Lho Lhoray is
ollocLivo and vhaL dosos Lo uso, and Ihaso III conaros Lho Lhoray Lo curronL,
sLandard Lhoray, or il ossillo Lo lacolo. In all Lhoso hasos, Lho aLionL and Lho
docLor havo inorLanL luncLions.

4. What kind of clinical information is needed?

Tho clinician has an inorLanL rolo in naling Lho liolanls roliallo as sourcos ol
inlornaLion. \haL is noodod is inlornaLion alouL Lho aLionL`s origin, Lhoir liliaLion,
as voll as nodical, clinical and liological daLa. GonoLic oidoniology noods largo
cohorLs ol hundrods or Lhousands ol aLionLs, luL sLudios on voll dolinod aLionL
grous nighL lo noro cosL-ollicionL. ThaL roquiros Lho aLionLs Lo lo voll
characLorisod loLh aL Lho nolocular lovol and viLh rogard Lo lanily hisLory and lilo-
sLylo lacLors.
Tho aLionLs do noL rosonL Lhonsolvos viLh Lho sano high rocision as
Lhoir gonos nay lo soquoncod. Cn Lho conLrary, Lhoy aoar as a hugo grou ol
individuals viLh varying conlainLs, inlluoncod ly Lhoir gonoLic horiLago and social
and onvironnonLal laclground lacLors. Tho Lasl ol Lho clinician is Lo lind Lho noodlo
in Lho haysLacl, Lho ono LhaL disLinguishos ono arLicular aLionL in a hoLorogonoous
grou. This roquiros Lho lolloving:

4.1 Case history
All nodical sLudonLs aro Lrainod Lo Lalo a carolul anannosis, luL nany docLors undor
Lino sLross novadays only asl quosLions vhich soon Lo lo rolovanL Lo aLionLs`
rosonL conlainLs. Hovovor, inlornaLion LhaL soons irrolovanL lor Lho nononL
nay lo ol valuo laLor, orhas nany yoars laLor vhon nov gonoLic inlornaLion is
availallo. \hon sLoring liological naLorial lron a aLionL, arLicular caro vill lo
noodod in Laling Lho anannosis. Thoro aro corLainly nany lacLors, Lho inorLanco ol
vhich is unlnovn aL rosonL, luL Lho lolloving nusL lo aid aLLonLion Lo:

Ianily hisLory as sLrossod oLhorviso in Lho chaLor.
Irovious disoasos, o. g. hoaLiLis B and C and oLhor inlocLions.
IioL lays an inorLanL rolo in nany disordors
4
, cancor and cardiovascular
disoasos in arLicular. AlouL hall ol all cancor doaLhs aro duo Lo lour rincial
siLos: lung, lovol, lroasL and rosLaLo. Thoso cancors aro virLually alsonL in nany
dovoloing counLrios luL incroaso in incidonco vhon nigranLs novo lron lov Lo
high risl aroas. A consisLonL linding in nosL sLudios is LhaL vogoLallos and lruiL as
voll as a lood rich in non-sLarch olysaccharidos such as lilros roduco Lho risl ol
Lho nosL connon cancors. Thoro is also anlo ovidonco LhaL Lho sano lacLors
roduco Lho risl ol cardio-vascular disoasos. Sinilarly Lhoro is consisLoncy lor
incroasod risl viLh high consunLion ol laL and noaL, arLicularly vhon
larlocuod or oLhorviso lurnL or lriod.
Snoling is Lho singlo lilosLylo lacLor LhaL has Lho groaLosL nogaLivo inlluonco on
hoalLh.

4
Cunnings, J.H., Binghan, S.A. 1998.
24
`~ ~~ ~ ~ ~ ~ ~
Alcohol consunLion is also an inorLanL hoalLh lacLor, luL as viLh nany
lilosLylo lacLors, iL is dilliculL Lo olLain a Lruo osLinaLo ol Lho roal inLalo. Social
inLorviov Lochniquos aro noodod in ordor Lo nalo Lho aLionL ovorcono his
looling ol shano.

An idoal lody voighL is inorLanL lor voll-loing. CvorvoighL incroasos Lho risl
ol ronaLuro doaLh duo Lo loLh cancor and cardio-vascular disoasos and an
incroasod lody nass indox (BMI} is a risl lacLor corrolaLod Lo nany oLhor
disoasos as voll. BMI is Lho voighL in lilograns dividod ly hoighL in noLors
squarod (lg/n
2
}. Idoally Lho BMI should lo loLvoon 19 and 25. IndorvoighL
incroasos Lho risl ol corLain disoasos o.g. osLooorosis. CvorvoighL is dolinod as a
BMI loLvoon 25 and 29,9 and olosiLy alovo J0 lg/n
2
.
Ihysical acLiviLy docroasos Lho risl ol loLh cardio-vascular disoasos and cancor.
Irug inLalo (including lirLh conLrol ills}. Advorso drug roacLions aro an
inorLanL causo ol adniLLanco Lo hosiLals and Lo doaLh in nany counLrios. Sono
roacLions nay locono nanilosL nonLhs or yoars alLor oxosuro. IarLicular
vigilanco is roquirod Lo idonLily advorso roacLions in Lho oldorly. Thoy nay
noLaloliso nodicinos loss ollicionLly and lo noro sonsiLivo Lo Lhoir ollocL. Also
Lhoy olLon Lalo a nunlor ol nodicinos, and aro Lhoroloro lilolior Lo oncounLor
drug inLoracLions. Childron aro anoLhor grou LhaL roquiros social aLLonLion.
Many drugs rouLinoly usod aro noL liconsod lor uso in childron. An accuraLo drug
inLalo hisLory is nocossary lor naling lull uso ol Lho harnaco-gonoLic
Lochniquos in Lho liolanls.
Horlal ronodios. AlLhough sono horlal nodicinos aro liconsod lor uso, Lhoro aro
nany horlal ronodios on gonoral salo. Sono ol Lhon inLoracL viLh drugs or causo
danago Lo Lho livor and oLhor organs. In nany counLrios, a sulsLanLial nunlor ol
oolo uso horlal ronodios luL do noL Loll Lhoir hysicians unloss oxliciLly
aslod. IL is inorLanL LhaL Lho uso ol horlal ronodios and all susocLod advorso
roacLions Lo Lhon lo roorLod so LhaL Lhoir saloLy can lo noniLorod.

4.2 Laboratory investigations
In ordinary laloraLory raxis, roloronco valuos aro givon viLh 95' conlidonco liniLs.
Accordingly, 5' ol Lho oulaLion lall ouLsido Lhis arliLrary liniL and aro ly
doliniLion considorod oxLrono casos. This grou nay concoal aLionLs viLh sono
lorn ol inorLanL gonoLic doviaLion. Thoir rosulLs should Lhoroloro noL lo disnissod
as duo noroly Lo randon variaLion, luL lo scruLinisod ly conlining clinical daLa
viLh lioinlornaLion.

4.3 Uniform terminology
\iLhouL a unilorn Lorninology ol synLons, signs and diagnosos, ovon Lho nosL
scruulous anannosis is ol liniLod valuo. Tho nodical rolossion has an olligaLion Lo
Lry Lo agroo on connon doliniLions lor nosL ol Lho Lorns usod in clinical raxis.

4.4 Computerised medical records
In nosL laloraLorios Loday conuLors aro usod vhon roorLing Lho rosulLs ol
chonical, lacLoriological, viral and oLhor analysos. In ordor Lo nalo clinical daLa
availallo, olocLronic inlornaLion nusL lo usod in clinical vorl, nuch in Lho sano
vay as iL is usod in lioinlornaLics. I Lill nov, nosL nodical rocords havo loon
sLorod in aor lorn. ConsoquonLly Lhoy havo noL loon availallo lor largo-scalo
inlornaLion soarchos. ConuLorisod nodical rocords nalo iL ossillo Lo soarch ly
25
_ p i
socilic Lorns or oxrossions, vhich alvays should havo Lho sano noaning in all
rocords. Svodon has noro Lhan 20 dilloronL daLa sysLons in uso. Thoy nusL lo nado
conaLillo Lo connunicaLo viLh oach oLhor. Thoso aro dilliculL goals Lo achiovo luL
aro alsoluLoly ossonLial il Lho lull oLonLial ol Lho liolanls is Lo lo roalisod.
\hon nov nuLaLions or nov liochonical narlors aro lound, Lhis
inlornaLion can lo cross-naLchod viLh Lho inlornaLion lron rovious aLionLs` caso
hisLorios and laloraLory lindings in Lho nodical rocords. In Lhis vay, luLuro aLionLs
vill lonoliL lron nov discovorios.

5. Examples of diseases and the need for clinical and related data

Many disoasos nay lo hoLorogonoous, ovon il vo aro unavaro ol iL aL Lho nononL.
Tho oLonLial ol all nov Lochniquos as aliod Lo sanlos in Lho liolanls is LhaL Lho
diagnosLics vill lo rolinod vhich vill load Lo a noro causal Lhoray. I vill Lurn nov
Lo discuss sono disoasos in noro doLail and sLross Lho daLa LhaL is noodod in ordor Lo
characLoriso Lho grous.

5.1 Breast cancer
BroasL cancor is considorod Lo lo a nulLilacLorial disordor causod ly loLh gonoLic and
non-gonoLic lacLors. Tho risl ol an individual dovoloing lroasL cancor nay lo
osLinaLod lron hor lanily hisLory. Tho lolloving asocLs nay lo usod Lo idonLily
avorago-risl, nodoraLo-risl and high-risl individuals:

Nunlor ol rolaLivos allocLod.

RaLio ol allocLod and unallocLod rolaLivos.
Biological alliniLy ol rolaLivos allocLod.
Agos aL cancor diagnosos.
Irosonco ol lilaLoral/nulLilocal lroasL cancor.
Irosonco ol ovarian cancor.
Nunlor ol childron (rognancios}.
Iso ol lirLh conLrol ills.

Individuals viLh a high risl ol dovoloing lroasL cancor nay vish Lo havo a gonoLic
LosL orlornod. IL is Lho rosonsililiLy ol Lho clinician Lo rovido inlornaLion loloro
Lho LosL. Tho inorLanco ol roviding inlornaLion and olLaining consonL rior Lo
orlorning LosLs lor cancor-rodisosing gono nuLaLions has loon onhasisod ly
sovoral oxorL grous.

5.2 Cardiovascular disorders
Cardiovascular disoasos aro a rosulL ol lilosLylo lacLors such as dioL, snoling haliLs,
alcohol aluso, sLross and lacl ol oxorciso, luL gonoLic lacLors also lay a rolo. IL is
ossillo Lo osLinaLo Lho risl lilolihood ly olsorving Lho ouLconos in oLhor lanily
nonlors, LhaL is Lho oniric risl. Il sovoral nonlors ol a lanily havo cardiovascular
disoasos, Lho rolaliliLy incroasos LhaL Lhoro is a gonoLic conononL. Tho ossililiLy
ol oLhor lanily nonlors having an incroasod risl doonds on:
Tho Lyo ol hoarL rollon.
Tho nunlor ol allocLod lanily nonlors.
Tho closonoss ol Lho rolaLionshi.
26
`~ ~~ ~ ~ ~ ~ ~

AL vhaL ago Lho hoarL rollons lirsL occurrod (in Lho individual and his or hor
rolaLivos}.
Tho rosonco ol oLhor hoalLh rollons.

5.3 Metabolic disorders
MoLalolic disordors havo a groaL inacL on Lho risl ol cardio-vascular disoasos.
IroninonL anong Lhoso aro dialoLos and olosiLy.

5.3.1 Diabetes

5.3.1.1 Diabetes type I (juvenile onset diabetes)
Tho lolloving lacLors should lo considorod:
Ianily hisLory. In dialoLos Lyo I, Lho inhoriLanco lacLor is rolaLivoly snall,
alLhough a lanily hisLory ol dialoLos incroasos Lho risl ol dovoloing Lho disoaso,
luL no singlo gono has loon conlirnod Lo lo Lho nain causo.
Irovious inlocLions. Tyo I dialoLos olLon aoars alLor a virus inlocLion.
Irugs. Sono drugs aro LhoughL Lo causo dialoLos, such as onLanidino, usod Lo
LroaL nounonia and L-asaraginaso, usod lor LroaLnonL ol cancor.
IioL. IL has loon soculaLod LhaL looding inlanLs viLh cov`s nill nay incroaso
Lho risl ol dovoloing Lyo I dialoLos, vhich is an auLo-innuno disoaso. Tho
inlanL`s innuno sysLon nay roduco anLilodios againsL Lho cov`s roLoin. Iuo
Lo sinilariLios loLvoon Lhis and Lho roLoin on Lho surlaco ol Lho ancroaLic loLa
colls, Lhoso anLilodios nay dosLroy Lho loLa colls, causing dialoLos.

5.3.1.2 Diabetes type II
IialoLos Lyo II is a gonoLically conlox disoaso involving nulLilo gonos and
nulLilo gono-onvironnonL inLoracLions. In Lho caso hisLory, Lho lolloving lacLors
should lo aid aLLonLion Lo:
Ianily hisLory ol dialoLos.
ClosiLy, vhich is ly lar Lho nosL inorLanL causo ol Lyo II. ClosiLy is LhoughL
Lo incroaso Lho insulin rosisLanco. Ioolo carrying Lhoir laL alovo Lho hi (alo-
shao} viLh a vaisL-hi raLio alovo 0.9 havo a groaLor risl Lhan oar-shaod
oolo viLh a vaisL-hi raLio lolov 0..
IioLs high in laL can load Lo dialoLos, luL oxcoss calorios in any lorn aro sLorod as
laL, vhich incroasos Lho risl ol dialoLos.
Ago groaLor LhaL 45 yoars incroasos Lho risl, luL Lhoro is nov a raid incroaso in
Lho juvonilo grou duo Lo olosiLy and a dioL ol roducLs viLh high glycaonic
indox.
ILhnic grous. Sono oLhnic grous, such as aloriginals, naLivo Anoricans,
Alrican- and Hisanic Anoricans havo an incroasod incidonco ol dialoLos Lyo II
in associaLion viLh olosiLy.
High llood rossuro.
IialoLos during rognancy or a laly voighing noro Lhan 4 lg.

5.3.2 Obesity
ClosiLy is incroasing raidly in nany counLrios and inlios an incroasod risl ol
conlicaLing disoasos and ronaLuro doaLh. Tho \HC
5
has roconLly assossod Lho

5
\HC \orld hoalLh roorLs 2002.
27
_ p i
glolal lurdon ol disoaso lron 22 hoalLh risl lacLors. A sodonLary lilosLylo is ono ol
Lho Lon loading causos ol doaLh and disaliliLy in Lho vorld and also a loading causo ol
olosiLy. Ihysical inacLiviLy is olLon conlinod viLh a high consunLion ol laL, Lho
oloso individuals oaLing noro Lhan Lhoy nood. Tho nain causo ol Lhis ovoroaLing is
Lho inLalo ol raidly alsorlod carlohydraLos, vhich loads Lo a oal in insulin
roducLion, vhich in Lurn raidly nalos Lho individual lool hungry again duo Lo lov
llood sugar lovols. This is a glolal rollon and \HC has dolinod olosiLy as a
vorldvido oidonic.
Thoro aro sovoral oLhor roasons lor olosiLy, including gonoLic, sychological,
culLural, noLalolic and onvironnonLal lacLors. Il sono onvironnonLal variallos
nanilosL Lhonsolvos only in corLain gonoLyos, ollorLs Lo rovonL olosiLy aL a ullic
hoalLh lovol can lo locusod on rocogniLion and counsolling ol suscoLillo individuals.
In addiLion, arociaLing Lho inorLanco ol gonoLic variaLion as an undorlying causo
hols Lo disol Lho noLion LhaL olosiLy rorosonLs an individual dolocL in lohaviour
viLh no liological lasis aL all, and rovidos a sLarLing oinL lor ollorLs Lo idonLily Lho
gonos involvod
6
. \hy aro inLorvonLions lasod on dioL and oxorciso noro ollocLivo lor
sono oolo Lhan oLhors \haL aro Lho liological dilloroncos loLvoon Lhoso high
and lov rosondors Hov do vo uso Lhoso insighLs Lo Lailor inLorvonLions Lo socilic
noods InLorvonLions LhaL rovonL olosiLy aro inorLanL and hysicians havo an
olligaLion Lo vorl in a vory sysLonaLic vay in ordor Lo dolivor voll-caLogorisod
naLorial Lo liolanls dovoLod Lo sLudios ol Lhis inorLanL hoalLh rollon.

5.4 Prostate cancer
IrosLaLo cancor is Lho socond nosL connon cancor in nany counLrios.
Iidoniological sLudios indicaLo LhaL doninanLly inhoriLod suscoLililiLy gonos viLh
high onoLranco causo 5-10 ' ol all rosLaLo cancor, and as nuch as 40' ol oarly
onsoL disoaso. Irolally onvironnonLal lacLors lay an inorLanL rolo. Tho risl ol
rosLaLo cancor is sLrongly allocLod ly Lho lanily hisLory such as:

Tho nunlor ol rolaLivos allocLod.
RaLio ol allocLod and unallocLod rolaLivos.
Biological alliniLy ol rolaLivos allocLod.
Ago aL cancor diagnosos.

A groaLor nunlor ol lanily nonlors allocLod and oarly onsoL anong lanily
nonlors aro Lho nosL signilicanL rodicLors ol risl ol rosLaLo cancor. CurronL
ovidonco doos noL jusLily scrooning asynLonaLic non lor rosLaLo cancor, luL non
viLh a sLrong lanily hisLory nusL lo inlornod ly Lhoir hysicians ol Lho lonoliLs and
risls ol oarly doLocLion and LroaLnonL. A noLhodological aroach is noodod in
Laling Lho lanily hisLory as voll as in Lho diagnosLic rocoduros. Clinical daLa and
Lho rosulLs lron gonoLic sLudios givo Lho oLonLial lor dirocLod rosoarch inLo Lho
causos ol rosLaLo cancor and lor rolinononLs in Lho curronL scrooning racLicos Lo
doLocL Lhis connon disoaso. IrosLaLo cancor highlighLs nany ol Lho oLhical,
onoLional and ragnaLic conLrovorsios in nodicino concorning scrooning. IL is
inorLanL Lo rononlor LhaL nosL non dio viLh Lhoir cancor, noL locauso ol Lho
cancor.

6
Barash, G.S., Iarooqi, S., CRahilly, S. 2000.
28
`~ ~~ ~ ~ ~ ~ ~
5.5 Inflammatory disorders
Many inllannaLory disoasos such as Lho sondyloarLhroaLhios (anlylosing
sondyliLis, RoiLor syndrono, roacLivo arLhriLis, soriaLic arLhriLis, and
sondyloarLhroaLhios associaLod viLh inllannaLory lovol disoaso} aro linlod Lo Lho
HLA-gono. Thoso disoasos insLanco Lho lacL LhaL Lho oxrossion ol Lho gonoLic LraiL is
nodiliod ly onvironnonL. Thoy aro noro vidosroad anong oolo in counLrios
vhoro rod noaL is connonly oaLon (o.g. Iuroo and ISA}, luL aro vory raro in
Lhoso arLs ol Lho vorld (o.g. Asia} vhoro vholograin, lruiLs and vogoLallos nalo u
nosL ol Lho dioL and dairy roducLs aro raroly oaLon. \hon oolo onigraLo lron
Asia Lo vosLorn counLrios and adaL a vosLornisod dioL, arLhriLis loconos connon
anong Lhon.

5.6 Mental disorders

5.6.1 Mental retardation
IaLionLs viLh nonLal roLardaLion lolong Lo a vory hoLorogonoous grou and Lho
najoriLy ol Lhon do noL havo a sociliod diagnosis. IL is Lhon arLicularly inorLanL
Lo uso liolanls Lo rolino Lho diagnosLic noLhods in ordor Lo lind a causal Lhoray in
nany noro casos Lhan aL rosonL. A carolul anannosis and a clinical and laloraLory
invosLigaLion nay disLinguish a arLicular grou viLhin Lho largo grou. An
illusLraLivo oxanlo ol Lhis is aLionLs viLh Salla disoaso, a lysosonal sLorago
disordor
. Salla disoaso is nanod alLor Lho aroa in Iinland lron vhich Lho lirsL
aLionLs originaLod. Thoy voro doLocLod Lhanls Lo carolul clinical invosLigaLions.
\iLhin Lho lirsL Lvo yoars ol lilo Lho aLionLs rosonL viLh sychonoLor roLardaLion,
aLaxia and hyoLonia. MosL aLionLs survivo Lo adulLhood, luL viLh sovoro nonLal
roLardaLion.

5.6.2 Dementia
Moro Lhan 50 disoasos aro lnovn Lo lo associaLod viLh dononLia, Alzhoinor`s
disoaso loing Lho losL lnovn ol Lhon. Sinco Lho discovory ol Lho anyloid rocursor
roLoin in 1991
8
, our undorsLanding ol Lho disoaso rocoss has incroasod
onornously. Sinilar rogross has occurrod in oLhor Lyos ol dononLia, naling iL
ossillo Lo Lailor Lhoraios il only Lho clinical daLa aro good onough Lo solocL Lho
righL individuals (aLionLs and concornod rolaLivos} lor gonoLic LosLing and
sulsoquonL oarly LroaLnonL. AL rosonL, Loo nany aLionLs viLh dononLia do noL
havo a sociliod diagnosis.

5.6.3 Psychiatric disorders and alcohol abuse
GonoLics is a raidly oxanding aroa ol sychiaLric rosoarch. IndorsLanding Lho
nolocular nouroliology ol sychiaLric disordors nay load Lo Lho dovolononL ol
noro socilic drugs. In nany sychiaLric disordors and in alcohol aluso, gonoLic
lacLors aro susocLod, luL so lar, a dirocL gonoLic linl has noL loon idonLiliod. In
Lhoso disordors, iL is arLicularly inorLanL Lo havo groaL rosocL lor Lho inLogriLy ol
Lho aLionLs.

Aula, I., AuLion, S., Raivio, K.C., Raola, J., Thodon, C.J., Koslola, S.L., Yanashina, I. 199.
8
GoaLo, A., CharLior-Harlin, M.C., Mullan, M., Brovn, J., Cravlord, I., Iidani, I., Giullra, L.,
Iorical-\anco Haynos, A., Irving, N., Janos, L., ManL, R., NovLon, I., Roolo, K., Roquos, I., TalloL
C.M., Rosos, A,, \illianson, R., Rossor, M., Cvon, M., Hardy, J. 1991.
29
_ p i

6. Pharmaco-genetics

Clinical Lrials Lry Lo noniLor lor oLonLial advorso roacLions during Lho dovolononL
ol a drug, luL iL is inoviLallo LhaL Lhoir liniLod sizo vill noL caLch all oLonLial
aLionL-drug inLoracLions.
Tho ollocLs ol drugs vary vidoly anong aLionLs. IL is dilliculL Lo doLornino
vhoLhor a drug has a lonolicial ollocL and is salo lor a socilic orson. Cno ol Lho
lirsL sLudios vhoro gonoLics voro usod in drug dovolononL vas ullishod in 199
9
.
A drug vas LosLod againsL Alzhoinor`s disoaso. Tho auLhors sLudiod 108 suljocLs and
lound LhaL Lho drug had no ollocL. Thon Lhoy suldividod Lho aLionLs inLo Lvo
grous, ono ol vhich had a varianL ol a corLain gono vhilo Lho oLhor did noL. Tho
analysis Lhon shovod LhaL Lho lonolicial ollocL ol Lho LroaLnonL vas conlinod Lo Lho
grou viLh Lho varianL gono. GonoLic LosLing is suosod Lo havo a groaL oLonLial lor
Lailoring drugs in Lho luLuro. InsLoad ol Lho Lrial-and-orror nodicino ol Loday, docLors
vill lo allo Lo analyso an individual`s gonoLic rolilo and roscrilo Lho losL availallo
Lhoray lron Lho loginning aL a doso lasod on Lho aLionLs gonoLics.
Tho inorLanco ol clinical olsorvanco is illusLraLod ly Lho Thalidonido

Lragody, ovon il gonoLic lacLors voro noL involvod. Thalidonido
vas narloLod in Lho

laLo 1950s as a slooing ill and Lo LroaL norning siclnoss during rognancy. In
1961, iL vas discovorod LhaL an incroasing nunlor ol lalios voro loing lorn viLh a
nov Lyo ol nallornaLion. A connon dononinaLor vas LhaL Lhoir noLhors had
Lalon Thalidonido
. In lacL, jusL ono doso Lalon oarly in rognancy sovoroly allocLod

Lho grovLh ol looLal linls and causod injuros Lo Lho oyos, hoarL, lidnoy and oLhor
organs.

7. Gene therapy

Many laLally ill oolo havo conLrod Lhoir hoos ol curo on gono Lhoray. So lar
Lhoso hoos havo loon lullillod only aL a vory liniLod oxLonL, luL orhas Lho
Lhoray vill ouLgrov iLs rollons, jusL as oLhor Lochnologios havo dono.

8. What is the task of the physician?

IL should lo cloar lron Lhis ovorviov ol sono ol Lho noro connon disoasos viLh a
rovon or susocLod gonoLic connocLion LhaL Lho clinician has a Lasl involving groaL
rosonsililiLy. Ihysicians havo a rosonsililiLy Lo ronain avaro ol curronL advancos
in lionodical scioncos and Lo undorsLand Lho alicaLion ol ronising nov idoas Lo
clinical nodicino. IL is Lhoir rosonsililiLy Lo onsuro LhaL Lho laclground lacLors lor
Lho aLionLs dolivoring sanlos Lo Lho liolanls aro collocLod and rosonLod in a
sysLonaLic vay so LhaL Lho oLonLials ol Lho ronising nov gononic Lochniquos can
lo lully roalisod.
Bocauso hunans do noL lorn honogonous oulaLions, gonoLic dilloroncos
can lo lound loLvoon and viLhin grous, and Lho lordors loLvoon hoalLh and

9
Richard, I., Hollocquo, N., Nounan, I., Guoz, I., Lovy, R.199.
30
`~ ~~ ~ ~ ~ ~ ~
disoaso aro noL alvays disLincL. Iolynorhisn noans inLor-individual dilloroncos in
INA soquonco LhaL nay undorlio dilloroncos in hoalLh. A lov disordors aro causod
ly nuLaLion ol a singlo gono, nosL havo a olygonic laclground. Iolygonic disordors
rosulL lron Lho conlinod acLion ol allolos ol noro Lhan ono gono. AlLhough such
disordors aro inhoriLod, Lhoy doond on Lho sinulLanoous rosonco ol sovoral allolos
and Lho horodiLary aLLorns aro noro conlox.
\hon rosoarchors aro sLudying a grou ol individuals, Lhoy Lry Lo lind
sonoLhing LhaL is connon anong Lho nonlors ol Lho grou and LhaL dilloronLiaLos
Lho grou lron oLhor grous. Tho aLionLs nusL lo caLogorisod in such a vay LhaL
Lho analysos aro orlornod on Lhoso sanlos LhaL havo Lho groaLosL chanco ol
oxlaining vhy sono oolo goL ill and hov Lo rovonL iL. BoLh rosonL and luLuro
aLionLs vill Lhon lonoliL.
\hon Lho hunan gonono vas docodod IrosidonL Bill ClinLon said: Today
vo aro loarning Lho languago in vhich God croaLod lilo," and roclainod a nov
Canon, Tho Bool ol Lilo, vriLLon in a lour loLLor languago. Tho gonono consisLs ol a
conloLo soL ol insLrucLions lor naling an organisn. Randon changos in Lhis
insLrucLions nay causo a disoaso, luL disoasos in hunans aro nuch noro Lhan LhaL.
Tho gonoLyo corrosonds Lo ono nodol ol disoaso, and Lho honoLyo Lo anoLhor. In
Lho orson vho is consulLing a hysician Lho gonoLyo is nodiliod ly all Lho social,
siriLual, nonLal, inLollocLual and onvironnonLal lacLors allocLing a hunan loing
during his or hor lilo.
GonoLic characLorisLics havo a sLrong synlolic signilicanco. Thoy signily Lho
asL (ancosLors}, Lho rosonL (rorosonLaLion ol soll} and Lho luLuro (doscondanLs}.
Ihysicians occuy an inLornodiary osiLion: Lhoy havo Lo nodiaLo loLvoon Lho
nocossiLy ol scionLilic rogross and Lho rosonsililiLy ol onsuring LhaL Lho aLionLs`
hunan digniLy is nainLainod. Hov can vo roconcilo, in racLico, Lho roLocLion ol
oolo`s inLogriLy and rivaLo lilo viLh nodical inoraLivos and ullic hoalLh vhon
using Lho gonoLic narlors Ihysicians havo Lo inLograLo Lho rulos ol good caro and
rosoarch racLicos viLh oLhical valuos vhon uLilising liolanls.

31
_ p i
References

Aula, IorLLi, AuLio, Soo, Raivio, Kari C., Raola, Juhani, Thodon, Carl-Johan, Koslola,
Sirlla-Liisa, Yanashina, Iluo (199}. Salla disoaso" a nov lysosonal sLorago disordor.
^ kI \ol. J6, 88-94.

Barash, Grogory S., Iarooqi, I. Sadol, CRahilly, SLohon (2000}. GonoLics ol lody
rogulaLion. k~I \ol. 404 . 644-51.

Cunnings, John H., Binghan, Shoila A. (1998}. IioL and Lho rovonLion ol cancor. _
j~ g~, \ol. J1 . 16J6-40.

GoaLo, Alison, CharLior-Harlin, Mario-ChrisLino, Mullon, Milo, Brovn, Jorony, Cravlord,
Iiona, Iidani, Liana, Giullra, Luis, Haynos, Androv, Irving, Nicl, Janos, Louiso, ManL,
Rolocca, NovLon, Ihillia, Roolo, Karon, Roquos, Ionoloo, TalloL, Chris M., Iorical-
\anco, MargaroL, Rosos, Allon, \illianson, RolorL, Rossor, MarLin, Cvon, Milo, Hardy,
John (1991}. SogrogaLion ol a nissonso nuLaLion in Lho anyloid rocursor roLoin gono viLh
lanilial Alzhoinor`s disoaso. k~I \ol. J49, 04-6.

LandsLoinor, Karl (1901}.Ilor AggluLinaLionsorschoinungon nornalon nonschlichon BluLos.
t t, \ol. 24, 11J2.

Richard, Iloronco, Hollocquo, Nicolo, Nounan, Iric, Guoz, Iavid, Lovy, Raynond.
(199}. AICI gonoLying and rosonso Lo drug LroaLnonL in Alzhoinor`s disoaso. i~I
\ol. J49, 5J9.

\aLson, Janos, Cricl, Irancos (195J}. Molocular sLrucLuro ol nucloic acids. k~. \ol.
11, J-8.

\HC \orld HoalLh RoorL 2002, chaLor 4.

\irchov, Rudoll (1858}. Iio ZollularaLhologio in ihror Bogrndung aul hysiologischo und
aLhologischo Govololohro. Borlin: \orlag von AugusL Hirschvald. InLornoL odiLion
<hLL://sLall-vvv.uni-narlurg.do/~gloning/vc-L.hLn>.
32
xamples jrom Suedish biobanl research

J

Examples from Swedish biobank research

Magnus Kaijser, hD

Karolinsla lnstitutet
Department oj Medicine at Karolinsla Hospital, Clinical pidemiology Unit

This article, exemplijying the variety oj questions that can be addressed through the use oj
Suedish biobanls, consists oj a categorisation oj hou Suedish biobanl material is collected
and examples oj studies based on such material. Research methods, consent procedures,
and potential causes oj misleading results are discussed in commentaries on the studies.

1. Introduction

Thoro is a lroad varioLy ol liolanls in Svodon, ranging lron snall collocLions ol
liological socinons assonllod lron socilic sulsoLs ol aLionLs, Lo Lho hundrods ol
Lhousands ol sanlos collocLod annually viLhin Lho lranos ol various scrooning
rogrannos. A snall ninoriLy aro osLallishod oxclusivoly lor rosoarch urosos, luL
Lho uroso ol Lho ovorvholning najoriLy is Lo onallo hosiLals, nodical
laloraLorios, and oLhor hoalLh caro insLiLuLions Lo rovido accuraLo diagnosLics and
salo caro. Rogardloss ol Lhoir nain urosos, hovovor, Lhoso liolanls havo rovod Lo
lo an invaluallo Lool lor nodical rosoarch.
Bolov lollovs a caLogorisaLion ol hov Svodish liolanl naLorial is collocLod. In
connocLion viLh oach caLogory, oxanlos aro givon ol sLudios lasod on such naLorial.
Ior oach oxanlo Lhoro is an oxlanaLory connonLary locusing on Lho addiLional
daLa roquirod Lo conducL Lho sLudy, consonL rocoduros, and hov Lho choico ol
noLhods nay havo inlluoncod Lho rosulLs.

2. Collection of Swedish biobank material:

I. MaLorial collocLod lor diagnosLics
a. Scrooning ol hoalLhy (o.g. IKI-LosLs and corvical cancor scrooning}
b. IiagnosLics ol susocLod disoaso (o.g. liosios and lacLoriological LosLs}
c. Iollov-u ol lnovn disoaso (o.g. sorological LosLs ol aLionLs viLh rhounaLoid
arLhriLis}
II. MaLorial collocLod lor luLuro clinical and diagnosLic uso (o.g. sLorod ova lron
assisLod roroducLion and llood sanlos lor LosLing oLonLial lidnoy
LranslanL rociionLs}
III. MaLorial collocLod lor naing (o.g. rogisLor ol oLonLial lono narrov
donors}
I\. MaLorial collocLod oxclusivoly lor rosoarch
a. In hoalLh caro
33
Magnus Kaijser

i. lron aLionLs (o.g. llood lron aLionLs viLh dialoLos}
ii. lron docoasod individuals (o.g. lrain Lissuo}
iii. lron hoalLhy individuals (o.g. conLrol naLorial Lo oLhor sLudios and hoalLh
inLorvonLion sLudios}
b. In lionodical conanios (sLill unconnon}

3. Examples

I a) Research on material collected through screening.

Example 1

Background
IL is voll docunonLod LhaL hunan aillonavirus (HI\} can olLon lo
doLocLod in Lunours ol Lho uLorino corvix. BuL vhaL is causo and vhaL
is ollocL A orson viLh corvical cancor could lo rodisosod Lo
inlocLion, raLhor Lhan Lho virus loing a risl lacLor lor cancor.
Methods
Through linlago loLvoon a cyLology rogisLry and Lho Svodish Cancor
RogisLry, all vonon rosiding in \asLorloLLon CounLy vho had
arLiciaLod in Lho scrooning rogranno lor corvical cancor, had
cyLological snoars rosorvod and laLor dovolood corvical cancor
could lo idonLiliod. Ior oach caso a conLrol vas solocLod LhaL had also
arLiciaLod in Lho scrooning rogranno luL noL dovolood cancor.
Tho cyLological snoars lron casos and conLrols voro Lhon conarod
viLh rogard Lo hunan aillonavirus inlocLion.
Results
Thoro vas a sixLoon-lold incroaso in risl ol dovoloing corvical cancor
anong Lhoso inlocLod aL Lho Lino ol oxaninaLion conarod Lo Lhoso
vho voro noL. Tho virus is Lhus noro liloly Lo causo cancor Lhan Lo
lo an ollocL ol iL.
Consent
A ross conloronco vas hold aL vhich Lho sLudy lan vas rosonLod.
\onon vho did noL vanL Lo arLiciaLo voro in Lhis vay givon Lho
oLion ol loing oxcludod.
(Wallin et al., 1999)

Comments
This sLudy oxonlilios Lho uso ol liolanl naLorial originaLing lron hoalLhy
individuals. Tho naLorial vas collocLod viLhin Lho lrano ol a corvical cancor
scrooning rogranno, and corvical cancor is Lho Loic ol Lho sLudy. IurLhor insighLs
in Lho aoLiology ol Lhis cancor lorn can lo oxocLod Lo load Lo inrovononLs ol Lho
scrooning rogranno or so. Tho sLudy is also an oxanlo ol Lho uso ol Lho so-callod
oL-ouL" noLhod ol inlornod consonL. Sinco inlocLion viLh hunan aillonavirus
can lo osiLivoly associaLod viLh lilo sLylo lacLors LhaL ly Lhonsolvos aro nogaLivoly
associaLod viLh acLivo arLiciaLion in sLudios, Lho choico ol a dilloronL consonL
rocoduro vould rolally havo lod Lo nisloading rosulLs.

In ordor Lo conducL Lho sLudy, Lho auLhors noodod Lho lolloving inlornaLion:
1. naLional rogisLraLion nunlors ol all vonon arLiciaLing in Lho scrooning
rogranno,
34
2. Lho rosulLs ol Lho scrooning,
J. archivod cyLological sanlos lron Lho scrooning, and
4. cancor rogisLry daLa on corvical cancor incidonco anong Lho vonon.

Tho sanlos voro Lalon during Lho oriod 1969 Lhrough 1995 and Lho rosulLs lron
Lhis scrooning voro linlod Lo cancor rogisLry daLa lron 1995. Sinco Lho cancor
rogisLry daLa aro ugradod annually, Lhis sLudy vould havo loon inossillo il Lho
cyLological sanlos had loon sLorod in codod lorn and Lho coding loys dosLroyod.
Adding daLa aL Lho Lino ol sanlo collocLion vould lo ol no hol, sinco cancor
rogisLry daLa voro lasod on ovonLs occurring u Lo 26 yoars alLor sanlo collocLion.

Example 2

Background

Hunan aillonavirus is also susocLod Lo lo a risl lacLor lor anal
cancor. Tho sLrongLh ol Lhis allogod risl lacLor is, hovovor, unlnovn.
Methods
By uso ol Lvo largo sorun lanls in Norvay and Iinland, iL vas
ossillo Lo LosL sora lor anLilodios againsL hunan aillonavirus. In
LoLal, sora lron 28 cancor casos voro conarod viLh sora lron 1,500
conLrols.
Results
Thoro vas a Lhroo- Lo lourlold incroaso in risl ol anal cancor anong
soroosiLivo aLionLs conarod viLh soronogaLivo.
Consent
This sLudy had aroval lron Lho oLhics conniLLoo Lo lo orlornod
viLhouL inlornod consonL.

(Ljorge et al., ?00?)

Comments
This sLudy is sinilar Lo Lho rovious oxanlo, oxcoL LhaL Lho locus has shilLod Lo
anoLhor cancor lorn. This sLudy could Lhus lo considorod Lo havo a nov uroso. IL
vas conducLod viLhouL inlornod consonL, luL Lho oL-ouL noLhod" could havo
loon usod. Il Lho rosoarchors had loon olligod Lo olLain lrosh inlornod consonL lron
oach ol Lho noro Lhan 1,500 aLionLs LhaL arLiciaLod, racLical and ocononical
concorns vould rolally havo nado Lhis sLudy inossillo. Ior Lho sano roasons as
nonLionod in Lho rovious oxanlo, iL is also liloly LhaL Lho sLudy vould havo lod Lo
nisloading rosulLs.

Example 3

Background

\iLh Lho incroasing ullic avaronoss LhaL snoling is hazardous lor
hoalLh, iL can lo susocLod LhaL a groving nunlor ol individuals vill
lo unvilling Lo Loll Lho LruLh alouL Lhoir snoling haliLs. Snoling
during rognancy incroasos Lho risl ol loLh grovLh roLardaLion and
niscarriago. In anLonaLal caro, undor-roorLing ol snoling haliLs
could load Lo rognanL snolors noL loing givon inorLanL
inlornaLion and high-risl rognancios ronaining undoLocLod. IL is,
hovovor, uncloar vhoLhor undor-roorLing ol snoling in anLonaLal

35
Magnus Kaijser

Background
(cont.)
caro is ol such nagniLudo LhaL iL can lo considorod a rollon. IL is
also unlnovn Lo vhaL oxLonL rognanL vonon aro oxosod Lo
onvironnonLal snolo, and il onvironnonLal snolo oxosuro has
consoquoncos lor looLal and inlanL hoalLh.

Methods

CoLinino is a noLaloliLo ol nicoLino LhaL can lo doLocLod in Lho
circulaLion sovoral days alLor nicoLino oxosuro. By assossing llood
lovols ol coLinino, acLivo as voll as assivo snolors can lo
disLinguishod lron non-snolors. Sinco llood sanlos aro Lalon lron
all vonon arLiciaLing in anLonaLal caro, Lho accuracy ol soll-
roorLod snoling haliLs can lo validaLod Lhrough conarison viLh
coLinino lovols in Lhoso llood sanlos.
Results

Cl Lho vonon rolossing Lo lo non-snolors, alouL 6' voro liloly Lo
lo snolors, and aL loasL J' voro liloly Lo lo oxosod Lo
onvironnonLal snolo. Ior alouL a Lhird ol Lho vonon vho roorLod
snoling 1 Lo 10 cigaroLLos or day, Lhoir daily consunLion vas liloly
Lo lo highor.
Consent
All vonon voro aslod lor inlornod consonL, and 9' voro villing Lo
arLiciaLo.

(Lindqvist et al., ?00?)

Comments
This sLudy is inLorosLing in sovoral vays. Many vonon vould rolally considor iL
inLrusivo il Lhoir llood sanlos voro usod Lo chocl vhoLhor Lhoy roorLod snoling
haliLs LruLhlully or noL. Cn Lho oLhor hand, Lho sLudy can lo considorod as a noro
validaLion sLudy, sorving Lo chocl hov voll Lho diagnosLic rocoduros ooraLo. Iron
Lhis oinL ol viov, a sLudy assossing hov good quosLions aro lor disLinguishing
snolors lron non-snolors can lo conarod viLh sLudios assossing hov good a chosL
x-ray is lor doLocLing nounonia. Tho sLudy vas lasod on inlornod consonL, and Lho
non-arLiciaLion raLo vas vory lov. Il Lho non-arLiciaLion raLo had loon highor,
Lho rosulLs vould rolally havo loon nisloading. IL is noLovorLhy LhaL Lho sLudy vas
conducLod viLh codod llood sanlos and LhaL Lho rosoarchor orlorning Lho
coLinino analysis had no accoss Lo Lho codo loy. By Lhis rocoduro, rosulLs lron Lho
coLinino analysis voro loL soaraLo lron Lho idonLiLy inlornaLion, and Lho risl ol
invading Lho arLicianLs` rivacy vas roducod Lo a nininun.

I b) Research on material collected from tests of suspected disease

Example 4

Background

BarLonolla lacLoria aro lnovn Lo causo disoasos such as caL scraLch
disoaso and Lronch lovor. Moro roconLly, nov BarLonolla socios havo
loon discovorod, luL iL is insullicionLly lnovn Lo vhaL oxLonL Lhoso
nov socios also inlocL hunans.

36

Methods
All llood sanlos sonL Lo Lho clinical nicroliology laloraLory aL Lho
Isala InivorsiLy HosiLal Lo lo LosLod lor BarLonolla voro
roanalysod using nov and inrovod noLhods. A Lissuo sanlo lron a
nan docoasod in nyocardiLis vas also analysod. As conLrols, llood
lron hoalLhy llood donors and Lissuo sanlos lron aLionLs viLhouL
nyocardiLis vas usod.
Results

\hon analysing Lho naLorials ly inrovod noLhods, a nunlor ol
sanlos roviously considorod lroo lron lacLoria voro lound Lo lo
inlocLod. Tho nan vho diod ol nyocardiLis also rovod Lo lo
inlocLod. Tho associaLion loLvoon BarLonolla inlocLion and
nyocardiLis vas roviously unlnovn.
Consent
Tho roanalysis ol Lho sanlos vas conducLod viLhouL inlornod
consonL.
(Holmberg et al., 1999)

Comments
Sinco Lho llood sanlos voro iniLially Lalon in ordor Lo lo LosLod lor BarLonolla, and
Lho Lasl ol Lho invosLigaLors vas Lo orlorn a noro Lhorough BarLonolla analysis, Lhis
sLudy could lo arLly considorod as orLaining Lo Lho original analysis. Indor Lho
nov logislaLion on oLhical conniLLoo ovaluaLion, hovovor, Lhis sLudy is Lo lo
considorod as rosoarch roquiring oLhical conniLLoo aroval. To lind ouL vhoLhor
Lho novly discovorod lacLoria inlocL hunans, codod llood sanlos viLhouL any
accoss Lo Lho codo loy vould havo loon sullicionL. Such a rocoduro, on Lho oLhor
hand, vould havo nado iL inossillo Lo lollov Lhoso vho voro inlocLod, vhich, in
Lurn, could rosulL in Lhoso aLionLs rocoiving inadoquaLo caro.

Example 5

Background

Coliac disoaso, or gliadin (gluLon} inLoloranco, allocLs alouL 1 in 250.
Tho disoaso onLails gasLroinLosLinal synLons, losions ol Lho inLosLinal
nucosa, and, il unLroaLod, nalalsorLion. TroaLnonL consisLs ol lilo-
long alsLinonco lron gliadin conLaining lood. Sinco such LroaLnonL
has rolound consoquoncos lor Lho aLionLs, Lho accuracy ol Lho
diagnosis nusL lo oxLronoly high. AL rosonL, Lho diagnosis is lasod
on a LoLal ol Lhroo snall inLosLinal liosios lor childron and Lvo
liosios lor adulLs. A largo roorLion ol aLionLs viLh coliac disoaso
dovolo Lho disoaso as inlanLs, and lor Lhoso inlanLs, Lho rolaLivoly
largo nunlor ol liosios aro a causo ol nuch sulloring. By assossing
Lho lovols ol anLilodios againsL gliadin, anong oLhor sulsLancos,
aLionLs viLh lov rolaliliLy ol having Lho disoaso can lo idonLiliod
and honco Lho nunlor ol unnocossary liosios roducod. Tho noLhods
lor assossing Lho anLilodios, hovovor, aro raLhor conlicaLod and
Lino-consuning. Novor LosLs LhaL aro oasior Lo handlo havo loon
dovolood, luL loloro using Lhon in clinical racLico, iL is inorLanL
Lo lo suro LhaL Lhoir qualiLy oquals LhaL ol Lho LosLs usod in curronL
raxis.
37
Magnus Kaijser

Methods
In Lho aodiaLric vards ol Linling and Ino InivorsiLy HosiLals,
Lhoro voro 1JJ childron vho had undorgono coliac disoaso
invosLigaLion lor vhich snall inLosLinal liosios and llood sanlos
voro rosorvod in a liolanl. By using Lho llood sanlos, Lvo novly
dovolood LosLs lor gliadin anLilodios voro conarod viLh Lho
noLhods usod in curronL racLico. Tho rosulLs ol Lho liosios voro
usod as gold sLandard.
Results

Ior childron vho voro noL on a gliadin-lroo dioL, a nogaLivo llood LosL
according Lo Lho nov noLhods shovod Lho risl ol having Lho disoaso
Lo lo lolov 1 or conL. Tho nov LosLs Lhus havo Lho sano accuracy as
Lho noLhods curronLly usod.
Consent
Tho childron`s aronLs consonLod Lo an iniLial sLudy on coliac disoaso
and no nov consonL vas olLainod lor Lhis sLudy.
(Crodzinsly et al., ?001)

Comments
As in Lho oxanlo alovo, Lhis sLudy is a roanalysis ol LosLs orlornod roviously. Tho
scoo ol Lho sLudy is Lo assoss Lho accuracy ol LosLs usod Lo docroaso Lho nunlor ol
unnocossary liosios. To orlorn Lho sLudy, Lho rosoarchors had Lo havo accoss Lo:
1. rooaLodly Lalon llood sanlos,
2. collocLod naLorial lron Lhroo consocuLivo liosios, and
J. nodical rocord daLa.

Tho sLudy vas conducLod viLhouL olLaining lrosh inlornod consonL and Lhoroloro
had no nissing daLa duo Lo non-arLiciaLion. Non-arLiciaLion in Lhis lind ol
sLudios could consLiLuLo a sorious rollon, sinco Lho non-arLiciaLion can lo
associaLod viLh oLhor lacLors caallo ol allocLing Lho rosulLs. A hyoLhoLical
oxanlo: Il childron oxosod Lo cigaroLLo snolo aL hono havo lovor lovols ol
anLilodios in Lhoir llood, a nov LosL lor anLilodios could lo ol loss rocision vhon
usod on Lhoso childron. Il non-arLiciaLion is highor anong childron vhoso aronLs
snolo, Lho nov LosL vould Lhon aoar Lo lo noro rociso Lhan iL acLually is. Il such
a nov LosL is inLroducod alLor ovaluaLion in sLudios LhaL all havo Lho sano lind ol
non-arLiciaLion, Lho rosulL nay lo a lovor qualiLy ol caro lor childron ol snolors,
sinco Lho coliac disoaso ol Lhoso childron nay ass undoLocLod.

Example 6

Background

IoanuL allorgy is considorod Lho connonosL causo ol laLal lood
anahylaxis. In siLo ol oanuL consunLion in Svodon loing
rolaLivoly lov, Lhoro aro indicaLions ol an incroasing rovalonco ol
oanuL allorgy. \hoLhor Lhis is Lruo or noL, hovovor, has noL loon
sullicionLly sLudiod.

38

Methods
AroxinaLoly 94,000 LosLs on lood allorgy voro orlornod aL Lho
Allorgy LaloraLory , Sahlgronsla InivorsiLy HosiLal, GLolorg,
loLvoon 1994 and 1998. Anong Lhoso, all LosLs lor oanuL allorgy
voro idonLiliod. A sanlo ol aLionLs viLh osiLivo rosulLs voro also
conLacLod and givon quosLionnairos alouL Lhoir ago aL allorgy onsoL,
Lho Lyo and sovoriLy ol synLons oLc.
Results

Tho nunlor ol LosLs lor oanuL allorgy incroasod during Lho sLudy
oriod, and so did Lho roorLion ol osiLivo LosLs. IoanuL allorgy is as
connon in Svodon, a lov consunLion aroa, as iL is in counLrios
vhoro consunLion is sulsLanLially highor. Cl Lhoso vho LosLod
osiLivo, 40' voro unavaro ol Lhoir allorgy loloro Laling Lho LosL.
Consent

Ior Lho sLudy ol nunlors and rosulLs lron oanuL allorgy LosLs, Lhoro
vas no inlornod consonL. Ior Lhoso ansvoring Lho quosLionnairos, Lho
rosoarchors lirsL had Lho rolorring hysician`s ornission Lo conLacL
Lho aLionLs and Lhon Lho consonL ol Lho suljocLs Lhonsolvos.
(van Cdijl et al., ?001)

Comments
This sLudy had Lvo ains. Tho lirsL vas Lo assoss vhoLhor oanuL allorgy rovalonco
has incroasod ovor Lino, and Lho socond vas Lo gain lurLhor lnovlodgo ol Lho
synLons associaLod viLh oanuL allorgy. Through Lho quosLionnairos, Lho
rosoarchors succoodod in Lho socond ain. Tho sLudy cannoL, hovovor, lo considorod
Lo havo ansvorod Lho lirsL quosLion viLh corLainLy. Sinco only LosLs LhaL voro
originally dosignaLod Lo assoss oanuL allorgy sLaLus voro includod, Lho sLudy is lasod
on a solocLod naLorial. IL is concoivallo LhaL oanuL allorgy rovalonco ronainod
consLanL during Lho sLudy oriod, luL Lho rolorring hysicians havo loarnL loLLor Lo
docido vho is Lo lo LosLod. In ordor Lo assoss vhoLhor oanuL allorgy rovalonco has
incroasod ovor Lho lasL 5 Lo 10 yoars, ono should uso oLhor naLorial, such as llood
sanlos collocLod in anLonaLal caro or lron llood donors. Such a sLudy could lo
conducLod viLhouL any idonLiLy inlornaLion, rovidod LhaL no addiLional
inlornaLion is noodod lron Lhoso LosLod.

I c ) Research on material collected in connection with treatment or follow-up of a known
disease.

Example 7

Background

IhoochronocyLona and aragangliona aro Lunours roducing
caLocholaninos such as adronalino. Tho groaL najoriLy ol Lho Lunours
aro lonign and aro curod ly surgory. In aroxinaLoly 10' ol Lho
casos, hovovor, Lho Lunour grovs invasivoly or dovolos noLasLasos.
IL vould Lhoroloro lo ol groaL valuo il a rognosLic narlor ol
nalignanL LranslornaLion voro Lo lo doLocLod.

39
Magnus Kaijser

Methods

All 85 aLionLs ooraLod lor hoochroncyLona or aragangliona aL
Lho Karolinsla HosiLal, SLoclholn, during Lho oriod loLvoon 196
and 1999 inclusivo voro lollovod viLh rogard Lo Lunour rogrossion
and survival. Molocular liology analysos voro orlornod on sLorod
naLorial lron ronovod Lunours. Sono ol Lho aLionLs voro also
inLorviovod Lhrough nailod quosLionnairos.
Results

Tvo ronising narlors ol nalignanL LranslornaLion voro idonLiliod.
In Lho luLuro, uso ol Lhoso narlors nay lo a Lool lor loLLor rodicLion
ol vhich aLionLs viLh hoochronocyLona or aragangliona LhaL aro
aL risl lor nalignanL disoaso.
Consent

Tho liolanl vas osLallishod on Lho lasis ol inlornod consonL, and
inlornod consonL vas also olLainod lor Lhis sLudy lron all aLionLs
vho voro sLill alivo.
(dstrm lder, ?00?)

Comments
This sLudy oxonlilios Lho uso ol naLorial collocLod in connocLion viLh LroaLnonL.
To orlorn Lho sLudy, Lho rosoarchors noodod Lo havo accoss Lo:
1. Lho RogisLor ol IoulaLion and IoulaLion Changos,
2. Lho Causo ol IoaLh RogisLor
J. Lunour naLorial
4. addrossos, and
5. nodical rocord daLa.

Tho iniLial rosonso raLo vas 89'. Sinco Lho nunlor ol aLionLs in Lho sLudy vas
liniLod, iL vas loasillo Lo conLacL all non-rosondors ly Lolohono. AlLor Lhis, Lho
rosonso raLo incroasod Lo an asLonishing 100'. Sinco Lho LoLal nunlor ol aLionLs
vas snall, Lho nunlor ol aLionLs viLh noLasLaLic disoaso vas ovon snallor. Tho
snallor Lho nunlor, Lho groaLor is Lho risl ol chanco allocLing Lho rosulLs. In Lhis
sLudy, such chanco ollocLs nay includo ronising narlors ronaining undoLocLod, as
voll as narlors ol no clinical valuo aoaring Lo lo associaLod viLh noLasLaLic
disoaso. To lo corLain ol Lho rognosLic valuos ol Lho ronising narlors idonLiliod in
Lhis sLudy, largor nunlors ol aLionLs aro noodod. This, on Lho oLhor hand, roquiros
rosoarch roLocols, including consonL rocoduros, LhaL aro loasillo on a largor scalo.

Example 8

Background
TroaLnonL lor lroasL cancor includos inLonsivo chonoLhoray vhich
can lo vory agonizing lor Lho aLionL. Tho ollocL ol Lhis
chonoLhoray varios loLvoon individuals, and Lo avoid unnocossary
uso ol chonoLhoray, loLLor noLhods lor idonLilying aLionLs vho
vill noL rosond Lo LroaLnonL aro varranLod. An inorLanL sLo in
cancor dovolononL is vhon Lhoro is a nuLaLion in a gono callod 5J.
This gono rogulaLos Lho roducLion ol a roLoin LhaL rovonLs

40

unliniLod coll grovLh. Il Lhoro is a nuLaLion in Lho 5J gono in a coll,
Lhis coll nay sLarL Lo grov and divido viLhouL cossaLion, and cancor
nay lollov. Thoro is a Lhoory LhaL Lho ollocL ol lroasL cancor
chonoLhoray doonds on vhoro in Lho 5J gono Lho nuLaLion has
Lalon laco.
Methods
By using Lho olynoraso chain roacLion Lochniquo (ICR}, Lho 5J
gono could lo soquoncod in sLorod Lunour naLorial lron lroasL
cancor aLionLs. This onallod idonLilicaLion ol vhoro in Lho gono Lho
nuLaLion had occurrod. Tho aLionLs voro Lhon lollovod viLh rogard
Lo ollocL ol LroaLnonL and survival.
Results
MuLaLions in sono rogions ol Lho 5J gono voro associaLod viLh loLh
oor rognosis and oor ollocL ol LroaLnonL. InLonsivo chonoLhoray
LhaL soriously allocLs qualiLy ol lilo can Lhoroloro lo ol loss valuo Lo
aLionLs viLh Lhoso nuLaLions, sinco Lho ollocL ol LroaLnonL is liniLod.
Consent
This sLudy had aroval lron Lho oLhics conniLLoo Lo lo orlornod
viLhouL olLaining inlornod consonL.
(Lergh et al., 199)

Comments
This is a varianL ol Lho rovious oxanlo, luL in Lhis sLudy Lho rosoarchors also
vanLod Lo ovaluaLo Lho ollocL ol curronLly usod Lhoraios. To orlorn Lho sLudy, Lho
rosoarchors noodod Lunour naLorial and nodical rocords. Avoidanco ol unnocossary
sulloring nusL lo a rinary goal ol all nodical caro, and iL is Lhoroloro ossonLial LhaL
Lhis lind ol sLudios can lo orlornod viLh high qualiLy also in Lho luLuro. Il Lho
arLiciaLion raLo is associaLod viLh LroaLnonL, such as vonon viLh liLLlo ollocL ol
LroaLnonL loing loss villing Lo arLiciaLo in Lho sLudy, Lho rosulLs lron Lho sLudy
vill lo llavod. This could load Lo vonon viLh lroasL cancor loing oxosod Lo
agonizing LroaLnonLs LhaL has liLLlo or no ollocL.

Example 9

Background

Loulaonia is a llood nalignancy viLh an unliniLod roducLion ol
dolocLivo loulocyLos (vhiLo llood colls}. ChonoLhoray lor
loulaonia is lasod on nodicaLion LhaL lills loulocyLos. Il succosslul,
LroaLnonL vill lill all dolocLivo loulocyLos, vhoroas Lhoro aro onough
hoalLhy sLon colls lolL Lo onallo loulocyLo roducLion onco Lho
chonoLhoray is sLood. Thoro is a risl, hovovor, LhaL Lho lilling ol
loulocyLos nay havo long-sLanding ollocLs on anLilody roducLion.
This could load Lo loss ol innuniLy Lo a nunlor ol disoasos, such as
noaslos and rulolla, lor oxanlo. Moaslos and rulolla aro nornally
quiLo unconlicaLod vhon allocLing childron. Ior adulLs, hovovor,
Lhoy nay load Lo noningiLis and sLoriliLy.

41
Magnus Kaijser

Methods

Blood sanlos lron 4J childron vho had loon succosslully LroaLod
lor loulaonia voro assossod lor anLilodios againsL noaslos and
rulolla. Irior Lo disoaso, all childron had loon innunisod in Lho
naLional innunisaLion rogranno, and Lhoy had donaLod llood
sanlos loloro, during, and alLor LroaLnonL.

Results

As nany as 40' ol Lho childron losL innuniLy againsL noaslos, and
J0' losL Lhoir innuniLy againsL rulolla. Il Lho childron voro
innunisod do novo, hovovor, Lhoy rogainod Lhoir innuniLy.
Consent
Tho aronLs ol all arLiciaLing childron had givon consonL Lo Lho
sLudy.
(Nilsson et al., ?00?)

Comments
Tho Loic ol Lhis sLudy is no longor Lho disoaso lor vhich Lho aLionLs voro LroaLod,
luL Lhoir innuniLy againsL oLhor disoasos. Il Lho liolanl usod in Lhis sLudy vas
dosignaLod lor rosoarch on loulaonia, Lhis sLudy nay lo considorod as having a nov
uroso. Cn Lho oLhor hand, Lho sLudy can lo rogardod as a noro lollov-u ol Lho
aLionLs vho had loon LroaLod. IL is noLovorLhy LhaL non-arLiciaLion in Lhis sLudy
nay load Lo a loss ol innuniLy LhaL goos undoLocLod. To ansvor Lho quosLion ol
vhoLhor ono can loso innuniLy alLor chonoLhoray, codod llood sanlos aro
sullicionL. Such a rocoduro, hovovor, vould havo nado iL inossillo Lo ollor ro-
innunisaLion Lo Lhoso vho had losL Lhoir innuniLy.

II) Research on material collected for future use and diagnostics.

Example 10

Background

In Lho nid-1990s, a nov virus vas discovorod LhaL vas susocLod ol
causing hoaLiLis. Il Lho virus causos hoaLiLis, scrooning all llood
donors lor Lhis virus nay lo varranLod.
Methods

Blood lron llood donors, usod in an oarlior sLudy on anoLhor
hoaLiLis-causing virus, vas LosLod lor Lho nov virus. A LoLal ol 600
llood sanlos collocLod lron llood donors in Maln during Lho
oriod 1992 Lo 1994 voro LosLod and ol Lhoso, 18 voro lound
osiLivo.
Results

Sono ol Lho aLionLs vho LosLod osiLivo shovod signs ol livor
disoaso, luL Lho rosulLs as a vholo voro LhaL Lhoro aro no roasons lor
LosLing all llood donors lor Lhis nov virus.
Consent

Ior roanalysing Lho llood, Lhoro vas no inlornod consonL, luL all
vho LosLod osiLivo consonLod Lo conLinuod lollov-u and 1J/18
ovon consonLod Lo undorgo a livor liosy.
(Ljorlman et al., ?000)

42
Comments
This sLudy oxonlilios rouLino uso ol sLorod liological sanlos. Tho risls onLailod ly
noL doing Lhis lind ol rosoarch aro olvious, sinco aLionLs rocoiving llood Lhus vould
lo in oril ol loing inlocLod. In Lhis sLudy, Lho roanalysis ol Lho llood vas dono viLh
codod sanlos and Lho codo vas lrolon only lor Lhoso vho LosLod osiLivo. By doing
so, Lho rosoarchors could roduco Lho risl ol rivacy oncroachnonL Lo a nininun.

Example 11

Background

IL is lnovn LhaL cadniun, load, and norcury can lo accunulaLod in
Lho lidnoys and havo nogaLivo ollocLs on lidnoy luncLion. MosL oarlior
sLudios, hovovor, havo usod naLorial lron auLosios. Sinco auLosios
aro orlornod on a solocLod naLorial lor sono rior roason, iL ronains
unlnovn Lo vhaL oxLonL cadniun, load, and norcury aro also
accunulaLod in Lho lidnoys ol hoalLhy individuals. Kidnoy lovols ol
Lhoso noLals can only lo assossod Lhrough liosy, a rocoduro soldon
orlornod viLhouL sLrong roasons.
Methods

SLorod liosios lron lidnoy LranslanLs viLh living donors voro
analysod. Tho lidnoy donors voro also givon quosLionnairos alouL
occuaLional hisLory and onvironnonLal oxosuros.
Results

Tho lovols ol cadniun, load, and norcury voro in concordanco viLh
oarlior roorLs, and roviously doscrilod causos ol accunulaLion voro
conlirnod.
Consent
This sLudy vas conducLod viLhouL inlornod consonL.
(Barrogard oL al., 1999}

Comments
This sLudy raisos sono inLorosLing quosLions. \hich aLionL should lo aslod lor
consonL, Lho ono vho donaLod Lho lidnoy or Lho ono vho acLually carrios iL JusL as
sono gonoLical LosLs can causo oLhical concorn ly roviding inlornaLion noL only
alouL Lho aLionL, luL also alouL his or hor aronLs, sillings and ollsring, Lhis sLudy
doos. Cno can oso a aLionL a nunlor ol quosLions alouL Lho lidnoy LhaL nov
lolongs Lo anoLhor. \ho shall givo consonL Lo sLorago in a liolanl

III) Research on material collected for mapping:

Example 12

Background

ShorL Landon rooaLs aro soquoncos ol INA LhaL aro alundanL
LhroughouL Lho gonono and vary vidoly loLvoon individuals. Iuo Lo
Lhis varioLy, Lhoy can lo usod Lo inrovo Lho accuracy ol linshi and
crino invosLigaLions. Boloro using shorL Landon rooaL assossnonL in
such invosLigaLions, hovovor, lurLhor ovaluaLion is noodod.
Methods

In Lho Tolias RogisLry, a Iurooan rogisLry ol oLonLial lono narrov
donors, 52 individuals viLh idonLical varianLs ol a corLain gono voro
idonLiliod, and Lho inLor-individual variaLion ol Lho shorL Landon
rooaLs vas assossod.

43
Magnus Kaijser

Results

Sono rogions ol Lho gono conLainod sovoral varianLs ol shorL Landon
rooaLs. By analyzing shorL Landon rooaLs, Lho validiLy ol gonoLic
LosLs can lo inrovod.
Consent
This study uas based on an injormed consent.
(Vorechovsly et al., ?001)

Comments
Tho inorLanco ol rocision in gonoLic LosLs is olvious. Tho Loic ol Lhis sLudy is noL
rolaLod Lo Lho roason vhy Lho Tolias RogisLry vas osLallishod, luL viLhouL such a
rogisLor, Lho sLudy vould havo loon inossillo. Thoro vas no nood lor idonLiLy
inlornaLion oxcoL vhon addrossing Lho llood donors lor consonL. Sinco Lho loLLors
asling lor consonL voro adninisLorod Lhrough Lho Tolias RogisLry, Lho rosoarchors
could orlorn Lho sLudy viLhouL any lnovlodgo ol Lho idonLiLios ol Lho suljocLs.

IV a i.) Research on material collected exclusively for research, in health care, from
patients

Example 13

Background

Tho aLhology ol nulLilo sclorosis (MS} includos dosLrucLion ol Lho
vhiLo naLLor viLhin Lho conLral norvous sysLon. Tho disoaso is olLon
liniLod Lo ono oisodo, luL sonoLinos iL is noro aggrossivo and loads
Lo doaLh. Tho aoLiology is unlnovn, luL hunan horosvirus -6
inlocLion has loon suggosLod as a risl lacLor.
Methods

Corolrosinal lluid lron aLionLs viLh nulLilo sclorosis vas LosLod
lor hunan horosvirus-6, and sLorod llood sanlos voro LosLod lor
anLilodios againsL Lho virus. Tho sano analysos voro also orlornod
on llood and corolrosinal lluid lron aLionLs vho did noL havo
nulLilo sclorosis.
Results
Hunan horosvirus-6 vas noL associaLod viLh nulLilo sclorosis.
Consent
This sLudy had aroval lron Lho oLhical conniLLoo Lo lo orlornod
(nbom et al., 1999)

Comments
This sLudy oxonlilios Lho uso ol naLorial collocLod lor Lho solo uroso ol rosoarch.
All naLorial, hovovor, vas collocLod lron aLionLs vho voro undorgoing LroaLnonL
oiLhor lor nulLilo sclorosis or lor anoLhor nourological disoaso. In Lhis caso, no
idonLiLy inlornaLion vas noodod, luL il horos virus-6 had loon associaLod viLh Lho
disoaso, a llind dosign vould lo rollonaLic, sinco iL vould Lhon havo loon
inossillo Lo ollor Lho aLionLs any LroaLnonL.

44
Example 14

Background

IL is voll lnovn LhaL high lovols ol corLain sorun liids incroaso Lho
risl ol coronary hoarL disoaso. Loss is lnovn alouL Lho associaLion
loLvoon llood liids and rognosis lor Lhoso vho havo alroady
dovolood coronary hoarL disoaso.
Methods

Blood sanlos voro savod lron 988 aLionLs vho had loon
invosLigaLod Lhrough coronary angiograhy loLvoon 1985 and 198.
In 1998, Lho viLal sLaLus ol Lhoso aLionLs vas assossod. Lovols ol
sorun liids and sono cholosLorol varianLs voro assossod, as voll as
Lho associaLion loLvoon Lhoso lovols and norLaliLy.
Results

Lov lovols ol HIL- cholosLorol voro associaLod viLh an incroasod
norLaliLy. HIL is a cholosLorol varianL vhich is nogaLivoly associaLod
viLh coronary hoarL disoaso. Surrisingly, lov lovols ol LIL-
cholosLorol voro also associaLod viLh an incroasod norLaliLy. Tho
incroasod norLaliLy vas nainly duo Lo oLhor roasons Lhan coronary
hoarL disoaso, and iL aliod only Lo non.
Consent

This sLudy vas arovod ly Lho oLhical conniLLoo lor orlornanco
(LundsLan oL al., 2002}

Comments
Tho scoo ol Lhis sLudy doviaLos sonovhaL lron Lho original inLonLion vhon Lho
sanlos voro collocLod. Tho sanlos voro collocLod vhon Lho aLionLs undorvonL
coronary angiograhy, and voro Lhon usod Lo sLudy Lho associaLion loLvoon llood
liids and norLaliLy. To orlorn Lho sLudy, Lho rosoarchors noodod accoss Lo Lho
aLionLs` nanos and naLional rogisLraLion nunlors. Through Lho uso ol Lhoso, viLal
sLaLus could lo assossod in Lho Causos ol IoaLh RogisLor and Lho RogisLor ol
IoulaLion and IoulaLion Changos. Sono aLionLs voro also lollovod Lhrough
nodical rocords. IL vould Lhoroloro havo loon dilliculL Lo orlorn Lho sLudy in a
llind dosign. Ivon Lhough Lho sLudy vas noL conducLod in LoLal concordanco viLh
Lho original inLonLion vhon osLallishing Lho liolanl, iL can lo considorod as a
validaLion sLudy ol curronL Lhoray. LiLLlo is gainod ly succosslul LroaLnonL ol sorun
liids il Lhis doos noL allocL norLaliLy. Tho sLudy is Lhoroloro a good oxanlo ol Lho
inorLanco ol loing allo Lo chango Lho locus ol rosoarch vhon nov quosLions ariso.

IV a ii.) Research on material collected exclusively for research, in health care, from
deceased individuals.

Example 15

Background
Sovoral gonoLic risl lacLors havo loon suggosLod in Lho aoLiology ol
Alzhoinor`s disoaso. To lo corLain ol Lho diagnosis Alzhoinor`s
disoaso, oLhor roasons lor dononLia, such as lrain Lunour or lrain
inlarcLion, nusL lo oxcludod. Tho salosL vay ol doing Lhis is aL
auLosy.

45
Magnus Kaijser

Methods
Tissuo lron 188 docoasod aLionLs viLh Alzhoinor`s vas conarod
viLh Lissuo lron noro Lhan 200 docoasod aLionLs viLhouL
Alzhoinor`s disoaso. Tho rovalonco ol Lho suggosLod gonos vas
assossod.
Results
A gono LhaL had roviously loon suggosLod as a risl lacLor vas lound
noL Lo lo associaLod viLh Alzhoinor`s disoaso.
Consent
Tho sLudy vas lasod on inlornod consonL lron Lho lanilios ol Lho
aLionLs.
(Llennou et al., ?000)

Comments
This is an oxanlo in vhich naLorial collocLod aL Lino ol auLosy vas usod. Ior
sLudying Lho associaLion loLvoon gonoLyo and Alzhoinor`s disoaso, only
inlornaLion on disoaso sLaLus vas noodod.

IV a iii.) Research on material collected exclusively for research, in health care, from
healthy individuals.

Example 16

Background
Insulin-lilo grovLh lacLor-1 (IGI-1} is a roLoin LhaL nay sLinulaLo
rosLaLic grovLh and Lhoroly incroaso Lho risl ol rosLaLo cancor in
aninal sLudios. Loss is lnovn ol vhoLhor Lhis is alicallo also Lo
hunans.
Methods
MaLorial lron Lvo largo sLudios in Lho counLy ol \asLorloLLon, Lho
\II and Monica sLudios, vas usod. Tho \II-sLudy is a hoalLh
inLorvonLion sLudy on cardiovascular disoaso and cancor. In Lhis sLudy,
all rosidonLs in \asLorloLLon CounLy aro inviLod Lo a hoalLh survoy
vhon Lhoy roach Lho agos ol J0, 40, 50, and 60 yoars. In connocLion
viLh Lhoso oxaninaLions, llood sanlos aro collocLod, and so lar noro
Lhan 50,000 vonon and non havo arLiciaLod. Tho Monica-sLudy
has in a sinilar lashion includod 6,000 orsons Lo sLudy
cardiovascular disoaso. All incidonL casos ol rosLaLo cancor in Lho Lvo
sLudy cohorLs voro idonLiliod Lhrough Lho cancor rogisLry. Ior oach
caso, Lvo conLrols voro solocLod. Blood sanlos Lalon rior Lo
diagnosis voro analysod lor IGI-1.
Results
High lovols ol IGI-1 voro associaLod viLh an incroasod risl ol
rosLaLo cancor also in hunans.
Consent
All arLicianLs had consonLod Lo Lho iniLial sLudios.
(Stattin et al., ?000)

46
Comments
This sLudy oxonlilios Lho uso ol naLorial collocLod lron hoalLhy volunLoors
consonLing Lo rosoarch. To orlorn Lho sLudy, Lho cohorLs voro linlod Lo Lho Causos
ol IoaLh RogisLor, Lho Cancor RogisLor, and Lho RogisLor ol IoulaLion and
IoulaLion Changos. This linlago roquiros inlornaLion alouL Lho naLional
rogisLraLion nunlor. Il Lho liolanl rogisLor had ollocLod Lho linlago loLvoon Lho
rogisLors and Lhon dolivorod codod daLa Lo Lho rosoarchors, Lho sLudy vould havo
loon loasillo viLhouL idonLiLy inlornaLion. Tho sLudy also oxonlilios Lho quosLion
ol Lho liniLs lor Lho inlornod consonL. Should a nov consonL lo roquirod vhon locus
shilLs lron ono ullic hoalLh concorn Lo anoLhor

Example 17

Background

SoroLonin is a nouroLransniLLor LhaL nay havo inlluonco on nood,
inulso conLrol, and aggrossion. An onzyno, LryLohan hydroxylaso,
is insLrunonLal in soroLonin rogulaLion. Irovious sLudios havo shovn
dilloronL varianLs ol Lho gono LhaL codos lor LryLohan hydroxylaso,
and Lhoro aro roorLs ol a corLain varianL loing associaLod viLh an
incroasod risl ol suicido. Il Lhoso roorLs aro corrocL is, hovovor, sLill
unsuro.
Methods

In Lho Svodish Tvin RogisLry, J6 nonozygoLic Lvins vho had
conniLLod suicido voro idonLiliod. Sinco nonozygoLic Lvins aro
gonoLically idonLical, Lho surviving sillings could lo LosLod. This vas
dono, and Lho rosulLs voro Lhon conarod viLh rosulLs lron LosLs ol
hoalLhy conLrols rosiding in SLoclholn.
Results

A corLain onzyno varianL vas nuch noro connon anong sillings ol
Lvins LaL had conniLLod suicido.
Consent
Cl Lho J6 Lvins idonLiliod, 28 gavo consonL Lo Lho sLudy.

(Roy et al., ?001)

Comments
This sLudy is lasod on inlornod consonL. A rollonaLic loaLuro is LhaL ono cannoL
lnov viLh corLainLy LhaL Lho gono doscrilod is associaLod viLh an incroasod risl ol
suicido. Sinco Lho rosonso raLo vas around 5', iL is ossillo LhaL Lho gono has liLLlo
or no connocLion viLh suicidal lohaviour, luL a sLrong associaLion viLh aLLiLudos
Lovards sLudy arLiciaLion. To oxcludo Lhis ossililiLy, conloLo arLiciaLion
vould lo roquirod.

Example 18

Background
Soloniun is a ninoral vhich ly nany is considorod Lo docroaso Lho
risl ol cancor. Moro roconLly, a soloniun conLaining roLoin callod
solonoroLoin I has loon idonLiliod. Tho roLoin is suggosLod Lo havo
anLioxidanL roorLios. AnLioxidanLs aro also considorod Lo docroaso
cancor risl. A nov noLhod has loon dovolood LhaL onallos

47
Magnus Kaijser

Background
(contd.)
quanLilicaLion ol solonoroLoin I. Tho associaLion loLvoon
solonoroLoin I and cancor can Lhoroloro lo sLudiod.
Methods

BoLvoon 194 and 1982, 12,500 non arLiciaLod in a hoalLh
inLorvonLion sLudy in vhich llood sanlos voro collocLod. Sinco
Lhon, 400 non had dovolood cancor. Ior oach cancor caso, Lvo
conLrols voro solocLod, and Lho associaLion loLvoon solonoroLoin
and cancor vas assossod.
Results

Lov lovols ol solonoroLoin I voro associaLod viLh lung cancor and
gasLroinLosLinal cancor.
Consent
All arLicianLs consonLod Lo Lho iniLial hoalLh inLorvonLion sLudy.
(erssonMoschos et al., ?000)

ConnonLs
This sLudy is an insLanco ol nov quosLions arising long alLor Lho lanning ol Lho
iniLial sLudy. To orlorn Lho sLudy, Lho cohorLs voro linlod Lo Lho Causos ol IoaLh
RogisLor, Lho Cancor RogisLor, and Lho RogisLor ol IoulaLion and IoulaLion
Changos. This linlago roquiros arLiculars ol naLional rogisLraLion nunlors. Tho
associaLions loLvoon soloniun and cancor voro novor LhoughL ol vhon Lho sLudy
vas lannod. NovorLholoss, Lho uroso ol Lho iniLial sLudy vas Lo do oxacLly Lhis
lind ol rosoarch.

48
References

Barrogard, L., Svalandor, C., SchuLz, A., \osLlorg, G., SallsLon, G., Blohno, I., Molno, J.,
ALLnan, I. C. and Haglind, I. (1999} nviron Health erspect,10, 86-1.

Borgh, J., Norlorg, T., Sjogron, S., Lindgron, A. and Holnlorg, L. (1995} Nat Med, 1,
1029-J4.

Bjorgo, T., Ingoland, A., LuosLarinon, T., Morl, J., Gisloloss, R. I., Jollun, I., Koslola, I.,
LohLinon, M., Iullala, I., Thoroson, S. C. and Iillnor, J. (2002} Lr 1 Cancer, 8, 61-4.

Bjorlnan, I., SundsLron, G., \oross, B. and \idoll, A. (2000} Vox Sang, 8, 14J-8.

Blonnov, K., RiclsLon, A., Irinco, J. A., Broolos, A. J., Inahazion, T., \asslavil, C.,
Bogdanovic, N., Androason, N., BaLsnan, S., Marcusson, J., Nagga, K., \allin, A., Rogland,
B., Clolsson, H., Hosso, C., Iavidsson, I., MinLhon, L., Jansson, A., IalnqvisL, L. and
Ryno, L. (2000} 1 Neural Transm, 10, 1065-9.

IdsLrn Ildor, I. (2002} heochromocytoma and abdominal paraganglioma . clinical and
genetic aspects, Karolinsla insLiLuLoLs lill., SLoclholn.

Inlon, M., \ang, I. Z., Irodrilson, S., MarLin, C., Iahl, H. and Lindo, A. (1999} Clin
Diagn Lab lmmunol, 6, 545-9.

Grodzinsly, I., Ivarsson, A., JuLo, I., Clcon, I., IalLh-Magnusson, K., Iorsson, L. A. and
Hornoll, C. (2001} Clin Diagn Lab lmmunol, 8, 564-0.

Holnlorg, M., McGill, S., Ihronlorg, C., \osslon, L., Hjoln, I., Iarolid, J., Blad, L.,
IngsLrand, L., Rognory, R. and Irinan, G. (1999} 1 Clin Microbiol, J, 1J81-4.
LindqvisL, R., Londahls, L., Tolllon, C., Alorg, H. and Halansson, A. (2002} Acta Cbstet
Cynecol Scand, 81, 240-4.

LundsLan, I., HorliLz, J., Karlsson, T., Lindon, T. and \illund, C. (2002} 1 lntern Med,
251, 111-8.

Nilsson, A., Io MiliLo, A., IngsLron, I., Nordin, M., NariLa, M., Grillnor, L., Chiodi, I. and
Bjorl, C. (2002} ediatrics, 109, o91.

Iorsson-Moschos, M. I., SLavonov, L., Alosson, B. and Lindgardo, I. (2000} Nutr Cancer,
J6, 19-26.

Roy, A., Rylandor, G., Iorslund, K., Aslorg, M., MazzanLi, C. M., Goldnan, I. and
Niolson, I. A. (2001} Neuropsychobiology, 4J, 2JJ-6.

SLaLLin, I., Bylund, A., Rinaldi, S., Biossy, C., Iochaud, H., SLonnan, I. H., Igovad, L.,
Riloli, I., Hallnans, G. and Kaals, R. (2000} 1 Natl Cancer lnst, 92, 1910-.

\allin, K. L., \illund, I., AngsLron, T., Borgnan, I., SLondahl, I., \adoll, G., Hallnans,
G. and Iillnor, J. (1999} N ngl 1 Med, J41, 16JJ-8.
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5J-.

49
Magnus Kaijser

\orochovsly, I., Kralovicova, J., Laycocl, M. I., \olsLor, A. I., Marsh, S. G., Madrigal, A.
and HannarsLron, L. (2001} ur 1 Hum Cenet, 9, 590-8.
50
Clinical Cenomics Companies and Liobanls

4

Clinical genomics companies and biobanks
The use of biosamples in commercial research on the genetics of common diseases

Associate rojessor 1ens LaageHellman

Chalmers University oj Technology
and lnstitute jor Management oj lnnovation and Technology (lMlT)

harmaceutical and diagnostics companies are increasingly interested in using human
biobanls in searching jor diseasepredisposing genes and related targets jor drug and
marler development. Direct cooperation betueen industrial jirms and academic scientists
is one uay oj commercially using biosamples collected by public institutions. Another
option, dealt uith in the present chapter, is indirect cooperation uith a genomics company
acting as an intermediary. Three such commercialisation ventures have been studied.
deCode Cenetics in lceland, Cxagen in the UK, and UmanCenomics in Sueden. The
study, using a netuorl approach, compares the three cases jrom an organising perspective.
The analysis addresses a number oj economic, ethical and legal issues that need to be
considered by those involved in the commercialisation oj biobanls. Due partly to
contextual dijjerences, it is impossible to identijy one single best uay oj organising
commercialisation ventures oj this lind. Nonetheless, the results oj the study provide
important insights and lessons that should be usejul uhen choosing or developing solutions
jor a specijic venture.

1. Introduction

In AugusL 1996, doCodo GonoLics, a vonLuro-caiLal-linancod lioLoch sLarL-u
socialising in hunan gonoLics, vas loundod on Lho iniLiaLivo ol Icolandic clinical
nourologisL Kari SLolansson and his Harvard Modical School colloaguo Joll Gulchor.
Tho lasic idoa vas Lo conducL rosoarch inLo Lho inhoriLod causos ol connon disoasos
ly using corLain uniquo qualiLios ol Lho Icolandic oulaLion. Tho rosulLs in Lho lorn
ol lnovlodgo concorning nov disoaso gonos and drug LargoLs, and rolaLod sorvicos,
voro Lo lo sold Lo Lho harnacouLical indusLry and Lho hoalLh caro socLor. A yoar
and a hall laLor, doCodo signod a lroalLhrough collaloraLivo agroononL viLh
I.Hollnann-La Rocho, vhich could lring in as nuch as MISI 200 in rosoarch
lunding and nilosLono aynonLs, and royalLios on luLuro drug salos on Lo ol LhaL.
doCodo grov raidly ovor Lho lolloving yoars, and ly nid-2002 iL had 650
onloyoos, nainly in Icoland, and had roachod ovor MISI J0 in annual rovonuo.
51
1ens LaageHellman
doCodo vas noL Lho lirsL lioLoch conany Lo uso collocLions ol hunan liological
naLorial (liolanls"
1
} lor drug rosoarch. BuL iL soon locano ono ol Lho largosL
vorldvido and iL cano Lo aLLracL a loL ol inLornaLional aLLonLion (nainly Lhanls Lo a
liconco lron Lho Icolandic govornnonL giving iL oxclusivo righLs Lo luild and ooraLo
a hoalLh caro daLalaso covoring Lho onLiro Icolandic oulaLion}. Sovoral oLhor
clinical gononics conanios" viLh sinilar lusinoss idoas voro lornod during Lho
lolloving yoars, noL loasL in Iuroo, vhich had loon lagging lohind Lho IS in Lho
connorcialisaLion ol gono Lochnology and oLhor nodorn lioLochnologios. IL vas
vidoly loliovod LhaL Iuroo ollorod noro lavourallo condiLions Lhan Lho IS lor
conducLing rosoarch on hunan liolanls, osocially viLh lanily-lasod aroachos.
2

In 199, lor oxanlo, Cxagon vas loundod in Lho IK ly a grou ol Cxlord
scionLisLs. Tvo yoars laLor, in 1999, InanGononics vas osLallishod in Svodon lor
Lho uroso ol connorcialising an oxisLing oulaLion-lasod liolanl. Moro
roconLly, a sinilar conany vas loundod in IsLonia, linlod Lo a naLional gonono
rosoarch rojocL.
This chaLor locusos on clinical gononics conanios as an inLornodiary
loLvoon Lho harnacouLical and diagnosLics indusLry
J
and Lho ullic socLor,
rorosonLod ly univorsiLios and hoalLh caro insLiLuLions. Tho Lvo laLLor caLogorios
rovido Lho gononics conanios viLh liosanlos, vhich aro usod in connorcial
rosoarch rojocLs. In Lho noxL socLion lolov, sono lasic loaLuros ol clinical gononics
conanios vill lo rosonLod. In Lho Lhird socLion, a nunlor ol inorLanL issuos
rolaLod Lo Lho connorcialisaLion ol liolanls aro idonLiliod. This is lollovod ly a
shorL noLo on Lho noLhodology usod in Lho sLudy on vhich Lho rosonL chaLor is
lasod. NoxL cono Lhroo shorL caso doscriLions (doCodo GonoLics, Cxagon, and
InanGononics}, vhich aro sulsoquonLly analysod. A coulo ol shorL ronarls
concludo Lho chaLor.

2. The clinical genomics company: some features

As oxonliliod in Lho inLroducLion, doCodo and oLhor sinilar conanios rorosonL a
raLhor nov olononL in Lho raidly groving lioLochnology indusLry. Tho lioLoch
indusLry, according Lo Lho lroad doliniLion connonly usod Loday, consisLs ol a raLhor
hoLorogonoous grou ol lusinossos. Cno loaLuro connon Lo all is LhaL Lhoy aro
scionco-lasod and Lhoroloro Lond Lo havo closo rolaLionshis viLh acadonic and oLhor
scionLilic insLiLuLions. Tho laLLor roduco nuch ol Lho nov lnovlodgo and nov
Lochnologios LhaL aro connorcialisod ly Lho lioLoch indusLry. IL is osLinaLod LhaL

1
Biolanls aro dolinod as sLrucLurod collocLions ol liological naLorial, such as Lissuos socinons and
llood sanlos and oxLracLod INA. Cno can disLinguish loLvoon hoalLh caro-lasod (or clinical}
liolanls croaLod lor diagnosLic urosos and rosoarch-lasod liolanls croaLod socilically lor Lho
uroso ol rosoarch. A Lyical oxanlo ol clinical liolanls is Lho aLhology archivos, vhich olLon
conLain largo nunlors ol Lissuo socinons collocLod ovor a long oriod ol Lino. Tho hoalLh caro-lasod
liolanls aro sonoLinos also usod lor scionLilic urosos. Tho rosoarch-lasod liolanls can lo oiLhor
disoaso-socilic or collocLod lron a oulaLion, o.g., lor Lho uroso ol rosocLivo sLudios.
2
Ior oxanlo, Iurooan counLrios Lond Lo havo LighLor lanily grouings, ullicly linancod hoalLh
caro, and conLralisod nodical rocords. Conarod Lo Lho IS, Lhoro is also loss oLhnical divorsiLy and
goograhical sroad.
J
Ior Lho salo ol sinliciLy, Lho Lorns harnacouLical indusLry and harnacouLical conany as usod in
Lhis chaLor vill also includo lirns socialising in diagnosLics.
52

Lhoro aro sono 4,J00 lioLoch conanios vorldvido. Tho IS is Lho undisuLod
vorld loador. In 2001, Lhoro voro 1,45J conanios onloying 141,000 oolo and
viLh rovonuos oxcooding BISI 25. By conarison, Iuroo had 1,89 lioLoch
conanios, luL Lhoy voro snallor Lhan Lhoir IS counLorarLs, onloying around
J4,000 oolo and viLh salos LoLalling BISI .5 .
4
Tho largosL nunlor ol conanios
can lo lound in Lho IK and Gornany, lollovod ly Iranco and Svodon.
AlLhough Lho oLonLial liolds ol alicaLion aro nunorous, Lho nain locus ol
Lho lioLoch indusLry has loon on nodicino in arLicular drugs and diagnosLics,
vhoro Lho lusinoss oorLuniLios havo loon orcoivod Lo lo Lho nosL lucraLivo. In
oLhor vords, sinco long conanios socialising in drug discovory and dovolononL
consLiLuLo Lho coro ol Lho lioLoch indusLry (aroxinaLoly hall ol Lho conanios}.
In Lho 1990s, rogross in gononics, such as Lho gonono soquoncing rojocLs
and Lho onorgonco ol nov ollicionL Lools lor gonoLics rosoarch (o.g., INA chis}, lod
Lo incroasing inLorosL in using gononics as sLarLing oinL lor drug dovolononL
rolaLod noL only Lo Lho so-callod inhoriLod (nonogonoLic} disoasos luL also Lo
connon, conlox (nulLi-lacLorial} disoasos. IL vas oxocLod LhaL gononics
rosoarch, carriod ouL on nodol organisns and hunans, vould lo an ollocLivo vay Lo
idonLily disoaso-rodisosing gonos and rolaLod liological LargoLs lor dovolononL ol
nov gononics-lasod" drugs and diagnosLic narlors. SniLhKlino Boachan`s MISI
125 invosLnonL in Hunan Gonono Scioncos in 199J is olLon rogardod as Lho lirLh
ol Lho gononics indusLry". Sinco Lhon, a largo nunlor ol gononics lirns havo loon
loundod, osocially in Lho IS, lasod on Lho lusinoss idoa ol linding disoaso gonos
and solling Lho rosulLs Lo Lho harnacouLical indusLry. Tho soquoncing ol Lho hunan
gonono accoloraLing Lovards Lho ond ol Lho docado did nuch Lo onhanco loLh
inLorosL and oxocLaLions. Iroviously, Lho harnacouLical indusLry had had sono 500
lnovn LargoL roLoins Lo vorl viLh. IL vas oxocLod LhaL Lhanls Lo Lho soquoncing
ol Lho hunan gonono sovoral Lhousands ol nov LargoLs vould lo idonLiliod during
Lho coning yoars. AlLhough iL vas voll undorsLood LhaL iL nighL Lalo u Lo Lon yoars
lor Lho lirsL gononics-lasod drug Lo aoar on Lho narloL, analysLs osLinaLod LhaL
LvonLy yoars laLor 20-J0 or conL ol all nov drugs vould lo ol LhaL caLogory (soo,
o.g., Red Herring, 2000}.
Iarallol Lo Lhis dovolononL, loading drug discovory conanios such as
Millonniun IharnacouLicals and Gonzyno, as voll as sovoral ol Lho largo harna-
couLical conanios, havo Lo varying dogroos incororaLod gononics in Lhoir rosoarch
sLraLogios.
As nonLionod in Lho inLroducLion, a snall nunlor ol gononics conanios
havo choson a clinical (or hunan} gononics aroach", vhich noans LhaL Lhoir
rosoarch is lasod on collocLions ol hunan liological naLorial. IL can lo disoaso-
socilic collocLions or, noro raroly, largo oulaLion-lasod liolanls. In Lhis caLogory
ol gononics lirns vo lind, lor oxanlo, Ardais, INA Scioncos, IzGonos, Gononics
CollaloraLivo, Myriad GonoLics and Soquonon, all ol vhich aro IS lirns. Signal
Gono and Novloundland Gononics aro Lvo Canadian conanios vorling in Lho
sano liold. Bosidos Lho Lhroo alovo-nonLionod Iurooan conanios dodicaLod Lo
clinical gononics, GonsoL in Iranco can lo nonLionod as an oxanlo ol a najor
Iurooan gononics conany LhaL is using liolanls. Gonini Gononics in Lho IK
usod Lo lo a najor layor in Lho liold, luL a coulo ol yoars ago iL vas acquirod ly

4
Tho liguros aro Lalon lron a roorL ullishod ly IrnsL & Young (2002}.
53
1ens LaageHellman
Soquonon, and Lho Lvin-lasod liolanl naLorial vas Lranslorrod Lo Lho IS. Boloro
LhaL haonod Gonini had acquirod Iurona Modical in Svodon, vhich vas a
ionoor in harnacogononics and a usor ol sovoral ullic liolanls. IL is nov a
sulsidiary ol Soquonon. IndoulLodly, Lhoro aro oLhor snall lioLoch conanios in
Iuroo, such as IsLonian Igoon, Svodish Aroxis and Icolandic I\S, vhich uso
clinical gononics, luL Lo Lho auLhor`s lnovlodgo Lhoro is no ullic daLa availallo on
Lhis arLicular indusLry.

2.1 The use of biobanks
ScionLilic aroachos Lo gononics vary. BoLh in acadonia and indusLry, nuch ol Lho
rosoarch is carriod ouL on nodol organisns and coll culLuros. Hovovor, as an
alLornaLivo and conlononL Lho uso ol hunan (or clinical} aroachos has gainod
nononLun during roconL yoars arLly as a rosulL ol Lho naings ol Lho hunan
gonono and gonoLic varialiliLy anong individuals. As alroady oxonliliod, sovoral
lioLoch conanios havo loon osLallishod lasod on Lho socilic idoa Lo uso rosoarch
on liolanls as a noans Lo idonLily disoaso gonos. Hovovor, Lho nunlor ol such
lirns is rolaLivoly liniLod, and Lhoy aro cloarly in Lho ninoriLy anong Lho lioLoch
lirns involvod in drug rosoarch.
Tho sLraLogios ursuod ly clinical gononics conanios vary a loL viLh rogard
loLh Lo hov Lhoy goL accoss Lo liosanlos and hov Lho rosulLs aro connorcialisod.
Sono conanios, nainly in Lho IS as iL soons, luild u Lhoir ovn liolanls, lor
oxanlo, ly collocLing sanlos and inlornaLion lron sicl or hoalLhy individuals
sonoLinos luL noL alvays via Lho hoalLh caro socLor (soo liguro 1}. CLhors chooso Lo
vorl viLh sanlos lron oxLornal liolanls lolonging Lo univorsiLios, rosoarch
insLiLuLos or hosiLals (soo liguro 2}. This soons Lo lo a connon nodol osocially in
Iuroo.

Figure 1. Genomics company with its own biobank

54

Figure 2. Genomics company without its own biobank

2.2 Exploitation of the research results
\hon iL conos Lo oxloiLing Lho rosoarch rosulLs, lusinoss nodols and sLraLogios
dillor lron ono clinical gononics conany Lo anoLhor. Sono ol Lhon havo choson Lo
lo uro rosoarch conanios solling lnovlodgo Lo harnacouLical and diagnosLics
conanios usually Lhrough collaloraLivo and liconco agroononLs. In sono casos,
Lho indusLrial arLnor conos in oarly in Lho rosoarch rocoss as a linancior and olLon
also as an acLivo arLicianL in Lho scionLilic vorl. In oLhor casos, Lho arLnor conos
in aL a laLor sLago, vhon Lho rosoarch has alroady roducod sono ronising rosulLs,
such as Lho idonLilicaLion ol chronosonal linlago rogions or Lho locaLion or isolaLion
ol a disoaso gono. Ior Lho cusLonor, Lho laLLor arrangononL noans a lovor risl, luL
on Lho oLhor hand Lho rico is usually highor.
Thon again, sono rosoarch conanios go lurLhor Lhan oLhors in Lho
innovaLion rocoss. Cno oLion, originally lollovod ly nany conanios is Lo
conconLraLo on gono hunLing", LhaL is, Lho idonLilicaLion and validaLion ol disoaso
gonos. Tho Lrond nov is lor gononics conanios, noL loasL Lhoso dodicaLod Lo clinical
gononics, Lo inLograLo lorvard inLo drug LargoLs, load sulsLancos, candidaLo drugs,
and ovon inLo clinical Lrials, carriod ouL oiLhor in-houso or in collaloraLion viLh
indusLrial arLnors. In oLhor vords, Lhoy aro shilLing Lhoir lusinoss sLraLogy in Lho
dirocLion ol loconing roal" drug dovolononL conanios. This Lrond has cono as a
rosonso Lo Lvo Lyos ol changos in Lho onvironnonL. IirsL, Lho lig harnacouLical
conanios, loing undor rossuro lron Lho linancial narloLs Lo sood u grovLh, aro
rinarily looling lor rosoarch rosulLs LhaL can lo Lurnod inLo nov narloLallo
roducLs as quiclly as ossillo. Thoroloro, nany gononics conanios havo
oxorioncod rolucLanco on Lho arL ol oLonLial cusLonors Lo goL ongagod in oarly
sLago rojocLs. Socond, Lhoro is groving avaronoss in Lho scionLilic connuniLy LhaL
linding good LargoLs on Lho lasis ol gononics nighL noL lo as oasy as iL vas LhoughL
sono yoars ago. Thoro is a nood lor dooor lnovlodgo alouL Lho liological aLhvays
Lhrough vhich Lho gonoLics, in conlinaLion viLh onvironnonLal lacLors, causo
55
1ens LaageHellman
disoaso. This nalos oLhor noarly lio-scionLilic rosoarch liolds, such as roLoonics
and noLalolonics, inorLanL Lools in Lho soarch lor luncLionally validaLod drug
LargoLs.
Sono gononics-orionLod lioLoch lirns go ono sLo lurLhor ly dovoloing,
roducing and narloLing Lhoir ovn nodical roducLs (insLoad ol liconsing ouL
rosoarch rosulLs}. Ior oxanlo, Myriad GonoLics in Lho IS has locono lanous lor iLs
aLonLod lroasL cancor LosLs, viLh vhich Lho conany is Lrying Lo nonooliso Lhis
lind ol diagnosLic LosLing.
5
CLhor lirns, such as Lho roviously nonLionod Hunan
Gonono Scioncos, aro sLriving Lo locono harnacouLical lirns.
Thoro aro sono conanios LhaL havo choson Lo socialiso in solling
inlornaLion conLainod in rorioLary gononic daLalasos. Tvo oxanlos lron Lho IS
aro Colora Gononics and IncyLo. Tho lornor locano lanous lor iLs conLriluLion Lo
Lho soquoncing ol Lho hunan gonono. Hovovor, Colora is nov rodirocLing iLs nain
lusinoss locus lron inlornaLion solling Lo loconing a gononics-lasod harna-
couLical conany.

2.3 The role as intermediary
As has alroady loon oxlainod, Lho ond-usors ol Lho lnovlodgo roducod ly Lho
gononics conanios aro Lho harnacouLical conanios. Thoy dovolo, nanulacLuro
and narloL Lho linal roducLs (drugs and diagnosLic LosLs}. Thoy also conducL Lhoir
ovn oxloraLory rosoarch as a lasis lor roducL dovolononL, and nany ol Lhon
havo includod gononics as ono aroach Lo drug discovory.
6

As vo havo soon, hunan liolanls consLiLuLo an inorLanL rosourco LhaL,
doonding on Lho scionLilic sLraLogy choson, can lo usod ly Lho harnacouLical
conanios in Lhoir soarch lor disoaso gonos and drug LargoLs. This lind ol rosoarch
luilds noL only on Lho sanlos sLorod in Lho liolanls. Thoro is also a nood lor
inlornaLion alouL Lho donors ol Lho sanlos. This nay lo clinical inlornaLion, such
as daLa conLainod in nodical rocords, and inlornaLion alouL lilosLylo and oLhor
onvironnonLal lacLors. Co-ooraLion viLh hysicians and clinical rosoarchors can lo
ono vay ol gaining accoss Lo sanlos and inlornaLion.
A rovious sLudy viLhin Lho rosonL rojocL shovod LhaL in Svodon
harnacouLical and lioLoch conanios, viLh lov oxcoLions, havo noL invosLod
rosourcos in luilding u liolanls ol Lhoir ovn.
InsLoad, Lhoy havo choson Lo

collaloraLo viLh acadonic rosoarchors having sinilar inLorosLs (i.o. undorsLanding Lho
nolocular nochanisns lohind corLain disoasos}. According Lo Lho LradiLional nodol
ol univorsiLy-indusLry collaloraLion, Lhoso lirns linancially suorL sLudios carriod
ouL ly Lho acadonics. This givos Lhon Lho oorLuniLy Lo aLonL Lho rosulLs and uso
Lho invonLions lor Lho uroso ol inLornal roducL dovolononL (olLon according Lo
Lho righL ol lirsL rolusal rincilo}. And Lhoy can do so viLhouL having dirocL accoss
Lo liolanls. AlLhough Lhis co-ooraLion is highly valuod, harnacouLical conanios

5
Myriad GonoLics, lasod in SalL Lalo CiLy, has collocLod a largo nunlor ol sanlos lron Lho vory
disLincLivo Mornon connuniLy in ILah. Lilo Lho Icolandors, Lho Mornons aro culLurally conniLLod
Lo gonoalogy. (Soo, o.g., Roso, H. 2001, . 8}
6
Tho goal ol drug discovery, consisLing ol an oxloraLory and an oLinisaLion rosoarch haso, is Lo
roduco CandidaLo Irugs. Tho sulsoquonL drug development sLarLs viLh a ro-clinical dovolononL
haso, loading Lo an InvosLigaLional Nov Irug, vhich goos inLo clinical LosLing and rogisLraLion.
Laago-Hollnan, J. 2001a and l.

56

nay sonoLinos also lilo Lo uso sanlos in inLornal rosoarch rojocLs, vhich aro noro
closoly linlod Lo Lhoir roducL dovolononL.
This direct lorn ol co-ooraLion is Lho doninanL nodol lor Lho indusLrial uso
ol liolanls in Svodon, and rolally also in oLhor counLrios (ibid.}. BuL as vo havo
alroady soon, Lhoro oxisLs an alLornaLivo nodo ol co-ooraLion vhich can lo
characLorisod as indirect. This occurs vhon Lhoro is a clinical gononics conany
acLing as an inLornodiary loLvoon acadonic and hoalLh caro insLiLuLions on Lho ono
sido and harnacouLical conanios on Lho oLhor. IL is Lho gononics conany LhaL
has dirocL conLacL viLh hoalLh caro rovidors and clinical rosoarchors, and lron
vhich Lhoy gain accoss Lo liosanlos and inlornaLion. Tho rosoarch on Lho liolanl
naLorial is carriod ouL oiLhor ly Lho gononics conany iLsoll or as a noro or loss
closo collaloraLion viLh acadonic rosoarchors. Tho lunding nay cono lron Lho
gononics conany or a cusLonor.
IirocL co-ooraLion is a voll-osLallishod and ollicionL vay lor harna-
couLical conanios Lo gain accoss Lo lnovlodgo LhaL can lo dorivod lron liolanl
rosoarch. In casos vhoro Lho indusLrial arLnor doos noL vorl viLh Lho liosanlos,
Lho connorcial olononL in Lho (indusLry-sonsorod} rosoarch is lairly unrollonaLic
viLh rogard Lo liolanl uso. AL loasL, Lho oLhical rollons concornod viLh Lho
roLocLion ol Lho donors` rivacy aro noL vory dilloronL lron Lhoso in nornal
acadonic rojocLs (o.g., Lhoro is no risl ol inlornaLion alouL individuals loing
assod on Lo Lho conany}. Hovovor, lor a lov yoars nov harnacouLical
conanios havo shovn incroasing inLorosL in using liosanlos in noro aliod
sLudios noro closoly linlod Lo Lho inLornal drug discovory rogrannos. Cno
concoivallo soluLion is ol courso Lo goL naLorial lron liolanls ooraLod ly
univorsiLios or hoalLh caro insLiLuLions. AnoLhor soluLion is indirocL co-ooraLion, LhaL
is, Lhrough sono gononics conany. IL soons LhaL Lhis nodol lor indusLrial
uLilisaLion ol liosanlos coning lron Lho ullic socLor is onorging as an inorLanL
conlononL Lo dirocL co-ooraLion. Tho osLallishnonL ol sovoral clinical gononics
conanios sinco Lho nid-1990s suorLs Lho assunLion LhaL Lhoro is such a Lrond.
Noodloss Lo say, Lho connorcial uso ol liolanls croaLod in Lho ullic socLor
raisos a nunlor ol issuos. As discussod in noro doLail in oLhor chaLors ol Lhis lool,
Lho uso ol liolanls lor rosoarch urosos, gonorally soaling, noans LhaL dilloronL
inLorosLs havo Lo lo lalancod in ordor Lo uso liolanls in vays LhaL aro loLh
ollicionL and oLhically accoLallo. Thoro aro noL only oLhical luL also logal, social and
ocononic issuos LhaL havo Lo lo doalL viLh ly Lhoso involvod in dilloronL caaciLios.
In Lho noxL socLion, sono inorLanL issuos LhaL aro arLicularly rolovanL Lo Lho rolo ol
clinical gononics conanios in liolanl connorcialisaLion vill lo idonLiliod.

3. The commercial use of biobanks: important issues

Tho ovorall quosLion addrossod in Lhis chaLor is hov losL Lo organiso, in a lroad
sonso, Lho connorcialisaLion ol liolanls Lhrough clinical gononics conanios. LoL
us lirsL osLallish LhaL Lhis is noL an oasy quosLion Lo ansvor. \o havo a conlox
honononon Lo doal viLh. IirsL, Lhoro aro nany inLorosLod arLios, viLh arLly
conllicLing inLorosLs, involvod in Lho connorcialisaLion rocoss. Sono ol Lho acLors
aro individuals, such as donors ol Lho liosanlos, hysicians, acadonic rosoarchors,
local oliLicians, and oolo vho havo invosLod in Lho gononics conany. CLhor
57
1ens LaageHellman
acLors aro organisaLional, such as hosiLals, univorsiLios, conanios, rosoarch-lunding
agoncios, insLiLuLional invosLors, and rogulaLing auLhoriLios. Socond, Lho quosLion ol
hov Lo organiso Lho connorcialisaLion ol liolanls has ocononic as voll as oLhical,
logal and social asocLs.
As a LhooroLical sLarLing oinL, iL is assunod LhaL Lho connorcialisaLion Lalos
laco in a noLvorl ol rolaLionshis, viLhin vhich various acLors inLoracL viLh oach
oLhor.
8
Soo liguro J, vhich schonaLically illusLraLos hov Lho dilloronL Lyos ol acLors
aro rolaLod in Lho liolanl connorcialisaLion noLvorl". Tho rolaLionshis, vhich
nay lo noro or loss long lasLing, luncLion as channols lor oxchango and Lranslor ol
valuallo rosourcos. Sono ol Lho rolaLionshis conLain a lusinoss oxchango, oLhors do
noL.

Figure 3. Actors and relationships in the biobank commercialisation network

58

8
Tho LhooroLical lranovorl lor Lho sLudy is a noLvorl aroach, vhich has rovod Lo lo a usolul Lool
lor analysing indusLrial innovaLion rocossos. Soo Laago-Hollnan, J. 200J lor noro doLails.

Tho liolanl uniL" in Lho liguro is an acLor rosonsillo lor collocLing, and olLon also
sLoring and using, liosanlos. IL can lo an acadonic rosoarch grou (or ovon an
individual scionLisL}, a univorsiLy doarLnonL, a clinic or hosiLal laloraLory, an
individual hysician, or a social organisaLion onLrusLod viLh adninisLoring ono or
sovoral liolanls. IL is Lho liolanl uniL LhaL has conLacL viLh Lho donors (o.g.
aLionLs}. In nosL casos Lho liolanl uniL consLiLuLos arL ol a largor organisaLion,
such as a hosiLal or a univorsiLy. Bosidos oLhor uniLs in Lho organisaLion LhaL uso
sanlos lor rosoarch, Lho liolanl uniL nay havo inorLanL rolaLionshis viLh oLhor
Lyos ol uniL, discharging lor oxanlo adninisLraLivo and nanagorial luncLions.
Sono ol Lho acLors concornod viLh connorcialisaLion, such as rogulaLory
auLhoriLios and local oliLicians, nay noL havo dirocL rolaLionshis viLh oLhor acLors
in Lho noLvorl. InsLoad, Lhoy nay allocL Lho rocoss ly naling lavs and rogulaLions
or ly oLhor noans inlluoncing Lho acLors dirocLly involvod.
As onhasisod in Lho liguro, Lho rolaLionshi loLvoon Lho liolanl uniL and
Lho gononics conany is conLral Lo connorcialisaLion. This local rolaLionshi linls
Lho Lvo loy acLors, rosonsillo lor collocLing Lho sanlos and using Lhon lor
connorcial rosoarch rosocLivoly. IL should lo noLod LhaL a gononics conany can
havo arallol rolaLionshis viLh sovoral liolanl uniLs. Ivory such uniL in Lurn nay
havo rolaLionshis viLh oLhor gononics conanios.
Cn Lho lasis ol Lho lranovorl illusLraLod in liguro J, sovoral inorLanL
organisaLional issuos can lo idonLiliod viLh rogard Lo Lho local rolaLionshi and Lho
Lvo loy acLors, LhaL is, Lho liolanl uniL and Lho clinical gononics conany.

3.1 Organising the focal relationship
Tho nain raLionalo lor osLallishing Lhis lind ol rolaLionshi is Lo givo Lho gononics
conany accoss Lo liosanlos and rolaLod inlornaLion, Lo lo usod in connorcial
rosoarch rojocLs. A loy quosLion is Lhoroloro on uhat conditions the company gains
this access. Basod on Lho oxorioncos lron Lho connorcialisaLion vonLuros oxaninod
in Lho rosonL sLudy, Lho lolloving noro socilic issuos havo loon lound Lo lo ol
inorLanco:

\ho has Lho righLs ol disosal ovor Lho sanlos and Lho liolanl

\haL aro Lho ocononic condiLions lor Lho Lranslor and uso ol sanlos
To vhaL oxLonL is Lho conany givon oxclusivo righLs Lo connorcialiso sanlos
and rosoarch rosulLs
Hov do lavs and rogulaLions allocL Lho rolaLionshi (o.g., Lho conLonL ol Lho
agroononL loLvoon Lho arLios}
\haL aro Lho rouLinos and rulos according Lo vhich Lho Lranslor Lalos laco

Tho ansvoring ol Lhoso quosLions roquiros considoraLion ol ocononic, oLhical as voll
as logal asocLs. BuL all uso ol liolanls lor rosoarch, including Lho connorcially
orionLod lind, also givos riso Lo oLhor ethical questions concorning hov Lo roLocL Lho
rivacy and inLogriLy ol Lho donors. Tho lolloving noro socilic issuos havo loon
idonLiliod:

\hich noLhods aro usod Lo onsuro LhaL inlornaLion alouL Lho donors is noL
nisusod or assod on Lo unauLhorisod orsons
59
1ens LaageHellman
Hov aro Lho inLorosLs ol Lho donors roLocLod In arLicular, vhaL Lyo ol
inlornaLion and consonL rocoduro is aliod Hov can Lho donors inlluonco Lho
Lyo ol urosos lor vhich Lho sanlos aro usod

Hov is socioLy`s inLorosL in using liolanls as ollicionLly as ossillo lor rosoarch
lalancod againsL Lho inLorosLs and vishos ol Lho individual donors

3.2 Organising the biobank unit and the genomics company
Tho division oj labour loLvoon dilloronL acLors in Lho noLvorl, and osocially
loLvoon Lho liolanl uniL(s} and Lho clinical gononics conany, is an inorLanL
issuo. Ivon il Lho lasic rolo ol Lho conany as a lridgo Lo Lho harnacouLical
indusLry is givon, Lho acLiviLios and rosourcos can lo variously organisod. Ior
oxanlo, iL is noL alvays ovidonL vho should carry ouL a corLain sLo ol Lho scionLilic
vorl. A rolaLod quosLion is vhoro Lho nocossary rosourcos, such as laloraLory
oquinonL and socilic slills, should lo locaLod. Thus:

\hich liolanl-rolaLod acLiviLios aro carriod ouL ly Lho liolanl uniL and Lho
gononics conany rosocLivoly (CuLsourcing Lo a Lhird arLy is anoLhor ossillo
soluLion.}
\hich rosourcos do Lho Lvo acLors havo in-houso

IL vill lo roadily undorsLood LhaL Lho division ol lalour aliod in a corLain vonLuro
allocLs Lho characLorisLics ol Lho local rolaLionshi LhaL linds Lho Lvo acLors. BuL Lho
aLLorn ol socialisaLion in Lho noLvorl also has consoquoncos lor Lho internal
organising oj the biobanl unit and the genomics company rosocLivoly, vhich vo vill
nov Lurn Lo considor.
Thoro aro a nunlor ol organisaLional and nanagononL issuos LhaL aro
rolovanL lron Lho viovoinL ol liolanl connorcialisaLion:

Iinancing, ovnorshi and conLrol ol Lho uniL/conany
CrganisaLion and nanagononL sLrucLuro
Gonoral visions, goals and anliLions rogarding luLuro dovolononL
ScionLilic goals and sLraLogios (o.g. aroach Lo gonoLic sLudios}
MarloLing sLraLogy (o.g. vho aro Lho LargoL usors/cusLonors}

All Lhoso issuos aro ol rolovanco Lo loLh Lho liolanl uniL and Lho conany, luL in
slighLly dilloronL vays.

3.3 The performance of biobank ventures
Tho variallos discussod alovo can lo usod Lo characLoriso a corLain
connorcialisaLion vonLuro involving a clinical gononics conany and ono or noro
liolanl uniLs. Ioonding on hov Lho vonLuro is organisod, Lho ouLcono vill vary.
Iorlornanco can lo noasurod in dilloronL dinonsions vhich Lo varying dogroos aro
rolovanL Lo Lho inLorosLod arLios (soo liguro 4}. InorLanL variallos aro scionLilic
rosulLs (lnovlodgo croaLion}, connorcial and ocononic succoss ol Lho conany,
ollocLs on hoalLh caro, and ollocLs on local indusLrial dovolononL and grovLh.
IurLhornoro, Lhoro nay lo dilloronL social ollocLs" concornod, lor oxanlo, viLh
hov Lho ciLizons (rinarily Lho donors and Lhoir rolaLivos} aro allocLod ly Lho
connorcialisaLion.
60

Figure 4. The performance of commercialisation ventures

Clviously, dilloronL acLors havo dilloronL inLorosLs in Lho vonLuro and Lhoroloro
nalo dilloronL rioriLios anong Lhoso orlornanco variallos. As a consoquonco, Lho
orcoivod orlornanco dillors doonding on vho nalos Lho ovaluaLion. Ior
oxanlo, loL us say LhaL a corLain vay ol uLilising a liolanl lor indusLrial rosoarch is
scionLilically and connorcially succosslul and loads Lo inrovononLs in hoalLh caro
(Lhanls Lo nov roducLs dovolood ly Lho cusLonors ol Lho gononics conany}.
Many acLors vill orcoivo Lhis as a good rosulL. BuL il aL Lho sano Lino Lhoro aro
donors vho lool LhaL Lhoir inLogriLy is violaLod, Lhoso individuals vill noL, lron Lhoir
orsocLivos, havo a sololy osiLivo aLLiLudo Lo Lho vonLuro (ovon Lhough Lhoy nay lo
avaro ol Lho lonoliLs Lho rosoarch conlors}. CLhor acLors, such as Lho hysicians
LroaLing Lho aLionLs or acadonic rosoarchors conoLing lor Lho (liniLod} liological
naLorial, nay also lo criLical ol Lho vonLuro, lron Lhoir socilic orsocLivos. In
conclusion, Lhis varioLy ol inLorosLs has Lo lo Lalon inLo accounL vhon organising a
connorcialisaLion vonLuro.
IL nusL lo onhasisod LhaL Lho connorcialisaLion ol liolanls (and rolaLod
rosourcos} is noL a sLaLic honononon. Ivon Lhough Lho lasic sLrucLuro in a corLain
caso nay ronain lairly sLallo, Lho noLvorl is consLanLly changing as a rosulL ol
acLiviLios undorLalon ly acLors. ThaL is vhy Lho arrov in liguro 4 goos in Lvo
dirocLions. Honco, Lho acLors involvod in Lho vonLuro vill adaL Lhoir lohaviour
doonding on Lho ouLcono, and Lhis vill in Lurn allocL Lho vonLuro`s characLorisLics.
Thoro nay also lo changos in Lho vidor onvironnonL LhaL allocL Lho vonLuro,
and orlornanco. Ior oxanlo, scionLilic lroalLhroughs and Lochnological advancos
nay croaLo nov oorLuniLios LhaL Lho acLors in Lho noLvorl Lry Lo Lalo advanLago ol
lor oxanlo, ly osLallishing nov lusinossos or nov co-ooraLivo rolaLionshis.
IurLhornoro, Lho onacLnonL ol nov lavs and rogulaLions nay allocL Lho condiLions
lor corLain acLiviLios and Lhoroly load Lo various adaLaLions. As a rosulL ol such
acLions ly individual acLors, Lho noLvorl ovolvos (noro or loss raidly} in dirocLions
LhaL nay lo orcoivod as osiLivo ly sono arLios and nogaLivo ly oLhors. In oLhor
vords, Lho sLudy ol liolanl connorcialisaLion nusL lo carriod ouL in a dynanic
orsocLivo. This also noans LhaL sLrucLuros aro inorLanL as voll as rocossos.

61
1ens LaageHellman
4. The methodology of the study

Tho rosonL chaLor is lasod on a sLudy roorLod in iLs onLiroLy in a soaraLo
ullicaLion.
9
Tho coro ol Lho sLudy consisLs ol an in-doLh caso sLudy ol Inan-
Gononics, a conany croaLod lor Lho uroso ol using a oulaLion-lasod liolanl
in NorLhorn Svodon lor connorcial rosoarch. This is a ionooring vonLuro viLh
uniquo characLorisLics. IL has lov counLorarLs in oLhor counLrios as yoL, luL Lhoro is
undoulLodly groving inLorosL in oLhor arLs ol Lho vorld in sLarLing u sinilar
lusinossos. Irosunally, Lhoroloro lnovlodgo and insighLs gainod ly sLudying Lhis
vonLuro vould also lo ol rolovanco ouLsido Svodon.
As a conlononL Lo Lho InanGononics caso sLudy and as a lasis lor
conaraLivo analysis, Lvo oLhor connorcialisaLion vonLuros alroady nonLionod,
nanoly Lhoso conLrod on Cxagon and doCodo, voro also sLudiod, Lhough loss dooly.
Thoso vonLuros do noL consLiLuLo Lruo caso sLudios, sinco Lhoir dovolononL ovor
Lino has noL loon sysLonaLically oxaninod.
In Lho rosonL chaLor, saco vill noL orniL a longLhy doscriLion ol Lho
Lhroo vonLuros invosLigaLod. Tho casos" vill lo only lriolly rosonLod as a sLarLing
oinL lor Lho conaraLivo analysis vhich lollovs, doaling viLh sono ol Lho issuos
idonLiliod in Lho rocoding socLion. Ior a noro oxLonsivo doscriLion and analysis ol
Lho casos, Lho roador is rolorrod Lo Lho lull roorL (ibid.}.
Tho daLa vas collocLod nainly Lhrough inLorviovs viLh loy individuals
rorosonLing Lho conanios, liolanl uniLs and rosoarchors Lhoy co-ooraLo viLh,
and, Lo a lossor oxLonL, govornnonL agoncios and Lho lilo. AlLogoLhor, closo on lorLy
oolo voro inLorviovod, ono or sovoral Linos oach. As a conlononL, vriLLon
naLorial lron Lho liLoraLuro, Lho ross and volsiLos vas also usod.

5. deCode Genetics

5.1 Background and history
doCodo is a oulaLion-lasod gononics conany" vhoso hoadquarLors and nain
ooraLions aro locaLod in Royljavil, Icoland. As alroady sLaLod, iL vas loundod in
1996 ly Kari SLolansson and Joll Gulchor, lasod on Lho idoa LhaL Icoland ollorod
uniquo advanLagos lor rosoarch inLo Lho inhoriLod causos ol connon disoasos. Cl
arLicular inorLanco voro Lho rolaLivo honogonoiLy ol Lho Icolandic oulaLion and
Lho availaliliLy ol gonoalogical rocords daLing lacl sovoral hundrod yoars. BoLh Lhoso
circunsLancos havo loon assunod Lo laciliLaLo Lho soarch lor disoaso gonos. Tho lacLs
LhaL Icoland has had a conLralisod hoalLh caro sysLon sinco 1915 and LhaL Lho
oulaLion is voll oducaLod and gonorally has a osiLivo aLLiLudo Lo arLiciaLion in
nodical rosoarch aro oLhor advanLagos LhoughL Lo lonoliL a gononics conany.
Tho loundors had Lvo dilloronL luL inLorconnocLod oljocLivos. Tho lirsL vas
Lo osLallish a connorcial laloraLory Lo carry ouL lionodical rosoarch in Icoland. IL
vould sool collaloraLion viLh clinicians inLorosLod in socilic disoasos and having
conLacL viLh aLionLs lron vhon llood or Lissuo sanlos could lo olLainod.
doCodo dillorod lron oLhor gononics conanios using a hunan gonoLics aroach
in LhaL lron Lho vory loginning iL vas lanning Lo linl clinical and gonoLic
inlornaLion inLo Lho gonoalogios. Tho idoa vas Lo uso Lhis gonoalogic aroach Lo

9
Laago-Hollnan, J. 200J.
62

dovolo nov drugs and diagnosLic LosLs LogoLhor viLh harnacouLical conanios.
Tho socond and noro anliLious oljocLivo vas Lo consLrucL a largo, conuLorisod
daLalaso conLaining gonoLic, gonoalogical, and honoLyic inlornaLion alouL Lho
Icolandic oulaLion. IL vas LhoughL LhaL such a daLalaso vould onhanco Lho
ossililiLy ol radically ronoving Lho nanagononL and dolivory ol hoalLh caro.
Iundod ly vonLuro caiLal raisod in Lho IS, doCodo sLarLod u gono
discovory rogrannos LargoLing lorLy connon disoasos. In 1998, doCodo onLorod
inLo an inorLanL agroononL, covoring Lvolvo ol Lhoso disoasos, viLh I.Hollnann-La
Rocho (Rocho"}, a largo Sviss harnacouLical conany. Tho conLracL gavo doCodo
MISI 0 in rosoarch lunding, noro Lhan MISI 1J0 in ossillo nilosLonos and Lho
righL Lo royalLy on luLuro roducL salos.
In 2000, Lvo inorLanL ovonLs occurrod. IirsL, Lho Icolandic govornnonL
avardod Lho conany a 12-yoar liconco Lo croaLo an Icolandic HoalLh SocLor
IaLalaso (IHI}. This liconco allovod doCodo Lo collocL daLa lron nodical rocords
ol ullic hoalLh caro insLiLuLions and soll-onloyod rolossionals, and Lo Lranslor
such daLa in oncryLod lorn inLo a conLralisod daLalaso conLaining non-orsonally
idonLiliallo inlornaLion. This daLalaso vould Lhon lo usod ly doCodo, in
conlinaLion viLh gonoLic and gonoalogy daLa, as a suorL ol Lho gono discovory
rogrannos and Lo dovolo various hoalLh caro-inlornaLics sorvicos.
10
Socond,
doCodo conloLod iLs iniLial ullic olloring and locano lisLod on Lho Nasdaq and
Iasdaq sLocl oxchangos.
In January 2002, doCodo and Rocho unvoilod a nov collaloraLivo agroononL
lolloving u Lho achiovononLs ol Lho lirsL agroononL. Building on idonLiliod disoaso
gonos and drug LargoLs and locusing on lour solocLod disoasos, Lho nov haso ol Lho
allianco vas ainod aL dovoloing nov LhoraouLic conounds and Laling Lhon inLo
clinical Lrials. This shilL in locus lron gonoLic sLudios Lo drug dovolononL vas
ossillo Lhanls Lo doCodo`s oxanding laciliLios lor dovnsLroan rosoarch, ainod aL
Lranslorning doCodo lron a uro gononics conany Lo an inLograLod drug dovolo-
nonL lirn.
Thanls Lo Lho crucial agroononLs viLh Rocho and succoss in aLLracLing
vonLuro caiLal doCodo has loon allo Lo grov raidly. Iarnings in 2001 LoLallod
MISI J1.6, and in Lho nid-2002 doCodo had sono 650 onloyoos, nainly in
Icoland. Lilo nany oLhor young lioLoch lirns, doCodo vas sLill sulloring lron lig
linancial lossos (MISI 4.8 in 2001}.

5.2 The use of biobanks in deCodes research
Thanls Lo Lho IHI rojocL, and Lho conLrovorsy surrounding iL, doCodo has had
onornous ulliciLy inLornaLionally. Hovovor, ouLsido Icoland Lhoro is a groaL doal ol
nisundorsLanding. IL is noL Lruo, as nany soon Lo loliovo, LhaL doCodo has loughL
Lho oxclusivo righLs Lo Lho Icolandic gonono". In lacL, Lho daLalaso doCodo has goL a
liconco lor vill noL conLain any gonoLic daLa aL all, jusL corLain codod inlornaLion
lron Lho nodical rocords. IL is Lruo, hovovor, LhaL Lho liconco orniLs doCodo Lo

10
Tho assing in 1998 ol Lho lill granLing doCodo Lho righL Lo luild, ooraLo and connorcialiso Lho
IHI had loon rocodod ly a 9-nonLh inLonsivo ullic dolaLo. CriLicisn uL lorvard ly Lho Icolandic
Modical AssociaLion, anong oLhors, had lod Lo sovoral changos in Lho lill conarod Lo Lho original
roosal. NonoLholoss, Lho vholo rojocL around Lho IHI, and Lho rolaLod logislaLion, is sLill a suljocL
ol criLicisn and discussion donosLically as voll as inLornaLionally. Ior oxanlo, concorn has loon
oxrossod rogarding such issuos as Lho consonLing rocoduros, conlidonLialiLy, and scionLilic oonnoss.
63
1ens LaageHellman
sLaLisLically cross-roloronco daLa lron Lho IHI viLh daLa lron iLs ovn rorioLary
gonoLic and gonoalogic daLalasos. Thus, doCodo vill havo Lo croaLo gonoLic daLa ly
analysing liosanlos LhaL iL gains accoss Lo in oLhor vays. \o vill roLurn Lo Lhis
naLLor in duo courso.
IirsL, Lhough, iL has Lo lo nado cloar LhaL Lho IHI doos noL yoL oxisL. In
lacL, Lho collocLion ol daLa has noL yoL logun. Tho rocoss ol socilying Lho socuriLy
LargoLs LhaL Lho inlornaLion sysLon vill havo Lo nooL is sLill going on. IurLhornoro,
doCodo is sLill nogoLiaLing Lho condiLions lor inlornaLion accoss viLh Lho univorsiLy
hosiLal.
BuL, indoondonLly ol Lho daLalaso rojocL doCodo has a largo nunlor ol
gonoLic rosoarch sLudios going on. Thoso aro disoaso-socilic. Isually, Lho rosoarch
suljocLs, consisLing ol aLionLs and hoalLhy rolaLivos in oxLondod lanilios (idonLiliod
viLh Lho hol ol doCodo`s gonoalogy daLalaso, Tho Bool ol Icolandors"} aro
rocruiLod Lhrough collaloraLion viLh hysicians. Tho rocoduro lor solocLing Lho
arLicianLs, goLLing Lhoir inlornod consonL, Laling Lho llood sanlo, and collocLing
Lho inlornaLion is quiLo conlicaLod. IL involvos Lho NaLional BiooLhics ConniLLoo
and Lho IaLa IroLocLion AuLhoriLy. AL Lho lohosL ol Lho laLLor, doCodo has
osLallishod a social sorvico uniL, in Lho lorn ol a non-roliL organisaLion soaraLod
lron doCodo, vhich handlos Lho racLicaliLios ol collocLing sanlos and inlornaLion
and carrios ouL Lho coding rocoduros roquirod Lo roLocL Lho donors` rivacy. Tho
acLiviLios ol Lhis sorvico uniL as voll as all oLhor vorl associaLod viLh Lho collocLion
ol sanlos aro linancod ly doCodo.
As Lo Lho inlornod consonL, Lho donors havo Lvo oLions. Thoy can oL lor
Lho sanlo Lo lo usod only lor Lho sLudy in quosLion, and Lhon dosLroyod, or lor iL Lo
lo savod lor luLuro rosoarch. In Lho laLLor caso Lho sanlo vill lo sLorod in doCodo`s
ovn liolanl consisLing ol a nunlor ol sul-collocLions lor dilloronL disoasos. Accord-
ing Lo ullic sLaLononLs nado ly doCodo, 88-96 or conL ol Lho donors chooso Lhis
laLLor lorn ol consonL. doCodo nov has a LoLal ol 0,000-80,000 sanlos in iLs
liolanl.
Tho sorvico uniL also has a rolo Lo lay vhon doCodo in sono casos vishos Lo
uso Lissuo sanlos sLorod in clinical liolanls aL hosiLals. Hovovor, in Lhoso casos
doCodo is only allovod Lo carry ouL Lho lannod analysis, according Lo Lho roLocol
arovod. Thus, iL cannoL sLoro Lhis naLorial in Lho liolanl.
Tho hysicians/rosoarchors vho aro holing doCodo Lo olLain sanlos and
clinical inlornaLion can lo noro or loss acLivoly involvod in doCodo`s rosoarch. IL
soons LhaL Lho losL scionLilic rosulLs havo loon achiovod vhon doCodo has had closo
collaloraLion viLh clinical rosoarchors aL Lho univorsiLy hosiLal. AsLhna, schizo-
hronia, soriasis, rhounaLoid arLhriLis and sLrolo aro nonLionod as oxanlos ol
disoasos vhoro doCodo has succoodod voll. \hon Lhoro is collaloraLion, vriLLon
conLracLs aro signod loLh viLh Lho hosiLal and Lho individual scionLisLs involvod. IL
is sLaLod, lor oxanlo, LhaL doCodo vill covor all cosLs ol Lho sLudy. Tho conany
vill roLain all inLollocLual roorLy righLs, luL Lho hosiLal vill goL a royalLy on
ossillo rovonuos.
\hon iL conos Lo doCodo`s luLuro uso ol gonoLic daLa in connocLion viLh
Lho IHI, Lhoro is no rojocL in Icoland, as nany loroign olsorvors soon Lo loliovo, Lo
luild u a nov oulaLion-lasod liolanl (i.o. on sinilar linos Lo vhaL is dono in
IsLonia and Lho IK}. InsLoad, doCodo is lanning Lo uso daLa olLainod ly
gonoLying sanlos in Lho rosonL disoaso-lasod collocLions. Hovovor, givon Lho
64

largo nunlor ol sanlos alroady conLainod in doCodo`s oxisLing liolanl and Lho
conLinuing sanling acLiviLios, iL soons LhaL viLhin Lho noL Loo disLanL luLuro
doCodo vill in ollocL havo a liolanl covoring a vory largo roorLion ol Lho
Icolandic oulaLion.

5.3 The development of the company and the database project
doCodo has ursuod an aggrossivo grovLh sLraLogy. As nonLionod oarlior, doCodo is
nov sLriving Lo inLograLo lorvard and locono a lully-llodgod drug discovory
conany. Anong oLhor sLos, a IS conany socialising in nodicinal chonisLry and
roLoonics vas acquirod oarly in 2002. This sLraLogy is vory cosLly, and Lho
conany`s linancial lossos aro sLoadily incroasing. AL Lho sano Lino, Lho curronL
rollons on caiLal narloLs aro naling iL dilliculL Lo raiso nov oquiLy, noL loasL lor
lioLoch conanios.
11
As a consoquonco, doCodo announcod in CcLolor 2002 LhaL a
najor raLionalisaLion rogranno vould lo inlononLod. This noanL roducing Lho
LoLal vorllorco, viLh innodiaLo ollocL, lron 650 Lo 450. MosL ol Lho roducLion
concornod oolo ongagod in Lho Royljavil-lasod gonoLics rosoarch ooraLions. Tho
goal vas Lo achiovo a osiLivo cash-llov in 200J. IL vas also sLaLod LhaL, Lhanls Lo
Lho raLionalisaLion oorLuniLios ollorod ly nov auLonaLod laloraLory oquinonL,
Lho aco and lroadLh ol Lho conany`s rosoarch rogrannos vould noL lo noLally
allocLod.
Tho IHI rojocL is sLill loing ursuod ly doCodo, alLhough iL is aaronLly
noL loing ushod as hard as roviously. Ior oxanlo, runour has iL LhaL nany ol
Lhoso vorling on Lho daLalaso rojocL havo loon laid oll. doCodo is nov involvod in
long-lasLing and Lough discussions viLh Lho govornnonL rogarding Lho doLails ol Lho
rojocL lor oxanlo, hov Lo dosign Lho inlornaLion sysLon. Tho IHI AcL assod
ly Lho arlianonL in Ioconlor 1998 lacos vory sLricL donands on Lho socuriLy
soluLions (Lhis in Lurn loing a consoquonco ol Lho lacL LhaL oxliciL, inlornod
consonL lron Lho individuals vill noL lo roquirod}. IL soons LhaL Lho socuriLy LargoLs
vill lo so Lough LhaL Lho daLalaso vill noL lo as usolul as originally inLondod. This is
ono roason vhy nany Icolandors, noL vorling lor doCodo luL having good insighL
inLo Lho rocoss, doulL il doCodo is roally inLorosLod in conloLing Lho rojocL. IL is
vidoly loliovod aL rosonL LhaL Lho rojocL vill novor lo roalisod. As sovoral oolo
oinL ouL, doCodo vould noL ollicially adniL LhaL Lho IHI is givon lovor rioriLy,
sinco Lho vholo rojocL has loon usod as a loy ingrodionL in Lho conany`s narloL-
ing.
12

6. Oxagen

Cxagon (CXlord Aliod GINoLics} vas loundod in 199 on Lho iniLiaLivo ol
rosoarchors aL Lho InivorsiLy ol Cxlord and Lho \ollcono TrusL ConLro lor Hunan
GonoLics. Irolossor John Boll, ono ol Lho co-loundors and a roninonL scionLisL, had
soon Lho groaL ossililiLios in using hunan gonoLics Lo Lacllo conlox disoasos and

11
\hon doCodo vonL ullic in 2000, Lho sharo rico vas ISI 18. Nov, aL Lho ond ol 2002 Lho
rico has lallon Lo around ISI 2.
12
Cno inLorviovoo oinLod ouL LhaL doCodo has novor Lriod Lo corrocL Lho nisundorsLandings. Ho
nainLains LhaL lor Lho conany Lho inago ol having oxclusivo accoss Lo Lho onLiro Icolandic gonono is
good lron a IR and narloLing oinL ol viov.
65
1ens LaageHellman
achiovo a najor inacL on hunan hoalLh. BuL ho also undorsLood LhaL in ordor Lo
ovorcono Lho lig scionLilic challongos and Lo Lranslorn Lho lnovlodgo roducod aL
univorsiLios inLo nov roducLs holing Lo rodicL, diagnoso and rovonL disoaso, a
connorcial acLiviLy vas noodod. Thus, Lho idoa vas Lo sLarL u a rivaLo gononics
conany orlorning conlononLary rosoarch acLiviLios dirocLod aL connorcial
alicaLions. Tho conany should raiso vonLuro caiLal, acquiro largo-scalo
oquinonL, luild an ollicionL organisaLion, and osLallish collaloraLion viLh clinical
arLnors and indusLrial lirns. Tho ain ol Lho conany vould lo Lo idonLily disoaso
gonos, novol drug LargoLs, and diagnosLic narlors ly alying innovaLivo gonoLic
analysis. IaLonLs and oLhor inLollocLual roorLios rolaLod Lo Lhon, or noro idoally Lo
Lho LhoraouLic conounds, vould lo Lho conany`s nain ouLuL.
Cxagon is curronLly sLudying nino connon disoaso aroas in Lhroo najor
LhoraouLic liolds, viz., cardiovascular disoaso, inllannaLory disoaso and
noLalolic/ondocrino disordors. Tho nain scionLilic goal is Lo idonLily and validaLo
disoaso gonos ly orlorning largo-scalo lanily sLudios lasod on collocLions ol clinical
sanlos and daLa. Iron Lho loginning Lho sLraLogy has loon Lo run Lhoso gono
discovory rogrannos LogoLhor viLh loading harnacouLical conanios. Tho lirsL
rosoarch agroononL, locusing on Lho gonoLic laclground Lo coronary arLory disoaso
and lasLing lor livo yoars, vas signod viLh AsLra lron Svodon (nov AsLraZonoca} in
1998. This vas lor a long Lino Lho only connorcial arLnorshi, luL in 2002 a
sinilar agroononL on asLhna vas nado viLh Ilizor lron Lho IS.
Iron Lho vory loginning iL vas olvious LhaL Lho choson clinical gononic
aroach Lo gono discovory vould roquiro collaloraLion viLh dilloronL rosoarch
grous noL only in Cxlord luL also in oLhor lacos. Thoroloro, viLhin oach disoaso
aroa, Cxagon has solocLod ono or sovoral clinical collaloraLors conLriluLing sanlos
collocLod in Lhoir rosocLivo onvironnonLs. Today, Cxagon has co-ooraLivo agroo-
nonLs viLh noro Lhan LhirLy rosoarch conLros, nainly in Lho IK and oLhor Iurooan
counLrios.
Through Lhoso collaloraLions, Cxagon has gainod oxclusivo accoss Lo Lho
lanily collocLions lor connorcial alicaLions in LoLal J4,000 sanlos. This accoss
Lo liolanls in conlinaLion viLh Lho conany`s ovn rorioLary Lochnology
laLlorn consLiLuLos Lho cornorsLono on vhich Lho conany`s conoLiLivo ovor is
lasod.
In 2001, Cxagon had J.J nillion in rovonuo and R&I oxonsos anounLing
Lo 11. nillion. Tho rosulLing noL loss anounLod Lo 8. nillion. In Lho ond ol
2002, Lho LoLal sLall consisLod ol around 100 oolo.

6.1 PROCARDIS: an example
Tho rosoarch rojocL on coronary arLory disoaso (CAI} illusLraLos ono ol Lho casos
vhoro Cxagon is vorling viLh nulLilo conLros. Horo, lour dilloronL insLiLuLions
lron Lho IK, Gornany, ILaly and Svodon havo lornod a consorLiun callod
IRCCARIIS. Tho Loan is sooling Lo collocL and gonoLyo sono 4,000 lanilios
(aroxinaLoly 15,000 individuals} viLh Lho uroso ol linding CAI-associaLod
gono locus and isolaLo LhoraouLic LargoLs.
Nornally, Cxagon lirsL osLallishos a discovory rogranno and laLor on sools
a connorcial arLnor. Horo, lor hisLorical roasons AsLraZonoca has loon involvod
lron Lho vory sLarL and has closo dirocL conLacLs viLh Lho clinical conLros.
66

Tho lirsL sLo vas Lo sLarL collocLing sanlos and inlornaLion. As alvays, Lhis vas
dono viLh aroriaLo inlornod consonL lron Lho donors. All sanlos havo loon
codod and sonL Lo Cxagon`s laciliLios, vhoro Lhoy aro nov sLorod in a liolanl.
Cxagon has usod Lhoso sanlos Lo nalo vholo gonono scanning ly using iLs
advancod high-LhroughuL gonoLying oquinonL. Tho rosulLs in Lho lorn ol
inLorosLing chronosonal linlago rogions aro Lhon invosLigaLod in noro doLail ly Lho
acadonic rosoarchors in collaloraLion viLh scionLisLs lron Cxagon and AsLraZonoca.
Tho laLLor has sono LvonLy oolo involvod.
In Lhis caso, also lor hisLorical roasons, Lho lunding ol Lho clinical conLros has
cono dirocLly lron AsLraZonoca. In oLhor rojocLs, iL is Cxagon LhaL lunds Lho
sanling acLiviLios, luL usually noL all Lho rosoarch carriod ouL ly Lho clinical
arLnors.
Tho rojocL has rogrossod according Lo Lho lans and Lho arLios aro
saLisliod viLh Lho ouLcono so lar. IL is Loo oarly Lo say vhoLhor Lhoro vill lo any
aLonLallo rosulLs.
AsLraZonoca oxrossos groaL saLislacLion viLh Cxagon`s conLriluLions.
Bosidos Lho inlrasLrucLuro lor liolanling and gonoLying and Lho scionLilic
conoLonco, AsLraZonoca arociaLos Cxagon`s aliliLy Lo handlo rolaLions viLh Lho
acadonic arLnors and Lho high oLhical sLandards characLorising iLs ooraLions. Tho
lasL oinL is osocially inorLanL sinco harnacouLical conanios alvays run Lho risl
ol loing scruLinisod lor Lhoir lohaviour. ThaL is vhy AsLraZonoca alvays vanLs Lo
lnov hov iLs arLnors handlo oLhics.

6.2 Some recent changes
Cxagon has lound iL dilliculL Lo goL Lho largo harnacouLical lirns inLorosLod in
lunding oarly sLago rosoarch rojocLs. In Lho rosonL siLuaLion, lig harna" is
rinarily looling lor validaLod drug LargoLs or nov sulsLancos undor dovolononL.
This narloL siLuaLion has lorcod Cxagon Lo lollov Lho nain Lrond in Lho gononics
indusLry, LhaL is, Lo run Lho rojocLs longor in-houso loloro onLoring inLo connorcial
arLnorshis. ThaL is vhy a sLraLogic shilL vas announcod in Lho sunnor ol 2002.
Tho nov sLraLogy noans incroasing locus on LargoL validaLion and drug discovory. In
oLhor vords, Lho conany is inLograLing lorvard. InsLoad ol jusL ouL-liconsing
discovorios ol gonos or LargoLs Cxagon vill in solocLod disoaso aroas dovolo in-houso
LhoraouLic conounds and Lalo Lhon Lo clinical Lrials ond ol haso II as longosL.
In diagnosLics Loo, Cxagon nay dovolo roducLs or sorvicos.
GonoLics vill ronain a coro conoLonco, luL according Lo Lho nov sLraLogy
Lho rinary ollorLs vill lo dirocLod Lo rogrossing oxisLing load gono discovorios
Lhrough luncLional liology and on inLo chonisLry. This vill roquiro acquisiLion ol
addiLional rosourcos dodicaLod Lo Lhoso aroas.
Tho LranslornaLion ol Cxagon inLo a drug rosoarch conany unavoidally
incroasos Lho caiLal nood. AL Lho sano Lino, Lho curronL rollons in Lho oquiLy
narloLs nalo iL dilliculL lor lioLoch lirns Lo raiso nov vonLuro caiLal. Thoroloro
Cxagon had Lo inlononL a cosL-cuLLing rogranno vhoroly 20 or conL ol Lho
onloyoos (sono LvonLy oolo}, nainly in gonoLics and lioinlornaLics, had Lo
loavo Lho conany.
Cn Lho oLhor hand, an oxocLod advanLago ol Lho nov sLraLogy ol rocossing
Lho rosoarch lindings longor and solling aL a laLor sLago is LhaL Lho rico vill lo highor
67
1ens LaageHellman
and a loLLor roLurn vill lo achiovod on Lho invosLnonLs. \hoLhor Lhoso oxocLaLions
vill lo lullillod ronains Lo lo soon.

7. UmanGenomics

This is a snall gononics conany locaLod in Ino in NorLhorn Svodon. IL vas
loundod in 1999 on Lho iniLiaLivo ol Ino InivorsiLy and Lho \asLorloLLon CounLy
Council, Lho rincials ol Lho Modical Biolanl. Tho laLLor is a largo, oulaLion-
lasod liolanl LhaL has loon luilL u sinco Lho nid-1980s and nov consisLs ol llood
sanlos and lilosLylo inlornaLion lron 8,000 individuals. This includos 66,000
oolo vho havo donaLod a llood sanlo in connocLion viLh a sLill ongoing
counLyvido hoalLh-scrooning rogranno (Lho \II cohorL}.
AL Lho ond ol 2002, InanGononics had 16 onloyoos. Thoro voro aL LhaL
oinL in Lino no ongoing assignnonLs lron cusLonors.

7.1 Historical background
Tho iniLiaLivo Lo luild a liolanl vas Lalon ly clinical rosoarchors aL Lho univorsiLy
hosiLal. Anong oLhor scionLilic oorLuniLios, Lhoy sav LhaL Lho llood sanlos
could lo usod in Lho soarch lor lionodical narlors lor dilloronL disoasos. A loy
orson vas rolossor Gran Hallnans, vho is nov hoad ol Lho Modical Biolanl, Lho
organisaLional uniL viLhin Lho counLy council LhaL is rosonsillo lor ooraLing Lho
liolanl. IL should lo noLod, Lhough, LhaL Lho rosonsililiLy lor Lho liolanl is sharod
viLh Ino InivorsiLy (Lo vhich Lho liolanl lolongod organisaLionally unLil 2000}.
In Lho loginning, Lho liolanling and rolaLod rosoarch acLiviLios rocoivod
liLLlo suorL lron Lho scionLilic connuniLy, and linancing vas Lhoroloro a lig
hurdlo. Hovovor, in Lho nid-1990s aLLiLudos changod as a rosulL ol raid scionLilic
and Lochnological rogross in gonoLics and gononics. IL vas roalisod ly nany LhaL Lho
liolanl consLiLuLod a valuallo assoL vhich could lo usod lor rosoarching Lho gonoLic
and onvironnonLal lacLors rodisosing lor connon disoasos. Thus, Lho liolanl
cano Lo lo usod in an incroasing nunlor ol acadonic sLudios, rinarily in Ino luL
also olsovhoro.
Tho lirsL idoas lor using Lho liolanl lor connorcial rosoarch cano u in Lho
oarly 1990s, arLly in rosonso Lo Lho lunding rollons. IL vas LhoughL LhaL
harnacouLical conanios vould lo inLorosLod in using Lho liosanlos in Lhoir
soarch lor disoaso gonos and gonoLic narlors. Tho lirsL aLLonLs ly Gran Hallnans
and sono colloaguos Lo sLarL u connorcialisaLion in co-ooraLion viLh a largo
lioLoch conany voro noL roalisod lor various roasons. InsLoad, Ino InivorsiLy
and Lho \asLorloLLon CounLy Council docidod in 1998 Lo sLarL InanGononics. Tho
idoa vas Lo luild u an organisaLionally indoondonL gononics conany LhaL vould
carry ouL rosoarch on Lho liolanl naLorial on lohall ol harnacouLical conanios.
InanGononics goL a sLrong agroononL viLh Lho Lvo rincials ol Lho liolanl
giving iL oxclusivo righLs Lo uso Lho \II-sanlos lor connorcial urosos. In ordor
Lo roLocL Lho inLorosLs ol Lho donors and Lho oulaLion and nalo suro LhaL sanlos
aro noL nisusod, an oLhics nodol vas dovolood. IL consisLs ol Lhroo lovols. Cn Lho
individual lovol, inlornod consonL is rocoivod lron oach donor. Socondly, on Lho
socioLal lovol inlluonco is oxorLod Lhrough Lho rogional rosoarch oLhics conniLLoo.
Thirdly, Lho inLorosLs ol Lho oulaLion should lo rovidod lor ly giving Lho ullic
68

socLor (Lhrough Lho univorsiLy`s holding conany} conLrolling inLorosL in
InanGononics.
Gran Hallnans and sono ol his colloaguos lolL LhaL Lhoy had loon run ovor
ly Lho univorsiLy nanagononL. Thoy clainod LhaL Lho rosoarchors lohind Lho
liolanl should havo Lho righL ol disosal ovor Lho liosanlos, and accordingly havo
Lho lasL vord on Lhoir uso. This vas inorLanL, noL loasL, in ordor Lo lullil olligaLions
Lovards Lho donors and Lho oxLornal linanciors ol Lho liolanl rosoarch, iL vas
arguod. Thoy also noanL LhaL Lho connorcialisaLion concoL had loon sLolon lron
Lhon. Thus, a conllicL aroso rogarding Lho disosal ol Lho liolanl and Inan-
Gononics` accoss Lo iL.

7.2 The development of the company
To sLarL u Lho conany, Irolossor Suno Rosoll vas hirod as chiol oxocuLivo ollicor
(CIC}. Ho had roLirod lron AsLra, vhoro anong oLhor osiLions ho had sorvod as
rosoarch dirocLor. Ho had loon ongagod ly Ino InivorsiLy as chairnan ol Lho
loard lor Lho Modical Biolanl. In 1999 ho sLarLod Lo luild u Lho organisaLion ly
rocruiLing a nanagononL Loan.
RighL lron Lho sLarL, InanGononics` lusinoss idoa has loon Lo discovor
disoaso-rolaLod gonos, oxloro Lhoir luncLion, and narloL Lhis lnovlodgo".
Criginally, Lhis vould lo dono ly orlorning conLracL rosoarch on lohall ol
harnacouLical conanios. Anong ossillo roducL ollorings, validaLion ol
candidaLo gonos using SNI analysis vas iniLially LhoughL Lo ollor Lho nosL ronising
rosocLs (givon Lho accoss Lo a uniquo, oulaLion-lasod liolanl and high-qualiLy
disoaso rogisLors}. Hovovor, Lho idonLilicaLion ol nov disoaso gonos vas also arL ol
Lho roducL sLraLogy.
Tho narloLing iniLially LargoLod Lho harnacouLical conanios lohind Lho
SNI ConsorLiun (lornod ly sono Lon largo conanios including AsLraZonoca,
Iharnacia CororaLion and Anorshan Bioscioncos}. ConLacLs voro osLallishod viLh
sovoral oLonLial cusLonors, luL nogoLiaLing a doal rovod Lo lo noro Lino-
consuning Lhan oxocLod. Hovovor, in 2000 a lirsL najor conLracL (in Lho liold ol
roLoonics} vas signod viLh a largo lioLoch conany, luL Lhis arLnorshi soon had
Lo lo LorninaLod vhon Lho cusLonor changod iLs lusinoss sLraLogy.
In 2001 Suno Rosoll rosignod as lannod, and Ir \ayno Iavios Lool ovor as
CIC. Ho is a ScoLLish scionLisL viLh long oxorionco ol Lho lioLoch indusLry. In Lho
sano yoar, InanGononics lloaLod a righLs issuo (MSIK J0} dirocLod Lo insLiLuLional
invosLors and rivaLo individuals, sono ol vhon voro onloyoos ol Lho univorsiLy.
AlLor Lhis rivaLo lacononL, Ino InivorsiLy ovnod 60 or conL ol Lho sharos
Lhrough iLs holding conany.
IosiLo iLs narloLing ollorLs InanGononics did noL succood in goLLing any
conLracLs lron harnacouLical conanios. AL Lho sano Lino, Lhoro vas a Lrond in
Lho onvironnonL vhoroly rosoarch inLorosL in lioscionco vas shilLing lron gono
hunLing" Lovards luncLional gononics and roLoonics. Thoso olsorvaLions Lriggorod
a sLraLogic chango. Tho rioriLy roviously givon Lo validaLion sLudios vas
alandonod. Iisoaso gono idonLilicaLion locano oqually inorLanL. BuL aL Lho sano
Lino, InanGononics docidod Lo inLograLo lorvard inLo drug LargoLs and roLoonics,
and Lo run sono rosoarch rojocLs in-houso. To inlononL Lhis nov sLraLogy, vhich
nocossiLaLod Lho hiring ol nov sLall and urchasing ol nov oquinonL, noro caiLal
had Lo lo raisod (osLinaLod Lo MSIK 200}.
69
1ens LaageHellman
To raiso Lhis anounL ol caiLal iL vas judgod nocossary, lor a nunlor ol roasons, Lo
roduco Lho univorsiLy`s ovnorshi Lo lolov 50 or conL and lring in nov nonoy
lron Lho vonLuro caiLal narloL. This also noanL LhaL Lho original agroononL
loLvoon InanGononics, Lho univorsiLy and Lho counLy council had Lo lo
ronogoLiaLod, sinco iL rosunod najoriLy ovnorshi ly Lho ullic socLor. This
condiLion had loon includod as arL ol Lho oLhics nodol. Sinco a nov Biolanls AcL
vas Lo lo inLroducod in Svodon lron 1 January 200J, Lho arLios judgod LhaL ullic
najoriLy ovnorshi vould no longor lo nocossary in ordor Lo roLocL Lho inLorosLs ol
Lho oulaLion. Iarly in 2002, a nov agroononL including sono oLhor changos vas
dralLod, and alLor sono nodilicaLions, arovod ly Lho arLios. Hovovor, Lho nov
agroononL aggravaLod Lho alovo-nonLionod disuLo ovor conLrol ol Lho liosanlos.

7.3 The present situation
IosiLo a lailuro ly oononLs Lo havo Lho agroononL doclarod unlavlul ly a courL,
Gran Hallnans and his associaLos conLinuo Lo clain disosal ol Lho liolanl and
ooso Lho vay in vhich InanGononics gains accoss Lo sanlos. AL Lho rosonL
Lino, Lhis disuLo has yoL Lo lo rosolvod.
Tho disuLo has undoulLodly harnod InanGononics and Lho vholo
connorcialisaLion vonLuro. IL is hard lor Lho conany Lo narloL iLs sorvicos vhilo
uncorLainLios ronain rogarding iLs accoss Lo Lho liolanl. Tho lannod linancing
round, inLondod Lo lring in Lho caiLal noodod Lo inlononL Lho nov sLraLogy, has
also loon dolayod.

8. Comparative analysis

As doscrilod in Lho rocoding socLions, Lho rinary lusinoss idoas ol Lho Lhroo
conanios aro sinilar. Basod on liolanls as a loy rosourco, all ol Lhon sLudy Lho
gonoLic lacLors lohind connon disoasos viLh Lho ain ol solling Lho rosulLing
lnovlodgo Lo harnacouLical and diagnosLics conanios. In roconL yoars, all Lhroo ol
Lhon havo nado sLraLogic novos in Lho dirocLion ol lorvard inLograLion in Lho
innovaLion chain. Iron an iniLial locus on discovory or validaLion ol disoaso gonos,
Lhoy aro nov sLriving Lo run Lhoir rosoarch rojocLs longor, LhaL is, Lovards idonLili-
caLion ol drug LargoLs and dovolononL ol nov drugs.
IosiLo Lhoso sinilariLios iL is olvious LhaL in oLhor rosocLs Lho Lhroo
vonLuros aro quiLo dilloronL, noL loasL viLh rogard Lo Lhoir vay ol using liolanls.
Sono ol Lhoso lundanonLal dilloroncos aro highlighLod in Lallo 1 and vill lo lriolly
connonLod on.

70

Table 1. Some facts about the commercialisation ventures

deCode Oxagen UmanGenomics
Type of biobanks
Iisoaso-socilic
Neu
Iisoaso-socilic
Neu
IoulaLion-lasod
reexisting
Number of biobanking
partners
Many
(lcelandic physicians)
Arox. J0
(uropean academic
groups)
Cno
(The Medical
Liobanl)
Does the company have
own biobanks?
Yos No No
Where are the biosamples
physically stored?
doCodo Cxagon Tho Modical
Biolanl
Does the company have
exclusive rights to
commercialise?
Yos (viLhouL liniLs} Yos (2-5 yoars} Yos (20 yoars}
Year of foundation
1996 199 1999
Number of employees (end
of 2002)
Arox. 450 Arox. 100 16
Revenue (2001)
MSIK 290
(MUSD J?)
MSIK 50
(MUSD .)
0
Net loss (2001)
MSIK 4J0
(MUSD 48)
MSIK 125
(MUSD 14)
n.a.
Key industrial partners
Rocho
Morcl
AsLraZonoca
Ilizor

Private/public company
Iullic IrivaLo IrivaLo
University ownership
Nono ' 60'

Il vo sLarL viLh InanGononics, Lhis conany vas loundod lor Lho socilic uroso
ol connorcialising ono largo and alroady oxisLing liolanl (soo liguro 5}. This
liolanl can lo usod lor conducLing rosocLivo sLudios on a largo nunlor ol
dilloronL disoasos. Tho liolanl ronains undor Lho conLrol ol Ino InivorsiLy and
Lho \asLorloLLon CounLy Council, luL InanGononics has a sLrong agroononL viLh
Lho Lvo rincials giving iL oxclusivo righLs lor LvonLy yoars Lo uso Lho liolanl lor
connorcial rosoarch.
InanGononics is sLill a vory snall conany, and unlilo Lho oLhor Lvo iL
has noL yoL concludod any agroononL viLh cusLonors/arLnors in Lho harnacouLical
indusLry. Tho largo ullic socLor ovnorshi (via Ino InivorsiLy} also disLinguishos
InanGononics lron doCodo and Cxagon, vhich voro linancod ly vonLuro caiLal
lron Lho loginning. BuL as nonLionod, InanGononics vill lo lurLhor rivaLisod.

71
1ens LaageHellman
Figure 5. Simplified illustration of UmanGenomics in its network

Lilo InanGononics, Cxagon vas sLarLod u in closo conLacL viLh a univorsiLy. BuL
unlilo Lho lornor iL cannoL lo characLorisod as a Lruo sin-oll. IL vas acadonics LhaL
Lool Lho iniLiaLivo in osLallishing Lho conany, luL iL did noL goL any sLarL-u accoss
Lo socilic Lochnologios, conoLoncios or liolanl rosourcos lron Lho InivorsiLy ol
Cxlord or Tho \ollcono TrusL. Cxagon had Lo go ouL and nogoLiaLo such accoss
viLh various clinical arLnors. Iron Lho loginning iL vas cloar LhaL Lho conany
vould osLallish collaloraLion viLh a nunlor ol acadonic rosoarch grous in Lho IK
and alroad. This vas nocossary, duo Lo Lho scionLilic sLraLogy ol carrying ouL disoaso-
socilic sLudios lasod on lanily collocLions. CollaloraLivo agroononLs havo loon
nado viLh sono J0 acadonic grous viLhin nino dilloronL disoaso aroas (soo liguro
6}. In nosL ol Lhoso casos, Cxagon is linancing Lho collocLion ol sanlos, vhich aro
socilically inLondod lor Lho rojocL. Thus, in conLrasL Lo InanGononics, Cxagon
doos noL nornally nalo uso ol ro-oxisLing liolanls. AnoLhor dilloronco is LhaL
Cxagon has closo collaloraLion viLh Lho rosoarchors vho collocL Lho sanlos.
InanGononics is lanning Lo uso Lho sanlos in-houso, viLhouL involvononL ol Lho
Modical Biolanl (luL in ordor Lo gain accoss Lo clinical inlornaLion InanGononics
vill rolally nood Lo osLallish co-ooraLion viLh clinical rosoarchors}.

72

Figure 6. Simplified illustration of Oxagen in its network

Lilo Cxagon, doCodo is Lho rosulL ol a LoLally rivaLo iniLiaLivo LhaL is, iL did noL
sin oll lron a arLicular insLiLuLion. BuL lilo InanGononics, insLoad, iL has a
sLrong local anchorago in Lho rogion vhoro iL is locaLod, and lron vhich all rosoarch
suljocLs aro rocruiLod. Icoland and Lho CounLy ol \asLorloLLon in lacL havo roughly
Lho sano hoad ol oulaLion (sono 20,000}. Hovovor, Lho scionLilic aroach
raLhor rosonllos Cxagon`s, luilding as iL doos on a nunlor ol disoaso-socilic
collocLions vhich aro croaLod lor oach rojocL and viLh lull lunding lron doCodo.
Tho collocLing ol sanlos and inlornaLion is dono Lhrough collaloraLion viLh nany
individual hysicians and clinical rosoarchors vho havo conLacL viLh Lho aLionLs (soo
liguro }. A najor dilloronco lron Lho oLhor Lvo conanios is LhaL doCodo has lull
disosal ol Lho collocLions, vhich aro sLorod in Lho conany`s ovn liolanl. ThaL is,
doCodo has unliniLod accoss Lo Lho sanlos. NonoLholoss, in nany rojocLs doCodo
has choson Lo collaloraLo viLh Icolandic clinical rosoarchors vho can conLriluLo
addiLional conoLoncios and inlornaLion.

73
1ens LaageHellman
Figure 7. Simplified illustration of deCode in its network.

Tho lolloving noro sysLonaLic conarison ol Lho Lhroo casos Lalos iLs sLarLing oinL
in Lho issuos idonLiliod in socLion J. \o vill sLarL ly discussing hov Lho local
rolaLionshi loLvoon Lho liolanl uniL(s} and Lho gononics conany is organisod.
\o vill Lhon Lurn Lo considor Lho characLorisLics ol Lho nain acLors.

8.1 Conditions for access to biosamples
Tho condiLions lor Lho Lranslor ol liosanlos lron Lho liolanl uniL Lo Lho gononics
conany aro a crucial and nany-lacoLod issuo. As Lho InanGononics caso in
arLicular has illusLraLod Lhoro aro sovoral quosLions LhaL nood Lo lo sorLod ouL.
IirsL Lhoro is Lho rollon ol disposal oj the samples in Lho liolanl. In all
Lhroo casos, Lho sanlos aro collocLod ly or Lhrough clinical rosoarchors, hysicians
or caro conLros. Thoy havo conLacL viLh Lho aLionLs/rosoarch suljocLs and inviLo
Lhon Lo donaLo Lhoir llood lor rosoarch. In Lho caso ol doCodo, Lho conany ays
lor all Lho vorl involvod in collocLing and handling Lho sanlos and Lho inlornaLion,
vhich aro sulsoquonLly Lranslorrod Lo Lho conany`s laciliLios lor sLorago and uso.
ConsoquonLly, in Lhis caso, Lho liolanl doliniLivoly lolongs Lo doCodo. IL has Lho
lull righL ol disosal, viLhin Lho liniLs givon ly Lho inlornod consonL olLainod lron
Lho donors (i.o., Lho uroso lor vhich Lho sanlo has loon donaLod}. Tho
hysicians and rosoarchors vho holod doCodo Lo goL Lho sanlos cannoL clain Lo
havo any righLs Lo conLrol Lho uso ol Lho sanlos. In oLhor vords, Lho siLuaLion is
quiLo sLraighLlorvard.
1J

1J
In sono rojocLs, doCodo also usos liosanlos sLorod in a clinical liolanl aL a hosiLal or in Lho
liolanl ol a rivaLo rosoarch insLiLuLo (such as Lho Icolandic HoarL AssociaLion}. In Lhoso casos,
74

Lilo doCodo, Cxagon nornally covors all Lho cosLs ol collocLing Lho sanlos and
luilding Lho liolanl. Tho collocLing is dono ly Lho clinical arLnors, luL sonoLinos
viLh suorL lron Cxagon`s orsonnol. \hilo doCodo carrios ouL nosL ol Lho
scionLilic vorl in-houso, Cxagon`s clinical arLnors aro rosonsillo lor Lho sLudios
LogoLhor viLh Cxagon. Tho collaloraLion agroononLs givo Lho rosoarchors Lho righL
ol disosal ovor Lho sanlos (Lho guardianshi" as Cxagon rolors Lo call iL} in
siLo ol Lho sanlos, lor racLical roasons, loing hysically sLorod aL Cxagon.
Cxagon ossossos suiLallo oquinonL lor handling and sLorago ol sanlos (and donor
inlornaLion} and carrios ouL Lho gonoLic analysos. Tho rosoarch carriod ouL ly Lho
clinical arLnors is also lundod lron oLhor sourcos, vhich is vhy Cxagon cannoL
clain Lo lo Lho ovnor" ol Lho liolanls. IL vould, hovovor, rolor such a siLuaLion,
as conlorring sLrongor and noro long-Lorn conLrol ol Lho sanlos, luL Lhon Cxagon
vould havo Lo ay noro and iL cannoL allord Lo. Nov, in roLurn lor iLs conLriluLions,
linancially and in lind, Cxagon has goL oxclusivo righLs Lo connorcialiso Lho rosulLs
lron Lho sLudios as long as Lho agroononL is valid, LhaL is 2-5 yoars (viLh a ronoval
oLion}. Again, iL can lo concludod LhaL Lho siLuaLion is lairly sLraighLlorvard, and iL
soons LhaL so lar Lho disosal issuo has noL causod any conllicL loLvoon Cxagon and
iLs arLnors.
In Ino, ly conLrasL, Lho quosLion ol vho has Lho righL ol disosal ovor Lho
sanlos has givon riso Lo a rolound conllicL viLh doLrinonLal ollocLs on Lho
conany. Tho laclground is LhaL sono ol Lho rosoarchors and oLhor orsons lohind
Lho Modical Biolanl, including Lho hoad ol LhaL uniL, arguo LhaL Lhoy havo Lho righL
ol disosal ovor Lho liosanlos. AlLhough Lhoy do noL ooso Lho connorcialisaLion
as such, Lhoy do noL lilo Lho vay iL is dono and Lhoy havo noL accoLod Ino
InivorsiLy and Lho \asLorloLLon CounLy Council signing agroononLs viLh
InanGononics viLhouL asling lor Lhoir aroval. Thoso orsons clain LhaL Lho
rosoarchors" should conLrol InanGononics` uso ol Lho sanlos. This vould lo
nocossary in ordor Lo dischargo olligaLions Lovards Lho donors and Lho linanciors ol
Lho liolanl rosoarch. Ior oxanlo, Lhoy nainLain LhaL corLain granLs havo loon
nado on condiLion LhaL sanlos vill lo availallo lor Lho suorLod rojocLs. Givon
LhaL Lho sanlo volunos aro scarco, Lhoy loar LhaL connorcial uso vill load Lo Lho
oxhausLion ol corLain valuallo arLs ol Lho liolanl unloss Lho laLLor is conLrollod
ly Lho rosoarchors.
Tho counLorarLy has rojocLod Lhoso clains, arguing, inter alia, LhaL Lho
Loachor oxcoLion" lor Svodish univorsiLios, or oLhor inLollocLual roorLy righLs, is
noL alicallo in Lhis caso. Tho Loachor oxcoLion noans LhaL acadonic rosoarchors
havo Lho righL Lo connorcialiso Lho inLollocLual roorLios rosulLing lron Lhoir ovn
lroo rosoarch".
14

As Lho InanGononics caso illusLraLos, Lho quosLion ol vho has Lho righL ol
disosal nay Lurn ouL Lo lo logally conlicaLod vhon an alroady oxisLing liolanl is
Lo lo usod lor connorcial urosos. Ior oxanlo, Lho quosLion is vhoLhor anyono
holds coyrighL roLocLion (upphovsratt in Svodish} lor Lho liolanl (i.o., in Lorns ol

doCodo only has accoss Lo naLorial lor analysis, and doCodo is suosod Lo dosLroy Lho ronaining
naLorial vhon Lho sLudy is linishod.
14
Soo \oll, S. 2002 lor a noro oxLonsivo discussion ol Lho Loachor oxcoLion and iLs alicaLion in
liolanl conLoxLs.
75
1ens LaageHellman
iLs alsLracL sLrucLuro noL Lho hysical liosanlos as such}.
15
In Lho caso ol Lho
Modical Biolanl iL has loon rolininarily concludod ly civil lav rosoarchors LhaL
Lhis liolanl nay noL havo a sullicionLly uniquo sLrucLuro Lo qualily lor coyrighL
roLocLion.
16
BuL insLoad a sinilar roLocLion lasod on Lho sui generis righL nighL
ossilly aly.
1
BoLh righLs conlinod could also aly Lo Lho liolanl.
Il Lho rosoarchors vho luilL Lho liolanl havo such a coyrighL or sui generis
righL, Lhoy can oljocL Lo corLain disosiLions viLh Lho liolanl in sono casos
including Lho naLorial conLainod Lhoroin il Lhoy vish. This righL doos noL gonorally
covor Lho viLhdraval ol individual sanlos. Hovovor, Lhis nay lo Lho caso in sono
siLuaLions. Ior insLanco, il a viLhdraval ol sanlos conLains Lho roLocLod sLrucLuro
ol Lho liolanl, Lho coyrighL holdor nusL givo his or hor ornission. Tho oxLracLion
ol sanlos nay also consLiLuLo a lroach ol Lho sui generis righL. In Lho caso ol
InanGononics, oach viLhdraval vould conriso Loo liniLod a nunlor ol sanlos
rolally loss Lhan 1,000 in nosL sLudios, conarod Lo Lho 66,000 sanlos in Lho
\II cohorL}. Hovovor, il a largo nunlor ol sanlos aro usod in sLudios carriod ouL
ly InanGononics ovor a longor oriod ol Lino, Lhis nay lo rogardod as an
unauLhorisod oxLracLion ol Lho liolanl and Lhus lall undor Lho sui generis roLocLion.
IL should lo noLod, hovovor, LhaL Lhis has noL yoL loon Lriod in courL.
Thoso linds ol inLollocLual roorLy righLs ariso auLonaLically lron Lho
croaLion ol a vorl or Lho roducLion ol a daLalaso. In inlringononL rocoodings,
Lhoroloro, a courL can only osLallish Lho oxisLonco ol Lho righLs. IL should lo noLod
LhaL Lhoro is no rogisLraLion rocoduro as viLh oLhor Lyos ol inLollocLual roorLios
(aLonLs, Lradonarls, oLc} LhaL could sorvo as rool ol Lho oxisLonco ol Lho righLs.
An addiLional rollon in Lhis caso is Lo docido vho has Lhis ossillo righL.
Thoro aro nany individuals (and linanciors} vho havo loon involvod in liolanling
sinco Lho nid-1980s. Clviously, oinions vary concorning Lho rolo layod ly
dilloronL individuals and organisaLions. Rosolving Lhis doos noL lool lilo loing an
oasy Lasl.
Givon Lho rosonL uncorLainLy surrounding Lho logal asocLs ol Lho disosal
ol liolanl naLorials in Svodon, iL vould lo usolul il a concroLo caso, such as Lho
conllicL in Ino, voro lroughL loloro Lho CourL ol JusLico ol Lho Iurooan
ConnuniLios. ThaL vould rolally hol Lo clarily Lho siLuaLion.
As Lo Lho Lranslor ol individual (hysical} sanlos Lo gononics conanios,
anoLhor inorLanL asocL ol Lho disosal has Lo do viLh Lho conLracLs" viLh Lho
donors. In Lho doCodo and Cxagon casos, Lho consonL lorn signod ly Lho donors
cloarly sLaLos LhaL Lho sanlo vill lo usod ly a conany (lor a sociliod uroso}, so
Lhoro is no rollon in Lhis rogard. In Ino, no connorcial uso vas iniLially

15
Iron an inLollocLual roorLy righLs orsocLivo, a liolanl consLiLuLos a daLalaso, and undor corLain
condiLions iL can lo roLocLod undor Lho CoyrighL AcL. IL should lo olsorvod LhaL Lho coyrighL and
oLhor sinilar inLollocLual roorLy righLs, lilo Lho closoly rolaLod sui generis righL, aro noL concornod
viLh roLocLion ol Lho hysical oljocLs as such (o.g. liosanlos}. \haL Lhoso righLs roLocL is an
alsLracL honononon, such as Lho sLrucLuro according Lo vhich sanlos in a liolanl aro organisod in
Lho caso ol coyrighL. Hovovor, Lho oxorciso ol Lho righLs nay concorn Lho hysical naLorial as arLs
ol a roLocLod oljocL. Soo HollsLadius, A. (2002} lor a noro doLailod discussion ol liolanls and
inLollocLual roorLy righLs.
16
HollsLadius, A. 2002.
1
Tho sui generis righL noans LhaL sonoono vho has invosLod considorallo rosourcos in roducing a
caLaloguo, Lallo or oLhor sinilar daLalaso can lo granLod a righL Lo roduco coios ol Lho vorl and
nalo iL availallo lor Lho ullic (soo, o.g., HollsLadius, A. 2002}.
76

inLondod. Thoso vho donaLod llood in Lho asL did iL lor Lho uroso ol disoaso-
rovonLion rosoarch". Tho rociionLs voro Ino InivorsiLy and Lho \asLorloLLon
CounLy Council. Nov, LhaL InanGononics, a roliL-drivon conany, vishos Lo uso
old sanlos", Lho agroononLs vill havo Lo lo ronogoLiaLod" in sono vay. Cno
ossillo soluLion is Lo go lacl Lo Lho donors on a rojocL-ly-rojocL lasis and asl
Lhon lor a ronovod inlornod consonL. This is nanagoallo, ol courso, luL vill cosL
nonoy and rolally load Lo sono rosoarch suljocLs droing ouL.
Cno gonoral conclusion LhaL can lo dravn lron Lho Svodish caso is LhaL Lho
disosal issuo noods Lo lo sorLod ouL loloro sLarLing Lho connorcialisaLion ol an
oxisLing liolanl. IL is advisallo Lo idonLily all Lhoso vho nay clain any righLs Lo Lho
liolanl and Lo solvo ossillo disuLos in advanco, lor oxanlo, ly signing lornal
agroononLs viLh all acLors involvod. CLhorviso, any conllicLs arising nay jooardiso
Lho vholo vonLuro, as vo havo soon in Lho caso ol Lho Modical Biolanl in Ino. As
Irlan Iaulsson and Rolocla Irisl vriLo in anoLhor chaLor in Lhis lool, givon Lho
uncloar logal siLuaLion viLh rogard Lo Lho disosal ol liolanls, conanios aro advisod
Lo socuro Lho nocossary righLs ly naling agroononLs loLh viLh Lho univorsiLy and
viLh Lho rosoarchors.
AnoLhor sonovhaL rolaLod issuo has Lo do viLh Lho noro socilic com
mercialisation rights. IL is connon lor clinical gononics conanios Lo lo granLod
oxclusiviLy Lo uso a corLain liolanl connorcially, aL loasL lor a corLain oriod ol
Lino. \o havo soon oxanlos ol Lhis in all Lho Lhroo casos quoLod alovo (soo, o.g.,
Lallo 1}. Givon Lho lacL LhaL Lho sanlos aro collocLod, in nosL casos, viLh Lho hol
ol onloyoos in Lho ullic socLor, iL is roasonallo Lo quosLion vhoLhor Lhis is a good
olicy. Ivon il Lhoro is no liniLaLion on non-connorcial rosoarch, such an agroononL
has Lho ollocL ol oxcluding oLhor conanios lron using Lho liolanl. Cno ossillo
ollocL is LhaL corLain rosoarch rojocLs LhaL nighL havo rosulLod in valuallo nov
lnovlodgo or hoalLh caro roducLs vill noL lo carriod ouL. This loads Lo a vollaro
loss Lo socioLy.
BuL Lhoro aro also argunonLs in lavour ol granLing oxclusiviLy. IirsL, vhon
conanios lilo doCodo and Cxagon covor Lho cosLs ol liolanling iL is lair, ol courso,
LhaL Lhoy should goL oxclusivo righLs. Tho Ino siLuaLion is dilloronL. Horo, Lho
Modical Biolanl has oxisLod lor a long Lino. InanGononics vill ay only a liniLod
sun (MSIK 2 or yoar} Lo covor Lho addiLional cosL ol sanlo and inlornaLion
handling. Ivon so, iL has goL oxclusivo righLs lor LvonLy yoars. Cno ollocL ol Lho doal
is LhaL acadonic rosoarchors aL Ino InivorsiLy vho aro using Lho liolanl aro noL
allovod Lo collaloraLo dirocLly viLh harnacouLical lirns (unloss Lhoy goL aroval
lron InanGononics}. This is a disadvanLago ol Lho rosonL arrangononL.
NonoLholoss, aL loasL ono argunonL can lo uL lorvard in dolonco ol such a doal.
\hon, as in Ino, Lho ain is Lo uso Lho liolanl and iLs connorcialisaLion as a Lool
Lo dovolo Lho local indusLry and rosoarch onvironnonL, Lho conany has Lo lo
assurod ol socuro accoss Lo sanlos (vhich rorosonL a liniLo rosourco}. This is
locauso a nov gononics conany osLallishod adjaconL Lo Lho liolanl vould havo Lo
invosL in various laciliLios, vhich noans LhaL iL is Laling a linancial risl. \iLhouL
granLing oxclusiviLy lor a roasonally long oriod, iL nighL lo dilliculL Lo lind rivaLo
invosLors roarod Lo nalo Lho roquisiLo invosLnonLs.
Cno concoivallo soluLion Lo Lhis rollon vould lo Lo loL Lho ullic socLor linanco
Lho conany ly using LaxaLion rovonuo and viLhouL donanding a linancial roLurn.
Thon iL vould lo oasior lor Lho conany Lo accoL Lho liolanl rosourco loing
77
1ens LaageHellman
sharod viLh oLhor lirns. Hovovor, such a soluLion nay noL lo loasillo or dosirallo
lor a varioLy ol roasons. Tho ullic insLiLuLions concornod nay noL havo onough
nonoy availallo. IL can also lo quosLionod vhoLhor iL should lo Lho rolo ol ullic
insLiLuLions Lo ongago Lhonsolvos in Lhis lind ol risly lusinoss vonLuro. Moroovor,
Svodish lav liniLs Lho righL ol ullic insLiLuLions Lo run lusinossos.
IL can lo nonLionod LhaL Lho lan Lo croaLo a largo oulaLion-lasod liolanl
in Lho IK doos noL includo Lho osLallishnonL ol any lusinoss or Lho lavouring ol any
socilic conany. IharnacouLical lirns vill lo allo Lo aly lor accoss Lo Lho
liolanl. BuL Lho IK Biolanl vill carry ouL all gonoLying, on Lho conanios`
accounL. Tho lirns vill havo Lo lood lacl all rosoarch rosulLs, luL Lhoy vill lo givon
a 6-nonLh graco oriod lor aLonLing.
To sunnariso, iL can lo concludod LhaL dosiLo Lho dravlacls ol giving
oxclusivo connorcialisaLion righLs Lo a solocLod lirn, Lhoro nay in sono casos lo
valid roasons lor doing so. \iLhouL such inconLivos Lho oLonLial lor connorcial
rosoarch lasod on a corLain liolanl nay noL lo roalisod aL all, or aL loasL noL locally.
Tho economic conditions lor accoss Lo sanlos and inlornaLion havo alroady
loon Louchod uon. \hon nov liolanls aro croaLod lor Lho uroso ol connorcial
rosoarch Lhoro is in gonoral no rollon. Tho conany ays lor Lho sanling and goLs
Lho aroriaLo righLs in roLurn. Again, Lho quosLion is noro conlicaLod vhon iL
conos Lo oxloiLing oxisLing liolanls. Hov nuch should Lho conany ay lor Lho
accoss InanGononics, according Lo Lho rosonL agroononL viLh Lho rincials ol
Lho Modical Biolanl, only covors arLs ol Lho liolanl`s running cosLs. IL doos noL
ay anyLhing Lovards Lho hoavy invosLnonL cosLs onloddod in Lho liolanl.
According Lo a rovious agroononL, InanGononics vould havo had Lo ay Lho
rincials an addiLional annual royalLy on iLs salos. Hovovor, Lhis clauso had Lo lo
doloLod undor a nov Svodish AcL on Biolanls in HoalLh caro, vhich cano inLo lorco
on 1 January 200J. Tho AcL rohiliLs Lho Lranslor ol liosanlos lor linancial gain.
Tho logislaLors` inLonLion vas Lo rovonL individuals or organisaLions oarning nonoy
on Lho Lrading ol liological naLorials. Cno consoquonco ol Lho lav is LhaL ullic
insLiLuLions luilding u a liolanl lor rosoarch
18
cannoL rocovor arL ol Lhoir caiLal
oxondiLuro ly naling conanios ay a royalLy. BuL Lhoro should lo oLhor vays ol
charging connorcial usors a rico LhaL Lalos inLo accounL Lho LoLal cosL ol luilding
Lho liolanl, viLhouL violaLing Lho lav. Hovovor, iL vould noL lo ossillo Lo chargo
a narl-u rico" corrosonding Lo Lho narloL valuo ol Lho liolanl, il LhaL is highor.
Tho curronL aynonL condiLions aliod in Ino noan LhaL Lho
connorcialisaLion righLs aro Lranslorrod aL a vory lov rico, givon Lho LoLal cosLs
incurrod in luilding Lho liolanl and givon iLs rosunod valuo. In casos vhoro
oxclusivo righLs havo loon granLod Lo ono lirn, Lho roasonallonoss and lairnoss ol
such a soluLion can lo quosLionod. IL can lo soon as a sulsidisaLion ol an individual
lirn.
19

Thoro is no doulL LhaL Lho uso ol ullicly ooraLod liolanls in connorcial rosoarch
is inorLanL Lo socioLy, sinco iL nay conLriluLo Lo Lho dovolononL ol nov roducLs

18
A rosoarch liolanl is covorod ly Lho nov acL il sono hoalLh caro rovidor is involvod in Lho collocL-
ing ol sanlos.
19
Moroovor, iL can lo arguod on Lho lasis ol rocoivod ocononic Lhoory LhaL Lho rohiliLion ol uLLing
a narloL rico on accoss Lo liosanlos (o.g., LranslaLod inLo a royalLy orconLago} vill load Lo
inollocLivo allocaLion ol scarco rosourcos (givon Lho dilliculLios ol aroriaLing Lho gains lron
liolanl invosLnonLs}.
78

LhaL inrovo hoalLh caro. Hovovor, il rivaLo lioLoch conanios should lo allovod
Lo nalo roliLs on Lhoir uso ol ullic liolanls iL is noL unroasonallo LhaL Lhoy
should sharo Lhoir roliLs viLh Lhoso vho laco Lho liolanl naLorial aL Lhoir
disosal. This Lyo ol indusLrial uso ol liosanlos cannoL lo conarod viLh Lho
(unoLhical} Lrading ol hunan organs and oLhor liological naLorials LhaL consLiLuLos
Lho nain LargoL ol Lho nov Biolanls AcL in Svodon (and Lho oldor TranslanLaLion
AcL}. IL is noL Lho individual sanlo LhaL is ol inLorosL Lo Lho rocoivor, luL Lho rosulL
LhaL can lo olLainod ly analysing a largo nunlor ol sanlos. Thoroloro, Lho roliL
rohiliLion in Lho Svodish lav, as iL is lornulaLod Loday, soons Lo lo unviso aL
loasL in Lho conLoxL ol Lho nornal uso ol liosanlos in connorcial rosoarch. Ior
oxanlo, Lho aynonL ol royalLy as discussod alovo should noL lo rogardod as
unoLhical, and Lhoroloro lo lorliddon. IL can lo noLod, incidonLally, LhaL Lhis lind ol
soluLion is aliod in Icoland in Lho caso ol Lho hoalLh socLor daLalaso. ThaL is,
doCodo vill ay a royalLy Lo Lho Icolandic govornnonL lor iLs righL Lo luild and
ooraLo Lho daLalaso. To Lho auLhor`s lnovlodgo, Lhoro havo loon no roLosLs
againsL Lhis in Lho hoaLod oLhics dolaLo on Lho rojocL. IL is Lruo LhaL doCodo`s
liconco doos noL includo accoss Lo liosanlos, luL nonoLholoss Lho caso illusLraLos an
inLorosLing alicaLion ol Lho royalLy soluLion in a sinilar conLoxL.
20

Tho discussion ol Lho roliL rohiliLion illusLraLos ono inorLanL ollocL ol
legislation and regulation on Lho connorcialisaLion ol liolanls. This is only ono ol
sovoral rulos conlirnod ly Lho nov Svodish Biolanls AcL, vhich is alicallo vhon
a hoalLh caro rovidor carrios ouL liolanling. Rosoarch liolanls conLaining sanlos
olLainod lron a hoalLh caro rovidor aro also covorod ly Lho AcL. A noro gonoral
discussion ol Lho rovisions inLroducod ly Lho nov lav can lo lound in IlisaloLh
Rynning`s chaLor in Lhis lool.
IL should lo noLod LhaL Lho lav doos noL covor liolanls luilL u viLhouL
connocLion Lo hoalLh caro, lor oxanlo, vhon conanios collocL sanlos dirocLly
lron oolo. BuL vhon conanios gain accoss Lo liolanls covorod ly Lho lav Lhoy
aro concornod in Lho sano vay as oLhor usors, such as acadonic rosoarchors. Cno
asocL Lo lo discussod laLor on is Lho roquirononL ol inlornod consonL.
Tho connorcialisaLion ol ullic liolanls nay ol courso also lo allocLod ly
oLhor lavs. In Svodon, lor oxanlo, Lho Local GovornnonL AcL rogulaLos vhaL Lho
counLy councils can do. Anong oLhor Lhings, Lho AcL lorlids counLy councils Lo
ongago in indusLrial acLiviLios viLh a viov Lo linancial gain. ThaL is vhy Lho
\asLorloLLon CounLy Council cannoL lo a sharoholdor ol InanGononics. Tho
Svodish univorsiLios aro noL allovod Lo run lusinossos, luL in roconL yoars Lhoy havo
loon givon Lho oorLuniLy ol sLarLing sLaLo-ovnod holding conanios Lo suorL
connorcialisaLion ol rosoarch lindings. Ininova Holding`s sharoholding in
InanGononics is ono such oxanlo. Tho issuo ol ullicly ovnod conanios and
Lho connorcial uso ol liolanls is connonLod on in Illa Bjrlnan`s chaLor in Lhis
lool. In a soaraLo aor, sho concludos LhaL arrangononLs ol Lho Lyo inlononLod
in Ino aro doulLlul lron a logal oinL ol viov.
21

Noodloss Lo say, Lho Lranslor ol liosanlos and inlornaLion Lo Lho gononics
conany nusL lollov corLain rules and routines agrood uon ly Lho arLios. To sono

20
Tho rohiliLion ol lor-roliL Lranslor ol hunan Lissuo in Lho Svodish Biolanls AcL is discussod in
noro doLail in Ionoij, B. 2000-01 and 2001, and in Bjrlnan, I. 2002.
21
Bjrlnan, I. 2002
79
1ens LaageHellman
oxLonL Lho dosign ol Lho Lranslor rocoss is allocLod ly logislaLion, lor oxanlo, viLh
rogard Lo oLhical aroval ol rosoarch on hunans.
Tho rouLinos aliod in Lho Lhroo casos aro doscrilod in sono doLail in Lho
lull roorL.
22
IL shovs lor oxanlo LhaL Lho Modical Biolanl has in roconL yoars
dovolood a sysLon ol qualiLy assuranco, arLly in rosonso Lo donands lron
InanGononics. Tho ooraLions ol Lho harnacouLical and lioLochnology indusLry
aro sLricLly conLrollod ly dilloronL rulos and sLandards, such as Lho inLornaLional
rincilos ol Good Clinical IracLico (GCI} and Good LaloraLory IracLico (GLI}. IL
is noL unusual LhaL such rulos aro lirsL inLroducod in Lho indusLry and laLor on aliod
ly univorsiLios. Conanios in gonoral aro vory concornod viLh such issuos as qualiLy,
socuriLy and oLhics. Il Lhoso aro noL handlod in an aroriaLo vay, Lho conanios
nay sullor soriously lron lad ulliciLy. Thoroloro, iL is noL surrising LhaL Lho
involvononL ol conanios in liolanling loads Lo inrovononLs in Lho gonoral
rouLinos ly vhich liolanl vorl is guidod.
\hon iL conos Lo Lho socilic rouLinos lor Lranslorring sanlos and
inlornaLion Lo Lho conany, rivacy roLocLion Lo lo olaloraLod lolov is a loy
issuo. AnoLhor quosLion is hov Lho rosulLs ol analysis aro Lo lo handlod. In Lho caso
ol doCodo, vhich has iLs ovn liolanl, Lho rosulLs logically lolong Lo Lho conany.
In Lho caso ol Lho Modical Biolanl, Lho rincilo long sinco aliod is LhaL all rosulLs,
o.g. lron gonoLying, should lo lod lacl and sLorod lor luLuro sLudios. Gonorally,
Lhis is a good racLico LhaL incroasos Lho valuo ol Lho liolanl lor rosoarch. BuL
aliod Lo a conany lilo InanGononics iL osos raLhor a rollon. According Lo
InanGononics, oLonLial cusLonors aro unvilling Lo accoL Lho rosulLs olLainod
loing nado availallo Lo oLhor rosoarchors. IndorsLandally so. Tho soluLion roosod
lor Lho IK Biolanl soons Lo lo a good ono, in casos vhoro ullicly linancod
liolanls aro usod connorcially. Horo, Lho conanios havo Lo roorL lacl all
analysis rosulLs as voll as conclusions, luL only alLor Lhoy havo had Lino Lo socuro
inLollocLual roorLy righLs. This is sinilar Lo Lho racLicos aliod in clinical Lrials ol
drugs, vhoro Lho lindings aro ullishod alLor sonsoring conanios havo had a
chanco Lo lilo aLonL alicaLions.

8.2 Protecting the donors integrity
Inloss Lho liosanlos aro conloLoly anonynisod, Lho protection oj the donors'
privacy loconos an inorLanL issuo in all linds ol rosoarch on liolanls. SocuriLy
sysLons and racLicos aro noodod Lo onsuro LhaL sonsiLivo inlornaLion alouL
individuals is noL connunicaLod Lo unauLhorisod orsons. Tho risl ol inlornaLion
alouL disoaso rodisosiLion coning Lo Lho lnovlodgo ol insuranco conanios and
onloyors has aLLracLod arLicular aLLonLion. IL is noL unroasonallo Lo susocL LhaL
conanios viLh accoss Lo liolanls nighL havo a connorcial inLorosL in solling such
inlornaLion. Irivacy roLocLion oughL Lhoroloro Lo lo osocially inorLanL in Lho
conLoxL ol connorcial rosoarch. BuL Lochnically soaling, Lho rollon is rincially
Lho sano as vhon liosanlos aro usod ly oLhor oxLornal rosoarchors.
Coding orsonal idonLiliors loloro Lranslorring sanlos and inlornaLion Lo Lho
conany is Lho doninanL nodo ol roLocLion Loday. Thus, a docoding loy oxisLs, luL
iL is loL socroL ly Lho liolanl uniL or sono oLhor ullic socLor organisaLion. Tho

22
80

lacL is, hovovor, LhaL conanios carrying ouL gononics rosoarch do noL nornally
nood Lo lnov Lho donors` idonLiLy.
ConuLorisod Lochniquos, sono noro sohisLicaLod Lhan oLhors, aro usod Lo
oncryL Lho idonLiLy, and sonoLinos Lho inlornaLion as voll. In Icoland, noL loasL, a
loL ol ollorLs has loon uL inLo daLa roLocLion. Today`s uso ol liosanlos ly
doCodo (and oLhor sinilar conanios} has Lo conly viLh sLricL socuriLy donands
lron Lho auLhoriLios. As Lo Lho lannod hoalLh socLor daLalaso and iLs conlinaLion
viLh gonoLic daLa, olLainod lron doCodo`s liolanl, Lho socuriLy roquirononLs lron
Lho govornnonL aro so lar-roaching LhaL nany olsorvors loliovo Lho daLalaso vill lo
ol liLLlo uso lor rosoarch. This oxanlo illusLraLos Lho dangor ol insisLing on vory high
socuriLy lovols. Tho dangor is LhaL Lho uso ol a liolanl vill lo nado so conlicaLod
and cosLly as Lo rondor Lho rosoarch unroliLallo, and also LhaL Lho liolanl`s
oLonLial lor dovoloing nov roducLs nighL noL lo usod Lo Lho losL ossillo
advanLago.
In Lho Icolandic caso ono ol Lho noLivos lor roquiring such a high lovol ol
socuriLy is LhaL Lho hoalLh daLalaso luilds on rosunod, as oosod Lo oxliciL,
consonL
2J
, and nusL only conLain non-orsonally idonLiliallo daLa (i.o., Lhoro should
lo no loy}. Hovovor, Lhoro aro criLics vho clain LhaL Lho uso ol a ono-vay coding
sysLon doos noL conloLoly olininaLo Lho ossililiLy ol Lracing idonLiLios, and LhaL
consonL should Lhoroloro lo olLainod a riori.
24

Insuring conlidonLialiLy ol idonLiLy is noL onough. Good oLhical racLico
according Lo curronL inLornaLional sLandards lor clinical rosoarch also roquiros
protection oj the donors' interests, and osocially roLocLion lron unvanLod risl
oxosuro. ThaL is vhy Lho rincilo ol inlornod consonL is olLon aliod loLh vhon
Laling and sLoring sanlos and vhon using Lhon lor rosoarch laLor on.
25
In lacL, Lho
nov Svodish Biolanls AcL sLiulaLos oxliciL inlornod consonL on loLh occasions.
\hoLhor or noL Lho original consonL Lo sLorago vill sullico vhon a sanlo is Lo lo
usod lor rosoarch aL a laLor oinL in Lino is lor Lho rosoarch oLhics conniLLoo Lo
docido. Tho docision should lo lasod, inter alia, on Lho uroso sociliod in Lho lirsL
consonL.
\hon sanlos aro usod in connorcial rosoarch iL is inorLanL LhaL donors lo
inlornod ol cororaLo involvononL. Tho inlicaLions ol Lhis havo alroady loon
connonLod on in socLion 8.1.
\hon croaLing a nov liolanl lor Lho sLudy ol a socilic disoaso, as doCodo
and Cxagon aro doing, Lho uroso ol Lho rosoarch can oasily lo sociliod. BuL vhon
ro-oxisLing liolanls, lilo Lho ono in Ino, aro usod, Lhings goL noro conlicaLod.
Ioonding on Lho conLonL ol Lho iniLial consonL and Lho uroso ol Lho sLudy, iL nay
lo nocossary Lo go lacl Lo Lho donors lor lrosh inlornod consonL. Many rosoarchors
orcoivo Lhis Lo lo an inconvonionco, luL in nany siLuaLions such a rocoduro is
rolally an unavoidallo ollocL ol nodorn oLhical guidolinos and logislaLion. IL is Loo
oarly yoL Lo say hov Lho nov Svodish Biolanls AcL vill vorl in racLico. IL ronains

2J
Givon Lho lroad uso inLondod, Lho concoL ol inlornod consonL in a Lruo sonso nighL noL lo
ossillo Lo inlononL in Lhis caso.
24
Arnason, I. 2002.
25
According Lo Lho guidolinos ol Lho Holsinli IoclaraLion, vhich logan Lo lo dovolood in Lho 1960s,
inlornod consonL should alvays lo olLainod lron hunan rosoarch suljocLs.
81
1ens LaageHellman
Lo lo soon il Lhoro vill lo any chango conarod viLh Lho curronL (unrogulaLod}
racLicos LhaL havo onorgod in roconL yoars.
26

IL is inLorosLing Lo noLo LhaL Icoland is discussing Lho inLroducLion ol a nov
Lyo ol vriLLon consonL vhich vould givo donors Lho oLion ol orniLLing vory
lroad uso, il Lhoy vish. According Lo Lho roononLs, Lhis Lyo ol oxliciL consonL
has Lho advanLago ol laciliLaLing Lho vorl ol oLhics conniLLoos. IurLhornoro, iL is
LhoughL LhaL such a racLico vould lonoliL conanios collocLing liosanlos lor
lroad rosoarch rogrannos. BuL Lhoro is sono uncorLainLy vhoLhor Lho Icolandic
Biolanls AcL vill havo Lo lo anondod, sinco iL roquiros inlornod consonL lor Lho
luilding ol scionLilic liolanls.
2

This Icolandic iniLiaLivo rorosonLs a ragnaLic aLLonL Lo lind soluLions LhaL
nalo liolanl rosoarch noro ollicionL aL Lho sano Lino as oach individual donor is
givon Lho oorLuniLy Lo docido Lho scoo ol Lho consonL. IL soons LhaL a najoriLy ol
Lho oulaLion vould lo roarod Lo granL lroad consonL according Lo Lho roosal,
luL Lhis ronains Lo lo soon.
As shovn in Lona Ring and Asa KoLLis Lindllad`s chaLor, lasod on a iloL
sLudy, Lho gonoral ullic in Svodon soons Lo havo a osiLivo aLLiLudo Lo Lho uso ol
liosanlos in nodical rosoarch. To vhaL oxLonL LhaL also orLains Lo connorcial
rosoarch ronains Lo lo oxaninod.

8.3 Organising the genomics company
Tho division oj labour loLvoon Lho gononics conany and Lho liolanl uniL(s} is noL
givon lolorohand. Tho Lasls LhaL nood Lo lo carriod ouL can lo dividod u in
dilloronL vays. doCodo and Cxagon rorosonL Lvo oosiLo aroachos. In Lho
lornor caso, Lho conany Lalos a vory acLivo arL in Lho sanling rocoss and is
nainly soll-sullicionL viLh rogard Lo Lho sulsoquonL rosoarch acLiviLios. Cxagon, ly
conLrasL, rolios Lo a groaL oxLonL on Lho inLollocLual vorl carriod ouL ly Lho clinical
conLros. Tho doCodo vay is noro oxonsivo, ol courso, luL givos Lho conany a
loLLor conLrol ovor Lho liolanl and Lho rosoarch acLiviLios. Cxagon is noro
doondonL on iLs liolanling arLnors, luL can on Lho oLhor hand Lalo advanLago ol
Lho conoLoncios and rosourcos ossossod ly Lho acadonic insLiLuLions.
IL is noL ossillo Lo osLallish, on Lho lasis ol Lho daLa collocLod in Lho rosonL
sLudy, vhich ol Lho Lvo aroachos yiolds Lho losL scionLilic rosulLs (or loads Lo
loLLor connorcial and ocononic succoss}. IL can lo hyoLhosisod LhaL loLh nodols
aro vorlallo il aroriaLoly inlononLod. BuL iL is inLorosLing Lo noLo LhaL in sono
disoaso aroas doCodo has osLallishod co-ooraLion viLh acadonic rosoarch grous in
Icoland. IL soons, in lacL, LhaL Lho losL rosulLs havo loon olLainod in Lhoso sLudios.
This shovs Lho groaL advanLago ol linling Lho gononics conany Lo univorsiLy
rosoarch.
InanGononics havo noL yoL sLarLod Lo uso sanlos lron Lho Modical
Biolanl, luL Lho rosonL agroononL onLiLlos iL Lo uso Lhon lor in-houso rojocLs.
InanGononics has alroady osLallishod co-ooraLion viLh clinical scionLisLs in Ino
in Lho liolds ol disoaso rogisLors and laniliar disoasos. Also vhon iL conos Lo Lho
luLuro uso ol Lho liolanl, assuning LhaL Lho rosonL conllicL vill lo solvod in ono

26
A rovious sLudy viLhin Lho rojocL shovod LhaL rosoarchors in loLh indusLry and acadonia loarod
LhaL Lho nov lav vould luroaucraLiso Lho uso ol liolanls (Laago-Hollnan, J. 2001l}.
2
By conLrasL, rosunod consonL is sullicionL lor saving sanlos in clinical liolanls (luL noL lor Lhoir
uso in rosoarch}.
82

vay or anoLhor, iL vill lo advanLagoous Lo Loan u viLh clinicians aL Lho univorsiLy
hosiLal. AcLually, Lhis vill rolally lo nocossary Lo sono oxLonL in ordor Lo accoss
Lho clinical inlornaLion noodod Lo conducL Lho sLudios.
Many inLorosLod arLios soo InanGononics as a Lool lor dovoloing Lho
local onvironnonL. Thoro soons Lo lo a loL ol high-qualiLy rosoarch in Ino. BuL lor
Lho long-Lorn dovolononL ol Lho conany iL nighL lo a good idoa Lo lroadon Lho
acadonic laso and also osLallish co-ooraLion viLh clinical rosoarchors lron oLhor
arLs ol Svodon (and naylo alroad}. Thoso rosoarchors should lo in Lho lorolronL in
Lho disoaso aroas LargoLod ly InanGononics. Thoy could vorl viLh naLorial lron
Lho Modical Biolanl and/or viLh oLhor collocLions. Such an aroach vould noL
LhroaLon Lho local connocLion ol Lho lusinoss acLiviLios in Ino as long as rogional
inLorosLs havo a docisivo inlluonco on Lho conany`s docision-naling. BuL Lho
osLallishnonL ol collaloraLivo rolaLionshis viLh a groaLor nunlor ol acadonic
arLnors vould sLrongLhon Lho conany`s rosourco laso and nalo iL a noro
aLLracLivo arLnor Lo Lho harnacouLical conanios.
IL goos viLhouL saying LhaL Lho succoss ol any conany is doondonL on the
choice oj business model, strategies and internal organisation. This issuo is noL only ol
inorLanco Lo Lho sharoholdors and nanagors ol clinical gononics conanios. Long-
Lorn connorcial and ocononic succoss is a roroquisiLo lor Lho conany`s aliliLy Lo
ollocLivoly orlorn iLs rolo in Lho innovaLion rocoss and Lhoroly conLriluLo Lo
inrovononLs in hoalLh caro. In oLhor vords, il Lho conany lails in Lho narloL, Lho
oLonLial lonoliLs ol using liolanls Lo dovolo nov roducLs nighL lail Lo lo
roalisod osocially in casos vhoro a singlo conany has oxclusivo righLs Lo con-
norcialisaLion. This vould lo a loss Lo luLuro aLionLs and socioLy in gonoral.
\o can noLo LhaL Lho lusinoss nodol and sLraLogios lor Lho coro acLiviLios aro
quiLo sinilar as loLvoon Lho Lhroo conanios invosLigaLod, dosiLo groaL dilloroncos
in Lhoir achiovononLs hiLhorLo. Thoy all lollov Lho gonoral Lrond in Lho gononics
indusLry Lo inLograLo lorvard inLo drug dovolononL. Givon Lho curronL changos in
Lho harnacouLical indusLry Lhis lind ol novo soons Lo lo a roroquisiLo ol survival.
doCodo Loday is considorally largor Lhan Lho oLhor Lvo conanios, in Lorns
ol loLh orsonal sLrongLh and oarnings (soo Lallo 1}. ILs lasLor grovLh can lo
aLLriluLod, anong oLhor Lhings, Lo iLs raising a largo anounL ol vonLuro caiLal and Lo
iLs oarly allianco viLh Rocho, vhich gavo doCodo a llying sLarL. InanGononics has
loon losoL viLh groving ains, vhich aL loasL arLly aro a dirocL consoquonco ol Lho
disuLo ovor accoss Lo liosanlos. IurLhornoro, unlilo doCodo and Cxagon,
InanGononics has loon a conany ovnod and conLrollod ly ullic socLor
inLorosLs. \iLh hindsighL, Lho connorcial visdon ol Lhis arrangononL is oon Lo
quosLion. \iLh rogard loLh Lo linanco and lusinoss conoLonco, iL nighL havo loon
loLLor il a rivaLoly ovnod conany had loon lornod lron Lho loginning. \iLh
oarly linancing lron Lho \C narloL and accoss Lo noro conoLonco lron Lho
lioLoch indusLry, o.g. via loard nonlors, Lho rocondiLions lor Lho conany`s
dovolononL and grovLh nighL havo loon loLLor. As vo havo soon, hovovor, Lhoro
voro socilic circunsLancos rolaLod Lo Lho Modical Biolanl LhaL rondorod such a
soluLion dilliculL, il noL inossillo. Tho vonLuro is in lacL conlicaLod ly a
nulLiLudo ol logal, oLhical and ocononic conloxiLios. IL ronains Lo lo soon il Lho
ongoing rivaLisaLion, ainod aL giving InanGononics an ovnorshi sLrucLuro noro
sinilar Lo LhaL ol Lho oLhor Lvo lirns, vill hol Lo Lriggor a sound lusinoss
dovolononL. Thoro aro sLill sovoral olsLaclos Lo lo surnounLod.
83
1ens LaageHellman
JusL as viLh oLhor lioLoch sLarL-us, oarly jinancing is crucial Lo Lho lornaLion ol
clinical gononics conanios. Gonorally soaling, Lho uso ol vonLuro caiLal has
layod an inorLanL rolo lor Lho connorcialisaLion ol liolanls. In Lho 1990s, Lhoro
vas a sLrong, inLornaLional \C loon, viLh lonLy ol caiLal soarching lor invosLnonL
oorLuniLios. Tho lioLoch indusLry, orcoivod as olloring an aLLracLivo oLonLial lor
grovLh, Lhanls Lo raid advancos in Lho lioscioncos and sLraLogic changos in Lho
harnacouLical indusLry, locano a oular LargoL lor Lho vonLuro caiLalisLs. Tho
high valuaLion ol lioLoch lirns on Lho sLocl narloLs gavo ronising oxiL
ossililiLios. IL vas during Lhis oriod LhaL doCodo and Cxagon voro loundod. Tho
lornor osocially, Lurning Lo Lho largo Anorican \C narloL, nanagod Lo raiso a loL
ol nonoy.
Today, as vo all lnov, narloL condiLions aro vory dilloronL. IL has locono
dilliculL lor lioLoch conanios in gonoral Lo raiso nov caiLal. Bosidos Lho gonoral
slun in Lho \C and sLocl narloLs, Lho oor ocononic orlornanco ol nany
lioLoch lirns has holod Lo nalo invosLors chary ol Lho indusLry. This includos
conanios socialising in clinical gononics, sinco iL has Lurnod ouL Lo lo noro
dilliculL Lhan oxocLod Lo nalo nonoy ouL ol Lhis lusinoss, nainly, as iL soons,
locauso Lho harnacouLical conanios aro rolucLanL Lo invosL oxLornally in oarly-
sLago gononics rojocLs. InsLoad Lhoy rolor luying validaLod drug LargoLs or
sulsLancos in clinical Lrials, i.o. rosoarch rosulLs LhaL can lo Lurnod noro quiclly inLo
narloLallo roducLs.
This unlavourallo siLuaLion in Lho caiLal narloL, as voll as in Lho narloL
lor Lho gononics conanios` sorvicos, noans LhaL sLarLing u a nov clinical gononics
conany vould lo noro dilliculL Loday aL loasL il iL voro Lo lo linancod on Lho \C
narloL.
AarL Lho uroly linancial considoraLions, Lhoro aro oLhor asocLs Lo Lho
ounership oj the company. Ior oxanlo, givon Lho loy rolo ol ullic socLor
insLiLuLions in liolanling acLiviLios, is ullic socLor ovnorshi nocossary lor
roLocLing Lho inLorosLs ol Lho donors, socioLy and Lhoso vho collocL Lho sanlos
AaronLly noL. Thoro is noLhing Lo shov LhaL ullic socLor ovnorshi per se vould
load Lo loLLor uso ol liolanls lron an oLhical or ocononic oinL ol viov. Il
anyLhing Lho oosiLo is Lruo, as viLnoss dovolononLs in Ino. AarL lron Lho
logal roroquisiLos, rovidod lor oxanlo ly Lho nov liolanl lavs, Lho inorLanL
Lhing, as vo havo alroady discussod, is hov Lho condiLions lor accoss aro rogulaLod,
lor oxanlo Lhrough lornal agroononLs loLvoon Lho acLors concornod (soo socLion
8.1}.
Hovovor, vhon Lho ain is Lo uso Lho connorcialisaLion vonLuro Lo
sLrongLhon Lho local onvironnonL, as in Ino and Icoland lor insLanco, Lhon locally
osLallishod ovnorshi nay lo inorLanL. This rovidos a lind ol guaranLoo ol local
or rogional considoraLions loing Lalon inLo accounL in Lho conany`s docision-
naling, o.g. on locaLion issuos. BuL Lhis doos noL nocossarily noan LhaL Lho
sharoholdor nusL cono lron Lho ullic socLor. IrivaLo ovnors can lullil Lho sano
luncLion, il Lhoy aro locally conniLLod.
IL should lo noLod LhaL Lhoso (logiLinaLo} anliLions Lo connorcialiso
liolanls locally, lor oxanlo as an olononL ol indusLrial olicy, nay cono inLo
conllicL viLh oLhor orlornanco variallos (soo liguro 4}. Thus, iL nay lo LhaL corLain
sanlos in a liolanl can lron a scionLilic oinL ol viov lo noro ollocLivoly usod ly
sonoono locaLod olsovhoro (vho has suiLallo, conlononLary rosourcos and
84

conoLoncios}. Also lron Lho gononics conany`s oinL ol viov, iL doos noL go
viLhouL saying LhaL orlorning all acLiviLios locally is Lho nosL lusinosslilo soluLion.
In Lho caso ol doCodo, lor oxanlo, iL soons Lo lo an oon quosLion Lo vhaL oxLonL
Lho conany`s lannod invosLnonLs in dovnsLroan drug rosoarch vill lo locaLod in
Icoland or in Lho IS. Iron a lusinoss dovolononL oinL ol viov, Lho IS nighL lo
Lho losL locaLion. Hovovor, Lho Icolandic govornnonL, vhich is oxocLod Lo suorL
Lho conany ly issuing a sLaLo guaranLoo lor a convorLillo lond, is anxious lor Lho
invosLnonL Lo lo nado in Icoland.

8.4 Organising the biobank unit
Hov Lo organiso liolanling in Lho ullic socLor LhaL is, viLhin Lho hoalLh caro
sysLon and aL univorsiLios is an inorLanL issuo gonorally, rogardloss ol vhoLhor or
noL connorcialisaLion is lannod on, locauso liolanls, clinical as voll as rosoarch-
lasod, aro oxonsivo Lo luild and ooraLo and locauso Lhoro is a groving inLorosL in
using Lhon lor scionLilic urosos. This calls lor organisaLional soluLions loading Lo
cosL-ollicionL and qualiLy-assurod liolanling and raLional and socuro rocoduros lor
viLhdravals. In nany lacos, aL loasL in Svodon, vorl has loon iniLiaLod Lo
roorganiso oxisLing liolanl acLiviLios, lor oxanlo, ly croaLing coro laciliLios or co-
ordinaLing disLriluLod liolanls viLhin hosiLals.
Nov liolanl lavs and rogulaLions lannod or inlononLod in various
counLrios also inly roquirononLs lor organisaLional changos. Ior oxanlo, Lho nov
Biolanls AcL in Svodon has givon Lho rincials ol Lho hoalLh caro sorvicos (i.o., Lho
counLy councils} nov Lasls. Tho rincials havo Lo dovolo nov rouLinos lor
handling Lho inlornod consonL lor clinical sanlos Lo lo savod noro Lhan Lvo
nonLhs, vhich is nov roquirod ly Lho nov lav, Lo nonLion jusL ono oxanlo. IL
soons LhaL nany ol Lho counLy councils voro oorly roarod lor naling Lhoso
sLiulaLod changos vhon Lho nov lav cano inLo lorco only roconLly.
Thoso gonoral asocLs ol liolanl organisaLion aro inorLanL luL havo noL
loon addrossod in Lho rosonL sLudy. Tho rolovanL quosLion horo is hov Lho
organising nighL lo allocLod ly connorcialisaLion. In nany casos, Lho inlicaLions
aro noL vory lar-roaching. AcLually, nosL health carebased biobanls aro noL usod lor
connorcial urosos. BuL vhon Lhoy aro, Lhis usually noans acadonic rosoarchors
vho aro collaloraLing viLh indusLry using Lho sanlos lron Lho liolanl.
As has alroady loon ronarlod, Lhoro is a nood lor rouLinos rogulaLing Lho
viLhdravals ol sanlos lron Lho liolanl, luL Lhoro is no groaL nood Lo LroaL
indusLrial usors dilloronLly lron oLhor oxLornal usors (in casos vhoro conanios, viLh
or viLhouL acadonic arLnors, vish Lo uso liosanlos in connorcial rojocLs}. Cno
ossillo oxcoLion orLains Lo Lho ocononic condiLions. A vidosroad rulo
inLornaLionally is Lo noL chargo acadonic rosoarchors, Lho roason loing LhaL scionLilic
criLoria, noL nonoy, should doLornino Lho uso ol sanlos. BuL iL is noL unroasonallo
Lo nalo conanios ay, lor oxanlo, a loo or sanlo connonsuraLo viLh Lho cosL
ol running Lho liolanl. This rincilo is nov aliod in Icoland, vhoro doCodo and
oLhor conanios aro using sanlos lron Lho lig naLional Lissuo lanl aL Lho univorsiLy
hosiLal. Thoro is, hovovor, a disuLo rogarding Lho rico, vhich has liniLod Lho
nunlor ol sanlos usod so lar.
Tho indusLry is rinarily inLorosLod in researchbased biobanls conLaining voll-
characLorisod naLorials. \hon nov disoaso-socilic liolanls aro croaLod lor Lho
uroso ol connorcial (or indusLrially-sonsorod} rosoarch. an inorLanL
85
1ens LaageHellman
organisaLional issuo is vhoro Lo locaLo Lho liolanl hysically. IL is noL unusual lor
Lho sanlos Lo lo sLorod in Lho conany`s laciliLios. BoLh Cxagon and doCodo do so,
lor oxanlo. This is in nany casos a good soluLion, sinco conanios olLon havo noro
suiLallo rosourcos, rouLinos and sysLons lor nanaging liolanls saloly and ollicionLly
(conarod Lo univorsiLy doarLnonLs, unloss socialisod coro laciliLios havo loon
croaLod}. IurLhornoro, Lhis is racLical vhon Lho conany carrios ouL Lho gonoLic
analysos. IL is inorLanL, hovovor, LhaL Lho disosal issuo lo soLLlod in advanco.
This soluLion vorls vhon Lho rosoarch grou ooraLos oxclusivoly viLh ono
conany. Il Lho rosoarchors vanL Lo nainLain Lhoir lroodon Lo collaloraLo viLh
sovoral conanios, Lhon olviously Lhoy nood Lo havo lull conLrol ol Lho sanlos. BuL
a sLraLogy" ol Lhis lind nay also nalo iL hard goL conanios Lo ay lor Lho
sanling. Sinco Lho linancing ol liolanling is a rollon Lo nany acadonic
rosoarchors, Lho osLallishnonL ol arLnorshis viLh indusLrial lirns, o.g. gononics
conanios, nay lo a good soluLion. BuL LhaL vill also noan sono righLs having Lo lo
ronouncod.
Ior oulaLion-lasod liolanls Lho organisaLional issuo is sonovhaL
dilloronL. Inlilo Lho lornor, such a liolanl can lo usod lor sLudying dilloronL
disoasos. Thus, Lhoro aro nany oLonLial usors loLh in acadonia and indusLry. In Lho
IK, as alroady nonLionod, Lho oulaLion-lasod liolanl Lo lo croaLod Lhoro vill noL
havo social Lios Lo any individual lirn. IsLonia and Ino havo lor various roasons
choson a dilloronL aroach.
As Lo Lho organising ol Lho Modical Biolanl in Ino, iL is dilliculL aL
rosonL Lo gonoraliso lron Lhoir oxorioncos, duo Lo Lho conlox siLuaLion causod ly
Lho disuLo ovor connorcialisaLion. Hovovor, Lho sharing ol rosonsililiLy loLvoon
Lho univorsiLy and Lho counLy council soons Lo lo a good arrangononL. In Lhis vay
Lho liolanl can rolally lo usod noro ollicionLly loLh lor rosoarch and lor nodical
caro. Givon Lho valuo ol Lho liolanl, Lho sonsiLivo inlornaLion iL conLains and Lho
largo nunlor ol inLorosLod arLios, Lho conLrol asocL is inorLanL. In ordor Lo avoid
Lho Lyo ol sorious conllicL LhaL has arison in Ino, Lhoro is a nood lor a cloar
division ol rolos and rosonsililiLios and an unanliguous nanagononL sLrucLuro.
Ivorylody agroos LhaL Lho Modical Biolanl should lo organisaLionally
soaraLod lron Lho connorcial uniL. As vo havo alroady soon, InanGononics
Loday ooraLos as a LoLally indoondonL conany, luL viLh an agroononL giving iL
oxclusivo accoss Lo Lho liolanl. Gran Hallnans and oLhors havo roosod an
alLornaLivo connorcialisaLion nodol, naling connorcial acLiviLios sulordinaLo Lo
Lho liolanl. ThaL organisaLional nodol, doscrilod in Lho nain roorL
28
, noans LhaL
Lho connorcial rojocLs aro conLrollod, and Lo a largo oxLonL carriod ouL, ly
rosoarchors linlod Lo Lho liolanl. IurLhornoro, all roliLs aro channollod lacl Lo
acadonic rosoarch. In shorL, iL can lo concludod LhaL Lhis nodol has dilloronL goals
lron Lhoso ol Lho rosonL nodol. ILs nain uroso is Lo suorL acadonic rosoarch
raLhor Lhan luilding a Lhriving lioLoch conany. IL is an inLorosLing concoL, luL iL
should raLhor lo soon as a novol vay ol organising dirocL co-ooraLion loLvoon
acadonic rosoarch and Lho harnacouLical indusLry. As such iL dosorvos Lo lo Lalon
soriously and criLically oxaninod, luL lor roasons ol saco LhaL cannoL lo dono horo.

28
86

9. Concluding remarks

In socLion J, a nunlor ol inorLanL issuos rolaLod Lo Lho connorcialisaLion ol
liolanls Lhrough dodicaLod clinical gononics conanios voro idonLiliod. Basod on
Lho Lhroo casos, Lhoso issuos havo loon discussod and corLain conclusions dravn.
IvidonLly, all issuos havo noL loon doalL viLh in doLh, arLly duo Lo Lho liniLod
saco availallo horo. Tho inLorosLod roador is Lhoroloro rolorrod Lo Lho lull roorL.
IurLhornoro, Lho onirical daLa collocLod in Lhis sLudy has noL allovod a Lhorough
oxaninaLion ol all asocLs. Thus, Lhoro is a nood lor lurLhor rosoarch in ordor Lo gain
a loLLor undorsLanding, lor oxanlo, ol hov Lo luild a succosslul clinical gononics
conany and hov Lo organiso liolanls in Lho ullic socLor.
Tho lasic quosLion undorlying Lho rosonL sLudy vas hov losL Lo organiso
Lho connorcialisaLion ol liolanls Lhrough clinical gononics conanios. Hovovor,
as Lhis chaLor hoolully shovs, Lhoro is no univorsal losL vay" ol organising
connorcialisaLion. No such oLinal arrangononL oxisLs. IirsL and loronosL, Lho
roroquisiLos lor oach individual vonLuro vill alvays vary according Lo dilloroncos ol
local onvironnonL and hisLorical conLoxL. Tho soluLions choson nood Lo lo adaLod
accordingly. Socond, Lhoro aro alvays dilloronL arLios viLh varying inLorosLs
involvod. A arLicular soL ol soluLions, and Lho associaLod ouLcono, nay lo
orcoivod as good ly ono arLy and as unsaLislacLory ly anoLhor. ThooroLically, ono
should Lry Lo lind a conlinaLion ol soluLions loading Lo an oLinal lalanco loLvoon
Lho dilloronL inLorosLs. Givon Lho conloxiLy and dynanics ol Lho honononon,
linding such an oLinun lools lilo loing vory dilliculL in racLico. InsLoad, Lho ain
ol Lho rosonL sLudy, sunnarisod in Lhis chaLor, has loon Lo rovido Lhoso involvod
in liolanl connorcialisaLion viLh a loLLor undorsLanding ol Lho honononon and
viLh sono hol in solocLing or dosigning soluLions vhich vill nooL dilloronL
donands and oljocLivos. In oach caso, Lhoro vill alvays lo alundanL scoo lor
inrovononL in sovoral orlornanco dinonsions.
\o nay add LhaL a connorcialisaLion vonLuro is novor dosignod" ly ono
singlo acLor (ovon il Lho aLLonL lo nado}. Thoro vill alvays lo sovoral
inLordoondonL acLors Lrying Lo inlluonco Lho choico ol soluLions, lasod on Lhoir ovn
inLorosLs and noans ol ovor. Thus, Lho characLorisLics ol a corLain vonLuro, as iL can
lo olsorvod aL a corLain oinL in Lino, vill alvays lo Lho rosulL ol aLh-doondonL
inLoracLion rocossos loading Lo a loL ol conronisos. In oLhor vords, a
connorcialisaLion vonLuro cannoL lo organisod" in a Lruo sonso. RaLhor, iLs
organisaLional characLorisLics and Lho rosulLing orlornanco onorgo as a rosulL ol
inLorlay anong nany acLors vho aro carrying ouL arallol organising acLiviLios in Lho
noLvorl.
IL lollovs LhaL Lho acLors` aliliLy Lo inLoracL viLh oLhors and Lo luild
rolaLionshis in Lho liolanl noLvorl is crucial Lo Lhoir ovn succoss as voll as Lo Lho
dovolononL ol Lho vholo vonLuro. IL is olvious, lor oxanlo, LhaL Lho disaoinLing
dovolononL in Ino aL loasL Lo sono oxLonL is a consoquonco ol oor rolaLionshis
loLvoon corLain loy acLors.
As in oLhor indusLrial conLoxLs, lruiLlul inLoracLion viLh lusinoss arLnors and oLhors
alvays luilds on a good undorsLanding ol Lho counLorarLios (o.g., vhaL nalos Lhon
Licl \haL aro Lhoir goals and visions \haL caaliliLios and oLhor rosourcos do Lhoy
havo}. BuL Lhis is noL onough. IL is also inorLanL Lo undorsLand hov Lho counLor-
arLios aro linlod Lo and doondonL on oLhor acLors in Lho noLvorl, and hov Lhoso
87
1ens LaageHellman
rolaLionshis allocL Lho counLorarLios` lohaviour. Givon LhaL Lho connorcial uso ol
ullic liolanls is raLhor a nov honononon, iL is noL surrising LhaL nany ol Lhoso
involvod do noL havo sullicionL undorsLanding ol all Lho conloxiLios inhoronL in Lho
connorcialisaLion rocoss. Thoroloro, il Lhis sLudy can conLriluLo Lo a loLLor
lnovlodgo alouL Lho rocondiLions lor ollocLivo connorcialisaLion, an inorLanL
uroso vill havo loon acconlishod.

88

References

Arnason, Iinar (2002}. Iorsonal IdonLilialiliLy in Lho Icolandic HoalLh SocLor IaLalaso.
1ournal oj lnjormation, Lau and Technology, 2.

Bjrlnan, Illa (2002}. Konnorsioll vorlsanhoL inon lionodonrdoL och don ollonLliga
lorslningon (Connorcial acLiviLios in Lho lionodical aroa and ullic rosoarch}. IaculLy ol
Lav, Isala InivorsiLy (mimeo}.

Ionoij, BongL (2000-01}. HunanliologislL naLorial och vinningslrlud (Hunan liological
naLorial and roliL rohiliLion}. 1uridisl tidslrijt, No. 4, . J-89.

Ionoij, BongL (2001}. IrohiliLions AgainsL Lho Translor ol Hunan Tissuo lor IroliL. In
Hansson, MaLs G. (Id.} (2001}. The Use oj Human Liobanls. thical, Social, conomical and
Legal Aspects. Isala: Isala InivorsiLy, . 8J-86.

IrnsL & Young (2002}. Boyond Bordors: Tho Glolal BioLochnology RoorL 2002.

HollsLadius, Asa (2002}. Biolanlon och innaLorialraLLon (Tho liolanl and Lho inLollocLual
roorLy righL}. IoarLnonL ol Lav, SLoclholn InivorsiLy (mimeo}.

Laago-Hollnan, Jons (2001a}. Tho IndusLrial Iso ol Biolanls in Svodon: an Cvorviov. In
Hansson, MaLs G. (Id.} (2001}. The Use oj Human Liobanls. thical, Social, conomical and
Legal Aspects. Isala: Isala InivorsiLy, . 15-J4.

Laago-Hollnan, Jons (2001l}. Konnorsialisoring av svonsla liolanlor: oLL naringsoliLislL
orsolLiv (ConnorcialisaLion ol Svodish liolanls: an indusLrial olicy orsocLivo}, lMlT
Report ?001.1?1. SLoclholn: InsLiLuLo lor ManagononL ol InnovaLion and Tochnology
IMIT}.

Laago-Hollnan, Jons (200J}. Commercialisation oj Liobanls. A Study oj Liotech Companies
Dedicated to Human Cenetics (lorLhconing}.

Red Herring (2000}. Tho Gononics GonoraLion, Aril, . J0.

Roso, Hilary (2001}. The Commodijication oj Lioinjormatics. The lcelandic Health Sector
Database. London: Tho \ollcono TrusL.

\oll, Sanna (2002}. Biolanlon lorslarons ollor annans (Tho liolanl Lho rosoarchor`s
or sonoono olso`s}. IoarLnonL ol Lav, SLoclholn InivorsiLy (mimeo}.
89
1ens LaageHellman

90
rivacy versus the interests oj research

Public law aspects on the use of biobank samples
privacy versus the interests of research

Associate rojessor lisabeth Rynning

Department oj Lau, Uppsala University

ln this Chap., the use oj biobanls jor research purposes is discussed jrom the vieupoint oj
public lau. The ley issues concern the balancing oj the donors' right to privacy uith other
rights and interests involved, mainly related to jreedom oj research, the provision oj good
health care and the protection oj property. The neu Suedish Liobanls (Health Care) Act
(?00?.?97) is analysed in light oj relevant requirements laid doun in public international
lau, and compared to the rules on processing oj personal data. A jeu comparative notes are
also made uith regard to certain other jurisdictions. lt is shoun that on certain points the
neu Suedish biobanl legislation is stricter than the corresponding rules on personal data,
uhereas on other points it jails to provide the privacy protection required in international
lau. urthermore, the scope oj the Act has not been made sujjiciently clear and many
biobanls are lejt unregulated. lt is thus argued that the regulatory process must continue,
and that legal developments both uithin and outside the U should be closely observed.

1. Introduction

As is cloar lron Lho various conLriluLions Lo Lhis roorL, Lho consLrucLion ol a
saLislacLory rogulaLory lranovorl lor Lho uso ol hunan liolanls roquiros Lho carolul
lalancing ol a nunlor ol righLs and inLorosLs concornod. SonoLinos Lho inLorosLs ol
individuals coincido viLh Lhoso ol oLhor individuals and ol socioLy, vhoroas aL oLhor
Linos conllicLs ol inLorosL ariso.
1
In nany vays, Lho conllicLs ol inLorosLs LhaL can lo
soon in rolaLion Lo liolanling rosonllo Lhoso LhaL concorn Lho rocossing ol sonsiLivo
orsonal daLa. Hunan liological naLorial, hovovor, also has corLain characLorisLics
and roorLios LhaL disLinguish iL lron oLhor sourcos ol orsonal inlornaLion.
IurLhornoro, Lho sanlos nay noL lo ol inLorosL sololy lor inlornaLional urosos,
luL also as rav naLorial lor corLain roducLs. Nov asocLs Lhus add Lo Lho
conloxiLy ol Lho lalancing roquirod in Lho rogulaLory rocoss. NovorLholoss, iL sLill
ronains Lho duLy ol Lho logislaLor Lo rovido aroriaLo judicial roLocLion Lo loLh
rivaLo and ullic inLorosLs in liolanling. In Lhis rocoss, Lho sharod noral valuos
and lasic logal rincilos ol Lho counLry or rogion in quosLion nusL lo considorod, as
voll as sLaLo olligaLions undor inLornaLional lav.
Iolining Lho sLudy oljocL ol Lho rojocL, i.o. Lho concoL ol a hunan
liolanl, nighL soon Lo lo a sinlo Lasl. IL is cloar, hovovor, LhaL Lho Lorn

1
Cf. Hermern, G. 1997, p. 23.
91
lisabeth Rynning
liolanl" is usod in loLh lairly vido and noL-so-vido sonsos.
2
Sono liolanls nighL
Lhus includo any sizo or lorn ol hunan liological naLorial. SonoLinos, Lho Lorn is
ovon undorsLood Lo includo noL only Lho liological naLorial as such, luL also
inlornaLion on Lho orsons vho sulniLLod Lho sanlos, as voll as inlornaLion
olLainod lron Lho sanlos.
J
Loss olLon, Lho Lorn liolanl" nay lo usod Lo doscrilo
only Lho narrov concoLion ol a INA lanl. A Lissuo lanl is noro olLon luL noL
alvays orcoivod as a narrovor concoL Lhan a liolanl.
4

Cno gonoral characLorisLic ol liolanls, hovovor, is LhaL Lho collocLion
should in sono sonso lo sLrucLurod, and Lho sanlos disLinguishallo lron ono
anoLhor. uiLo olLon, iL is also roquirod LhaL Lho liological naLorial lo Lracoallo Lo
an idonLiliallo donor. Hov Lhis roquirononL should lo undorsLood is dolaLallo,
hovovor, sinco in nosL casos Lhoro is aL loasL a LhooroLical ossililiLy ol Lracing
hunan naLorial Lo iLs donor, ly noans ol gonoLic analysis and Lho alicaLion ol
oLhor oLonL rosourcos. Ivon in Lho raro casos vhoro alsoluLo anonyniLy nay lo
olLainod, Lho anonynous donors and grous rolaLod Lo Lhon vill sLill havo corLain
righLs and inLorosLs Lo lo olsorvod.
In Lhis roorL, Lho vidor liolanl concoL is usod, alLhough rosLricLod Lo Lho
liological naLorial and Lhoroly oxcluding inlornaLion rogisLorod ouLsido ol Lho
sanlos. All Lyos ol hunan liological naLorial Lhus lall viLhin Lho scoo ol Lho
liolanl concoL usod in Lho LoxL, and naLLors ol anonyniLy vill also lo discussod.
Tho ullic lav arL ol Lho Biolanl IrojocL has doalL viLh a lroad soL ol
issuos, viLh rogard Lo judicial roLocLion lor Lho righLs ol individuals and grous
concornod, as voll as Lho nood Lo laciliLaLo ollicionL nanagononL and jusLiliallo uso
ol Svodish liolanls.
5
Tho sLudy has involvod Lho analysis ol rolovanL aroas ol loLh
Svodish and inLornaLional ullic lav, and also conaraLivo asocLs rogarding Lho
inLornal lav ol corLain oLhor jurisdicLions, rinarily Lho Nordic counLrios. Iuo Lo
liniLaLions ol saco, hovovor, Lho rosonL roorL is locusod rinarily on corLain
asocLs ol Lho uso ol Svodish liolanls in rosoarch.
6

2. Some rights and interests to consider

2.1. Rights and interests of potential donors
Indor ArLiclo 8 ol Lho Iurooan ConvonLion lor Lho IroLocLion ol Hunan RighLs
and IundanonLal Iroodons (1950},
ovoryono has Lho righL Lo rosocL lor his or hor

rivaLo lilo. Tho scoo ol Lho roLocLion allordod ly Lhis arLiclo is considorallo, and
in Lho aroa ol lionodicino nado noro rociso ly various ArLiclos in Lho Iurooan
ConvonLion on Hunan RighLs and Bionodicino (199}.
8
This laLLor ConvonLion has

2
Soo lor oxanlo Research ethics guidelines jor using biobanls, especially projects involving genome
research, adoLod ly Lho Svodish Modical Rosoarch Council (MIR} in Juno 1999.
J
Soo SocLion 2 ol Lho Norvogian govornnonL`s roosal, Cdelstingsproposisjon. nr. o (?001?00?).
4
Soo lor oxanlo IGI 1998.
5
Soo roorL I lron Lho rojocL: Rynning, I. 2001.
6
A noro conrohonsivo, Svodish roorL on Lho rosulLs ol Lho ullic lav sLudy vill lo lorLhconing
during 200J.
Council ol Iuroo 1950. Also incororaLod as a arL ol Svodish donosLic lav, soo Lag (1994.1?19)
om den europeisla lonventionen angende slydd jr de manslliga rattigheterna och de grundlaggande
jriheterna.
8
Council ol Iuroo 199 a.
92
Lho socilic ain ol roLocLing Lho digniLy and idonLiLy ol all hunan loings and
guaranLooing ovoryono, viLhouL discrininaLion, rosocL lor Lhoir inLogriLy and oLhor
righLs and lundanonLal lroodons viLh rogard Lo Lho alicaLion ol liology and
nodicino. Tho righL ol rivacy is also ollorod judicial roLocLion in Lho aroa ol II
lav, rinarily Lhrough IirocLivo 95/46/IC on Lho roLocLion ol orsonal daLa. A
noro gonoral righL Lo Lho inLogriLy ol Lho orson is rocognisod in ArLiclo J ol Lho
CharLor ol IundanonLal RighLs ol Lho Iurooan Inion (2000},
9
oxliciLly including
Lho righL Lo rosocL lor hysical and nonLal inLogriLy as voll as rosocL lor Lho lroo
and inlornod consonL ol Lho orson concornod, in Lho liolds ol nodicino and liology.
Individual aLionLs and rosoarch suljocLs aro Lhus onLiLlod Lo havo Lhoir rivacy
rosocLod, aL loasL Lo Lho oxLonL LhaL inlringononLs ol Lhis righL aro noL nocossary Lo
roLocL corLain oLhor inorLanL inLorosLs rogulaLod in naLional lav.
10

AnoLhor inorLanL inLorosL ol individuals concorns Lhoir accoss Lo hoalLh
caro ol an aroriaLo sLandard. This is also considorod a righL roLocLod, lor
oxanlo, undor ArLiclo J ol Lho ConvonLion on Hunan RighLs and Bionodicino and
rocognisod in ArLiclo J5 ol Lho II CharLor ol IundanonLal RighLs. Assuring hoalLh
caro ol good qualiLy involvos Lho looing ol nodical rocords, and nay also roquiro
Lho rosorvaLion ol liological sanlos. IurLhornoro, aLionLs and rosoarch suljocLs
nay havo a dirocL or indirocL orsonal inLorosL in rosoarch loing orlornod, and
loLLor noLhods dovolood lor Lho LroaLnonL ol disoaso. Ivon so, rosocL lor rivacy
and orsonal inLogriLy sLill noans LhaL Lho rocossing ol orsonal inlornaLion nusL
lo suljocL Lo corLain rosLricLions and saloguards, and LhaL individuals nusL as lar as
ossillo lo allovod Lo docido vhaL inLorvonLions nay lo orlornod on Lhon, hov
arLs ol Lhoir lodios nay lo usod, and vhoLhor or noL Lhoy vish Lo arLiciaLo in
rosoarch and connorcial onLorrisos.

2.2. Rights and interests of researchers and industry
Rosoarchors havo a jusLiliod inLorosL in lrooly choosing Lhoir scionLilic rollons and
noLhods. This is a lroodon rocognisod in ArLiclo 1J ol II CharLor on IundanonLal
RighLs and Iroodons and a rincilo also laid dovn ly Svodish lav.
11
In ordor Lo
ursuo Lhis righL, rosoarchors nood accoss Lo Lho nocossary rosoarch naLorials, lo iL
inlornaLion or liological sanlos. Connoss and lroodon ol inlornaLion aro Lhus
inorLanL Lo rosoarchors. \iLh rogard Lo inlornaLion rogisLorod in ollicial
docunonLs, vhich includo nosL carriors ol inlornaLion roducod in Lho ullic
socLor, Lho righL ol accoss is also a lundanonLal rincilo laid dovn in Lho Svodish
ConsLiLuLion, soo Cha. 2, SocLion 1 ol Lho Iroodon ol Lho Iross AcL. JusL lilo Lho
individual righL Lo rivacy, hovovor, Lho righLs nonLionod horo aro noL unliniLod. In
a conllicL ol inLorosLs, Lho rosoarchor`s lroodon nay Lhus havo Lo yiold Lo oLhor
inorLanL righLs and inLorosLs. IL should ol courso also lo noLod LhaL individual
rosoarchors nighL havo an inLorosL in looing Lhoir ovn rosoarch naLorials and

9
As oosod Lo Lho Iurooan ConvonLion, hovovor, Lhis CharLor has no dirocL logally linding ovor.
10
RosLricLions lor oxanlo on Lho righL Lo rivacy rogulaLod in ArLiclo 8.1 ol Lho Iurooan
ConvonLion on Hunan RighLs and IundanonLal Iroodons aro only allovod Lo Lho oxLonL LhaL Lhoy
aro nocossary in a donocraLic socioLy in Lho inLorosLs ol naLional socuriLy, ullic saloLy or Lho
ocononic voll-loing ol Lho counLry, lor Lho rovonLion ol disordor or crino, lor Lho roLocLion ol
hoalLh or norals, or lor Lho roLocLion ol Lho righLs and lroodons ol oLhors, soo ArLiclo 8.2. Tho
rosLricLions nusL also lo in accordanco viLh Lho lav.
11
Soo Cha. 1, SocLion 6 ol Hgslolelagen (1992:14J4} (Lho Highor IducaLion AcL}.
93
lisabeth Rynning
rogisLors Lo Lhonsolvos, an inLorosL LhaL could cono inLo conllicL viLh Lho inLorosLs ol
oLhor rosoarchors in loing allovod Lo sharo Lhon.
IurLhornoro, rosoarch noods Lo lo linancod, and Lho soLLing u and looing
ol liolanls nay lo oxonsivo. Rosoarchors Lhus havo an inLorosL in noL loing Loo
rosLricLod viLh rogard Lo Lhoir lunding oorLuniLios, luL raLhor having a vido choico
ol ossillo linanciors, also ouLsido Lhoir ovn counLry. CollaloraLion viLh oLhor
rosoarch insLiLuLions could lo ono vay ol laciliLaLing Lho linancing ol rosoarch, co-
ooraLion viLh indusLry anoLhor.
IL is noL nornally arguod LhaL hunan liological naLorial can lo suljocL Lo
ovnorshi in Lho ordinary sonso ol Lho vord,
12
luL Lhis is only Lruo as long as Lho
naLorial is noL Lurnod inLo a roducL. Conanios nanulacLuring roducLs ol vhich
hunan liological naLorials lorn arL, naLurally havo an inLorosL in Lho roLocLion ol
Lhoir roorLy righLs viLh rogard Lo Lho roducLs. Tho inLorosL in roLocLion ol
inLollocLual roorLy righLs nay ariso ovon loloro a roducL has loon lully
dovolood. In Lho conLoxL ol liolanling, arLicular noLo should lo Lalon ol
IirocLivo 98/44/IC on Lho logal roLocLion ol lioLochnological invonLions. Such
righLs, sonoLinos ol considorallo ocononic valuo, nay lo duo Lo individual
rosoarchors as voll as organisaLions or rivaLo conanios. ArLiclo 1 ol Lho II
CharLor ol IundanonLal RighLs rocognisos Lho righL Lo roorLy in noro gonoral
Lorns, as doos ArLiclo 1 ol AddiLional IroLocol 1 Lo Lho Iurooan ConvonLion on
Hunan RighLs and IundanonLal Iroodons.
1J

2.3. The interests of society
IL is cloarly in Lho inLorosL ol socioLy Lo lurLhor good lionodical rosoarch and Lho
dovolononL ol scionco. Tho gonoraLion ol loLLor noLhods lor rodicLing, diagnosing
and LroaLing disoaso is ol najor inorLanco in Lho lighL againsL hunan sulloring. Tho
sLaLo is inLorosLod in having hoalLhy ciLizons, as voll as osLallishing and nainLaining
an ollicionL and ocononically sLallo hoalLh caro socLor. Tho gonoral inLorosL in sound
linancial dovolononL also involvos indusLry, and Lho inLroducLion ol logislaLion loss
lavourallo Lo indusLrial ooraLions nighL also havo a doLrinonLal ollocL on sLaLo
linancos.
\iLh rogard Lo Lho uso ol hunan liolanls, Lhoro is also Lho socioLal inLorosL
ol rosorving rosocL lor hunan digniLy as such. Tho Iurooan ConvonLion on
Hunan RighLs and Bionodicino rocognisos Lho nood Lo rosocL Lho hunan loing
loLh as an individual and as a nonlor ol Lho hunan socios and Lho inorLanco ol
onsuring Lho digniLy ol Lho hunan loing.
14
CorLain acLiviLios, vhich could lo
onvisagod as connorcialisaLion or connodilicaLion ol arLs ol Lho hunan lody, aro
olLon LhoughL Lo onLail risls in Lhis rosocL. SocioLy nay Lhus havo an inLorosL in
liniLing Lho lavlul uso ol hunan liological naLorial in corLain asocLs.

2.4 The balancing act
As nonLionod alovo, iL is Lho duLy ol Lho sLaLo Lo rovido an aroriaLo logal
lranovorl lor roLocLing Lho righLs ol individuals as voll as oLhor inorLanL
inLorosLs rolaLod Lo Lho rivaLo or Lho ullic socLor. In Lhis rocoss, a nunlor ol lasic

12
\osLorlund, L. & Iorsson, A.H. 2001, . .
1J
Council ol Iuroo 1952.
14
Iroanllo ol Lho ConvonLion.
94
rincilos nusL lo olsorvod.
15
Ior oxanlo, Lho ovors ol ullic agoncios nusL lo
cloarly dolinod in lav and Lho inlicaLions ol Lho oxorciso ol such ovors lorosooallo
Lo ciLizons. RosLricLions on Lho lroodon ol ciLizons, as voll as Lho inosiLion ol
various Lyos ol olligaLions and lurdons, nusL novor lo disroorLionaLo Lo Lho
uroso Lhoy aro Lo sorvo. Tho lav should also lo jusL in Lho sonso ol sinilar rulos
alying undor sinilar condiLions. SLaLo olligaLions undor inLornaLional lav nusL ol
courso lo honourod, vhich anong oLhor Lhings involvos Lho roLocLion ol hunan
righLs and lroodons. In Lho inLornaLional hunan righLs docunonLs, iL is nado cloar
LhaL Lhoy nusL noL lo inLorroLod as inlying a righL Lo ongago in acLiviLy ainod aL
Lho dosLrucLion ol any ol Lho righLs and lroodons rocognisod, or aL Lhoir liniLaLion Lo
a groaLor oxLonL Lhan is rovidod lor in Lho docunonL, soo ArLiclo 1 ol Lho
Iurooan ConvonLion on Hunan RighLs and IundanonLal Iroodons and ArLiclo 54
ol Lho II CharLor on IundanonLal RighLs.
GuaranLooing rosoarchors and indusLry a lavourallo clinaLo, viLh roady
accoss Lo valuallo rosoarch naLorials and noL Loo nany cunlorsono rosLricLions, is
in Lho inLorosLs ol loLh socioLy and Lhoso noro dirocLly ongagod in such acLiviLios.
Tho inLroducLion ol oxcossivo roquirononLs nay also lo conLrary Lo Lho inLorosLs ol
luLuro aLionLs, il Lho dovolononL ol loLLor LroaLnonL noLhods is olsLrucLod. AL
Lho sano Lino, hovovor, rosorving Lho conlidonco ol Lho ullic could rovo oqually
inorLanL Lo Lho dovolononL ol scionco and good hoalLh caro. Il oolo voro Lo lool
LhaL Lhoir LrusL and good vill voro loing alusod, Lhis could inair Lhoir roadinoss Lo
arL viLh sonsiLivo inlornaLion Lo hoalLh caro rovidors and Lo arLiciaLo in
rosoarch. Tho roLocLion ol individual rivacy nay Lhus also lo in Lho long-Lorn
inLorosL ol rosoarchors and socioLy. Tho sano alios Lo noasuros ainod aL socuring
Lho inarLialiLy and indoondonco ol rosoarchors.
InorLanL Lools lor Lho roLocLion ol rivacy and soll-doLorninaLion ol
aLionLs and rosoarch suljocLs includo aroriaLo inlornaLion and consonL
roquirononLs, as voll as Lho ossililiLy ol viLhdraving consonL givon roviously.
IilloronL soluLions nay lo jusLiliallo in dilloronL siLuaLions, doonding on Lho
orcoivod risl ol inLogriLy inlringononLs as voll as Lho voighL ol oLhor inLorosLs aL
sLalo. Ior oxanlo, iL vould noL soon unroasonallo il consonL roquirononLs lor Lho
rosorvaLion ol Lissuo sanlos lor hoalLh caro urosos, in Lho aLionL`s ovn inLorosL,
voro Lo lo loss sLricL Lhan Lho roquirononLs govorning Lho uso ol hunan naLorial in
rosoarch. IurLhornoro, rosoarch rojocLs also vary considorally, lor oxanlo, viLh
rogard Lo Lho oLonLial valuo Lo socioLy ol Lho rosulLs oxocLod and Lho risls and
dogroo ol rivacy inlringononL. IxcoLionally, iL nay ovon lo jusLiliallo Lo disrogard
Lho vishos ol Lho individual.
A arLicular issuo concorns Lho siLuaLion vhoro Lho risl ol rivacy
inlringononLs indirocLly rolaLos Lo nonlors ol a grou, such as Lho gonoLic rolaLivos
ol a donor or orsons lolonging Lo a corLain oulaLion. Tho grou or oulaLion
also consisLs ol individuals, viLh righLs and inLorosLs jusL as oLhor individuals. AL Lho
sano Lino, iL is oqually olvious LhaL LradiLional noLhods lor individual inlornaLion
and consonL cannoL alvays lo aliod Lo grous or oulaLions. This doos noL noan
LhaL Lho issuo can lo ignorod, luL oLhor rincilos lor Lho roLocLion ol rivacy nay
havo Lo lo aliod in Lhoso siLuaLions.

15
Soo, lor oxanlo, SLrnlorg, H. 2002, . 64-68.
95
lisabeth Rynning
3. Recent legal developments

3.1. European law and other international regulations
\iLhouL any doulL, Lho Council ol Iuroo nusL lo considorod ono ol Lho alsoluLoly
rino ronoLors ol Lho roLocLion ol hunan righLs. Tho lasic rincilos laid dovn
in Lho Iurooan ConvonLion on Hunan RighLs and IundanonLal Iroodons havo
alroady loon nonLionod, luL Lho Council has also roducod sovoral docunonLs
noro dirocLly rolovanL Lo Lho handling ol liolanl naLorials. MosL inorLanL in Lhis
conLoxL is Lho alovo nonLionod ConvonLion on Hunan RighLs and Bionodicino, noL
loasL in viov ol iLs logally linding characLor.
16
ArLiclo 2 ol Lho ConvonLion roscrilos
LhaL in Lho aroa ol lionodicino, Lho inLorosLs and vollaro ol Lho hunan loing shall
rovail ovor Lho solo inLorosL ol socioLy or scionco. Anong oLhor Lhings, Lho
ConvonLion dolinos a nunlor ol gonoral roroquisiLos lor lionodical rosoarch
involving hunans, and also includos corLain socilic rulos on hunan liological
naLorial. Thus ArLiclo 22 rovidos LhaL il any arL ol a hunan lody has loon
ronovod in Lho courso ol an inLorvonLion, iL nay lo sLorod and usod lor a uroso
oLhor Lhan LhaL lor vhich iL vas ronovod only il Lhis is dono in conlorniLy viLh
aroriaLo inlornaLion and consonL rocoduros. Indor ArLiclo 26, rosLricLions on
ArLiclo 22 nay lo roscrilod ly inLornal lav only Lo Lho oxLonL nocossary in a
donocraLic socioLy in Lho inLorosL ol ullic saloLy, lor Lho rovonLion ol crino, lor
Lho roLocLion ol ullic hoalLh or lor Lho roLocLion ol Lho righLs and lroodons ol
oLhors. No sinilar rosLricLion is allovod viLh rogard Lo ArLiclo 21, vhich lays dovn
LhaL Lho hunan lody and iLs arLs shall noL, as such, givo riso Lo linancial gain.
An addiLional roLocol Lo Lho ConvonLion, doaling viLh LranslanLaLion ol
organs and Lissuos ol hunan origin, vas adoLod in January 2002.
1
Sinco Lho
IroLocol doliniLion ol LranslanLaLion" covors Lho conloLo rocoss ol ronoval and
inlanLaLion ol an organ or Lissuo, including all rocoduros lor roaraLion,
rosorvaLion and sLorago, iL also has a loaring on lanling issuos. Tho rovisions ol
Lho roLocol includo roquirononLs concorning Lho onsuring ol LracoaliliLy and
rohiliLion ol linancial gain.
18
Tho rulos on consonL, hovovor, only aly Lo Lho
ronoval ol Lho organ or Lissuo.
19
AlLhough Lho vord inlanLaLion, in iLs LradiLional
sonso, doos noL includo Lho uso ol hunan naLorial in Lho lorn ol nodical dovicos or
harnacouLicals, iL is sLaLod in Lho IxlanaLory RoorL LhaL rolossional sLandards
inly LhaL Lho rincilos conLainod in Lho IroLocol rogarding saloLy, LracoaliliLy,
inlornaLion and consonL lor such usos should lo alicallo mutatis mutandis.
20
IL is
cloar lron Lho IxlanaLory RoorL LhaL Lho IroLocol alios Lo inLorvonLions carriod
ouL in connocLion viLh oxorinonLal LranslanLaLion, in vhich casos Lho rulos
govorning rosoarch nusL lo conliod viLh as voll.
21

16
Tho ConvonLion onLorod inLo lorco on 1 Ioconlor 1999, luL has noL yoL loon raLiliod ly Svodon.
Soo also Lho IxlanaLory RoorL, Council ol Iuroo 1996 and Rynning, I. 199.
1
18
Soo ArLiclos J and 21-22.
19
Cha. III ol Lho IroLocol. IL is roconnondod LhaL naLional lav or rolossional sLandards rovido a
noans ol rosolving rollons concorning Lho viLhdraval ol consonL Lo an agrood LranslanLaLion alLor
Lho ronoval ol Lho organ or Lissuo, soo SocLion 8 ol Lho IxlanaLory RoorL Lo Lho IroLocol, Council
ol Iuroo 2001.
20
Council ol Iuroo 2001, SocLion 26.
21
Council ol Iuroo 2001, SocLion 42.
96
An oarlior Council ol Iuroo roconnondaLion socilically doaling viLh hunan
Lissuo lanls roosos inter alia LhaL such lanling acLiviLios should lo carriod ouL ly
non-roliL-naling insLiLuLions.
22
IL is also roconnondod LhaL Lho disLriluLion ol
lanlod naLorials Lalo laco in such a vay as Lo orniL oLinal uso ol Lho Lissuos on
an oquiLallo lasis in accordanco viLh naLional lav, rulos and racLico and oljocLivo
solocLion criLoria". In oLhor docunonLs lron Lho oarly 1990s, Lho Council ol Iuroo
has voicod Lho idoa LhaL hunan Lissuo should lo considorod a sourco ol inlornaLion
and lo roLocLod in Lho sano vay as oLhor nodia carrying orsonal inlornaLion.
2J

RogroLLally, Lho issuo vould noL soon Lo lo discussod in Lho RoconnondaLion (9}
5 on Lho roLocLion ol nodical daLa.
24

Looling aL Iurooan lav lron a noro gonoral orsocLivo, Lho Iurooan
Inion is ol courso ly lar Lho nosL ovorlul and inlluonLial organisaLion. AlLhough
Lhoro aro a nunlor ol IC rogulaLions LhaL nay lo alicallo Lo various asocLs or
corLain Lyos ol hunan liolanls,
25
Lhoro is aL rosonL no logally linding IC
insLrunonL socilically addrossing liolanling as such. An oinion on hunan Lissuo
lanling vas adoLod ly Lho Iurooan Grou on ILhics in Scionco and Nov
Tochnologios (IGI} in 1998. Tho IGI givos a nunlor ol roconnondaLions inter
alia concorning issuos ol saloLy and socuriLy, inlornaLion and consonL, conlidonLialiLy
and Lho rovonLion ol discrininaLion, Lissuo availaliliLy and inLornaLional Lranslor. IL
is sLrossod LhaL vhilo iL vould lo dilliculL Lo rosorvo Lissuo lanl acLiviLios sLricLly lor
non-roliL naling organisaLions, iL is inorLanL LhaL lanls soL u ly indusLry lo
suljocL Lo Lho sano liconsing and noniLoring roquirononLs as non-connorcial
ooraLors. Tho IGI oinion covors nosL Lyos ol hunan Lissuo, including colls and
coll linos, luL oxliciLly oxcludos sono Lissuos, such as llood, ganoLos, roroducLivo
Lissuo and onlryos. Nor doos Lho oinion covor gononic lanls, also rolorrod Lo as
INA lanls or liolanls".
26

In viov ol Lho shorLconings and discroancios in Lho rulos on Lho
LhoraouLic uso ol sulsLancos ol hunan origin, Lho Connission has roconLly dravn
u a roosal lor a IirocLivo on soLLing sLandards ol qualiLy and saloLy lor Lho
donaLion, rocurononL, LosLing, rocossing, sLorago and disLriluLion ol hunan Lissuo
and colls.
2
Lilo Lho IGI oinion, Lho roosod IirocLivo is locusod on hunan
liological naLorial ainod lor alicaLion Lo Lho hunan lody.
28
\iLh corLain
oxcoLions, Lho roosal covors Lissuos and colls ol hunan origin lor alicaLion Lo
Lho hunan lody during Lho lirsL hasos ol Lhoir LhoraouLic uso (donaLion,
rocurononL and LosLing} and, il Lho Lissuos and colls aro inLondod lor
LranslanLaLion, during Lho rocossing, rosorvaLion, sLorago and disLriluLion
hasos.
29
IxcoLions nainly concorn organs, colls and Lissuo lor auLologous uso,
llood and llood conononLs. IurLhornoro, Monlor SLaLos vill lo allovod Lo Lalo
lasic docisions on Lho uso ol colls osing an oLhical rollon, such as onlryonic sLon
colls. Tho roosod noasuros aro ainod aL sLrongLhoning Lho roquirononLs rolaLing

22
2J
Council ol Iuroo 1992 a and 1992 l. Soo also Hondius, 199, . JJ8.
24
Council ol Iuroo 199 l.
25
Soo, lor oxanlo, IirocLivo 95/46/IC, IirocLivo 98/9/IC and IirocLivo 2001/20/IC.
26
IGI 1998, . 2.
2
roposal jor a Directive oj the uropean arliament and oj the Council on setting standards oj quality
and sajety jor the donation, procurement, processing, storage, and distribution oj human tissue and cells..
28
ArLiclo 1 ol Lho roosod IirocLivo.
29
Soo HoalLh and consunor roLocLion" 2002.
97
lisabeth Rynning
Lo Lho suiLaliliLy ol donors and Lho scrooning ol donaLod sulsLancos. SysLons vill lo
soL u Lo onsuro Lho LracoaliliLy ol Lissuos and colls, and Lo rogulaLo inorLs ol
hunan Lissuos and colls lron Lhird counLrios. CLhor ains involvo Lho osLallishnonL
ol conarallo naLional accrodiLaLion and noniLoring sLrucLuros, as voll as oquivalonL
Lraining ol sLall.
Cn Lho inLornaLional lovol, Lhoro aro nany docunonLs LhaL in sono vay or
oLhor aro gornano Lo liolanling. Thoy includo Lho INISCC Inivorsal IoclaraLion
on Lho Hunan Gonono and Hunan RighLs (199} and Lho \HC Iroosod
inLornaLional guidolinos on oLhical issuos in nodical gonoLics and gonoLic sorvicos
(199}. Non-govornnonLal organisaLions havo LradiLionally rovidod inorLanL
guidolinos lor lionodical rosoarch,
J0
and such organisaLions aro Loday dovoloing
sLandards lor various Lyos ol liolanling.

3.2 Domestic law
\iLh rogard Lo donosLic lav, nov AcLs ol logislaLion on hunan liolanls havo loon
inLroducod in sono counLrios, and aro in roaraLion in corLain oLhors. MosL
Iurooan counLrios, hovovor, do noL soon Lo havo any logislaLion socilically ainod
aL rogulaLing hunan liolanling. This doos noL noan LhaL such acLiviLios aro
nocossarily unrogulaLod, sinco noro gonoral logislaLion nay lo alicallo and Lhoro
nay lo social rovisions on liolanling in oLhor AcLs. IilloronL liolanl acLiviLios
nay, lor oxanlo, cono undor rogulaLions doaling viLh aLionLs` righLs, lionodical
rosoarch, Lho rocossing ol orsonal daLa or donaLion ol hunan Lissuo and organs.
Tho Nordic counLrios lorn a goograhic rogion vhoro Lho logal
dovolononLs viLh rogard Lo liolanling havo loon arLicularly nanilosL during Lho
asL lov yoars. Icoland vas Lho lirsL Lo adoL a Biolanls AcL (110/2000}. This
onLorod inLo lorco on 1 January 2001. In SoLonlor Lho sano yoar, Lho nov Iinnish
Iso ol Hunan Crgans and Tissuo (Modical Iurosos} AcL (101/2001} onLorod inLo
lorco,
J1
including corLain rovisions on Lho Laling, collocLion and lurLhor uso ol
hunan Lissuo. Tho Svodish Biolanls (HoalLh Caro} AcL (2002:29} vas assod in
May 2002 and is ollocLivo as ol 1 January 200J.
J2
Norvay is alouL Lo lollov Lho
Icolandic and Svodish oxanlos, viLh a roosod Biolanls AcL Lo lo discussod in
Lho Norvogian IarlianonL ly Lho ond ol January 200J.
JJ
Tho Ianos, on Lho oLhor
hand, soon aL rosonL Lo lo considoring Lho noLhod ol adding corLain rovisions Lo
oxisLing logislaLion, rinarily Lo Lho Ianish Logal SLaLus ol IaLionLs AcL.
J4

IL is inLorosLing Lo noLo LhaL circunsLancos such as goograhic roxiniLy, a
arLly connon culLural horiLago and a LradiLion ol logislaLivo co-ooraLion in nany
oLhor aroas, ly no noans vould soon Lo guaranLoo a connon logal aroach Lo Lho
aroa ol hunan liolanling. NoL only do Lho rogulaLory noLhods choson ly Lho
dilloronL Nordic counLrios vary, luL so do Lho scoo ol Lho logislaLion and, in a
nunlor ol asocLs, Lho naLorial conLonLs ol Lho lav.

J0
Ior a nunlor ol such guidolinos, soo, lor oxanlo, Codex Regler och riltlinjer jr jorslning.
J1
Lag om anvandning av manslliga organ och vavnader jr medicinsla andaml ?.?.?001/101.
J2
Lag (?00?.?97) om biobanler inom halso och sjulvrden m.m.
JJ
Cdelstingsproposisjon nr. o (?001?00?) and Sosiallomiteens lnstilling til Cdelstinget Nr. ? (?00?
?00J).
J4
Redegrelse om biobanler. orslag til retlig regulering aj biobanler inden jor sundhedsomrdet 2002.
98

4. Human biological material a carrier of personal data

4.1. General remarks
\hon liolanl sanlos aro loolod uon as a sourco ol valuallo, sonsiLivo
inlornaLion, Lhoy shov sulsLanLial sinilariLios Lo oLhor such sourcos ol inlornaLion,
lor oxanlo nodical rocords and naLional hoalLh rogisLors. IL is Lhoroloro ol inLorosL
Lo sLudy Lho rulos aliod in Lho rocossing ol such orsonal inlornaLion, and Lo
considor vhoLhor or noL Lhoso rulos nighL also lo alicallo Lo hunan liological
naLorial.
J5
IarL ol Lho oarly criLicisn againsL Lho Svodish Biolanls (HoalLh Caro} AcL
has concornod loars LhaL Lho collocLion and sLorago ol liolanl sanlos vill lo noro
rosLricLod Lhan Lho collocLion and rosorvaLion ol orsonal daLa lor nodical rocords
and naLional hoalLh rogisLors, and LhaL liolanling nay in lacL locono so dilliculL
and cosLly LhaL nany valuallo sanlos vill no longor lo savod.
J6

4.2. Swedish law on the protection of personal data in relation to biomedical research
Tho rinary Svodish logislaLion inlononLing IirocLivo 95/46/IC on Lho
roLocLion ol orsonal daLa is Lho Iorsonal IaLa AcL,
J
conlononLod ly Lho
Iorsonal IaLa Crdinanco.
J8
SinulLanoously Lvo nov lavs voro inLroducod lor Lho
aroa ol hoalLh caro and oidoniological rosoarch, nanoly Lho Modical Caro RogisLors
AcL and Lho HoalLh IaLa RogisLors AcL,
J9
loLh doaling oxclusivoly viLh corLain Lyos
ol auLonaLod rocossing. Thoro is also an AcL on Rosoarch RogisLors lor Ioronsic
IsychiaLry.
40
Tho rulos ol socrocy and conlidonLialiLy viLhin Lho ullic socLor,
hovovor, aro sLill nainly Lo lo lound in Lho Socrocy AcL .
41

Modical rocords viLhin Lho ullic hoalLh caro socLor, as voll as hoalLh daLa
rogisLors, rosoarch docunonLs roducod aL ullic univorsiLios oLc., consLiLuLo ollicial
docunonLs undor Cha. 2 ol Lho Svodish Iroodon ol Lho Iross AcL.
42
IaLalasos,
rocordings, hoLograhs oLc. all counL as docunonLs" in Lhis conLoxL. Biological
sanlos, hovovor, do noL consLiLuLo docunonLs undor Lho Iroodon ol Lho Iross AcL,
and Lhus lall ouLsido Lho scoo ol Lhis soL ol rulos.
4J
Tho lordorlino loLvoon a
liological sanlo and a docunonL doos noL soon all LhaL shar, hovovor, in a Lino
vhoro INA can lo digiLalisod and nany oLhor characLorisLics ol hunan Lissuo and
colls can lo rogisLorod in onlargod hoLograhs oLc.
Tho lacL LhaL a docunonL is considorod Lo lo an ollicial docunonL noans
LhaL iL nusL lo loL and rosorvod in accordanco viLh Lho Archivos AcL and Lho
Archivos Crdinanco, and nay only lo dosLroyod or alLorod undor corLain
condiLions.
44
IurLhornoro, ollicial docunonLs nusL lo rosonLod on roquosL, unloss

J5
Soo Rynning, I. 1998.
J6
Adani, H-C oL al 2002.
J
ersonuppgijtslag (1998.?04). TransiLional rovisions aly inLor alia viLh rogard Lo corLain Lyos ol
nanual rocossing ol orsonal daLa, soo LransiLional rovision J.
J8
ersonuppgijtsjrordning (1998. 1191)
J9
Lag (1998.44) om vrdregister and lag (1998.4J) om halsodataregister.
40
Lag (1999.JJ) om rattspsyliatrislt jorslningsregister.
41
Selretesslag (1989.100).
42
Trycljrihetsjrordning (KK 1949.10).
4J
Ruling ol Lho Surono AdninisLraLivo CourL, Regeringsrattens Arsbol 1994 noLo 465.
44
Arlivlag (1990.78?) and Arlivjrordning (1991.44o). Soo RaLLsliga asolLor dolunonLaLion och
arlivoring av naLorial i sanland nod nodicinsl lorslning.
99
lisabeth Rynning
Lhoro is an alicallo rovision on socrocy or conlidonLialiLy roLocLing Lho
inlornaLion rogisLorod in Lho docunonL, soo Cha. 2, SocLion 12 ol Lho Iroodon ol
Lho Iross AcL.
SocLion 1J ol Lho Iorsonal IaLa AcL rohiliLs Lho rocossing ol sonsiLivo
daLa, o.g. concorning hoalLh, is rohiliLod, luL oxcoLions aro Lhon nado lor a
nunlor ol siLuaLions. Thus iL is lavlul Lo rocoss sonsiLivo daLa viLh Lho oxross
consonL ol Lho daLa suljocL, soo SocLion 14. Irocossing ol sonsiLivo daLa lor hoalLh
and hosiLal urosos nay also lo lavlul viLhouL consonL, vhon Lho rocossing is
nocossary lor rovonLivo nodicino and hoalLh caro, nodical diagnosis, hoalLh caro or
LroaLnonL, or nanagononL ol hoalLh and hosiLal caro sorvicos, soo SocLion 18.
Tho rogisLraLion ol sonsiLivo orsonal daLa in nodical rocords is Lhus noL
suljocL Lo Lho orsonal vishos ol Lho aLionL concornod. Cn Lho conLrary, such
looing ol rocords is a nandaLory duLy ol Lho hoalLh caro orsonnol, soo SocLion 9 ol
Lho Modical Rocords AcL.
45
This alios Lo all Lyos ol docunonLaLion rolovanL Lo Lho
aLionL`s hoalLh, LroaLnonL oLc., soo SocLions 2-J. Il Lho hoalLh caro rovidor choosos
Lo loo Lho rocords in auLonaLod lorn, Lho aLionL nusL lo inlornod ol Lhis, luL Lho
rogisLraLion ol rolovanL hoalLh inlornaLion vill sLill Lalo laco rogardloss ol Lho
aLionLs` vill.
46
Tho Lranslor ol corLain hoalLh-rolaLod inlornaLion Lo naLional hoalLh
daLa rogisLors is also nandaLory, undor socilic logislaLion, and Lhus noL suljocL Lo
Lho vill ol Lho aLionL nor Lo LhaL ol Lho hoalLh caro rovidor, soo SocLion 6 ol Lho
HoalLh IaLa RogisLors AcL.
\hon iL conos Lo using hoalLh-rolaLod orsonal inlornaLion in lionodical
rosoarch, hovovor, Lhoro is lirsL Lho naLLor ol gaining accoss Lo Lho inlornaLion. In
sono casos, Lho inlornaLion noodod nay lo olLainod dirocLly lron Lho
aLionL/rosoarch suljocL, luL quiLo olLon Lho rosoarchor vould lilo Lo accoss
inlornaLion lron individual nodical rocords or lron naLional hoalLh daLa rogisLors.
Such accoss nay lo granLod only in accordanco viLh Lho alicallo rulos ol
conlidonLialiLy and socrocy. NoL ovon nonlors ol Lho hoalLh caro orsonnol vho
alroady havo accoss Lo Lho nodical rocords in Lhoir daily vorl, aro lroo Lo uso Lo Lho
inlornaLion lor urosos oLhor Lhan Lhoso rolaLod Lo Lho hoalLh caro acLiviLios.
4

\iLhin Lho aroa ol ullic hoalLh caro, inlornaLion alouL Lho sLaLo ol hoalLh or
oLhor orsonal circunsLancos ol an individual nusL noL lo disclosod unloss iL is cloar
LhaL Lho disclosuro vill noL consLiLuLo any harn Lo Lho orson concornod, or Lo
orsons closoly rolaLod Lo hin or hor, soo Cha. , SocLion 1 (1} ol Lho Socrocy AcL.
Sinilar rovisions aly in rivaLo hoalLh caro, soo Cha. 2, SocLion 8 ol Lho HoalLh
and Modical Sorvicos (Irolossional AcLiviLios} AcL (1998:5J1}. IxcoLions nay
aly in corLain siLuaLions, luL iL should lo noLod LhaL Lhoro is no gonoral oxcoLion
rogarding rosoarch. Tho rulos orLaining Lo inlornaLion in naLional hoalLh daLa
rogisLors aro no loss sLricL, oxliciLly roviding LhaL orsonal daLa lo disclosod lor
rosoarch urosos only vhon iL is cloar LhaL Lho disclosuro vill noL causo any harn Lo
Lho orson concornod, or Lo orsons closoly rolaLod Lo hin or hor, soo Cha. 9,
SocLion 4 ol Lho Socrocy AcL.

45
atientjournallag (198o.?0J}.
46
Such auLonaLod rogisLors aro rogulaLod in Lho Modical Caro RogisLors AcL, vhoro no roquirononL
lor Lho aLionLs` consonL is sLiulaLod.
4
Soo lor oxanlo Cha. 1, SocLion 4 ol Lho Socrocy AcL.
100
IL is Lho rosonsililiLy ol Lho orson or agoncy LhaL arLs viLh Lho inlornaLion, Lo
osLallish LhaL Lho nocossary roquirononLs aro noL.
48
Tho concoL ol harn" should
Lhon lo orcoivod lron Lho viovoinL ol Lho individual concornod.
49
IL nay lo
sullicionL LhaL ho or sho vould lool unconlorLallo viLh Lho inlornaLion loing
disclosod, in ordor lor harn Lo lo causod, alLhough sono adjusLnonL vould lo
ornissillo viLh rogard Lo inlornaLion noro gonorally considorod Lo lo harnloss.
50

In casos vhoro Lho risl ol harn cannoL lo oxcludod, hovovor, Lho orson concornod
can nornally vaivo Lho righL ol socrocy il ho or sho vishos Lo do so.
51
IsLallishing
viLh corLainLy vhoLhor or noL disclosuro lor Lho inLondod rosoarch vill causo no
harn, olLon roquiros dirocL consulLaLion viLh Lho aLionL. In racLico, hovovor, Lho
rulos ol conlidonLialiLy vould noL alvays soon Lo lo aliod quiLo as sLricLly as
LhaL.
52
IL should also lo noLod LhaL Lho disclosuro ol doorsonalisod inlornaLion is
nornally noL considorod Lo causo harn.
SocLion 19 (1} ol Lho Iorsonal IaLa AcL rovidos LhaL sonsiLivo orsonal
daLa nay lo rocossod lor rosoarch and sLaLisLics urosos ovon viLhouL Lho consonL
ol Lho daLa suljocL, rovidod Lho rocossing is nocossary and Lho inLorosL ol socioLy in
Lho rojocL is nanilosLly groaLor Lhan Lho risl ol inroor violaLion ol Lho orsonal
inLogriLy ol Lho daLa suljocL. Thoso roroquisiLos shall lo doonod saLisliod il Lho
rocossing has loon arovod ly a rosoarch oLhics conniLLoo, soo sulsocLion 2.
AlLhough Lho rosoarch oLhics conniLLoo nay Lhus auLhoriso Lho rocossing ol
sonsiLivo daLa in a corLain rosoarch rojocL, iL should lo rononlorod LhaL Lho
conniLLoo doos noL havo Lho ovor Lo granL Lho rosoarchors initial access Lo Lho
inlornaLion in quosLion. This is sLill a naLLor Lo lo docidod in accordanco viLh
gonoral rulos on socrocy and conlidonLialiLy, as doscrilod alovo.
NoLilicaLion ol Lho IaLa InsocLion Board, rogarding Lho rocossing ol
orsonal daLa, is noL nornally roquirod il Lho daLa conLrollor has aoinLod a daLa
rorosonLaLivo and givon noLico ol Lhis Lo Lho Board, soo SocLion J ol Lho Iorsonal
IaLa AcL. Nor is such noLilicaLion roquirod il Lho daLa suljocL has consonLod Lo Lho
rocossing.
5J
Irocossing ol orsonal daLa viLhin Lho hoalLh caro socLor, in accordanco
viLh SocLion 18 ol Lho Iorsonal IaLa AcL, is also oxcoLod lron Lho gonoral
noLilicaLion roquirononL in SocLion J6.
54

Hovovor, Lho oxonLions vhich havo nov loon nonLionod do noL aly Lo
corLain Lyos ol rocossing lor vhich rior noLico Lo Lho IaLa InsocLion Board is
mandatory. Such roquirononLs aro roscrilod viLh rogard Lo Lvo casos ol auLonaLod
rocossing.
55
Tho lirsL caso concorns rocossing ol sonsiLivo orsonal daLa lor rosoarch
urosos viLhouL Lho consonL ol Lho orson rogisLorod vhich has noL loon arovod
ly a rosoarch oLhics conniLLoo, in accordanco viLh SocLion 19 ol Lho Iorsonal IaLa

48
\iLhin Lho ullic socLor, Lho disclosuro ol inlornaLion in ollicial docunonLs is docidod uon in
accordanco viLh a corLain rocoduro laid dovn in Cha. 15, SocLions 6-8 ol Lho Socrocy AcL.
49
Rognor, G, Iliasson, M & Hounan, S. 2002 . III:14-15.
50
Ior a narrovor inLorroLaLion ol Lho concoL ol harn, soo Lho chaLor ly Ilric von Isson in Lhis
lool.
51
Cha. 14, SocLion 4 (1} ol Lho Socrocy AcL.
52
Rynning, I. 200J.
5J
This oxonLion is lound in SocLion 4 ol Lho IaLa InsocLion Board`s Codo ol SLaLuLos,
Datainspeltionens jreslrijter (DlS ?001.1) om andring av Datainspeltionens jreslrijter i jrga om
slyldigheten att anmala behandlingar av personuppgijter till Datainspeltionen.
54
SocLion 5 (o} ol Lho sano rogulaLion.
55
Soo SocLion 10 ol Lho Iorsonal IaLa Crdinanco, rolorring Lo SocLion 41 ol Lho Iorsonal IaLa AcL.
101
lisabeth Rynning
AcL. Il Lho daLa conLrollor choosos Lo orlorn Lho lalancing ol inLorosLs hinsoll or
horsoll, Lho rocossing ol daLa nusL Lhus lo noLiliod lor rior chocling.
56
Tho socond
caso rolors Lo rocossing ol orsonal daLa dorivod lron gonoLic invosLigaLion and
concorning a horodiLary disosiLion. Irior noLilicaLion is noL, hovovor, roquirod in
casos vhoro Lho rocossing is govornod ly socilic rogulaLions, vhich lor oxanlo
vould soon Lo lo Lho caso viLh auLonaLod nodical rocords, hoalLh daLa rogisLors and
rosoarch rogisLors in loronsic sychiaLry.
Tho siLuaLion vhoro Lho daLa suljocL viLhdravs his or hor consonL Lo Lho
daLa rocossing is rogulaLod in SocLion 12 (1} ol Lho Iorsonal IaLa AcL. Such
viLhdraval, hovovor, doos noL noan LhaL all lurLhor rocossing ol Lho daLa is
rohiliLod, only LhaL no additional orsonal daLa nay lo rocossod. IdaLing Lhus
vill noL lo ossillo, vhoroas conLinuod rocossing ol Lho alroady rogisLorod daLa is
sLill allovod. This vas considorod a suiLallo lalancing ol Lho conllicLing inLorosLs ol
Lho daLa suljocL and Lho daLa conLrollor.
5

4.3. The status of biobank materials
Hov, Lhon, aro liolanl naLorials loolod uon in various jurisdicLions viLhin Lho
II/IIA, vhoro IirocLivo 95/46/IC on Lho roLocLion ol orsonal daLa should lo
inlononLod \hoLhor or noL Lho liological sanlos in hunan liolanls aro
considorod Lo cono undor naLional logislaLion on Lho rocossing ol orsonal daLa, is
ol courso highly rolovanL Lo Lho orcoivod nood lor conrohonsivo liolanl
logislaLion raLhor Lhan jusL addiLional rulos addrossing corLain asocLs socilic Lo
liological sanlos. IL is oqually inorLanL LhaL Lho inLorroLaLion ol IirocLivo
95/46/IC should noL vary loLvoon Monlor SLaLos, in such a vay LhaL liolanl
sanlos aro oxorLod on Lho nisLalon suosiLion LhaL Lhoy vill lo sullicionLly
roLocLod in Lho rocoiving Monlor SLaLo, or viLhhold undor Lho nisLalon
arohonsion LhaL Lhoy vill noL' Tho sLand Lalon ly various Monlor SLaLos on Lhis
issuo, hovovor, doos noL soon Lo lo all LhaL cloar.
58
IL is naLurally olsorvod LhaL logal
rulos on Lho rocossing ol orsonal daLa nusL lo aliod viLh rogard Lo orsonal
inlornaLion linlod Lo liolanl naLorials. Tho uncorLainLy rinarily rolaLos Lo Lho
sLaLus ol Lho liological naLorial as such.
59

Cno counLry vhoro liolanl sanlos havo in lacL loon cloarly and ollicially
doclarod suljocL Lo orsonal daLa logislaLion is Ionnarl.
60
This is also Lho nain
roason vhy Lho Ianos do noL soon Lo lan on inLroducing any gonoral liolanl
logislaLion, only sulononLary rovisions in corLain oxisLing AcLs.

56
Indor SocLion J ol Lho roosod nov ILhics Roviov AcL, hovovor, Lhoro vill lo a nandaLory
roquirononL ol oLhics roviov ol rosoarch-rolaLod rocossing ol sonsiLivo orsonal daLa viLhouL
consonL, soo Lho GovornnonL Bill Regeringens proposition ?00?/0J.0 tilprvning av jorslning. Tho
daLa conLrollor vill Lhon no longor lo allo Lo chooso Lho alLornaLivo ol orlorning Lho lalancing ol
inLorosLs hinsoll or horsoll.
5
Cnan, S. & Lindllon, H-C. 2002, . 126.
58
Survey on opinions jrom National thics Committees or similar bodies, public debate and national
legislation in relation to human biobanls. 2002.
59
Tho naLLor is loing sLudiod as arL ol Lho Iurooan rosoarch rojocL IRI\IRIAL: Irivacy in
Rosoarch ILhics and Lav, co-ordinaLod ly Irolossor Iorycl Boylovold and Iavid Tovnond aL SIBLI,
Sholliold InivorsiLy. InlornaLion on Lhis rojocL can lo lound aL <hLL://vvv.riviroal.org/>.
60
Soo o.g. Bluno, I. 1996, . 29-J4 and Lho Inglish sunnary ol Lho roorL Redegrelse om
biobanler. orslag til retlig regulering aj biobanler inden jor sundhedsomrdet. 2002 . 245.
102
In Lho travaux preparatoires ol Lho Svodish Iorsonal IaLa AcL, Lho rocossing ol
liological sanlos is noL ovon nonLionod.
61
Tho Svodish GovornnonL has sinco
doclarod LhaL INA sanlos and oLhor arLs ol Lho hunan lody should in rincilo
lo considorod Lo consLiLuLo orsonal daLa, rovidod LhaL Lho naLorial can lo Lracod
Lo idonLiliallo living orsons.
62
Tho GovornnonL arguos, hovovor, LhaL Lho noro
looing ol sanlos in a so-callod liolanl doos noL cono viLhin Lho doliniLion ol
such arLly auLonaLod or nanual rocossing ol daLa as is rogulaLod in Lho Iorsonal
IaLa AcL. Sinco Lho looing ol liolanls sLill consLiLuLos a arLicularly sonsiLivo
acLiviLy, and ono vhich should lo suljocL Lo high sLandards lor Lho roLocLion ol
rivacy and orsonal inLogriLy sinilar Lo Lhoso laid dovn in IirocLivo 95/46/IC, a
social Biolanls (HoalLh Caro} AcL is noodod. As lor orsonal daLa rogarding Lho
sanlos in a liolanl, such inlornaLion is noL considorod Lo lornally consLiLuLo any
arL ol Lho liolanl as such.
6J

Tho noro rociso lordorlino loLvoon Lho scoo ol Lho Svodish Biolanls
AcL and LhaL ol Lho Iorsonal IaLa AcL sLill ronains raLhor vaguo. IL is noL cloar vhaL
lind ol rocossing ol liolanl sanlos could in lacL cono undor Lho Iorsonal IaLa
AcL, nor vhich AcL should lo givon rocodonco in a siLuaLion vhoro loLh AcLs could
lo considorod prima jacie alicallo. This could consLiLuLo a rollon, osocially Lo
Lho oxLonL LhaL Lho rulos ol Lho Biolanls AcL aro lound Lo dillor lron Lhoso ol Lho
Iorsonal IaLa AcL. Tho Biolanls AcL doos conLain a rovision sLaLing LhaL Lho AcL
vill noL aly il Lhoro aro divorging rovisions in oLhor AcLs ol logislaLion, soo Cha.
1, SocLion 4. This vould soon Lo givo rocodonco Lo Lho Iorsonal IaLa AcL in caso ol
a conllicL. InlorLunaLoly, hovovor, SocLion 2 ol Lho Iorsonal IaLa AcL conLains a
sinilar rovision, also olloring rocodonco Lo divorging rovisions in oLhor lavs and
ordinancos. Tho conoLiLion is Lhoroly lroughL Lo a sorL ol logal drav. IL could
orhas lo arguod LhaL Lho Biolanls AcL should lo givon rocodonco duo Lo iLs
characLor ol social logislaLion, also onacLod alLor Lho Iorsonal IaLa AcL. Il, hovovor,
Lho liolanl rovisions aro lound noL Lo lo in conlorniLy viLh Lho roquirononLs ol
IirocLivo 95/46/IC, should noL Lho Iorsonal IaLa AcL lo givon rocodonco, sinco iL
rovidos Lho naLional LransosiLion ol II logislaLion LhaL Svodon is undor an
olligaLion Lo inlononL

5. Parts of the human body as raw material

Biolanl sanlos nay sorvo noL only as inlornaLion carriors, luL also as oLonLial rav
naLorial lor corLain roducLs. Hunan llood and Lissuo can lo usod lor a varioLy ol
nodicinal roducLs, and hunan sLon colls nay in Lho luLuro lo culLivaLod Lo socilic
Lissuo or ovon organs. This ronLs quosLions on hov Lho hunan naLorial should lo
orcoivod aL Lho various sLagos ol culLivaLion or nanulacLuro. Hov long should Lho
original donor lo allo Lo viLhdrav his or hor consonL, and donand LhaL Lho sanlo
lo dosLroyod \hon doos Lho liolanl sanlo coaso Lo oxisL, having loon usod u or
Lurnod inLo sonoLhing olso Aro colls and coll linos culLivaLod in viLro sLill jusL
sanlos ol hunan liological naLorial, or do Lhoy consLiLuLo nodicinal roducLs Il
Lho origin ol Lho nov roducL" can sLill lo Lracod Lo an idonLiliallo donor, aL Lho

61
Rynning, I. 1998, . J18-J22.
62
Regeringens proposition ?001/0?.44 . J1.
6J
103
lisabeth Rynning
oinL vhoro Lho liolanl rogulaLion no longor alios, hov is Lho rivacy ol LhaL
orson Lhon roLocLod Tho quosLions aro also rolaLod Lo Lho connorcial inLorosLs ol
nanulacLurors and oLhors, sinco Lho salo ol roducLs is gonorally accoLod, vhoroas
Lho solling and luying ol hunan liological naLorial is suljocL Lo considorallo
rosLricLions in inLornaLional as voll as donosLic lav.
Tho quosLion ol vhon Lho liological naLorial has undorgono sullicionL
culLivaLion or naniulaLion Lo lo no longor loolod uon as jusL a sanlo, or arL ol a
sanlo, nay lo addrossod in raLhor dilloronL Lyos ol logislaLion. Ioos Lho naLorial,
lor oxanlo, cono undor rovisions rogulaLing nodicinal roducLs Could Lho
liological naLorial as such lo aLonLod MosL inorLanL in Lho rosonL conLoxL, has
Lho naLorial coasod Lo lo covorod ly Lho rulos on liolanling IL vould ol courso
soon loLh logical and convonionL il Lho doLorninod oinL ol LransiLion could lo Lho
sano, rogardloss ol Lho Lyo ol rogulaLion. Hovovor, in viov ol Lho variaLion
orLaining Lo Lho undorlying urosos ol Lho dilloronL rogulaLions, Lhis doos noL go
viLhouL saying. RogulaLion ainod aL guaranLooing Lho saloLy ol nodicinal roducLs
nighL lo rono Lo laco Lho oinL ol LransiLion aL an oarly sLago, in ordor Lo roLocL
Lho hoalLh ol aLionLs and rosoarch suljocLs. Il Lho sano aroach is Lalon viLh
rogard Lo liolanl rogulaLion, Lho roLocLion ol donor rivacy loconos, on Lho
conLrary, noro liniLod. IaLonL lav, linally, iLs rinary ain loing Lo sLinulaLo and
rovard scionLilic dovolononL, roquiros carolul lalancing il iL is noL Lo locono
counLor-roducLivo ly granLing oxclusivo righLs Loo oarly or Lo vidoly.
AL rosonL, Lho Iurooan Agoncy lor Lho IvaluaLion ol Modical IroducLs
(IMIA} vould soon Lo roconnond Lho lolloving doliniLion in ordor lor a hunan
sonaLic coll Lhoray roducL Lo lall viLhin Lho doliniLion ol a nodicinal roducL.
64

Tho roducL should lo suljocL Lo a nanulacLuring rocoss in viLro, onconassing
oxansion or noro Lhan nininal naniulaLion dosignod Lo alLor Lho characLorisLics
ol Lho rosulLing colls. IurLhornoro, Lho rosulLing roducL should lo dolinallo in
Lorns ol qualiLaLivo and quanLiLaLivo conosiLion.
As rogards Lho aLonLing ol hunan liological naLorial, Lho nain rulo
according Lo IirocLivo 98/44/IC on Lho roLocLion ol lioLochnological invonLions
ronains LhaL Lho sinlo discovory ol an olononL ol Lho hunan lody cannoL
consLiLuLo a aLonLallo invonLion, soo ArLiclo 5.1. NovorLholoss, undor viLh ArLiclo
5.2 an olononL isolaLod lron Lho hunan lody, or oLhorviso roducod ly noans ol a
Lochnical rocoss, nay consLiLuLo a aLonLallo invonLion, ovon il Lho sLrucLuro ol LhaL
olononL is idonLical Lo LhaL ol Lho naLural olononL. Indor ArLiclo 6, hovovor,
inLorvonLions aro noL aLonLallo vhoro Lhoir connorcial oxloiLaLion vould lo
conLrary Lo ordre public or noraliLy, as vould lo Lho caso lor oxanlo viLh usos ol
hunan onlryos lor indusLrial or connorcial urosos. Il lor insLanco a corLain sLon
coll lino voro Lo lo considorod aLonLallo, iL should sLill lo noLod LhaL Lho Iroanllo
ol IirocLivo 98/44/IC lays dovn LhaL il an invonLion is lasod on liological naLorial
ol hunan origin or usos such naLorial, vhoro a aLonL alicaLion is lilod, Lho orson
lron vhoso lody Lho naLorial is Lalon nusL havo had an oorLuniLy ol oxrossing
lroo and inlornod consonL LhoroLo, in accordanco viLh naLional lav.
65

Hovovor, Lho loundarios ol jusLiliallo aLonLaliliLy viLh rogard Lo hunan
liological naLorials aro sLill suljocL Lo a conLinuing dolaLo, voll alLor Lho adoLion ol

64
CIMI 2001, . J.
65
RociLal 26.
104
IirocLivo 98/44/IC.
66
Moro Lhan a yoar alLor Lho roquirod daLo ol inlononLaLion,
Lho najoriLy ol Lho Monlor SLaLos, including Svodon, havo yoL Lo inlononL Lho
IirocLivo. \iLh rogard Lo hunan sLon colls, Lho IGI has oxrossod Lho oinion LhaL
an osLallishod luL unnodiliod sLon coll lino can hardly consLiLuLo a aLonLallo
roducL.
6
Cn Lho oLhor hand, sLon coll linos LhaL havo loon nodiliod ly in viLro
LroaLnonLs or gonoLically nodiliod so LhaL Lhoy havo acquirod characLorisLics lor
socilic indusLrial alicaLion, aro considorod Lo lullil Lho logal roquirononLs lor
aLonLaliliLy.
AL vhaL oinL a culLurod sanlo ol hunan naLorial vill coaso Lo lo
rogardod as a sanlo undor Lho Svodish Biolanls (HoalLh Caro} AcL is noL cloar
ovon lron Lho travaux preparatoires. Tho only sLaLononL indicaLing a corLain
liniLaLion ol Lho scoo ol Lho AcL in Lhis rosocL, concorns Lho donor`s righL Lo
viLhdrav his or hor consonL and havo Lho sanlo dosLroyod.
68
\o road, viLh rogard
Lo sanlos usod lor rosoarch, LhaL vhaL should lo dosLroyod is Lho sanlo vhich has
loon suliod lor rosoarch, and noL Lho rosulLs ol Lho rosoarch. Hov Lho rosulLs
should lo disLinguishod lron Lho sanlo is noL discussod.

6. Using Swedish biobank materials in research

6.1. General rules and recommendations regarding biomedical research on humans
Cha. 1, SocLion 1 ol Lho nov Svodish Biolanls (HoalLh Caro} AcL, dolinos Lho
uroso ol Lho AcL as loing Lo rogulaLo Lho collocLion, sLorago and uso ol hunan
liological naLorial lor corLain urosos, in such a vay LhaL Lho inLogriLy ol individual
hunan loings is rosocLod. Tho scoo ol Lho Biolanls AcL, Lhon, is rosLricLod in a
nunlor ol vays, as vill lo shovn lolov. This noans LhaL sono liolanls vill noL lo
covorod aL all ly Lho nov logislaLion. Tho rulos govorning such lanls vill sLill havo
Lo lo lound in oLhor acLs ol logislaLion. \iLh rogard Lo Lho lanls LhaL do cono undor
Lho Biolanls AcL, rovisions laid dovn in oLhor lavs vill sLill Lalo rocodonco ovor
Lho nov AcL in nosL casos vhoro Lhoro is a discroancy, soo Cha. 1 SocLion 4 ol Lho
Biolanls AcL. Individuals and organisaLions concornod ly hunan liolanling Lhus
nood Lo loo Lhonsolvos inlornod also alouL nany oLhor rogulaLions.
69

Svodish lav doos noL yoL lay dovn any gonoral roroquisiLos lor lionodical
rosoarch involving hunans. Tho lasic rincilos aliod ly Lho logally unrogulaLod,
advisory rosoarch oLhics conniLLoos (RICs} aro nainly lound in naLional and
inLornaLional oLhical guidolinos.
0
In rosonso, hovovor, Lo roquirononLs ol
inLornaLional lav, Svodon is roaring logislaLion on oLhics roviov ol corLain rosoarch
rojocLs involving hunans.
1
IL has Lhus loon roosod LhaL a logal roquirononL lor
oLhics roviov and auLhorisaLion lo inLroducod, viLh rogard Lo corLain Lyos ol

66
Soo, lor oxanlo, Report jrom the Commission to the uropean arliament and the Council
Development and implications oj patent lau in the jield oj biotechnology and genetic engineering. 2002.
6
IGI. 2002.
68
Regeringens proposition ?001/0?.44 . 44.
69
Ior a noro conrohonsivo oxonlilicaLion ol such rulos and rogulaLions, soo Rynning, I. 2001.
0
Soo lor oxanlo Cuidelines jor ethical evaluation oj medical research involving human subjects. The
olicy and organization oj research ethics in Sueden. Tho Svodish Modical Rosoarch Council, MRC
roorL 2 1996, Inglish LranslaLion 1999.
1
Regeringens proposition ?00?/0J.0 tilprvning av jorslning.. Soo also roorL lron Lho MinisLry ol
IducaLion, tilprvning av jorslning som avser mannislor Ds ?001.o?.
105
lisabeth Rynning
rosoarch. Tho nov rulos vill, lor oxanlo, covor Lho uso ol idonLiliallo hunan
liological naLorial lor rosoarch urosos, and also rosoarch on sonsiLivo orsonal daLa
in casos vhoro Lho inlornod consonL ol Lho daLa suljocL is noL rocurod. A
lranovorl ol lasic rincilos lor jusLiliallo rosoarch vill lo laid dovn in Lho
logislaLion, including LradiLional roquirononLs concorning rosocL lor hunan digniLy,
inlornod consonL, risl-lonoliL-ovaluaLion oLc. Tho roviov vill lo orlornod ly a
nov organisaLion ol indoondonL Rogional Boards lor Rosoarch ILhics and a NaLional
Board vill Lry Lho aoals.
Irovisions on Lho Laling ol liological naLorials lron hunans lor rosoarch
urosos can lo lound in Lho TranslanLs AcL and in Lho AuLosy AcL,
2

sulononLod ly rogulaLions and roconnondaLions in Lho Codo ol SLaLuLos ol Lho
NaLional Board ol HoalLh and \ollaro.
J
Thoro is also Lho IorLilisod Hunan Cva
(Rosoarch or TroaLnonL AcLiviLios involving} AcL, and Lho Modical Scrooning (Iso
ol CorLain GonoLic Tochnology} AcL.
4
Socilic rovisions on Lho orlornanco ol
clinical drug Lrials can lo lound in SocLions 1J-14 ol Lho Modicinal IroducLs AcL,
5
in
addiLion Lo vhich Lhoro aro rogulaLions issuod ly Lho Modical IroducLs Agoncy, o.g.
on clinical Lrials ol nodicinal roducLs.
6
Thoro is also a Modical Iovicos AcL.

Irovisions noro socilically ainod aL liolanl acLiviLios aro laid dovn in Lho
alroady nonLionod Biolanls (HoalLh Caro} AcL, sulononLod ly an Crdinanco and
Lho Codo ol SLaLuLos issuod ly Lho NaLional Board ol HoalLh and \ollaro on Lho
sano suljocL.
8

Ioonding on Lho Lyo ol rosoarch LhaL is Lo lo orlornod, as voll as Lho
origin ol Lho sanlos, rovisions in sono or sovoral ol Lho alovo nonLionod lavs and
rogulaLions nay lo alicallo.

6.2. Different types of biobanks
\hon a nov liolanl is soL u lor urosos ol rosoarch, Lho rulos alicallo vill
doond on vho lornally docidos Lo soL u Lho lanl and also on Lho origin ol Lho
sanlos, or raLhor, Lho circunsLancos undor vhich Lhoy aro collocLod. Il a liolanl is
soL u viLhin Lho rolossional acLiviLios ol a hoalLh caro rovidor, Lho lanl vill cono
undor Lho nov Biolanls (HoalLh Caro} AcL, soo Cha. 1, SocLion J, oinL 1. Any
Lyo ol hunan liological naLorial nay qualily as a liolanl sanlo, as long as iL can
lo Lracod Lo an idonLiliallo hunan loing or looLus.
9
This noans LhaL organs and
Lissuo as voll as colls and INA sLrings vill lo covorod ly Lho rogulaLion, rovidod
LhaL all oLhor roroquisiLos lor Lho alicaLion ol Lho AcL aro noL. Tho hoalLh caro
rovidor is lroo Lo docido LhaL anoLhor organisaLion or agoncy, lor oxanlo a rosoarch
insLiLuLion or ovon a rivaLo conany, should adninisLraLo Lho liolanl, in vhich

2
Lag (199.8J1) om transplantation and lag (199.8J?) om obdultion.
J
Soo, lor oxanlo, Socialstyrelsens jreslrijter och allmanna rd (SCSS M) Crgan och
vavnadstagning jr transplantation eller jr annat medicinslt andaml and Socialstyrelsens jreslrijter och
allmanna rd (199o.?8) om llinisla obdultioner m.m.
4
Lag (1991.11) om tgarder i jorslnings och behandlingssyjte med bejrultade agg jrn mannisla and
Lag (1991.114) om anvandning av viss gentelnil i samband med allmanna halsounderslningar
5
Lalemedelslag (199?.89).
6
Lalemedelsverlets jreslrijter och allmanna rd (LVS 199o.17) om llinisl lalemedelsprvning.
Lag (199J.84) om medicinsltelnisla produlter.

8
rordning (?00?.74o) om biobanler inom halso och sjulvrden m.m. and Socialstyrelsens jreslrijter
och allmanna rd (SCSS ?00?.11 M) om biobanler i halso och sjulvrden m.m.
9
Biolanls (HoalLh Caro} AcL, Cha. 1 SocLion 2.
106
caso Lho lornal rosonsililiLy lor Lho lanl sLill ronains viLh Lho hoalLh caro
rovidor.
Tho Biolanls AcL also alios Lo lanls LhaL conLain sanlos handod ouL
lron Lho liolanl ol a hoalLh caro rovidor, i.o. a sorL ol socondary liolanls, soo
Cha. 1, SocLion J, oinL 2. Such lanls nay lo soL u ly oLhor hoalLh caro
rovidors, rosoarch insLiLuLions, harnacouLical conanios or oLhor juridical orson.
A nov liolanl lor rosoarch urosos, vhich is soL u oiLhor viLhin Lho
rolossional acLiviLios ol a hoalLh caro rovidor or ly Lho rocoiL ol sanlos lron
such a lanl, vill Lhus cono undor Lho Biolanls (HoalLh Caro} AcL, rovidod Lho
sanlos can lo Lracod Lo an idonLiliallo donor. CLhor liolanls lor rosoarch vill noL
lo covorod ly Lho nov logislaLion. This noans LhaL sanlos collocLod dirocLly ly o.g.
harnacouLical conanios, lioLoch conanios or rosoarch insLiLuLions, viLhouL any
connocLion Lo hoalLh caro acLiviLios, vill noL lo covorod ly Lho nov logislaLion. Nor
vill sanlos collocLod in Lho aroa ol loronsic nodicino cono undor Lho Biolanls AcL.
Tho rulos alicallo Lo such lanls vill Lhus havo Lo lo soughL in oLhor lavs and
rogulaLions, noL socilically addrossing liolanling.
80
\iLh Lho inLroducLion ol Lho
lorLhconing logislaLion on oLhics roviov, hovovor, a conlononLary soL ol consonL
roquirononLs vill aly Lo all rosoarch on such liolanl naLorials as do noL cono
undor Lho Biolanls (HoalLh Caro} AcL, rovidod Lhoro is an idonLiliallo donor.
Ior Lhoso liolanls vhich do cono undor Lho nov logislaLion, a vholo nov
soL ol rulos vill havo Lo lo aliod. To sono oxLonL Lho rulos dillor loLvoon hoalLh
caro rovidor liolanls and Lho Lyo ol lanls LhaL aro horo rolorrod Lo as socondary
liolanls. Inloss oLhorviso sLaLod, Lho rulos doscrilod lolov aly Lo loLh
caLogorios. Tho social rovisions rogarding Lho so-callod IKI liolanl, vhich aro
laid dovn in Cha. 5 ol Lho Biolanls AcL, vill noL lo discussod in Lhis roorL.

6.3. Setting up a new biobank
A liolanl undor Lho nov logislaLion is Lhus soL u Lhrough a docision ly Lho
rosonsillo rincial (i.o. Lho hoalLh caro rovidor or, in Lho caso ol socondary lanls,
Lho juridical orson Lo vhich Lho sanlos havo loon handod ouL}, soo Cha. 2,
SocLion 1 ol Lho Biolanls AcL. \hon Lho uroso ol Lho liolanl concorns rosoarch
or clinical Lrials, such a docision nusL noL lo Lalon viLhouL Lho rior aroval ol a
rosoarch oLhics conniLLoo, soo SocLion J. Tho docision Lo soL u Lho lanl, including
sono lurLhor inlornaLion, nusL Lhon lo noLiliod Lo Lho NaLional Board ol HoalLh
and \ollaro, vhich vill loo a rogisLor ol oxisLing liolanls, soo SocLions 5 and 6.
\iLh rogard Lo Lho collocLion and rosorvaLion ol liolanl sanlos, Lho
roquirononLs lor inlornaLion and consonL aro quiLo sLricL. Thus undor Cha. J,
SocLion 1 ol Lho Biolanls AcL, oxliciL consonL nusL nornally lo rocurod, alLor Lho
donor has loon inlornod ol Lho uroso or urosos lor vhich Lho liolanl nay lo
usod. Tho consonL nood noL nocossarily lo givon in vriLing, luL iL nusL lo
aroriaLoly docunonLod.
81
Il Lho donor is a docoasod orson, Lho lavs on
LranslanLaLion and auLosios aly, giving Lho rolaLivos a corLain righL ol voLo.
82

InconoLonL ninors aro rorosonLod ly Lhoir cusLody holdors, and looLusos ly Lho

80
Soo Rynning, I. 2001, . 88-90.
81
Cha. J, SocLion .
82
Cha. J SocLion 4.
107
lisabeth Rynning
(onco} rognanL vonan.
8J
\hon Lho liolanl sanlos consisL ol lorLilisod hunan
oggs, Lho consonL roquirononLs aro laid dovn in Lho rolovanL social logislaLion.
84

A considorallo llav in Svodish logislaLion concorns Lho lacL LhaL vicarious
docision-naling lor inconoLonL adulLs in hoalLh caro and lionodical rosoarch is yoL
Lo lo rogulaLod.
85
An ollicial connission is curronLly invosLigaLing Lho naLLor,
86
luL
unLil nov logislaLion is inLroducod, Lho Biolanls (HoalLh Caro} AcL doos noL allov
any lanling ol sanlos collocLod lron inconoLonL adulLs.
8
This vill ol courso havo
vory sorious nogaLivo ollocLs, anounLing Lo Lho discrininaLion ol inconoLonL
orsons in loLh hoalLh caro and rosoarch.
88

According Lo Cha. J, SocLion 6 ol Lho Biolanls AcL, Lho orson vho has
consonLod Lo Lho uso ol a liolanl sanlo nay aL any Lino viLhdrav his or hor
consonL. Il Lho viLhdraval concorns all lurLhor uso, Lho sanlo shall lo innodiaLoly
dosLroyod or depersonalised. Iron Lho viovoinL ol Lho donor, do-orsonalisaLion
vould orhas noL soon Lo lo quiLo Lho oquivalonL ol dosLrucLion,
89
ovon il is dono
in such a vay LhaL Lho donor can no longor lo Lracod. IL is cloar, hovovor, lron Lho
travaux preparatoires LhaL Lho choico loLvoon dosLrucLion and do-orsonalisaLion is
noL u Lo Lho donor.
90
IL is also sLaLod LhaL dosLrucLion vould only concorn Lho
sanlo and noL Lho rosulLs ol Lho rosoarch.

6.4. Older biobanks
Tho oldor liolanls, alroady oxisLing aL Lho onLry inLo lorco ol Lho Biolanls (HoalLh
Caro} AcL, nay also cono undor Lho nov logislaLion, rovidod Lhoy lolong Lo ono ol
Lho Lvo caLogorios nonLionod alovo (hoalLh caro rovidor lanls and socondary
lanls}. Tho oxisLonco ol such a liolanl nusL lo noLiliod Lo Lho NaLional Board ol
HoalLh and \ollaro viLhin a Lvo-yoar Lino liniL, il Lho lanl is Lo lo rosorvod.
91

Tho Biolanls AcL vill lo alicallo Lo noasuros LhaL aro Lalon viLh Lho sanlos or
Lho liolanl as such alLor Lho AcL has onLorod inLo lorco.
92
As alroady nonLionod, iL
could consLiLuLo a rollon LhaL sono ol Lho oldor liolanls nay noL havo loon soL
u in accordanco viLh Lho nov rulos on docision-naling ly Lho rosonsillo hoalLh
caro rovidor or oLhor rincial. Il lornaliLios aro uncloar, iL nighL lo dilliculL Lo
docido, lor oxanlo, vhoLhor Lho lanl is a hoalLh caro rovidor liolanl
adninisLraLod ly a rosoarch insLiLuLion, or a socondary liolanl soL u ly Lho
rosoarch insLiLuLion iLsoll, viLh sanlos rocoivod lron a hoalLh caro rovidor
liolanl. Tho original uroso ol an old liolanl nay lo vaguo and Lho origin ol Lho
sanlos nay vary viLhin Lho sano liolanl. IL vould lo dosirallo lor such

8J
Cha. J, SocLions 2-J.
84
Lag (1991.11) om tgarder i jorslnings och behandlingssyjte med bejrultade agg jrn mannisla (Tho
IorLilisod Hunan Cva (Rosoarch or TroaLnonL AcLiviLios Involving} AcL}.
85
Soo Rynning, I. 2001.
86
Soo Lho Lorns ol roloronco rovidod in rmyndare, gode man och jrvaltare. Direltiv ?00?..
8
Regeringens proposition ?001/?00?.44 . 42.
88
Sooling Lo nodily Lhis rollon aL loasL viLh rogard Lo such rosorvaLion ol sanlos as is considorod
nocossary lor Lho saloLy ol Lho aLionL, Lho NaLional Board ol HoalLh and \ollaro has nado an
oxonLion lor Lhis siLuaLion in iLs ovn rogulaLion, so Cha. 4, SocLion 4 ol Lho rogulaLion
Socialstyrelsens jreslrijter och allmanna rd (SCSS ?00?.11 M). Tho logaliLy ol Lhis rovision, vhich
is inconsisLonL viLh Lho AcL assod ly Lho IarlianonL, is highly dulious Lo say Lho loasL.
89
Soo discussion lolov, on coding and anonynisaLion.
90
Regeringens proposition ?001/?00?.44 . 44.
91
TransiLional rovision 2.
92
TransiLional rovision J.
108
conlicaLions Lo lo sonohov doalL viLh ly Lho NaLional Board ol HoalLh and
\ollaro, aL Lho Lino vhon Lho lanl is rogisLorod. Il, hovovor, Lho rincial
nisLalonly doos noL considor Lho liolanl Lo cono undor Lho nov AcL, Lho Board is
unliloly Lo lo noLiliod aL all.

6.5. Safety and security requirements
Tho Biolanls (HoalLh Caro} AcL doos noL roally rovido nuch guidanco viLh rogard
Lo saloLy and socuriLy noasuros. Cha. 2, SocLion 4 lays dovn LhaL a liolanl shall
lo loL in such a nannor LhaL Lho sanlos do noL risl loing dosLroyod and LhaL
unauLhorisod orsons do noL olLain accoss Lo Lhon.
9J
Cn Lho oLhor hand, Lho sanlos
nusL noL lo rosorvod lor a longor Lino Lhan is noodod in viov ol Lho uroso ol Lho
liolanl.
94
IisconLinuing a hoalLh caro rovidor liolanl as such, hovovor, and
dosLroying Lho sanlos, vill roquiro Lho auLhorisaLion ol Lho NaLional Board ol
HoalLh and \ollaro, soo Cha. 4, SocLion 9. Such auLhorisaLion nay lo granLod only
il Lho naLorial is no longor ol inorLanco Lo Lho uroso lor vhich Lho lanl vas soL
u, and Lhoro is no ullic inLorosL LhaL vould noLivaLo Lho rosorvaLion ol Lho
sanlos. Tho corrosonding rulo rogarding socondary lanls is sonovhaL loss sLricL,
alloving Lho rincial Lo docido LhaL Lho lanl shall lo disconLinuod vhon iL is no
longor noodod lor Lho uroso lor vhich iL vas soL u. Tho sanlos shall Lhon lo
dosLroyod or roLurnod Lo Lho original lanl.
Tho Biolanls AcL also conLains rovisions ainod aL roLocLing Lho rivacy
ol donors, ly noans ol coding oLc. IL is roscrilod LhaL codo loys shall lo socuroly
loL ly Lho hoalLh caro rovidor vho docidod Lo soL u Lho liolanl.
95

6.6. Coding and anonymisation
In ordor Lo roLocL Lho rivacy ol donors, dilloronL arrangononLs lor oncoding ol
sanlos and daLa rocordod nay lo usod. Thoro aro sovoral rovisions in Lho Biolanls
AcL vhoro such coding is roconnondod or ovon roscrilod. Tho coding or
anonynisaLion LhaL is roquirod lor oxanlo vhon sanlos aro Lranslorrod alroad
and/or assod on lron a socondary liolanl, in accordanco viLh Cha. 4, SocLion 5,
is also roconnondod as Lho sLandard rocoduro in oLhor siLuaLions. Inloss oLhorviso
is oxliciLly docidod, sanlos roloasod ly a hoalLh caro rovidor liolanl shall also lo
do-orsonalisod or codod, soo Cha. 4, SocLion 4.
In sono casos, Lho alLornaLivo Lo coding nay Lhus lo Lho conloLo do-
orsonalisaLion ol Lho sanlos, in such a vay LhaL Lhoy can no longor lo Lracod lacl
Lo Lho original donors. Tho do-orsonalisod or anonynous sanlos vill Lhon no
longor cono undor Lho Biolanls (HoalLh Caro} AcL. As nonLionod alovo, Lho AcL
only alios Lo sanlos LhaL can lo Lracod Lo an idonLiliallo, living or docoasod
hunan loing or looLus, soo Cha. 1 SocLion 2. AlLhough Lho anonynisaLion nay lo
ainod Lo roLocL Lho rivacy ol Lho donor, iL doos noL rovonL ovory lind ol rivacy
inlringononL and in ollocL rondors lurLhor oxorciso ol soll-doLorninaLion inossillo
as rogards LhaL arLicular sanlo. AnoLhor considoraLion is ol courso LhaL Lho uso ol

9J
Sono raLhor liniLod addiLional rovisions can lo lound in Cha. 5 ol Lho rogulaLion Socialstyrelsens
jreslrijter och allmanna rd (SCSS ?00?.11 M) issuod ly Lho NaLional Board ol HoalLh and
\ollaro.
94
Regeringens proposition 2001/2002:44 . 54-55 and Cha. 5, SocLions 5 and 6 ol Lho rogulaLion
Socialstyrelsens jreslrijter och allmanna rd (SCSS ?00?.11 M).
95
Cha. 4, SocLion 4, aragrah 2 ol Lho Biolanls AcL. Soo also Cha. 5, SocLions 1-2 ol Lho
rogulaLion Socialstyrelsens jreslrijter och allmanna rd (SCSS ?00?.11 M) .
109
lisabeth Rynning
anonynous naLorial is noL roally an oLion in nany Lyos ol lionodical rosoarch, in
viov ol Lho nood lor saloLy and qualiLy conLrol oLc. \iLh rogard Lo hunan naLorial
ainod lor alicaLion Lo oLhor hunan loings, Lho roquirononL ol LracoaliliLy is loing
sLrossod in sovoral Iurooan docunonLs ol rolovanco.
96

\iLhouL doulL, iL vould soon inorLanL LhaL concoLs such as
idonLilialiliLy, anonyniLy and coding aro cloarly dolinod, loLh viLh rogard Lo Lhoir
roroquisiLos and Lhoir consoquoncos. IL is unlorLunaLo LhaL no Iurooan consonsus
has loon roachod on Lhis oinL. \iLh rogard Lo Lho rocossing ol orsonal daLa,
dilloronL aroachos can lo soon in liLoraLuro.
9
Sono arguo a criterion oj
reasonableness, according Lo vhich Lho individual should noL lo rogardod as
idonLiliallo il idonLilicaLion vould roquiro an unreasonable anounL ol Lino and
nanovor. This noans LhaL oncodod daLa vould sonoLinos lo considorod
anonynous, doonding on vho has accoss Lo Lho codo. CLhors arguo LhaL Lhoro
should lo no LhooroLical ossililiLy ol idonLilying Lho orson concornod, rogardloss ol
Lho cosL and Lino involvod (the absolute anonymity criterion}. In LhaL caso, oncodod
daLa can novor lo considorod anonynous as long as sonoono has accoss Lo Lho codo.
BoLh inLorroLaLions havo loon arguod viLh rogard Lo ArLiclo 2 (a} ol IirocLivo
95/94/IC on Lho roLocLion ol orsonal daLa.
98
RociLal 26 ol Lho IirocLivo, hovovor,
doos rolor Lo all Lho noans liloly roasonallo Lo lo usod oiLhor ly Lho daLa conLrollor
or ly any other person Lo idonLily" Lho daLa suljocL, and Lho IxlanaLory
Monorandun adds LhaL Lho cosL and Lino roquirod lor Lho idonLilicaLion nood noL lo
givon any considoraLion.
99
This vould corLainly soon Lo indicaLo an inLorroLaLion
lairly closo Lo Lho alsoluLo criLorion nonLionod alovo.
A nov aLLonL aL olLaining Iurooan consonsus is curronLly loing nado ly
IMIA, viLh rogard Lo Lorninology in harnacogonoLics. A osiLion aor is Lhus in
roaraLion, sLaLing inter alia doliniLions ol concoLs such as idonLiliod sanlos and
daLa, singlo-codod and doullo-codod sanlos and daLa, anonynisod and anonynous
sanlos and daLa.
100
Tho ollorL is corLainly raisovorLhy, alLhough iL ronains Lo lo
soon il consonsus can also lo roachod in a vidor alicaLion ol Lhis Lorninology,
naLionally and inLornaLionally.
Indor Lho Svodish Iorsonal IaLa AcL, an individual is considorod Lo lo
idonLiliallo il anyone can dirocLly or indirocLly idonLily hin or hor in rolaLion Lo Lho
daLa. IL doos noL naLLor il Lho orson orlorning Lho rocossing doos noL hinsoll or
horsoll havo accoss Lo Lho all Lho inlornaLion nocossary lor Lho idonLilicaLion.
101
Nor
doos iL naLLor il Lho rocoss ol idonLilicaLion should roquiro a considorallo anounL
ol Lino, nonoy or oLhor rosourcos. This noans LhaL oncodod daLa vill lo considorod
idonLiliallo as long as sonoono has accoss Lo Lho codo loy.
102
Tho travaux

96
Soo lor oxanlo Lho alovo nonLionod roposal jor a Directive oj the uropean arliament and oj the
Council on setting standards oj quality and sajety jor the donation, procurement, processing, storage, and
distribution oj human tissue and cells, 2002.
9
Soo lor oxanlo Callons, S.1995, . J14-J16 and ArnardoLLir, Bjrgvinsson & MaLLhiasson, 1999,
. J29-J40.
98
Ior Lho sLricLor viov, soo o.g. IuLo, J.1998, . 19.
99
IxlanaLory Monorandun Lo IirocLivo 95/46/IC, . 9.
100
Iorsonal inlornaLion lron Sighild \osLnan Naosor aL Lho Svodish Modical IroducLs Agoncy,
Novonlor 2002.
101
Cnan, S & Lindllon, H-C. 2002, . 52 and lntegritet ojjentlighet injormationstelnil. (199}, .
JJ8.
102
Cnan, S & Lindllon, H-C. 2002, . 52-5J.
110
preparatoires ol Lho Biolanls (HoalLh Caro} AcL sLaLo LhaL idonLiliallo sanlos ol
hunan naLorial should lo allordod Lho sano roLocLion as orsonal daLa in oLhor
inlornaLion carriors.
10J
Tho quosLion ronains, hovovor, vhoLhor Lho alsoluLo
anonyniLy criLorion is roally inLondod Lo aly in Lho conLoxL ol Lho Biolanls
(HoalLh Caro} AcL. Such an inLorroLaLion vould nalo Lho roroquisiLos lor do-
orsonalisaLion or anonynisaLion ol liological sanlos oxLronoly dilliculL Lo lullil.
Cn Lho oLhor hand, using dilloronL doliniLions ol anonyniLy and idonLilialiliLy in
Lhoso Lvo acLs ol logislaLion, loLh ainod aL roLocLing Lho rivacy ol individuals,
vould lo lound Lo causo nisundorsLandings.
Il, on Lho oLhor hand, a loss sLricL criLorion lor anonyniLy is aliod, a
nunlor ol sanlos vill noL rocoivo any roLocLion undor Lho Biolanls AcL. Nor is iL
roosod LhaL rosoarch involving anonynous sanlos lo suljocL Lo any nandaLory
oLhics roviov undor Lho lorLhconing logislaLion.
104
IL could voll lo quosLionod
vhoLhor such lacl ol roLocLion is roally consisLonL viLh Lho individual`s righL Lo
rivacy and soll-doLorninaLion, aL loasL il Lho conclusion is LhaL anonynous naLorial
could lo usod lor any uroso, ovon conLrary Lo Lho donor`s vishos. Ivon viLhouL
Lho risl ol having sonsiLivo orsonal inlornaLion disclosod, oLhor asocLs ol Lho righL
Lo rivacy nighL risl loing inlringod il Lho donor is givon no oorLuniLy Lo docido
alouL Lho luLuro uso ol naLorial ronovod lron his or hor lody. Tho donor nay noL
vish Lo conLriluLo Lo corLain Lyos ol rosoarch, or nay ovon risl harn in Lho vay ol
sLignaLisaLion or discrininaLion, il ho or sho lolongs Lo a corLain idonLiliallo grou
or oulaLion.
Thoso rovisions ol Lho Biolanls AcL rogulaLing Lho lroaling ol codos and
disclosuro ol orsonal daLa do noLhing Lo nalo Lhings cloaror.
105
As doscrilod alovo,
undor Lho Iorsonal IaLa AcL, oncodod daLa is considorod Lo consLiLuLo orsonal daLa
as long as sonoono has accoss Lo Lho codo. In nany casos iL vould Lhus lo ossillo
lor a rociionL ol sanlos also Lo rocoivo codod orsonal daLa concorning Lho donors
ol individual sanlos, viLhouL nocossarily loing allo Lo idonLily Lho donors dirocLly.
In oLhor casos, hovovor, Lho rociionL nighL nood Lo idonLily Lho donors, lor roasons
ol qualiLy conLrol or in ordor Lo aly lor inlornaLion lron nodical rocords oLc. Tho
rolovanL rovisions in Lho Biolanls AcL, hovovor, do noL disLinguish loLvoon Lhoso
Lvo siLuaLions.
IL is Lhus roscrilod LhaL a roquosL Lo havo Lho codo lrolon in ordor Lo gain
accoss Lo orsonal daLa alouL an individual donor", shall lo handlod according Lo Lho
sano rocoduro as an alicaLion lor accoss Lo sanlos, soo Cha. 4, SocLion 4,
aragrah J. IurLhornoro, iL is roquirod LhaL il orsonal daLa concorning a donor is
handod ouL sinulLanoously viLh a codod sanlo lron Lho sano orson, Lhis shall lo
dono in such a vay LhaL Lho orsonal daLa cannoL lo connocLod Lo Lho sanlo", soo
Cha. 4, SocLion 10. IL is corLainly dilliculL Lo undorsLand vhaL inLorosL Lho rociionL
could havo in daLa LhaL cannoL lo connocLod Lo a socilic sanlo. An alLogoLhor
dilloronL naLLor is Lho ossililiLy, sLaLod alovo, ol Lho rociionL noL nooding Lo
ascorLain Lho identity ol Lho donor.

10J
Regeringens proposition ?001/0?.44 . J1-J2. As nonLionod alovo, Lhis is also Lho osiLion Lalon ly
Lho Council ol Iuroo in sovoral docunonLs.
104
Soo SocLion 4 ol Lho roosod ILhics Roviov AcL, Regeringens proposition ?00?/0J.0.
105
Soo Cha. 4, SocLions 4 and 10.
111
lisabeth Rynning
6.7. Using biobank materials for new purposes
Il a liolanl sanlo is Lo lo usod lor a uroso oLhor Lhan LhaL vhich Lho donor has
loon inlornod alouL and consonLod Lo, Lhon nornally Lho orson vho gavo Lho
original consonL vill lirsL havo Lo lo inlornod ol Lho nov uroso and consonL Lo iL,
soo Cha. J, SocLion 5 ol Lho Biolanls AcL. Il Lho donor is docoasod, his or hor closo
rolaLivos nusL lo inlornod and nusL noL havo oljocLod Lo Lho nov uroso, alLor
loing allovod aroriaLo Lino Lo considor Lho naLLor. \iLh rogard Lo rosoarch,
hovovor, a considorally noro lloxillo rulo is rovidod. Il Lho nov uroso Lhus
concorns rosoarch or a clinical Lrial, Lho RIC aroving Lho nov uroso shall also
docido Lho roquirononLs rogarding inlornaLion and consonL, lor using Lho liolanl
sanlos lor Lhis uroso.
106
IL is oxliciLly sLaLod in Lho travaux preparatoires LhaL Lho
RIC is Lhoroly onovorod Lo uso iLs discroLion in dociding vhoLhor or noL a
ronovod inlornod consonL should lo roquirod.
10
Tho GovornnonL rolors Lo Lho
oLhical guidolinos issuod ly Lho Svodish Modical Rosoarch Council, according Lo
vhich corLain oxcoLions lron Lho inlornod consonL roquirononL nay lo
jusLiliallo.
108
AlLornaLivos nonLionod includo, lor oxanlo, Lho uso ol an oL-ouL
nodol lor olLaining consonL. IL should lo noLod, hovovor, LhaL Lho rolovanL
rovision in Lho Biolanls AcL doos noL inoso any sLaLuLory rosLricLions on Lho
discroLion ol Lho oLhics conniLLoos. Conarod Lo Lho corrosonding rovision in
SocLion 19 ol Lho Iorsonal IaLa AcL, vhoro a corLain lalancing ol inLorosLs is
oxliciLly roquirod, Lho Biolanls AcL is surrisingly gonorous in Lhis rosocL.

6.8. Transfer of biobanks, samples and personal data
An inorLanL disLincLion is nado loLvoon Lho Lranslor ol a liolanl or arL ol a
liolanl as such, on Lho ono hand, and Lho roloaso or Lranslor ol liolanl sanlos on
Lho oLhor. Indor Cha. 4, SocLion ol Lho Biolanls AcL, Lho Lranslor ol a liolanl
or arL ol a liolanl roquiros auLhorisaLion ly Lho NaLional Board ol HoalLh and
\ollaro. Such auLhorisaLion is only granLod il Lhoro aro social roasons, such as
organisaLional changos or lanlruLcy.
109
A liolanl or arL ol a lanl nusL novor lo
Lranslorrod Lo a rociionL in anoLhor counLry. This sLandoinL is noLivaLod ly Lho
lacL LhaL Lho hunan liological naLorial in a liolanl ollors unliniLod ossililiLios ol
charLing and analysing gonoLic inlornaLion alouL individuals and grous ol
ciLizons.
110

Tho roloaso ol sanlos lron a liolanl, hovovor, is loss rosLricLod, osocially
as rogards hoalLh caro rovidor liolanls. IL is Lhus lor Lho orson rosonsillo lor Lho
liolanl Lo considor alicaLions lor accoss Lo sanlos in Lho lanl, soo Cha. 4,
SocLion 1 ol Lho AcL. Sanlos in socondary lanls should noL nornally lo assod on,
luL Lhoro aro also sulsLanLial oxcoLions Lo LhaL rulo, as vill lo shovn.
Il sanlos aro Lo lo Lranslorrod Lo a rociionL in anoLhor counLry, lor
rosoarch urosos, Lho alicaLion nusL lo nado ly a Svodish rosoarch insLiLuLion.
111

Tho loroign rociionL nusL undorLalo Lo roLurn Lho sanlos or dosLroy Lhon vhon
Lhoy aro no longor noodod lor Lho uroso lor vhich Lhoy voro handod ouL. IL is

106
Cha. J, SocLion 5, aragrah J.
10
108
Cl. Research ethics guidelines jor using biobanls, especially projects involving genome research, adoLod
ly Lho Svodish Modical Rosoarch Council (MIR} in Juno 1999.
109
Cha. 6, SocLion 5 ol Lho rogulaLion Socialstyrelsens jreslrijter och allmanna rd (SCSS ?00?.11 M).
110
111
Cha. 4, SocLion J.
112
sLaLod LhaL Lhis is Lho only siLuaLion vhoro sanlos nay lo roloasod Lo a rociionL in
anoLhor counLry.
Hovovor, Cha. 4, SocLion 5 ol Lho Biolanls AcL rovidos sovoral
oxonLions lron Lho sLricLor rulos doscrilod alovo. Indor corLain condiLions, iL is
Lhus lavlul Lo hand ovor sanlos Lo rociionLs in oLhor counLrios as voll as in
Svodon, loLh lron hoalLh caro rovidor liolanls and lron socondary lanls. Tho
roroquisiLos aro LhaL Lho donor consonLs, LhaL Lho sanlos aro codod or anonynisod,
and LhaL Lho sanlos aro roLurnod or dosLroyod vhon no longor noodod lor Lho
uroso lor vhich Lhoy voro Lranslorrod. Translor is Lhon allovod lor corLain
sociliod urosos, Lvo ol vhich concorn rosoarch and clinical Lrials rosocLivoly. IL
nay Lhus lo lavlul Lo Lranslor sanlos lron a liolanl usod in a rosoarch rojocL, Lo
anoLhor uniL lor rosoarch, insido or ouLsido Lho counLry. IurLhornoro, iL is
ornissillo Lo Lranslor sanlos LhaL havo loon roloasod Lo a conany lor a clinical
Lrial, Lo lo analysod aL anoLhor uniL viLhin Lho conany or anoLhor conany viLh
vhich an agroononL rogarding analysis has loon nado. This also alios vhon Lho
rociionL is locaLod in anoLhor counLry.
Clviously, Lho rulos rogarding Lho Lranslor ol a biobanl, or arL ol a lanl,
aro sLricLor Lhan Lho rulos alying Lo Lho roloaso or Lranslor ol samples. Much vill
Lhus doond on hov dilloronL Lranslor acLiviLios aro dolinod. Il, lor oxanlo, Lho
sanlos ol a hoalLh caro rovidor liolanl soL u lor a corLain rosoarch rojocL aro
gradually Lranslorrod Lo a rosoarch arLnor alroad, vill Lhis consLiLuLo Lranslor ol arL
ol Lho liolanl or jusL a roloaso ol sanlos \ill Lho ansvor doond on Lho nunlor
ol sanlos il any vhich aro lolL in Lho hoalLh caro rovidor lanl \ill iL lo ol
rolovanco vhoLhor or noL Lho sanlos aro ovor roLurnod lron alroad, or jusL
dosLroyod or usod u Tho travaux preparatoires do noL discuss hov Lhis lino should
lo dravn.
Is Lhoro Lhon any righL ol accoss Lo sanlos in a liolanl No, noL ovon Lho
donor vould soon Lo havo any such innodiaLo righL. As sLaLod alovo, Lho orson in
chargo ol Lho liolanl, or ulLinaLoly Lho rincial, docidos vho vill havo accoss Lo
Lho sanlos, viLhin Lho liniLs dolinod ly Lho uroso ol Lho liolanl. Il, hovovor,
Lho hoalLh caro rovidor and Lho orson rosonsillo lor Lho liolanl do noL considor
LhaL an alicaLion should lo granLod, Lho caso shall lo rolorrod Lo Lho NaLional
Board ol HoalLh and \ollaro, soo Cha. 4, SocLion 6. This nighL lo orcoivod as an
oorLuniLy Lo aoal, luL Lho Board has no lornal ovor Lo ordor Lho granLing ol
accoss Lo liolanl sanlos.
112
Any docision ol Lho Board on such a naLLor vill Lhus lo
no noro Lhan advisory.

6.9. Issues of commercialisation
Cha. 4, SocLion 8 ol Lho Biolanls AcL rohiliLs Lho Lranslor or roloaso ol liolanl
sanlos or arL ol sanlos viLh a viov Lo linancial gain. A sinilar rovision can lo
lound in SocLion 15 ol Lho TranslanLs AcL, vhoro Lho Laling, dolivoring, rocoiving or
rocuring ol liological naLorial lron a living or docoasod orson, or Lissuo lron an
alorLod looLus, viLh a viov Lo gain, is crininalisod. Tho sano alios Lo inLonLional
uso or collocLion ol such naLorial, in Lho lnovlodgo ol rovious noasuros lor Lho
uroso ol gain. Tho TranslanLs AcL, hovovor, nalos oxcoLions lor llood, hair,
lroasL nill and LooLh, duo Lo corLain LradiLional connorcial acLiviLios involving such
naLorials.

112
113
lisabeth Rynning
Tho corrosonding rovision in ArLiclo 21 ol Lho ConvonLion on Hunan RighLs and
Bionodicino roscrilos LhaL Lho hunan lody and iLs arLs shall noL, as such, givo riso
Lo linancial gain. No oxcoLion is nonLionod in Lho ArLiclo, luL iL is sLaLod in Lho
IxlanaLory RoorL LhaL Lho rovision doos noL rolor Lo such roducLs as hair and
nails, vhich aro discardod Lissuos, and Lho salo ol vhich is noL an allronL Lo hunan
digniLy.
11J

IL is Lho liological naLorial iLsoll o.g. Lho organs, Lho Lissuo or Lho colls oLc.
LhaL nay noL lo loughL or sold, vhoroas Lochnical acLs such as sanling, LosLing,
sLorago, culLuro, LransorL oLc., nay logiLinaLoly givo riso Lo roasonallo
ronunoraLion.
114
Nor do Lho rulos rohiliL Lho salo ol a nodical dovico incororaLing
hunan Lissuo vhich has loon suljocLod Lo a nanulacLuring rocoss. Cnco again, Lho
inLorosLing lordorlino loLvoon sanlo and roducL is sLrossod. Iolining Lho concoL
viLh a viov Lo linancial gain" is also roving Lo lo a challongo.
115

6.10. Supervision and sanctions
\hon iL conos Lo Lho noniLoring or suorvision ol liolanl acLiviLios rolaLod Lo
rosoarch, Lhoro aro sovoral ullic agoncios viLh dilloronL, sonoLinos ovorlaing
rosonsililiLios. Tho NaLional Board ol HoalLh and \ollaro, vhich alroady noniLors
clinical rosoarch in connocLion viLh Lho LroaLnonL ol aLionLs, vill Lhus suorviso
acLiviLios LhaL cono undor Lho nov Biolanls (HoalLh Caro} AcL.
116
Tho Board also
noniLors clinical Lrials rogarding nodical dovicos, vhoroas Lho Modical IroducLs
Agoncy noniLors all clinical drug Lrials.
11
Tho Svodish IaLa InsocLion Board,
hovovor, noniLors Lho rocossing ol orsonal daLa in all Lho aroas nonLionod.
118

Sono Lyos ol lionodical rosoarch LhaL is conducLod, lor oxanlo, ly rivaLo
conanios vould aL rosonL soon Lo oscao any roal noniLoring, oxcoL as rogards
orsonal daLa rocossing. \hon Lho nov logislaLion on oLhics roviov is assod,
hovovor, iL soons liloly LhaL Lho NaLional Board lor Rosoarch ILhics vill lo givon
Lho ovors Lo suorviso such rosoarch acLiviLios as do noL cono undor Lho
rosonsililiLios ol any oLhor suorvisory agoncy.
119

AlLhough lornally no rosoarch acLiviLios rolaLod Lo Lho uso ol hunan
liolanls vill lo lolL unsuorvisod, Lho nunlor ol suorvisory agoncios involvod
vould corLainly soon Lo indicaLo a corLain risl ol rosonsililiLios loing conlusod, and
Lhus orhas ovon noglocLod. Cn Lho oLhor hand, liolanl rincials and usors could
also risl loing lacod viLh varying and orhas ovon inconaLillo roquirononLs lron
Lho dilloronL agoncios. AL loasL, suorvision ol Lho liolanls vill consLiLuLo a
considorallo challongo viLh rogard Lo Lho nocossary co-ordinaLion and co-ooraLion
loLvoon Lho agoncios concornod.

In ordor Lo laciliLaLo iLs suorvisory duLios, Lho NaLional Board ol HoalLh and \ollaro
has loon rovidod viLh corLain ovors rogulaLod in Cha. 6, SocLions J-6 ol Lho

11J
Council ol Iuroo 1996, socLion 1JJ.
114
Council ol Iuroo 1996, socLion 1J2.
115
Soo lor oxanlo Lho chaLor ly Jons Lago Hollnan in Lhis lool, and Ionoij, B 2001 . 8J-86.
116
Cha. 6, SocLion 1 ol Lho HoalLh and Modical Sorvicos (Irolossional AcLiviLy} AcL, Lag (1998.J1)
om yrlesverlsamhet p halso och sjulvrdens omrde
11
SocLion 11 ol Lho Modical Iovicos Crdinanco, rordning (199J.87o) om medicinsltelnisla
produlter, and SocLion 2J ol Lho Modicinal IroducLs AcL, Lalemedelslagen (199?.89), rosocLivoly.
118
Liobanlers behandling av personuppgijter. 2000.
119
SocLions J4-J5 ol Lho AcL roosod in Lho GovornnonL Bill, Regeringens proposition ?00?/0J.0.
114
Biolanls AcL. Thoso ovors includo, lor oxanlo, a righL ol accoss Lo ronisos as
voll as sanlos, rolovanL docunonLs, oLhor naLorials, inlornaLion and any oLhor
assisLanco noodod lor Lho orlornanco ol an insocLion. Tho Board is onovorod Lo
issuo injuncLions, ovon in conlinaLion viLh dolaulL linos, and il nocossary nay
roquosL olico assisLanco in carrying ouL an insocLion.
Tho onal sancLion sLiulaLod in Cha. 6, SocLion 1 ol Lho Biolanls AcL is
liniLod Lo a lino, and only alios Lo such lroachos ol Lho AcL as aro oxliciLly
onunoraLod. Thus as rogards Lho rohiliLion ol Lranslor viLh a viov Lo linancial gain,
laid dovn in Cha. J, SocLion 8, no sancLion is roscrilod in Lho Biolanls AcL iLsoll,
vhich sinly nalos roloronco Lo Lho sancLions sLiulaLod in SocLions 15-16 ol Lho
TranslanLs AcL. Sinco Lho rohiliLion ol linancial gain in Lho TranslanLs AcL
oxliciLly oxcludos llood, vhich Lho corrosonding rohiliLion in Lho Biolanls AcL
doos noL, Lhoro doos noL soon Lo lo any sancLion alicallo Lo unlavlul connorcial
Lranslors ol llood sanlos or liolanls consisLing ol such sanlos.
To Lho oxLonL LhaL a lroach ol Lho rovisions laid dovn in Lho Biolanls AcL
causos danago Lo Lho donor or consLiLuLos an inlringononL ol his or hor orsonal
inLogriLy, Lho donor is onLiLlod Lo cononsaLion lron Lho rincial ol Lho lanl, soo
Cha. 6, SocLion 2 ol Lho Biolanls AcL. Ianagos nay lo adjusLod il Lho rincial is
allo Lo rovo LhaL ho or sho vas noL aL laulL.

7. Conclusions

7.1. The scope of the Swedish Biobanks (Health Care) Act
Tho rinary and orhas nosL olvious dravlacl ol Lho Svodish Biolanls AcL
concorns Lho olscuriLy ol iLs inLondod scoo. ConcoLs ol docisivo inorLanco lor
doLornining Lho scoo, such as idonLilialiliLy and anonyniLy, aro noL dolinod in Lho
AcL, or ovon discussod in Lho travaux preparatoires. IL doos noL soon Lo havo loon
considorod vhaL dogroo ol culLivaLion or rocossing vill lo roquirod in ordor lor Lho
liological naLorial Lo loso iLs sLaLus as a sanlo undor Lho AcL. Tho alicaliliLy ol
individual rovisions in Lho Biolanls AcL is also uncloar in rolaLion Lo Lho scoo ol
sono oLhor AcLs, such as Lho Iorsonal IaLa AcL.
Sono liolanls nay, lurLhornoro, havo loon soL u in a nannor LhaL is noL
consisLonL viLh Lho roquirononLs laid dovn in Lho nov AcL. This vill corLainly lo
Lho caso viLh sono ol Lho old lanls, luL nay oxcoLionally also aly Lo nov onos.
Il, lor insLanco, a liolanl lor rosoarch is soL u viLhin Lho rolossional acLiviLios ol a
hoalLh caro rovidor", luL Lho docision Lo do so is Lalon ly an unauLhorisod
onloyoo raLhor Lhan ly Lho rosonsillo rincial, vill Lho lanl sLill cono undor Lho
nov Biolanls AcL Tho onloyoo vill lo liloly Lo risl sono lind ol sancLion, aL
loasL in rolaLion Lo his or hor onloyor, luL rogardloss ol Lhis Lho donors as voll as
Lho rincial ol Lho hoalLh caro insLiLuLion concornod vill lo inLorosLod Lo lnov
vhoLhor or noL Lho Biolanls AcL is alicallo Lo Lho sanlos collocLod.
AnoLhor sorious shorLconing rolaLod Lo Lho scoo ol Lho Biolanls AcL is Lho
ronaining unclariLy rogarding vhaL rulos should lo aliod Lo liolanls not covorod
ly Lho AcL, and Lho consoquonL inlorior roLocLion ollorod Lo idonLiliallo donors
concornod. As has alroady loon nado cloar, liolanls soL u ly oLhor rincials Lhan
hoalLh caro rovidors aro only covorod ly Lho AcL il Lho sanlos havo loon roloasod
lron a hoalLh caro rovidor liolanl. This rollon vas oinLod ouL ly a nunlor ol
115
lisabeth Rynning
lodios Lo vhich Lho roosal vas rolorrod, and inLroducLion ol conlononLary
logislaLion rogarding Lho liolanls LhaL aro lolL ouL vas nonLionod in Lho
GovornnonL Bill.
120
So lar, hovovor, no such logislaLion vould soon Lo lo in
roaraLion.
YoL anoLhor rollon concorns Lho lacl ol roLocLion lor donors ol sanlos
LhaL aro considorod unidonLiliallo. As oinLod ouL in socLions 2.4 and 6.6, alovo,
anonynisaLion doos noL noan LhaL Lho donor is roLocLod againsL all Lyos ol rivacy
inlringononLs, and nay ovon nalo iL inossillo lor hin or hor Lo oxorciso righL Lo
soll-doLorninaLion, oxacLly because Lho sanlo cannoL lo Lracod. \hon anonynous
sanlos aro usod in rosoarch, no oLhics roviov is roquirod undor Lho Biolanls AcL,
nor undor Lho roosod nov AcL on ILhics Roviov.
121

7.2. Swedish law on the use of biobank samples versus personal data
To a corLain oxLonL, liolanl sanlos can lo conarod Lo oLhor carriors ol sonsiLivo
orsonal daLa. IL is also cloar LhaL logislaLion in loLh aroas aro lasod on Lho lalancing
ol inLorosLs rolaLod Lo Lho roLocLion ol individual rivacy on Lho ono hand, and
jusLiliod inLorosLs ol accoss and oonnoss on Lho oLhor.
Tho soLLing u ol a liolanl undor Lho Biolanls AcL, nusL lo noLiliod Lo Lho
suorvisory agoncy. A sinilar noLilicaLion rocoduro oxisLs undor Lho Iorsonal IaLa
AcL, luL Lho oxonLions lron Lho gonoral noLilicaLion roquirononL aro nunorous.
Hovovor, iL should lo rononlorod LhaL Lhoro is a nandaLory roquirononL lor prior
noLilicaLion viLh rogard Lo rocossing ol daLa concorning a horodiLary disosiLion
LhaL has loon dorivod lron gonoLic invosLigaLion. Cno roason lor looing a closo oyo
on hunan liolanls is ol courso Lho lacL LhaL Lho sanlos can lo usod lor gonoLic
analysis.
ConsonL roquirononLs lor Lho iniLial collocLion ol sanlos lor a liolanl aro
cloarly noro sLricL Lhan Lho rulos orLaining Lo Lho collocLion ol sonsiLivo orsonal
daLa lor corLain rogisLors, such as nodical rocords or naLional hoalLh daLa rogisLors.
Tho aLionL has no righL ol rolusal vhon iL conos Lo having his or hor hoalLh daLa
rogisLorod, vhoroas Lho Biolanls AcL soLs u a nandaLory roquirononL lor oxliciL
inlornod consonL viLh rogard Lo Lho collocLion and sLorago ol liological sanlos. IL
should lo noLod LhaL Lho nov AcL doos noL aly Lo rouLino sanlos Lalon sololy lor
analysis in rolaLion Lo hoalLh caro noasuros concorning Lho donor hinsoll/horsoll,
unloss Lho sanlos aro rosorvod lor noro Lhan Lvo nonLhs, luL Lho dilloronco is
sLill considorallo. IL can hardly lo jusLiliod ly a lossor inLorosL in rosorving liological
sanlos Lhan, lor oxanlo, X-ray icLuros, so Lho Liing ol Lho lalanco nusL lo duo
Lo a orcoivod highor risl ol rivacy inlringononL. Tho inlornaLion onloddod in a
sanlo ol hunan naLorial is in a vay loLh ondloss and unlorosooallo. Iron Lho vory
ouLsoL, Lhis argunonL lor a sLricL inlornod consonL roquirononL soons sonovhaL
quosLionallo vhon sanlos aro rosorvod in Lho losL inLorosLs ol Lho aLionL hinsoll.
Could noL an oL-ouL-lasod consonL nodol lo sullicionL lor such lanling \iLh
rogard Lo liolanling lor rosoarch urosos, Lho argunonL ol highor risl could lo
considorod noro Lonallo, luL viLh Lho ossililiLy ol digiLalising INA and Lhus
Lranslorring Lho liological inlornaLion Lo a docunonL, Lho dilloronco loLvoon
docunonLs and liological naLorial doos soon Lo dvindlo.

120
Regeringens proposition ?001/0?.44, JJ-J4.
121
This vould noL soon Lo lo Lho sLand Lalon ly Lho rosonL, logally unrogulaLod RICs, soo Rosoarch
oLhics guidolinos lor using liolanls, osocially rojocLs involving gonono rosoarch. 1999
116
\hon rogisLorod daLa is Lo lo accossod or usod lor rosoarch urosos, consonL ol Lho
daLa suljocL vould soon Lo lo noro or loss a sLandard roquirononL, as rogards loLh
rulos on socrocy and rulos on daLa rocossing. IL is Lruo LhaL Svodish lav on socrocy
and conlidonLialiLy doos noL lay dovn any oxliciL consonL roquirononLs lor Lho
disclosuro ol hoalLh-rolaLod inlornaLion, luL in ordor Lo osLallish viLh corLainLy LhaL
disclosuro vill noL causo Lho individual any harn, consulLaLion viLh Lho orson
concornod vould olLon soon nocossary. Thus Lho nain rulos do noL roally dillor
nuch lron Lho rovisions laid dovn in Lho nov Biolanls AcL, alLhough in racLico
Lho alicaLion ol Lho socrocy rulos soons sonovhaL laxor Lhan Lho sLaLuLory
rovisions inly.
122
Cn Lho oLhor hand, Lho nov Biolanls AcL loavos Lho quosLion ol
ronovod consonL conloLoly aL Lho discroLion ol Lho RICs, vhoroas Lho Iorsonal
IaLa AcL includos an oxliciL rovision on Lho lalancing ol inLorosLs roquirod in such
siLuaLions.
AnoLhor asocL ol Lho accoss issuo, hovovor, is LhaL viLh rogard Lo orsonal
daLa in an ollicial docunonL, Lho orson vhon Lho inlornaLion concorns nay
nornally vaivo Lho roLocLion ol socrocy, and Lho docunonL nusL Lhon lo rosonLod
on donand. \iLh liolanl sanlos, Lhoro is no sinilar righL ol accoss ovon il Lho
donor voro Lo givo his or hor oxliciL consonL. Tho rincial ol a liolanl is Lhus
undor no olligaLion Lo granL rosoarchors accoss Lo sanlos, rogardloss ol Lho donor`s
vishos.
12J
This could orhas lo noLivaLod ly Lho lacL LhaL liological sanlos do noL
consLiLuLo an ondloss rosourco, and sono rioriLisaLion loLvoon dilloronL rojocL is
roquirod, luL iL nighL also lo arguod LhaL accoss Lo Lhoso valuallo rosourcos should
lo oquiLallo.
So is Lho lav sLricLor vhon iL conos Lo sonding liological sanlos alroad,
conarod Lo Lho Lranslor ol orsonal daLa Tho disclosuro ol hoalLh-rolaLod orsonal
daLa Lo a rociionL alroad vould cono undor Lho sano rulos on socrocy and
conlidonLialiLy as disclosuro Lo a rociionL viLhin Lho counLry. Tho Lranslor ol
orsonal daLa nusL also lollov Lho gonoral rulos laid dovn in Lho Iorsonal IaLa AcL.
Cnly Lranslor ol orsonal daLa Lo so-callod Lhird counLrios, ouLsido Lho II/IIA, is
suljocL Lo any social saloguards.
124
This noans LhaL Lho Lranslor ol liolanl sanlos
Lo rociionLs in oLhor counLrios is cloarly noro rosLricLod Lhan such Lranslor ol
orsonal daLa, rovidod LhaL Lho sanlos cono undor Lho nov Biolanls AcL. In
vhaLovor counLry Lho rociionL is siLuaLod, sanlos lron a liolanl nay novor lo
sonL alroad lor urosos oLhor Lhan Lhoso onunoraLod in Cha. 4, SocLions J and 5
ol Lho AcL, ovon il Lho donor voro Lo givo his or hor consonL.
125
IurLhornoro, sanlos
sonL alroad nusL alvays lo roLurnod or dosLroyod alLor having loon usod lor Lho
uroso lor vhich Lhoy aro roloasod. Inloss Lho sanlos cono undor Cha. 4,
SocLion J, rogarding corLain Lranslor alroad lor rosoarch urosos, Lhoro is also a
nandaLory roquirononL ol Lho sanlos loing oncodod or anonynisod. A vholo
liolanl, or arL ol a lanl, nay noL undor any circunsLancos lo Lranslorrod Lo a
rociionL alroad.

122
Rynning, I. 200J.
12J
Ivon Lho donor hinsoll or horsoll vould noL soon Lo havo any righL ol accoss Lo Lho naLorial, undor
Lho Biolanls (HoalLh Caro} AcL.
124
Soo SocLions JJ-J5 ol Lho Iorsonal IaLa AcL.
125
IL should lor oxanlo lo noLod LhaL Lhoro is aL rosonL no rovision in Lho Biolanls AcL alloving
Lho Lranslor alroad ol liological naLorial lor LranslanLaLion urosos, vhich vould soon Lo inly
LhaL such Lranslor is lornally, unlavlul as ol January 1, 200J. Considoring Lho inLornaLional co-
ooraLion Laling laco in Lhis aroa, such a rovision vill corLainly lo nocossary.
117
lisabeth Rynning
Tho rosLricLions on sonding liolanls and sanlos alroad havo loon ronLod ly Lho
lacL LhaL hunan liological naLorial ollors unliniLod ossililiLios ol charLing and
analysing gonoLic inlornaLion alouL individuals and grous ol ciLizons.
126
Irovidod
LhaL Lho sano judicial roLocLion is sLill ollorod Lho rivacy ol donors, hovovor, Lho
crossing ol a naLional lordor should noL consLiLuLo such a risl ol rivacy
inlringononLs. Tho roal rollon vould Lhus soon Lo lio in Lho oxisLing uncorLainLy
rogarding Lho logal rogulaLion ol liolanls in oLhor counLrios, and Lho ossillo lacl ol
unilorniLy viLh rogard Lo Lho roLocLion guaranLood.

7.3. A few comparative notes concerning the domestic law of certain other jurisdictions
As nonLionod alovo, Lho Nordic counLrios havo all Lalon an inLorosL in invosLigaLing
and rogulaLing Lho uso ol hunan liolanls, alLhough Lho logal soluLions rolorrod
vary considorally. \hon conaring Svodon Lo Lho oLhor Nordic counLrios, iL should
also lo rononlorod LhaL Lhoy all havo lasic logislaLion on aLionLs` righLs and,
12

viLh Lho oxcoLion ol Norvay, gonoral logislaLion on lionodical rosoarch involving
hunans.
128
Such logislaLion is so lar sLill alsonL in Svodon.
Thus Lho Icolandic Biolanls AcL only rogulaLos noro ornanonL liolanls,
vhoro Lho sanlos aro Lo lo loL lor noro Lhan livo yoars. Rosoarch liolanls ol a
noro Lonorary characLor aro govornod ly Lho gonoral rulos on lionodical rosoarch
and Lho rocossing ol orsonal daLa.
129
Many rojocLs using liological sanlos vill
Lhus novor cono undor Lho roquirononLs ol Lho Biolanls AcL, ovon Lhough Lhis AcL
is noL liniLod Lo covor only lanls viLh sanlos collocLod viLhin Lho acLiviLios ol a
hoalLh caro rovidor.
Norvay is also considoring a social Biolanls AcL, luL noro sinilar Lo Lho
Svodish AcL Lhan Lo Lho Icolandic.
1J0
Tho roosod Norvogian AcL, hovovor, is noL
rosLricLod Lo sanlos collocLod viLhin Lho acLiviLios ol a hoalLh caro rovidor, and
viLh rogard Lo liolanls lor rosoarch, ovon covors inlornaLion oxLracLod lron Lho
sanlos.
Iinland has choson noL Lo inLroduco any AcL socilically rogulaLing
liolanls, luL has sulononLod Lho nov AcL on Lho Iso ol Hunan Crgans and
Tissuo lor Modical Iurosos viLh corLain rovisions on Lho collocLion and lurLhor uso
ol hunan Lissuo. A sinilar soluLion is loing considorod in Ionnarl, luL Lhoro Lho
conlononLary rulos vill lo inLroducod in Lho AcL on Lho Logal SLaLus ol IaLionLs
and in Lho AcL on ILhics Roviov. As has loon sLrossod alovo, undor Ianish lav Lho
liolanl sanlos aro also covorod ly gonoral rulos on Lho rocossing ol orsonal daLa.

Gonorally soaling, Lho consonL roquirononLs lor collocLion and rosorvaLion ol
liological sanlos lor hoalLh caro urosos aro loss sLricL in Lho oLhor Nordic

126
12
Soo Lag om patientens stallning och rattigheter 17.8.199?/78 (Iinnish AcL on Lho SLaLus and RighLs
ol IaLionLs}, Lho Icolandic Act on the Rights oj atients No. 74/1997, Lov om patienters retsstilling LCV
nr 48? aj 01/07/1998 (Ianish AcL on Lho Logal SLaLus ol IaLionLs} and Lov om pasientrettigheter
(pasientrettighetsloven). LCV1999070?oJ (Norvogian AcL (6J/1999} on IaLionLs` RighLs}.
128
Soo Lho Ianish AcL Lov om et videnslabsetisl lomitesystem og behandling aj biomedicinsle
jorslningsprojelter LLK nr o9 aj 08/01/1999, Lho Iinnish AcL Lag om medicinsl jorslning
9.4.1999/488 and Lho Icolandic Regulation on Scientijic Research in the Health Sector No. ?/1999.
129
Soo ArLiclos 2 and 15 ol Lho AcL on Lho RighLs ol IaLionLs No. 4/199.
1J0
Cdelstingets proposisjon nr o (?001?00?) Lov om biobanler (biobanlloven) and Sosiallomiteens
lnstilling til Cdelstinget nr. ? (?00??00J).
118
counLrios, conarod Lo Lho nov Svodish rulos. Biological sanlos lron aLionLs
vould soon Lo consLiLuLo a noro or loss inLograLod arL ol Lho nodical rocords,
vhich aro loL rogardloss ol Lho aLionLs` vishos.
1J1
In Lho roosod Norvogian
Biolanls AcL, sanlos lron aLionLs nay lo rosorvod in accordanco viLh rosunod
consonL undor Lho logislaLion on aLionLs` righLs. Svodon is Lhus Lho only Nordic
counLry vhoro oxliciL inlornod consonL is roquirod lor Lho lanling ol sanlos
sLorod lor hoalLh caro urosos, in Lho losL inLorosLs ol Lho aLionL.
Svodon vould also soon Lo lo Lho only Nordic counLry vhoro Lho donor
nay roquiro Lho sanlo Lo lo dosLroyod or doorsonalisod ovon vhon iL is loing loL
lor Lho hoalLh caro ol Lho donor. \iLh rogard Lo sanlos usod lor rosoarch urosos,
hovovor, all Lho oLhor counLrios soon Lo onLiLlo Lho donor Lo viLhdrav his or hor
consonL and havo Lho sanlo dosLroyod.
1J2
In Norvay, iL is ovon suggosLod LhaL Lho
donor nay insisL on inlornaLion oxLracLod lron Lho sanlo also loing orasod.
1JJ

In gonoral, Lho rulos rolaLod Lo Lho collocLion or uso ol liological sanlos lor
rosoarch urosos soon Lo lo loss divorgonL. Tho nain rulos in all Lho Nordic
counLrios Lhus includo roquirononLs lor oLhics roviov and inlornod donor consonL.
AL Lho sano Lino, all Lho Nordic counLrios allov corLain oxcoLions Lo Lho consonL
roquirononLs, viLh rogard Lo uso lor nov urosos ol sanlos alroady lanlod.
Thoso oxcoLions vary sonovhaL viLh rogard Lo loLh Lhoir roroquisiLos and Lhoir
consoquoncos luL, as in Svodon, oxonLions lron Lho consonL roquirononLs nood Lo
lo arovod ly Lho RIC, and in Lho roosod Norvogian logislaLion also ly Lho
MinisLry.
1J4

Looling loyond Lho Nordic rogion, Lho IniLod Kingdon is an oxanlo ol a
counLry vhoro sulsLanLial invosLnonLs in nov liolanls aro aL rosonL loing nado,
1J5

viLhouL Lho oxisLonco ol any socilic logislaLion rogulaLing such acLiviLios. InsLoad,
sovoral guidolinos havo loon issuod ly various agoncios, such as Lho Nulliold Council
on BiooLhics, Lho Modical Rosoarch Council and Lho IoarLnonL ol HoalLh.
1J6

1J1
Soo, lor oxanlo, SocLion 11 ol Lho roosod Norvogian AcL, and concorning Ionnarl,
Redegrelse om biobanler. orslag til retlig regulering aj biobanler inden jor sundhedsomrdet. 2002,
195-196.
1J2
SocLion ol Lho Icolandic Biolanl AcL, SocLion ol Lho Iinnish AcL on Lho Iso ol Hunan Crgans
and Tissuo lor Modical Iurosos, SocLion 14 ol Lho roosod Norvogian AcL and Lho roosod nov
SocLion 18 l. ol Lho Ianish AcL on Lho Logal SLaLus ol IaLionLs.
1JJ
SocLion 14 ol Lho roosod Norvogian AcL.
1J4
SocLion 1J ol Lho roosod AcL.
1J5
Soo, lor oxanlo, Lho IK Biolanl.
1J6
Soo Human Tissue thical and Legal lssues, 1995, Human tissue and biological samples jor use in
research. Cperational and thical Cuidelines 2001 and A Code oj ractice jor Tissue Lanls. providing
tissues oj human origin jor therapeutic purposes, 2001. Tho guidolinos ol Lho Modical Rosoarch Council
roquiro inlornod consonL vhonovor sanlos aro Lalon vholly or arLly lor uso in rosoarch. ConsonL
nusL also lo olLainod lor sLorago and oLonLial luLuro uso ol sanlos. Inloss Lho sanlo is Lo lo
anonynisod and unlinlod rior Lo sLorago, iL is noL accoLallo Lo sool uncondiLional llanloL consonL
(lor oxanlo covoring all liological or nodical rosoarch"}. \iLh rogard Lo uso ol so-callod surlus
naLorials ronovod in Lho courso ol nodical LroaLnonL oLc., iL is roquirod LhaL individual consonL lo
olLainod vhorovor racLicallo, and LhaL aL Lho vory loasL an oL-ouL nodol should lo aliod.
AlLhough accoss ly Lho connorcial socLor Lo liolanl naLorials collocLod in Lho courso ol MRC-
lundod rosoarch is oncouragod, iL is sLrossod LhaL no conany should lo givon oxclusivo righLs ol
accoss Lo a collocLion ol sanlos nado viLh Lho lonoliL ol ullic lunds. Ionors should lo inlornod il
Lhoir sanlos nighL lo usod in connorcial rosoarch. Aroval ly an aroriaLoly consLiLuLod oLhics
conniLLoo is also a nandaLory roquirononL ol Lho MRC, lor all rosoarch using sanlos ol hunan
liological naLorial.
119
lisabeth Rynning
According Lo Lho Nulliold RoorL, Lhoro is liniLod IK sLaLuLo lav rolaLing Lo hunan
Lissuo and Lho connon lav loavos iLs sLaLus uncorLain in nany rosocLs.
1J
Many
asocLs ol Lho lav rolaLing Lo Lho uso ol hunan liological naLorial nay Lhus lo
dilliculL Lo doLornino viLh corLainLy, as is also oinLod ouL in a roconL consulLaLion
roorL concorning Lho lav on hunan organs and Lissuo in Ingland and \alos.
1J8

Iolloving Lho oriod ol consulLaLion, conrohonsivo roosals vill nov lo roarod
lor Lho rogulaLion ol Lho sLorago and uso ol hunan Lissuo and organs.
1J9
Anong oLhor
issuos, Lho consulLaLion roorL considors Lho logal and oLhical rincilos ol consonL,
and sLaLos LhaL according Lo Lho nain rulo donors nusL lo rovidod viLh suiLallo
inlornaLion and givo Lhoir volunLary, oxliciL consonL (or, in sono insLancos, rogisLor
an oljocLion}.
140
Ior childron undor Lho ago ol 16, aronLs nay givo consonL,
141

vhoroas Lho lav rolaLing Lo incaaciLaLod adulLs is loss cloar.
142
IL is also lound LhaL
aLionLs should lo aslod vhoLhor organs or Lissuo lolL ovor lolloving diagnosis or
LroaLnonL nay lo roLainod and/or usod lor rosoarch", and LhaL all rosoarch using
sanlos ol hunan organs or Lissuo nusL lo arovod ly a roorly consLiLuLod
rosoarch oLhics conniLLoo".
14J
Also viLh rogard Lo Lho uso ol oxisLing sanlos,
considoraLion should lo givon as Lo vhoLhor iL is ossillo (or, doonding on Lho
naLuro ol Lho rosoarch, nocossary} Lo sool consonL lron Lho orson concornod".
144
IL is
sLrossod LhaL assunLions alouL such rosocLs should roally lo LosLod, and LhaL iL
nusL noL lo Lalon lor granLod LhaL organs or Lissuo olLainod loloro a corLain daLo aro
liloly Lo havo loon alandonod". IL vould Lhus soon LhaL Lho Inglish rulos on
consonL shov nany sinilariLios Lo Svodon`s, and LhaL in Ingland ovon donors ol
anonynous naLorials aro ollorod sono roLocLion.

7.4. Compliance with European requirements and standards
Ioos Svodish lav concorning hunan liolanls conly viLh Lho sLandards laid dovn
in Iurooan lav To sLarL viLh, Lho Svodish rulos vary doonding on Lho
circunsLancos undor vhich Lho liolanl sanlos aro collocLod. Tho lacl ol cloar
judicial roLocLion lor corLain donors vould noL soon Lo lo in looing viLh Lho
roquirononLs laid dovn in ArLiclo 22 ol Lho Iurooan ConvonLion on Hunan RighLs
and Bionodicino and ArLiclo 8 ol Lho Iurooan ConvonLion on Hunan RighLs and
IundanonLal Iroodons, nor viLh ArLiclo J ol Lho II CharLor on IundanonLal
RighLs and Lho oinion ol Lho IGI. Tho lacL LhaL no roLocLion ol rivacy is ollorod
viLh rogard Lo liological naLorial LhaL is anonynous or anonynisod also consLiLuLos
an inlringononL ol Lho righLs roLocLod ly ArLiclo 22. Il a rosLricLion ol, say, ArLiclo
22 is considorod nocossary in viov ol oLhor inLorosLs aL sLalo, Lhis vould nood Lo lo
cloarly sLaLod and dolinod in accordanco viLh ArLiclo 26.1. IL should also lo noLod
LhaL rolovanL linding II rogulaLions, such as IirocLivo 98/9/IC on in viLro
diagnosLic nodical dovicos and Lho roosod IirocLivo on soLLing sLandards ol qualiLy

1J
Human Tissue thical and Legal lssues 1995, InLroducLion SocLion 1J.8.
1J8
Human Lodies, Human Choices 2002.
1J9
Survey on opinions jrom National thics Committees or similar bodies, public debate and national
legislation in relation to human biobanls 2002, J2-JJ.
140
Human Lodies, Human Choices 2002 SocLion 6.1.
141
lbid, SocLion 6.2.
142
lbid, SocLion .4-5.
14J
lbid, SocLion 10.1J.
144
lbid, SocLion 10.22.
120
and saloLy lor hunan Lissuos and colls, oxliciLly rolor Lo Lho consonL roquirononLs ol
Lho Iurooan ConvonLion on Hunan RighLs and Bionodicino.
As yoL, Lhoro is no gonoral logal roquirononL lor oLhics roviov ol Svodish
lionodical rosoarch involving hunans or hunan liological naLorial. Tho Iurooan
ConvonLion on Hunan RighLs and Bionodicino, as voll as IirocLivo 2001/20/IC on
good clinical racLico in Lho conducL ol clinical Lrials, soLs a sLandard LhaL calls lor
adjusLnonLs in Svodish lav. LogislaLion on oLhics roviov nay lo inLroducod viLhin
Lho noar luLuro, and nov rulos on roxy consonL lor inconoLonL aLionLs and
rosoarch suljocLs aro also undor roaraLion.
145

An inorLanL quosLion is vhoLhor Svodish lav on liolanls is consisLonL
viLh IirocLivo 95/46/IC on Lho roLocLion ol orsonal daLa. Tho IirocLivo roquiros
a corLain dogroo ol rivacy roLocLion, luL iL is also cloar lron ArLiclo 1.2 LhaL
Monlor SLaLos shall noiLhor rosLricL nor rohiliL Lho lroo llov ol orsonal daLa
loLvoon Monlor SLaLos, lor roasons connocLod Lo Lhis roLocLion. To Lho oxLonL LhaL
sanlos ol hunan liological naLorial nighL cono undor Lho IirocLivo vhich is an
issuo yoL Lo lo clariliod Lho Svodish rosLricLions on Lho Lranslor ol liolanl sanlos
Lo oLhor Monlor SLaLos vould Lhus lo conLrary Lo II lav.
146

8. Closing remarks

Tho ain ol Lho Svodish Biolanls (HoalLh Caro} AcL is Lo laciliLaLo accoss Lo hunan
liological naLorial lor loLh hoalLh caro urosos and inorLanL rosoarch, vhilo aL
Lho sano Lino olloring aroriaLo roLocLion Lo rivacy ol individuals concornod.
14

Tho roquisiLo lalancing ol inLorosLs has noL rosulLod in quiLo Lho sano rulos lor
liolanl naLorials as aly Lo Lho rocossing ol orsonal daLa. IL could voll lo arguod
LhaL sono dilloroncos aro jusLiliod, lor oxanlo ly Lho lacL LhaL hunan liological
naLorial is noL only a sourco ol inlornaLion luL can also lo usod as rav naLorial lor
roducLs. Cn Lho oLhor hand, Lo Lho oxLonL LhaL hunan liological naLorial is only
usod in a vay sinilar Lo oLhor carriors ol orsonal daLa, dilloroncos in rogulaLion
nighL soon unroasonallo and ouL ol looing viLh gonoral anliLions lor consisLoncy
and cohoronco in Lho logal sysLon.
Tho Svodish Biolanls (HoalLh Caro} AcL doos noL nanago Lo clarily Lho
lordorlino and dilloroncos loLvoon orsonal daLa and hunan liological naLorial, nor
vhich rulos should lo aliod in corLain siLuaLions ol ossillo conllicL. To sono
oxLonL, Lhis should noL lo rogardod as a rollon Lo lo linally solvod ly Svodon
alono, luL as a naLLor Lo lo discussod and agrood on ly Lho II counLrios joinLly. Tho
sano could lo said concorning doliniLions ol such concoLs as anonyniLy and coding.
InLil such Lino as Lhoso rollons can lo givon a harnonisod Iurooan soluLion,
hovovor, Lho Svodish logislaLor nusL rovido rulos LhaL aro sullicionLly cloar aL loasL
lor donosLic uso. AL rosonL, Lho scoo ol Lho nov Biolanls AcL ronains raLhor
olscuro, Lo Lho doLrinonL ol all arLios in any vay allocLod ly Lho logislaLion. Thoro
aro also sovoral rollons viLh Lho Svodish liolanl logislaLion LhaL cannoL lo

145
Soo Regeringens proposition ?00?/0J.0 tilprvning av jorslning and Lho Lorns ol roloronco issuod
in rmyndare, gode man och jrvaltare, IirolLiv 2002:55.
146
Soo \ossnan, R. 200J.
14
Regeringens proposition ?001/0?.44 . 29 and 6.
121
lisabeth Rynning
llanod on uncorLainLy rolaLod Lo Iurooan lav, such as Lho lacL LhaL nany liolanls
aro lolL arLly unrogulaLod.
Tho lraning ol logislaLion on Lho uso ol hunan liolanls, vhich in a voll-
lalancod vay lullils inLornaLional roquirononLs as voll as donosLic noods, has
corLainly loon an urgonL Lasl, luL iL should also havo loon rocognisod as a highly
donanding ono. IL vould soon LhaL Lho Svodish govornnonL did noL Lalo Lhis issuo
soriously onough aL Lho ouLsoL, and Lhus lailod Lo socuro Lho Lhorough and qualiliod
invosLigaLion LhaL vas noodod. Tho rosulLing Svodish Biolanls (HoalLh Caro} AcL is
unlorLunaLoly conronisod ly inconsisLoncios, gonoral olscuriLios and oLhor
shorLconings.
148
\o havo succoodod in inLroducing rogulaLion ol hunan liolanls,
luL iL is a rogulaLion LhaL nay roquiro noro adjusLnonL and sulononLaLion Lhan
vould nornally lo dosirallo. IL is Lhoroloro inorLanL LhaL Lho rosonL Biolanls
(HoalLh Caro} AcL should noL lo considorod Lho ond oinL ol Lhis rogulaLory rocoss.
Tho logal dovolononLs and dolaLo loLh viLhin and ouLsido Lho II nood Lo lo
lollovod closoly and carolully considorod, il vo aro Lo achiovo our oljocLivo: a jusL
and aroriaLo lalanco loLvoon rivacy and inLorosLs ol rosoarch, in conlianco
viLh our duLios undor inLornaLional and Iurooan lav.

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128
ocusing on personal integrity violation legal guidelines jor ethical practice

o

Focusing on personal integrity violation
legal guidelines for ethical practice
1

Ulril von ssen, LLD

Department oj Lau, Stoclholm university

The rapid pace oj development in science has activated ethical questions in connection
uith research. Studies oj these questions in Sueden have resulted in a drajt thical
Revieu Act concerning research uhich entails processing oj personal data and studies oj
biological material. Since examination by the Loards jor Research thics uill constitute a
tasl involving exercise oj public authority regulated by statute, juture assessments must
lie uithin the limits determined by the statutory provisions. This paper discusses the legal
premises on uhich these ethical revieus should be based on.

1. Introduction

Tho raid aco ol dovolononL in scionco has acLivaLod oLhical quosLions in
connocLion viLh naLional and inLornaLional rosoarch. SLudios ol Lhoso quosLions havo
rosulLod in a dralL ILhical Roviov (Rosoarch Concorning Ioolo} AcL (ILhical
Roviov AcL}.
2
This AcL vill aly Lo all rosoarch discilinos, luL oughL Lo lo ol
rinary inorLanco lor nodical rosoarch.
Ivon Loday, nodical rosoarch is oxaninod lron Lho oLhical oinL ol viov. In
ovory hoalLh caro rogion Lhoro aro nodical rosoarch conniLLoos on oLhics vhoso
vorl is lasod on Lho Holsinli IoclaraLion and oLhor oLhical guidolinos.
J
Tho
IoclaraLion, vhich has loon adoLod ly Lho \orld Modical AssociaLion, conLains
oLhical guidolinos lor rosoarch on oolo. InsocLion ol nodical rosoarch is noL,
hovovor, logally rogulaLod novadays. This is considorod Lo lo a sorious shorLconing
vhich vill lo ronodiod ly Lho onLry inLo lorco ol Lho ILhical Roviov AcL.
Sinco oxaninaLion ly Lho Boards lor Rosoarch ILhics vill consLiLuLo a Lasl
involving oxorciso ol ullic auLhoriLy rogulaLod ly sLaLuLo, luLuro assossnonLs nusL
conlorn Lo Lho liniLs doLorninod ly Lho sLaLuLory rovisions. \hon doLornining Lho

1
This aor is lasod on an oarlior arLiclo, von Isson, Ilril (2002}. Liobanls och Registerjorslning.
IrvalLningsraLLslig LidslrilL, halLo 5-6, 2002, . J51-J80.
2
AL Lho Lino ol vriLing (January 200J} Lho GovornnonL had sulniLLod a Iroosal lor considoraLion
ly Lho Council on logislaLion, and Lho laLLor had roLurnod an oinion. A GovornnonL Bill 2002/0J:50
(Regeringens proposition ?00?/0J.0 tilprvning av jorslning) vas roosod in Iolruary. Tho AcL is
oxocLod Lo cono inLo lorco in January 2004.
J
Soo Lho guidolinos ol Modicinsla lorslningsrdoL (2000}. Riltlinjer jr etisl vardering av medicinsl
humanjorslning (MIR raorL 2/2000}. (Modical Rosoarch Council nov \orling Grou lor
Rosoarch on GonoLics in Modicino ol Lho ScionLilic Council ethical evaluation oj medical human
research, roorL 2/2000}.
129
Ulril von ssen
liniLs, considoraLion nusL lo aid noL only Lo Lho vording ol Lho sLaLuLory
rovisions, luL also ol Lho inLonLions oxrossod in Lho travaux preparatoires. Caro
nusL lo Lalon horo Lo avoid collisions loLvoon Lho various sLaLuLos in Lho aroa.

2. The Ethical Review Act

2.1 Purpose and terminology
Tho purpose ol Lho ILhical Roviov AcL is Lo roLocL Lho individual and guaranLoo
rosocL lor hunan digniLy in connocLion viLh rosoarch. IrivaLo individuals shall lo
roLocLod againsL violaLions ol orsonal inLogriLy and hysical injurios or onoLional
harn. \haL is inLondod horo is noL so nuch rovision ol alsoluLo roLocLion againsL
Lho lorogoing, luL raLhor, sinco a rosoarch rojocL nay onLail risls Lo Lho LosL
suljocLs, a balancing ol Lhoso risls againsL Lho oxocLod gain in lnovlodgo.
4
A
gonorally accoLod lalanco Lhoroloro noods Lo lo sLrucl loLvoon Lho qualiLy ol
rosoarch and Lho risls iL onLails Lo individual suljocLs and Lho valuo ol hunan
digniLy.
Research rolors horo Lo scionLilic rosoarch as voll as dovolononL rojocLs
lasod on scionLilic grounds. Tho govornnonL auLhoriLy or Lho naLural or logal orson
undor vhoso ausicos rosoarch is conducLod is rolorrod Lo in Lho logislaLivo roosal
as research representative, vhoroas Lho living orson allocLod ly Lho rosoarch is callod
research subject. Rogarding oLhor naLLors, Lho logislaLivo roosal conLains corLain
concoLs vhich aro dolinod in oLhor sLaLuLos, osocially in Lho Iorsonal IaLa AcL
(1998:204}(soo lolov}.

2.2 Scope
Tho scoo ol Lho ILhical Roviov AcL is rogulaLod ly SocLions J-5 ol Lho AcL. SocLion
5 lays dovn LhaL Lho AcL shall aly Lo rosoarch vhich is conducted in Sueden.
Rogarding inLornaLional rosoarch rojocLs, oLhical oxaninaLion shall aly Lo LhaL
arL ol Lho rojocL vhich is Lo lo conducLod in Svodon. SocLions J and 4 ol Lho AcL
doLornino Lho sulsLanLivo aroa ol Lho AcL`s alicaLion ly laying dovn LhaL oLhical
oxaninaLion shall lo conducLod viLh rogard Lo rosoarch concorning Lho handling ol
corLain personal data, or onLailing oiLhor hysical handling oj people or concorning
sLudios ol biological material olLainod lron oolo. Rosoarch ol Lhoso linds nay lo
conducLod only il iL has loon arovod lolloving oLhical oxaninaLion. Aroval
undor Lho lav doos noL onLail LhaL Lho rosoarch nay lo conducLod il iL is in violaLion
ol anoLhor sLaLuLo, lor oxanlo, Lho Hunan IorLilisod Cva (Moasuros lor Rosoarch
and TroaLnonL Iurosos} AcL (1991:115}.

2.2.1 Research entailing processing of personal data
Tho ILhical Roviov AcL shall lo alicallo Lo rosoarch onLailing, inter alia,
rocossing ol sonsiLivo orsonal daLa. Cno ol Lho roroquisiLos lor Lho alicaLion ol
Lho AcL is LhaL Lho rosoarch suljocL shall not havo givon his or hor explicit consent Lo
Lho rocossing ol daLa. Moroovor, Lho AcL alios only Lo rosoarch concorning
inlornaLion alouL living orsons. Tho Lorn sensitive personal data is dolinod in
SocLion 1J ol Lho Iorsonal IaLa AcL Lo vhich Lho ILhical Roviov AcL nalos
roloronco and onlracos, anong oLhor Lhings, orsonal daLa vhich rovoals raco or

4
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?) . 9.
130
oLhnic origin and vhich concorns hoalLh or sox lilo. An oxanlo ol rosoarch LhaL
vould lo covorod ly Lho AcL is vhon a rosoarchor vishos Lo uso daLa lron Lho
NaLional Board ol HoalLh and \ollaro`s hoalLh rogisLor.
Gonoral rovisions concorning rocossing ol orsonal daLa can lo lound in
Lho Iorsonal IaLa AcL, Lho oljocL ol vhich is Lo roLocL oolo lron violaLions ol
orsonal inLogriLy, lirsL and loronosL ly noans ol auLonaLic orsonal daLa
rocossing.
5
Tho noro rociso noaning ol Lho Lorn integrity has noL loon discussod in
Lho travaux preparatoires.
6
Tho Lorn processing rolors in Lhis conLoxL Lo any noasuro
or sorios ol noasuros Lalon in rosocL ol orsonal daLa. All handling ol such daLa
o.g. collocLion, rogisLraLion, sLoring, rocossing, uso, and dosLrucLion lalls, in
rincilo, viLhin Lho scoo ol Lho AcL, . ersonal data is dolinod as any Lyo ol
inlornaLion dirocLly or indirocLly rolorallo Lo a living, naLural orson. InlornaLion
LhaL can lo rolorrod Lo individual orsons luL only in Lhoir caaciLy as nonlors ol a
largor grou, lor oxanlo, snolors or lroasL cancor aLionLs, should noL lo
considorod as orsonal daLa. Cn Lho oLhor hand, oncryLod or oncodod daLa is
covorod ly Lho AcL, as long as Lhoro is sonoono vho can nalo Lho daLa roadallo and
in Lhis vay nalo ossillo Lho idonLilicaLion ol individual orsons. A orson vho
docidos Lho uroso and noans ol orsonal daLa rocossing is callod controller oj
personal data in logal Lorns. Tho AcL alios, viLh lov oxcoLions, oxclusivoly Lo
conLrollors osLallishod in Svodon.
Tho Iorsonal IaLa AcL is subsidiary in rolaLion Lo oLhor sLaLuLos or sLaLuLory
insLrunonLs, luL noL Lo rogulaLions issuod ly ullic auLhoriLios (SocLion 2}. Such
divorgonL rovisions can olLon lo lound in so-callod data jile statutes, vhich rogulaLo
Lho soLLing u and nainLaining ol noro inorLanL daLa lilos, rinarily in Lho ullic
socLor. A daLa lilo sLaLuLo Lhoroloro consLiLuLos a social rogulaLion in rolaLion Lo Lho
Iorsonal IaLa AcL, vhich iL is inLondod Lo sulononL or ovorrido Lo sono oxLonL. A
largo nunlor ol such sLaLuLos aro Lo lo lound,
viLh varying Laxonony and sLrucLuro.

Iorhas Lho nosL inorLanL in Lhis conLoxL is Lho HoalLh IaLa RogisLors AcL
(1998:54J}. Indor Lho rovisions ol Lho AcL and Lho corrosonding sLaLuLory
insLrunonLs, Lho hoalLh caro orsonnol rosonsillo nusL rovido inlornaLion Lo a
conLral adninisLraLivo auLhoriLy, rinarily Lho NaLional Board ol HoalLh and
\ollaro, so LhaL iL can lo onLorod in Lho naLional daLa lilo. Tho inlornaLion in Lhis
daLa lilo nay lo usod,, lor oxanlo lor urosos ol rosoarch or oidoniological
sLudios, on vhich occasions Lho naLional daLa lilo nay lo run concurronLly viLh
oLhor daLa lilos. Cnco a logaliLy LosL has loon carriod ouL and assod, Lho inlornaLion
nay lo lorvardod Lo Lho rosoarchors involvod in Lho rojocL, in loLh Lho ullic and
Lho rivaLo socLors. IL should lo olsorvod LhaL Lho rovisions rogulaLing disclosuro ol
inlornaLion ly auLhoriLios or individuals havo rocodonco ovor Lho rovisions ol Lho
Iorsonal IaLa AcL.
8
Such a duLy is soL ouL in Lho Iroodon ol Lho Iross AcL
(1949:105}, Lho Modical Rocords AcL (1985:562}, Lho Socrocy AcL (1980:100}, and
Lho HoalLh and Modical Sorvicos (Irolossional AcLiviLy} AcL (1998:5J1}.

5
This AcL Lransosos IirocLivo 95/46/IC ol Lho Iurooan IarlianonL and Lho Council ol 24 CcLolor
1995 on Lho roLocLion ol individuals viLh rogard Lo Lho rocossing ol orsonal daLa and on Lho lroo
novononL ol such daLa.
6
Cl. GovornnonL Bill 199/98:44 (Regeringens proposition 1997/98.44), . 115. Soo also Cnan,
Sron & Lindllon, Hans-Clol, ersonuppgijtslagen, 2nd od., . 4J l.
Cl. Lho MinisLry ullicaLions sorios, Is 2000:J4, . 58.

8
GovornnonL Bill 199/98:44 (Regeringens proposition 1997/98.44), . 116.
131
Ulril von ssen
The principal requirements concerning the processing ol orsonal daLa and siLuaLions in
vhich such rocossing is permissible aro dolinod in SocLions 9 and 10 ol Lho Iorsonal
IaLa AcL. Thoso socLions lay dovn quiLo olvious roquirononLs, o.g. LhaL orsonal
daLa shall lo rocossod only il Lho rocossing is lavlul and shall lo rocossod in a
corrocL nannor. IL is lurLhor sLiulaLod LhaL orsonal daLa nay only lo collocLod lor
socilic, oxliciLly sLaLod and jusLiliod urosos and LhaL orsonal daLa shall noL lo
rocossod lor any uroso LhaL is inconaLillo viLh LhaL lor vhich Lho inlornaLion
is collocLod. Iorsonal daLa nay lo rocossod only il Lho orson rogisLorod has givon
his or hor consonL Lo Lho rocossing. Thoro aro, hovovor, a nunlor ol oxcoLions Lo
Lho roquirononL ol consonL. Ior oxanlo, orsonal daLa nay lo rocossod vhoro
nocossary lor Lho orlornanco ol a Lasl ol ullic inLorosL, such as rosoarch.
9

Moro rosLricLivo rulos aly Lo Lho rocossing ol sensitive personal data,
rogarding hoalLh, lor oxanlo. Tho nain rulo is LhaL rocossing ol such daLa is
prohibited il Lho orson rogisLorod has noL givon his or hor explicit consent Lo Lho
rocossing (SocLion 15 ol Lho Iorsonal IaLa AcL}. In addiLion Lo Lho alovo-
nonLionod righL Lo Lho rocossing ol orsonal daLa ursuanL Lo dilloronL daLa lilo
sLaLuLos, a nunlor ol oxcoLions can lo lound. Ior oxanlo, rocossing ol orsonal
daLa lor Lho urosos ol hoalLh caro and nodical LroaLnonL is orniLLod.
SonsiLivo orsonal daLa nay lurLhor lo rocossod viLhouL consonL in
connocLion viLh research, suljocL Lo corLain condiLions. Thus SocLion 19 (1} ol Lho
Iorsonal IaLa AcL sancLions Lho rocossing ol sonsiLivo orsonal daLa lor Lho
urosos ol rosoarch, rovidod Lho rocossing is necessary in Lho nannor sLaLod in
SocLion 10 and Lho inLorosL ol socioLy in Lho rosoarch rojocL is nanilosLly groaLor
Lhan Lho risl ol inroor violaLion ol Lho orsonal inLogriLy ol Lho individual
involvod in Lho rocossing. Tho rovisions aro jusLiliod ly Lho lacL LhaL rosoarch nay
lo so inorLanL LhaL iL should noL lo doondonL on inlorning and olLaining consonL
lron ovory individual.
10
A conLrollor ol orsonal daLa, o.g. a rosoarchor or a rosoarch
insLiLuLion, nay docido on Lhoir ovn Lo noLily Lho IaLa InsocLion Board ol Lhoir
docision, or olso sulniL Lho rosoarch rojocL Lo a research ethics committee. Il Lho
rocossing ol orsonal daLa has loon arovod ly Lho rosoarch conniLLoo, Lho
roroquisiLos undor SocLion 19 (1} ol Lho AcL shall lo doonod saLisliod.
Tho alovo-doscrilod rogulaLory lranovorl vill chango alLor Lho
inlononLaLion ol Lho ILhical Roviov AcL. Tho nov AcL sLiulaLos insLoad an
obligatory ethical revieu ol rosoarch rojocLs in vhich sonsiLivo orsonal daLa aro
includod, and vhoro consonL has noL loon olLainod. Rosoarch nay noL lo
undorLalon il Lho rosoarch rojocL has noL loon arovod ly a Board lor Rosoarch
ILhics. In Lhis vay Lho rosoarchor vill no longor lo allo Lo nalo his ovn docision on
Lho lasis ol SocLion 19 ol Lho Iorsonal IaLa AcL. In consoquonco, vhon oxanining
rosoarch conLaining sonsiLivo orsonal daLa, Lho Board lor Rosoarch ILhics vill also
havo Lo givo an oinion on Lho rocossing ol Lhoso daLa. Assossing Lho rojocL and Lho
rocossing ol daLa should olLon lo Lho sano, luL iL cannoL lo rulod ouL LhaL corLain
rocossing noasuros nay lo considorod Loo lar-roaching, ovon il Lho rojocL and Lho
gonoral rocoduros aro rogardod as accoLallo. In iLs docision vhich vill lo nado
in accordanco viLh Lho rovisions ol Lho ILhical Roviov AcL (soo SocLion 4} Lho
Board shall nalo uso ol Lho assessment prerequisites vhich aro Loday oxrossod in

9
Svodish GovornnonL Cllicial RoorLs, SCI 199:J9, . J05, J55 and J61.
10
132
SocLion 19 ol Lho Iorsonal IaLa AcL.
11
Tho Iorsonal IaLa AcL vill Lhoroloro lo
sulononLod ly a nov rovision sLiulaLing LhaL sonsiLivo orsonal daLa nay lo
rocossod lor Lho urosos ol rosoarch, rovidod Lho rocossing has loon arovod
ly a Board lor Rosoarch ILhics according Lo Lho ILhical Roviov AcL.

2.2.2 Research entailing intrusive demands on people and studies of biological material
In addiLion Lo rosoarch onLailing rocossing ol corLain orsonal daLa, Lho ILhical
Roviov AcL shall aly Lo rosoarch onLailing hysical inLrusion on a rosoarch suljocL
and carriod ouL in a vay vhich vill inlluonco Lho rosoarch suljocL hysically or
nonLally, rosoarch concorning sLudios ol liological naLorial Lalon lron a living
orson and idonLiliallo as originaLing lron LhaL orson, rosoarch onLailing hysical
inLrusion on a docoasod orson or concorning sLudios ol liological naLorial Lalon lor
nodical urosos lron, lor oxanlo, a docoasod orson, and idonLiliallo as
originaLing lron LhaL orson (SocLion 4 ol Lho ILhical Roviov AcL}. Rosoarch
concorning lorLilisod ova, onlryos and looLusos insido Lho noLhor`s lody onLails
hysical inLrusion on Lho orson ol Lho noLhor, vhoroas rosoarch on lorLilisod oggs
ouLsido Lho lonalo lody, lor oxanlo in Lho caso ol onlryonic coll rosoarch,
consLiLuLos rosoarch on liological naLorial. In loLh casos oLhical roviov shall lo
orlornod. Il, on Lho oLhor hand, rosoarch consisLs in Lho lacL LhaL corLain liological
naLorial lron a orson is dovolood inLo sonoLhing noro Lhan iL originally vas, lor
oxanlo vhon INA is isolaLod, or vhon a arL ol a lorLilisod hunan ogg is
dovolood inLo an onlryonic coll lino, Lho individual connocLion no longor oxisLs and
no oLhical roviov is Lhoroloro nocossary.
12
Cinions nay dillor, hovovor, as rogards
Lho oxacL oinL in Lino aL vhich Lho Lissuo coasos Lo lo arL ol Lho original naLorial.
\haL is inLorosLing in Lhis conLoxL is rosoarch dono on ro-oxisLing liological
naLorial. InLorosL in such collocLions ol hunan liological naLorial has grovn vory
sLrong in roconL yoars.
1J
This is associaLod viLh Lho raid dovolononL ol lionodical
rosoarch and gonoLic Lochnology loLh in Svodon and alroad, vhich oons Lho doors
Lo Lronondous ossililiLios in loLh lionodicino and oLhor rosoarch. Tho
dovolononL rocoss is loing acconaniod, hovovor, ly loars LhaL inlornaLion
alouL individual orsons` gonoLic naLorial nay lo nisusod, and LhaL oolo vill lo
LroaLod dilloronLly, doonding on Lhoir gonoLic condiLion.
14
In Lho gonoral dolaLo,
roLocLion ol an individual orson`s inLogriLy has cono inLo locus, and iL is
considorod inorLanL Lo croaLo saloguards guaranLooing LhaL inLogriLy-sonsiLivo
inlornaLion is noL dissoninaLod in an unconLrollod and undosirallo vay. This
roLocLion ol individuals shall lo saloguardod, inter alia, ly noans ol Lho nov
Biolanls (HoalLh Caro} AcL (2002:29} (Lho Biolanls AcL} vhich onLors inLo lorco
on 1 January 200J, and in Lurn is sulononLod ly Lho ILhical Roviov AcL.
Tho uroso ol Lho Biolanls AcL, as alroady inLinaLod, is rogulaLion ol Lho
uso ol hunan liological naLorial lron Lho oinL ol viov ol rosocL lor orsonal
inLogriLy ol individuals. Tho oxacL noaning ol Lho Lorn ìnLogriLy` has noL loon
discussod in Lho travaux preparatoires, luL iL is indicaLod LhaL roLocLion ol

11
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 164 and 185.
12
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 99 l.
1J
Soo Rynning, IlisaloLh (1998}. Liobanlerna hg tid jr banlinspeltion` IrvalLningsraLLslig
LidslrilL, no. 6, 1998, . J0J-JJJ.
14
Soo in Lhis conLoxL RadoLzli, Marcus, RadoLzli, Marian & JuLh, Nillas Att nyttja genetisl
injormation, viLh roloroncos.
133
Ulril von ssen
individuals shall lo voighod againsL socioLy`s nood ol Lho liological naLorial in
quosLion lor Lho urosos ol rosoarch.
15
Tho AcL shall lo alicallo Lo liolanls in
Svodon. Tho Lorn biobanl rolors Lo liological naLorial lron ono or sovoral orsons
living, docoasod or looLusos vhich is collocLod and loL Lo lo usod aL a laLor daLo,
vhoso origins can lo Lracod Lo Lho orson or orsons concornod. NoL all liolanls
vill lo covorod ly Lho nov rogulaLory lranovorl, hovovor.
Tho lirsL condiLion lor a lanl Lo cono undor Lho Biolanls AcL is lor Lho
naLorial Lo lo traceable Lo Lho individual sanlo givors, lor oxanlo, ly loing allo Lo
lroal Lho oncoding loy. IL is lurLhor roquirod LhaL Lho naLorial has loon olLainod
lron aLionLs or oLhors in Lho conLoxL ol hoalLh caro or nodical LroaLnonL or in
connocLion LhoroviLh lor Lho urosos ol rosoarch, and LhaL iL is Lo lo stored lor an
indoliniLo or doliniLo oriod. Sanlos vhich havo loon collocLod indoondonLly lron
hoalLh caro acLiviLios, lor oxanlo sanlos Lalon ly rosoarch insLiLuLions, cono
ouLsido Lho scoo ol Lho AcL. Tho AcL alios, hovovor, Lo liolanls conLaining
naLorial olLainod lron liolanls loL ly nodical and hoalLh caro insLiLuLions, and
naLorial sLorod aL rosoarch insLiLuLos or harnacouLical conanios, lor oxanlo.
Sanlos Lalon lor Lho urosos ol nodical LroaLnonL and noL loL lor a longor
oriod ol Lino" aro noL covorod ly Lho rovisions ol Lho AcL. Tho AcL doos noL
socily Lho noaning ol Lho Lorn a longor oriod ol Lino", luL a oriod ol Lvo
nonLhs has loon indicaLod in Lho travaux preparatoires as such.
16
This vill rolally
onLail a nunlor ol rollons lor hoalLh caro sorvicos, sinco sanlos Lalon lor
LroaLnonL urosos nusL olLon lo loL longor Lhan LhaL.
1
Rogarding liolanls
conLaining sanlos olLainod lron novlorns social rulos aly undor Cha. 5 ol Lho
AcL.
18
Tho AcL is subsidiary in rolaLion Lo oLhor logislaLion, viLh Lho oxcoLion ol Lho
rovisions concorning Lho IKI rogisLor, vhich shall aly loloro all oLhor logislaLion.
A liolanl is established ly a docision ol a hoalLh caro rovidor or sono
oLhor insLiLuLion, such as, lor oxanlo, a rosoarch insLiLuLo or a harnacouLical
conany, vhich has rocoivod Lissuo sanlos lron Lho liolanl ol a hoalLh caro
rovidor. In connocLion LhoroviLh Lho rorosonLaLivo ol Lho liolanl shall also
doLornino Lho urosos ol Lho liolanl. Il a liolanl is osLallishod lor Lho urosos
ol rosoarch or clinical LosLing, iL shall alvays lo oxaninod and arovod ly a Board
lor Rosoarch ILhics. This oxaninaLion rocoduro nusL lo conloLod loloro sanlos
can lo sulniLLod lor rosoarch urosos.
19
A docision Lo soL u a liolanl shall lo
connunicaLod ly Lho rosoarch rorosonLaLivo Lo Lho NaLional \ollaro Board, vhich
shall loo a rogisLor ol liolanls.
Tho AcL sLiulaLos LhaL Lissuo sanlos nay noL lo collected and sLorod in Lho
liolanl unloss Lho sanlo rovidor has loon injormed ol Lho roason lor iL and Lho
oljocLivo or oljocLivos lor vhich Lho liolanl nay lo usod, and unloss ho has givon

15
GovornnonL Bill 2001/02:44 (Regeringens proposition ?001/0?.44), . 18 ll., and 6.
16
GovornnonL Bill 2001/02:44 (Regeringens proposition ?001/0?.44), . J0.
1
Soo Lindlorg, Bo, Clinical data a necessary requirement jor realising the potential oj biobanls, in Lhis
linal roorL.
18
Tho so-callod IKI LosL is a rouLino llood LosL orlornod on all novlorns in Svodish hosiLals in
ordor Lo uncovor a rolaLivoly raro disoaso vhich nay causo sorious lrain danago il Lho child is noL
suliod viLh a social dioL. AlLor a scrooning analysis, Lho sanlos aro sLorod in Lho so-callod IKI
rogisLor aL Lho Huddingo InivorsiLy HosiLal AB.
19
GovornnonL Bill 2001/02:44 (Regeringens proposition ?001/0?.44), . 1.
134
his or hor consent.
20
ConsonL can lo rovolod vholly or arLially aL any Lino. Il Lho
rovocaLion rolors Lo all uso, Lho sanlo shall lo dosLroyod or all idonLilicaLion lalols
ronovod. In Lhis rosocL Lho rogulaLory lranovorl dillors lron vhaL nornally
alios Lo orsonal daLa undor dilloronL daLa lilo sLaLuLos in Lho aroa ol nodicino,
vhoro an individual suljocL nornally has no righL Lo roquosL his or hor ronoval lron
such lilos. This is locauso Lho righL Lo lo sLrucl oll a rogisLor vould noan LhaL Lho
acLiviLios lor vhich Lho daLa lilo is suosod Lo lo usod hoalLh caro, rosoarch,
sLaLisLics, oLc. could noL lo saLislacLorily orlornod. IroquonLly, Lho inorLanco ol
accoss Lo largo anounLs ol naLorial lor nodical rosoarch urosos is also sLrossod, as
voll as Lho nood lor rosoarch acLiviLios oxLonding ovor a long oriod ol Lino.
21
Tho
sano argunonLs can, naLurally, lo involod againsL Lho righL ol rovocaLion ol consonL
Lo Lho uso ol liological naLorial in a liolanl. Il Lho naLorial in Lho lanl is Lo lo
usod lor another purpose Lhan Lho original uroso ol Lho collocLion, iL is u Lo Lho
Boards lor Rosoarch ILhics Lo oxanino Lho rosoarch rojocL in ordor Lo doLornino
vhaL shall aly rogarding inlornaLion and consonL (soo also SocLions 2.J and 4.4}.
Il a rosoarchor vishos Lo uso naLorial lron a liolanl ho nusL olLain
aroval lron a Boards lor Rosoarch ILhics undor SocLion 4 ol Lho ILhical Roviov
AcL. In conLrasL Lo rosoarch onLailing rocossing ol sonsiLivo orsonal daLa, oLhical
roviov in Lhoso casos is noL doondonL on Lho consonL ol Lho sanlo rovidors.

2.3 Information and consent
SocLions 1J-22 ol Lho ILhical Roviov AcL conLain rovisions on inlornaLion and
consonL. Tho nain alicaLion aroa ol Lhoso rovisions rolaLos Lo rosoarch vhich
onLails hysical inLrusion on individuals, locauso Lho rovisions aly only insolar as
Lhoro aro no oLhor social rovisions on inlornaLion and consonL in any oLhor
sLaLuLo.
\hon Lho liological naLorial is sLorod in liolanls and comes jrom health
and medical services, Lho rovisions ol Lho Biolanls AcL concorning inlornaLion and
consonL shall Lhus lo alicallo. Indor Lhis AcL, Lissuo sanlos nay noL lo collocLod
and sLorod in a liolanl viLhouL inlorning Lho sanlo rovidor ol Lho uroso and
oljocLivos lor vhich Lho lanl nay lo usod, and viLhouL olLaining his or hor
consonL. Il a rosoarchor vishos Lo uso Lho naLorial in a liolanl lor another purpose
Lhan LhaL onlracod ly Lho inlornaLion rovidod oarlior and lor vhich consonL has
loon olLainod, Lho sanlo rovidor has Lo lo injormed and his or her consent olLainod
lor Lhis nov uroso. An oxcoLion is nado rogarding Lho roquirononL ol consonL in
casos ol research and clinical testing. Il Lho nov uroso concorns such acLiviLios, iL is
insLoad the Loard jor Research thics vhich has Lo granL aroval lor Lho nov uroso
and also doLornino Lho roquirononLs concorning inlornaLion and consonL il Lho
Lissuo sanlos sLorod in Lho lanl aro Lo lo allovod Lo lo usod lor Lho nov uroso
(soo SocLion 4.4.}. Tho travaux preparatoires do noL discuss Lho issuo ol vhon a
sanlo is Lo lo considorod Lo lo usod lor a nov uroso, vhich can load Lo various
donarcaLion rollons.
Tho quosLion LhaL conos Lo nind concorns Lho Lyo ol inlornaLion LhaL an
individual orson nusL rocoivo in ordor Lo givo his or hor logally valid consonL Lo Lho
sLorago ol Lho naLorial in a liolanl. Tho travaux preparatoires indicaLo LhaL iL is

20
Social rulos aly Lo inlornaLion and consonL as rogards ninors, looLusos and docoasod orsons, as
voll as orsons vho ly roason ol unconsciousnoss, nonLal illnoss or sinilar aro unallo Lo givo consonL.
21
Soo, lor oxanlo, GovornnonL Bill 199/98:108 (Regeringens proposition 1997/98.108), . J9, 42 l. and 8J l.
135
Ulril von ssen
inossillo Lo rogulaLo oxacLly Lho roquirononLs ol inlornaLion and consonL in oach
individual caso, luL LhaL Lho sanlo rovidor should alvays lo inlornod alouL `Lho
inLonLion Lo loo a sanlo in a liolanl and Lho uroso lor vhich is shall lo usod`.
22

In Lho lighL ol Lho alorosaid and in roloronco Lo Lho oLhical roviov vhich vill lo
olligaLory lor rosoarch on hunan liological naLorial, iL should lo sullicionL, in ny
oinion, Lo inlorn a aLionL lriolly vhaL a liolanl is and vhaL rulos apply to iL,
roquosLing LhaL Lho aLionL docido Lo oiLhor givo or viLhhold his or hor consonL Lo
sLorago ol Lho sanlo and iLs uso lor Lho urosos ol `rosoarch`. RoquosLing LhaL a
aLionL consonL Lo a socilic rosoarch rojocL is quiLo unroalisLic, sinco iL is raroly
lnovn aL Lho Lino ol Lho sanlo Laling vhich rosoarch rojocL vill lo involvod. Tho
aLionL vill noL lo arLicularly inconvonioncod, sinco oLhical roviov vill havo Lo lo
nado onco Lho rosoarch rojocL is undorvay, and il any conononL ol Lho rosoarch
rojocL soons conLrovorsial Lho Board lor Rosoarch ILhics nay Lhon docido LhaL
consonL nusL lo olLainod again.
CollocLions ol liological naLorial LhaL havo loon gaLhorod rinarily ly
someone else than the health care provider in health care and medical services, lor
oxanlo, a rosoarch insLiLuLo or a harnacouLical conany, do noL cono undor Lho
Biolanls AcL. In Lhoso casos Lho rovisions ol Lho ILhical Roviov AcL aly as
rogards inlornaLion and consonL, luL havo Lho sano inlicaLions as Lho rovisions ol
Lho Biolanls AcL. Ivon in Lhoso casos iL is Lho Board lor Rosoarch ILhics LhaL shall
doLornino Lho roquirononLs Lo aly in rosocL ol inlornaLion alouL and consonL Lo
Lho uso ol Lho naLorial.
As rogards rosoarch onLailing rocossing ol sonsiLivo orsonal daLa, Lho
quosLion ol Lho rosoarch suljocL`s consent novor arisos. Il Lho consonL has loon givon,
rocossing is orniLLod undor Lho rovisions ol Lho Iorsonal IaLa AcL, and an oLhical
roviov ursuanL Lo Lho rovisions ol Lho ILhical Roviov AcL is noL nocossary.
2J
Tho
rosoarchor vill noL nood Lo rovido inlornaLion on Lho rocossing (SocLion 24 ol Lho
Iorsonal IaLa AcL, cl. SocLion 6 ol Lho ILhical Roviov AcL}.
24
Cn Lho oLhor hand,
Lho Board lor Rosoarch ILhics nay lay dovn condiLions concorning inlornaLion in
connocLion viLh Lho oLhical roviov (soo SocLion 4.4}.

3 Access to research material

3.1 Access to biological material
Tho roquirononLs vhich havo Lo lo saLisliod ly a rosoarchor in ordor Lo gain accoss
Lo Lho naLorial sLorod in a liolanl aro dolinod in Cha. 4 ol Lho Biolanls AcL. Tho
orson roquiring accoss Lo Lissuo sanlos has Lo aly lor iL Lo Lho orson rosonsillo
lor Lho lanl in quosLion, vho nay rolor Lho naLLor Lo Lho rincial arLy A rolusal
nay lo roviovod ly Lho NaLional \ollaro Board, luL iLs docision vill consLiLuLo only
a non-linding roconnondaLion,
25
Lho roason loing LhaL no sLaLuLory righL doLorninos
accoss Lo sanlos sLorod in a liolanl, and accordingly a hoalLh caro rovidor is
undor no olligaLion Lo hand ovor Lho sanlos. Tho alorosaid alios Lo liolanls in

22
GovornnonL Bill 2001/02:44 (Regeringens proposition ?001/0?.44), . J8.
2J
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 115.
24
Tho lornulaLion and conLonL ol SocLion 6 ol Lho ILhical Roviov AcL havo loon criLicisod ly Lho
Council on LogislaLion (soo Lho Council`s oinion, . 4 l.}.
25
GovornnonL Bill 2001/02:44 (Regeringens proposition ?001/0?.44), . 49.
136
loLh Lho ullic and rivaLo hoalLh caro socLors. Ior novly croaLod liolanls
socondary liolanls aL rosoarch insLiLuLos or suchlilo, vhich conLain naLorial
gaLhorod lron Lho liolanls ol various hoalLh-caro rovidors, Lhoro is no ossililiLy ol
àoal`, sinco sanlos sLorod in such lanls nay novor lo assod on Lo oLhor
arLios.
26
Tissuo sanlos collocLod rinarily lron ouLsido Lho hoalLh caro socLor, lor
oxanlo ly harnacouLical conanios, aro noL covorod ly Lho rovisions ol Lho
Biolanls AcL and iL is u Lo Lho òvnor` Lo docido vhoLhor and on vhaL condiLions
sanlos nay lo handod ouL. CLhor rulos aly Lo Lissuo sanlos vhich aro Lo lo
handod ovor Lo rociionLs in anoLhor counLry lor Lho urosos ol rosoarch (soo,
Cha. 4, SocLion J ol Lho Biolanls AcL}.
Inloss oLhorviso rovidod, Lissuo sanlos shall noL lo idonLiliallo, i.o. Lhoy
nusL lo coded loloro Lhoy aro roloasod. An alicaLion Lo lroal Lho codo in ordor Lo
gain accoss Lo orsonal daLa concorning an individual sanlo rovidor shall undorgo
Lho sano rocoduro as alicaLions lor accoss Lo sanlos in a liolanl. As nonLionod
oarlior, a rosoarch rojocL including sLudios ol sonsiLivo orsonal daLa shall undorgo
oLhical roviov. Aroval olLainod lron Lho alorosaid noans LhaL Lho rocossing is
ornissillo, luL Lho quosLion ol vhoLhor inlornaLion shall or nay acLually lo
disclosod shall lo docidod on Lho lasis ol Lho rulos concorning socrocy and
conlidonLialiLy (soo SocLion J.2}.

3.2 Access to personal data
SocLion 6 ol Lho ILhical Roviov AcL rovidos LhaL orsonal daLa nay lo disclosod in
ordor Lo lo usod in rosoarch rojocLs unloss oLhorviso indicaLod ly rovisions
concorning socrocy and conlidonLialiLy. IL is inorLanL Lo noLo LhaL Lho rovisions do
noL onLail an olligaLion Lo discloso orsonal inlornaLion. This is oxrossod in Lho
travaux preparatoires in such a vay LhaL Lho rovisions àllov Lho orson in
ossossion ol Lho inlornaLion Lo discloso iL only il ho or sho vishos Lo do so`,
2
,
rovidod iL is noL conLrary Lo Lho rovisions govorning socrocy and conlidonLialiLy.
This sLaLononL doos noL roally rollocL Lho Lruo siLuaLion, locauso a disLincLion has Lo
lo nado loLvoon a siLuaLion in vhich Lho inlornaLion is in Lho ossossion ol a
ullic auLhoriLy, and casos in vhich iL is in Lho ossossion ol a rivaLo suljocL.
Tho righL ol accoss Lo ollicial docunonLs is consLiLuLionally rogulaLod, and
Lho rovisions concorning Lho issuo nay lo lound in Lho Iroodon ol Lho Iross AcL.
Thoso rovisions aly, in rincilo, sololy Lo public (govornnonL or nunicial}
authorities, and noL Lo rivaLo arLios, such as, lor oxanlo, rivaLo hoalLh caro or
rosoarch insLiLuLions. A docunonL is rogardod as ollicial il iL is in Lho ossossion ol a
ullic auLhoriLy and il is has loon rocoivod ly Lho auLhoriLy or dravn u ly iL. Tho
nain rulo is LhaL anylody nay roquosL accoss Lo an ollicial docunonL. Tho righL Lo
Lho alorosaid the principle oj public access to ojjicial documents is rosLricLod,
hovovor, ly noans ol socrocy rovisions. IL nusL lo onhasisod LhaL ullic lodios
havo an uncondiLional duLy ol disclosuro ol ollicial docunonLs vhich aro noL
rosLricLod ly socrocy rovisions. No oquivalonL duLy ol disclosuro ol docunonLs
alios Lo individual arLios, such as, lor oxanlo, rivaLo hoalLh caro insLiLuLions.
28

26
\iLhin Lho lranovorl ol rosoarch co-ooraLion, naLorial nay lo assod on Lo anoLhor rosoarch uniL
lor rosoarch urosos in Svodon or alroad.
2
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 18J.
28
Sono noasuro ol olligaLion Lo discloso inlornaLion lollovs lron Lho rovisions ol SocLion 16 ol Lho
Modical Rocords AcL, luL Lhis olligaLion alios Lo Lho aLionL alono.
137
Ulril von ssen
Tho rovisions ol Lho Socrocy AcL concorning secrecy aro dirocLod, viLh lov
oxcoLions, aL public bodies. Clsorving socrocy noans a rohiliLion Lo discloso
inlornaLion, vhoLhor orally or ly noans ol naling an ollicial docunonL availallo, or
in any oLhor vay. Tho Socrocy AcL has Lhus loon dosignod Lo rogulaLo Lho issuos ol
secrecy and conjidentiality in Lho shoro ol ullic acLiviLios. Socrocy alios noL only
in rolaLion Lo individuals luL also betueen dijjerent authorities and Lo dilloronL shoros
ol acLiviLios viLhin ono and Lho sano auLhoriLy il Lhoy aro considorod as indoondonL
lron ono anoLhor. Tho rincial rulo LhaL socrocy alios loLvoon auLhoriLios is
suljocL, hovovor, Lo nany oxcoLions. Tho nosL inorLanL oxcoLion in Lhis conLoxL
is Lho ono laying dovn LhaL Lho rovisions on socrocy do noL rovonL disclosuro ol
inlornaLion Lo anoLhor auLhoriLy vhon Lho olligaLion Lo rovido inlornaLion lollovs
lron a lav or a sLaLuLory insLrunonL. Such rovisions on olligaLion Lo rovido
inlornaLion can lo lound, lor oxanlo, in Lho nany dilloronL daLa lilo sLaLuLos.
Rogarding certain particular subjects oquivalonL rulos on conlidonLialiLy aly
vhich can lo lound in oLhor sLaLuLos. Concorning rivaLo docLors and Lho lilo, such
rovisions can lo lound in Lho HoalLh and Modical Sorvicos (Irolossional AcLiviLy}
AcL. Thoro aro no sinilar rogulaLions rolaLing Lo a nunlor ol oLhor rivaLo suljocLs,
such as, lor oxanlo, conanios, insLiLuLos and loundaLions, Lhoso can lo lound,
hovovor, ly rohiliLions undor Lho Socrocy AcL, sinco an auLhoriLy sulying a
conlidonLial iLon ol inlornaLion vill sLiulaLo LhaL Lho inlornaLion nay noL lo
assod on or usod in anoLhor vay (Cha. 14, SocLion 9 ol Lho Socrocy AcL}.
Tho oljocLivo ol Lho socrocy lavs is Lo roLocL ullic and rivaLo inLorosLs.
Tho socrocy rovisions havo loon Lhoroloro gonorally lornulaLod in such a vay LhaL a
risl ol harn nusL lo assossod in oach individual caso in connocLion viLh Lhoir
alicaLion. Thoro aro Lvo Lyos ol so-callod harm conditions: `sLraighL` and
`convorso`. Tho lirsL noans LhaL Lho righL ol accoss Lo inlornaLion is Lho nain rulo,
and socrocy alios only il it disclosure uill presumably lead to harm, vhoroas Lho
socond noans LhaL socrocy is Lho nain rulo and alvays alios vhon it is not clear
LhaL Lho inlornaLion can lo disclosod uithout any risl oj harm. Tho laLLor harn
condiLion, i.o. a noro sLricL lorn ol socrocy, alios Lo Lho hoalLh caro socLor and Lo
inlornaLion suly lron corLain auLhoriLios` rogisLors, such as Lho NaLional Board ol
HoalLh and \ollaro, lor urosos ol rosoarch.
Isually, Lho socrocy rovisions aro lornulaLod in such a vay LhaL socrocy is
rosLricLod Lo inlornaLion vhich aoars in a corLain Lyo ol caso, lor oxanlo, viLhin
a corLain shoro ol acLiviLy or a arLicular auLhoriLy. Il an iLon ol inlornaLion is
assod on lron ono auLhoriLy Lo anoLhor, Lho nain rulo is LhaL socrocy rulos
alicallo Lo Lho inlornaLion sulying auLhoriLy (Lho rinary socrocy} do noL
oxLond Lo Lho rocoiving auLhoriLy. \hoLhor a docunonL vill or vill noL locono
suljocL Lo socrocy in Lho rocoiving auLhoriLy doonds on vhoLhor socrocy concorning
inlornaLion disclosuro alios Lo Lhis auLhoriLy or noL. SonoLinos, hovovor, vhon iL
is osocially rovidod secrecy protection is transjerred Lo Lho rocoiving auLhoriLy, vhoro
so-callod socondary socrocy vill aly. Tho casos in vhich such Lranslor is alicallo
aro rogulaLod in Chas. 11 1J ol Lho Socrocy AcL. Socondary socrocy alios, inter
alia, vhon ono auLhoriLy rocoivos conlidonLial inlornaLion lron anoLhor lor Lho
urosos ol rosoarch. AuLhoriLios nay rocoivo such inlornaLion undor sLaLuLory
rovisions or rogulaLions ly sLaLuLory ordor (Cha. 14, SocLion 1 ol Lho Socrocy
AcL}, uon oxonLion lron Lho GovornnonL (Cha. 14, SocLion 8 ol Lho Socrocy
AcL}, or uon harn assossnonL in accordanco viLh sono socrocy rovision, lor
138
oxanlo, ursuanL Lo Cha. , SocLion 1 ol Lho Socrocy AcL (hoalLh caro}. Tho
rovisions on socrocy Lranslor shall noL aly, hovovor, il a socrocy rulo lor Lho
roLocLion ol Lho sano inLorosL is in any caso aliod Lo Lho inlornaLion ly Lho
rocoiving auLhoriLy. Tho rocoiving auLhoriLy shall Lhon acL according Lo iLs ovn
socrocy rovisions, vhich noans LhaL socrocy roLocLion nay locono voalor or
sLrongor Lhan LhaL aliod ly Lho original auLhoriLy sulying Lho inlornaLion.
ConsoquonLly, il a rosoarchor vishos Lo olLain orsonal daLa lron, say, a
nodical lilo or a rogisLor loL ly a public authority, Lho docunonLs conLaining Lho
inlornaLion aro, as a rulo, Lo lo considorod as ollicial docunonLs. Tho roquosL vill
Lhon lo oxaninod ly Lho auLhoriLy, lor oxanlo a ullic hoalLh caro sorvico or a
conLral adninisLraLivo auLhoriLy, in accordanco viLh Lho rovisions ol Lho Socrocy
AcL and Lho Iorsonal IaLa AcL. As sLaLod loloro, ovory rosoarch rojocL vhich
includos Lho rocossing ol sonsiLivo orsonal daLa has Lo undorgo an oLhical roviov.
Aroval noans LhaL rocossing is ornissillo undor Lho Iorsonal IaLa AcL, luL Lho
quosLion ol vhoLhor Lho inlornaLion nay lo disclosod (concorning ullic hoalLh
caro rovidors} vill lo doLorninod on Lho lasis ol Lho Socrocy AcL. Il iL cannoL lo
said viLh corLainLy LhaL Lho inlornaLion nay lo disclosod viLhouL causing harn Lo
Lho individual suljocL, Lho inlornaLion nay noL lo assod on oLhorviso, iL nay. Il
Lho inlornaLion is inLondod lor rosoarch urosos, Lho oxaninaLion vill nosL olLon
load Lo Lho conclusion LhaL Lho inlornaLion nay and shall lo disclosod.
29
A docision
donying a roquosL Lo olLain docunonLs nay lo aoalod in Lho AdninisLraLivo CourL
ol Aoal undor Lho rovisions ol Lho Socrocy AcL.
Il a rosoarchor Lo vhon inlornaLion is sulniLLod vorls lor a ullic
auLhoriLy, lor oxanlo a ullic hoalLh caro rovidor, Lho socrocy rulos ol Lho
sulying auLhoriLy vill acconany Lho inlornaLion, il Lho inlornaLion vould noL
lo conlidonLial undor Lho socrocy rovisions aliod ly Lho rocoiving auLhoriLy.
\haLovor Lho oxacL caso nay lo, in Lho conLoxL ol nodical rosoarch iL is racLically
alvays Lho sLricLor lorn ol socrocy vhich alios. Il Lho rociionL is a rivaLo hoalLh
caro rovidor, Lho inlornaLion vill lo conlidonLial undor Lho HoalLh and Modical
Sorvicos (Irolossional AcLiviLy} AcL. Il Lho rociionL rosoarchor rorosonLs anoLhor
Lyo ol rivaLo suljocL, o.g. a harnacouLical conany, Lho inlornaLion is noL
suljocL Lo any socrocy rovisions Lhoro. Tho sulying auLhoriLy nay nalo a roviso,
hovovor, LhaL Lho inlornaLion nay noL lo assod on Lo anyono olso.
In Lho caso ol private health care providers, nodical lilos and oLhor
docunonLs concorning aLionLs do noL consLiLuLo ollicial docunonLs, vhich is vhy
Lhoso insLiLuLions aro noL olligaLod Lo discloso any inlornaLion doriving lron Lhon.
Thoro is noLhing Lo rovonL disclosuro ol inlornaLion, hovovor, rovidod socrocy
rovisions do noL aly, vhich is soldon Lho caso vhon inlornaLion is roquosLod lor
rosoarch urosos. BuL ovon il a givon hoalLh caro rovidor should docido LhaL
disclosuro ol inlornaLion vould noL causo any harn Lo Lho individual, ho has no
olligaLion Lo discloso inlornaLion, and his docision cannoL lo aoalod againsL.
Il inlornaLion is disclosod ly a rivaLo hoalLh caro rovidor Lo a rosoarchor
vorling in Lho ullic or rivaLo hoalLh caro socLor, Lho inlornaLion vill lo suljocL Lo
socrocy rovisions alicallo in Lho rociionL insLiLuLion. Il Lho inlornaLion is
disclosod Lo rivaLo suljocLs ouLsido Lho hoalLh caro socLor, iL nornally losos iLs

29
Bohlin, All, Cjjentlighet & selretess i myndighets jorslningsverlsamhet (Rilsarlivet, Report 1997.?) .
28 and Cjjentlighetsprincipen, 6Lh od. . 20J l.
139
Ulril von ssen
socrocy roLocLion and Lho sulior ol inlornaLion Lho rivaLo hoalLh caro rovidor
has no ossililiLy ol naling rovisos concorning iLs dissoninaLion.
IL should linally lo addod LhaL Lho rovisions ol Lho Socrocy AcL and Lho
HoalLh and Modical Sorvicos (Irolossional AcLiviLy} AcL lor Lho roLocLion ol Lho
individual`s inLogriLy aro sulononLod ly vhaL aro usually rolorrod Lo as internal
secrecy rulos. Indor Lho rovisions, lor oxanlo, ol SocLion ol Lho Modical Rocords
AcL (1985:562}, nodical docunonLs shall lo handlod and sLorod in such a vay LhaL
no unauLhorisod orsons can gain accoss Lo Lhon. IL is Lhus only Lho orsonnol
acLually nooding accoss Lo a aLionL`s lilos in Lhoir vorl vho shall havo Lho ossililiLy
ol accossing Lho aLionL`s lilos.
J0

4. Review by the Boards for Research Ethics

4.1 The premises on which ethical review is based
Tho rovisions ol SocLions 8-11 ol Lho ILhical Roviov AcL sLiulaLo ronisos lor
oLhical roviov concorning rosoarch onLailing inLrusivo donands on hunan loings or
sLudios ol hunan liological naLorial, or onLailing Lho rocossing ol sonsiLivo orsonal
daLa. Tho rovisions havo loon lornulaLod on Lho lasis ol ArLiclo 16 ol Lho
Iurooan ConvonLion on Hunan RighLs and Bionodicino, vhich in Lurn is
suorLod ly Lho Holsinli IoclaraLion. Tho ain ol an oLhical roviov is Lo docido
vhoLhor Lho rosoarch rojocL as such, including any rocossing ol orsonal daLa, can
lo arovod lron Lho oLhical oinL ol viov. Il Lho Board lor Rosoarch ILhics
arovos Lho rojocL iL nay also doLornino Lho rulos concorning inlornaLion and
consonL. This issuo is LroaLod lolov in socLion 4.4.
Tho roosod logislaLion conLains only corLain gonoral and raLhor vaguo
ronisos as Lo vhaL shall lo Lalon inLo considoraLion in connocLion viLh an oLhical
roviov. This is locauso iL is Lho organisaLion and lorn ol Lho oLhical roviov vhich
havo loon considorod in nood ol rogulaLion. Tho roviov ol Lho sulsLanLivo conLonL
has noL loon lound as suiLallo lor doLailod rogulaLion ly noans ol logislaLion.
J1
Sinco
roviovs ly Lho Boards lor Rosoarch ILhics vill consLiLuLo sLaLuLorily rogulaLod Lasls,
Lhoir luLuro docisions nusL olsorvo Lho rosLricLions ol Lho lranovorl doLorninod ly
Lho sLaLuLory LoxL and Lho inLonLions oxrossod in Lho travaux preparatoires.
Tho lirsL roquirononL LhaL has Lo lo saLisliod is LhaL rosoarch nay lo
arovod only il iL can lo conducLod viLh rosocL lor human dignity (SocLion 8 ol
Lho ILhical Roviov AcL}. This roquirononL is arLly connocLod viLh Lho rovisions ol
SocLion 9 ol Lho sano AcL, roviding LhaL human rights and jundamental jreedoms
shall alvays lo considorod in connocLion viLh oLhical roviovs, aL Lho sano Lino as
rogard shall lo aid Lo Lho dovolononL ol neu insights ly noans ol rosoarch,
oolo`s voll-loing, hovovor, shall alvays lo givon rioriLy ovor socioLy`s noods and
rosoarch inLorosLs. \haL doos Lhis noan Tho travaux preparatoires sLiulaLo only
LhaL roLocLion ol Lho arLicianLs in a rosoarch rojocL is ol najor inorLanco, and
LhaL Lhis concorn lor Lho individual can lo oxrossod in LhaL rosoarch nay lo
arovod only il iL rosocLs hunan digniLy. IL is lurLhor laid dovn LhaL Lhoso inLorosLs
do noL alvays, or ovon lroquonLly, havo Lo lo conLradicLory. Cn nany occasions
rosoarch can lo Lho vory Lhing LhaL losL ronoLos oolo`s inLorosLs. In gonoral, iL is

J0
GovornnonL Bill 1984/85:189 (Regeringens proposition 1984/8.189), . 4J.
J1
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 9J.
140
sLaLod LhaL Lho lalancing ol inLorosLs should lo dono in Lho lighL ol noro gonoral
considoraLions, o.g. LhaL Lho lundanonLal righLs and lroodons shall lo olsorvod in
connocLion viLh rosoarch in Lorns ol a long-Lino orsocLivo and noL only in Lorns
ol dirocL risls incurrod ly Lho arLicianLs. \haL Lhis rolors Lo, lor oxanlo, is
rosoarch LhaL nay onLail gonoLic inlluonco on luLuro gonoraLions. Horo again iL is hold
LhaL Lhoso roquirononLs nay soal loLh lor and againsL rosoarch, sinco oolo`s
vollaro is in gonoral ronoLod ly rosoarch, and sinco lron Lho socioLal oinL ol viov
iL is vory inorLanL Lo croaLo ossililiLios lor Lho advancononL ol lnovlodgo ly
noans ol rosoarch.
J2
NoiLhor Lho ConvonLion on Bionodicino nor Lho Holsinli
IoclaraLion rovido noro rociso guidolinos lor Lho inLorroLaLion ol Lhoso
rovisions.
Tho rovisions rosonLod alovo consLiLuLo in roaliLy a oliLical nanilosLo ol
liniLod logal inorLanco. Tho rovisions can Lhus lo conarod Lo Lhoso ol Lho Social
Sorvicos AcL (2001:45J} sLiulaLing LhaL `Lho social sorvicos shall ronoLo oqualiLy in
Lho oolo`s . living condiLions lor Lho urosos ol donocracy and solidariLy`, or
Lho roquirononLs ol Lho HoalLh and Modical Sorvicos AcL (1982:6J} LhaL hoalLh
caro shall `lo ol good qualiLy and nooL Lho aLionL`s noods ol socuriLy`. Thus no logal
rosLricLions lor Lho aroval ol rosoarch rojocLs aro inosod ly Lhoso rovisions,
oLhor Lhan in oxLrono casos.
Indor Lho rovisions ol SocLion 11 ol Lho ILhical Roviov AcL, a rosoarch
rojocL nay noL lo arovod il Lho oxocLod rosulL can lo achiovod in another uay
uhich is less hazardous to Lho rosoarch suljocL`s hoalLh, socuriLy and orsonal
inLogriLy. Rogarding rocossing ol sonsiLivo orsonal daLa, aroval nay lo granLod
only il Lho rocossing is necessary lor Lho carrying ouL ol Lho rosoarch rojocL. Tho
lirsL hraso in iLalics oxrossos Lho rincilo LhaL rosoarch rolaLing Lo oolo nay lo
conducLod only il no alLornaLivo, oquivalonL noLhods oxisL vhich do noL onLail
oxorinonLs on oolo or vhich aro loss risly. This vill Lhoroloro noL aly Lo
rosoarch on naLorial lron liolanls. Tho roquirononL ol nocossiLy, vhich
corrosonds Lo SocLion 10 ol Lho Iorsonal IaLa AcL, should nornally lo saLisliod in
connocLion viLh Lho rosoarch in quosLion.
SocLion 10 ol Lho ILhical Roviov AcL dolinos social roroquisiLos undor
vhich rosoarch nay lo arovod only il Lho risls onLailod ly iL Lo Lho rosoarch
suljocL`s hoalLh, socuriLy and orsonal inLogriLy aro counLorlalancod ly iLs scientijic
value. This should lo considorod as Lho nosL inorLanL rovision in Lhis conLoxL
JJ
.
Tho AcL orniLs rosoarch suljocLs Lo laco corLain risls, luL Lhoso nusL lo
roorLionaLo Lo scionLilic gain. ILhical roviov rocoods ly Lvo sLagos. IirsL conos
an assossnonL ol vhaL is callod scientijic cogency. This noans LhaL Lho rosoarchor has
Lo lo allo Lo shov LhaL his rosoarch rojocL can gonoraLo voll-sulsLanLiaLod
lnovlodgo. Tho doLorninaLion ol scionLilic cogoncy is ol docisivo inorLanco, sinco
Lho social roroquisiLos nonLionod alovo noan Lho oxocLod value ol lnovlodgo
LhaL nay lo gonoraLod ly Lho rosoarch loing osiLod againsL Lho risl ol harn. As
rogards Lho assessment oj risl, Lho travaux preparatoires sLaLo LhaL iL is in Lho naLuro ol
Lhings LhaL in a nornal caso Lho risls oughL Lo lo rosLricLod. Rogarding Lho
assossnonL ol risl iLsoll, ono has Lo doLornino lirsL Lho oxLonL Lo vhich any nogaLivo
consoquoncos can lo predicted. IncorLainLy concorning harn LhaL nay onsuo is said
Lo consLiLuLo an inorLanL argunonL againsL aroval. NoxL, Lho probability ol

J2
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 90 and 185.
JJ
Cl. Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 91.
141
Ulril von ssen
idonLiliallo nogaLivo consoquoncos nusL lo doLorninod. Iinally, Lho degree ol
inconvonionco or harn LhaL Lhoso consoquoncos nay onLail Lo oolo vho
arLiciaLo in or aro in sono oLhor vay involvod in Lho rosoarch shall lo osLallishod.
J4

4.2 Review of research concerning studies of biological material
As rogards rosoarch on naLorial lron biobanls, Lho rosoarchor has Lo shov, as has
loon dononsLraLod in Lho rovious socLion, LhaL Lho rosoarch rojocL saLislios Lho
nocossary condiLions lor Lho gonoraLion ol inorLanL nov insighLs. Il Lhis is Lho caso,
Lho rojocL should lo arovod lron Lho oLhical oinL ol viov, sinco only in
oxLronoly oxcoLional casos vill a risl ol harn ariso in Lho logal sonso. Rosoarch ol
Lhis lind doos noL onLail any hysical inLrusion on hunan loings and Lhoro is no risl
ol sychological harn involvod. Tho only Lyo ol harn LhaL nay locono rolovanL is
violation oj personal integrity. As nonLionod oarlior, Lissuo sanlos dolivorod ly a
liolanl shall as a rulo lo codod. Il Lhoy aro noL, or il Lho codo nay lo allovod Lo lo
lrolon laLor on, Lho Board lor Rosoarch ILhics vill also havo Lo carry ouL an oLhical
roviov ol Lho rosoarch rojocL, including Lho rocossing ol sonsiLivo daLa (soo lolov}.
Sinco Lho naLorial in connocLion viLh ùro` liolanl rosoarch, i.o. rosoarch vhich
doos noL involvo orsonal daLa, cannoL lo associaLod viLh any individual orsons,
Lhoro is no risl ol Lhoir inLogriLy loing violaLod.
J5

Tho noaning ol Lho Lorn integrity has noL loon dolinod in Lho sLaLuLo or Lho
travaux preparatoires, and Lho Lorn Lalos on dilloronL noanings in dilloronL conLoxLs
and sLaLuLos. Argually, Lhon, rosoarch on naLorial vhich has loon sulniLLod ly
orsons vho havo noL givon Lhoir consonL Lo a socilic rojocL alroady consLiLuLos a
violaLion ol inLogriLy. IL has noL loon Lho logislaLor`s inLonLion, hovovor, Lo givo Lho
Lorn Lhis inLorroLaLion,
J6
and Lhis should also lo cloar lron Lho lacL LhaL no oLhical
roviov undor Lho rovisions ol Lho ILhical Roviov AcL is nocossary il liological
naLorial cannoL lo linlod viLh an individual orson.
J
Il such a viov should
novorLholoss lo Lalon, Lho alovo-doscrilod araisal oughL Lo dononsLraLo LhaL
rosoarch should lo orniLLod as long as iL has Lho oLonLial lor incroasing our
lnovlodgo. IrodicLally, Lhoro is a risl horo ol sono individuals looling LhaL Lho
rosoarch can lo rojudicial Lo Lhoir inLogriLy. Indood, Lhoso orsons nay ossilly lind
Lho rosoarch ollonsivo. Tho dogroo ol Lhis inconvonionco nusL lo Lornod lairly
liniLod, hovovor, sinco daLa lron a liolanl cannoL lo linlod Lo any arLicular
individual.
Tho conclusion nusL lo LhaL rosoarch on naLorial lron liolanls is nornally
oLhically accoLallo lor Lho urosos ol Lho ILhical Roviov AcL. IxcoLions vill
rolor Lo casos vhon Lho rosoarchor cannoL shov LhaL his or hor rosoarch rojocL has
any scionLilic valuo, and casos vhoro Lho rosoarch as such can lo said Lo oxross a
viov ol oolo vhich is inconaLillo viLh Lho viovs and aLLiLudos rovailing in our
socioLy.

J4
Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion (Lagrdsremiss ?00?), . 91. Cl.
Modical Rosoarch Council`s RoorL, MIR roorL, 2/200, . 1J l., lasod on Lho Holsinli IoclaraLion.
J5
AgainsL Lhis viov iL can lo sLaLod LhaL hunan naLorial conLaining INA vhich is inLacL is alvays, in
rincilo, Lracoallo lacl Lo Lho rovidor. In ny oinion iL is noL onough, hovovor, aL loasL aL rosonL,
Lo clain LhaL locauso ol Lhis Lhoro is a risl ol inLogriLy danago.
J6
J
142
4.3 Review of research entailing processing of sensitive personal data
As rogards Lho uso ol sensitive personal data, Lho valuo ol Lho rosoarch nusL lo
voighod againsL Lho risl vhich iL onLails. As a rulo, accoss Lo orsonal daLa lays an
inorLanL rolo in Lho gonoraLion ol nov, valuallo lnovlodgo in Lho courso ol
rosoarch. IoLorninaLion ol risl should olviously lo orlornod on Lho lasis ol Lho
alovo-doscrilod rulos, and addiLionally, Lho rovisions LhaL unLil Lho coning inLo
lorco ol Lho ILhical Roviov AcL lollov lron SocLion 19 ol Lho Iorsonal IaLa AcL.
J8

Tho travaux preparatoires ol Lhis socLion sLiulaLo LhaL vhon conaring Lho rosoarch
rojocL`s inorLanco and Lho risl ol violaLion ol orsonal inLogriLy, Lho rocossing
security shall lo Lalon inLo accounL, Lho expense and time nocossary Lo olLain consonL,
and, Lo a corLain oxLonL, Lho dogroo ol dilliculLy involvod il sonoono should aLLonL
Lo identijy individual orsons on Lho lasis ol Lho orsonal daLa undorgoing rocossing.
IL shall lurLhor lo considorod vhoLhor inlornaLion is lorvardod in any lorn Lo Lho
orsons in quosLion, lor oxanlo ly advorLising or noLilicaLion, and vhoLhor Lho
orson vho so roquosLs has Lho righL Lo lo oxcludod.
J9

\hon doLornining Lho risl undor Lho ILhical Roviov AcL, ono nusL lirsL
doLornino Lho predictability ol any ossillo nogaLivo consoquoncos. This should noL
rosonL any najor rollons, sinco Lho risl usually consisLs ònly` in Lho ossililiLy ol
individuals loing ollondod ly inlornaLion alouL Lhon having loon usod in a rojocL.
Moroovor, Lho lilelihood ol Lhis haoning shall lo assossod, i.o. vhoLhor individual
sanlo rovidors nay roally lool LhaL Lhoir inLogriLy has loon violaLod. IL is hardly
ossillo Lo gonoraliso on Lhis issuo, hinging as iL doos arLly on hov inorLanL Lho
orsons in quosLion considor Lho rojocL Lo lo, and arLly on Lho Lyos ol daLa vhich
aro Lo lo rocossod. Il Lho inlornaLion rolors Lo alorLion or drug aluso, Lho
lilolihood ol a orson looling ollondod vill lo groaLor Lhan il Lho inlornaLion
concorns allorgios, child disoasos or oxorciso rouLinos. Iinally, Lho degree ol
inconvonionco or harn onLailod ly Lho rocossing shall lo osLinaLod.
As rogards Lho dogroo ol Lho oxocLod violaLion ol orsonal inLogriLy
vhich is Lho inorLanL issuo in Lhis conLoxL iL nusL lo onhasisod LhaL Lho
individual`s orcoLion cannoL lo vholly docisivo, and LhaL a noro oljocLivo
assossnonL has Lo lo nado. In oLhor vords, an individual has no `righL` Lo considor
jusL anyLhing as a sorious violaLion ol his or hor orsonal inLogriLy. Socrocy logislaLion
nornally sLiulaLos LhaL inlornaLion alouL an individual nay only lo disclosod il Lhis
is noL doLrinonLal or harnlul Lo Lho individual. Tho individual`s orcoLion ol such
doLrinonL consLiLuLos an indicaLion ol vhoLhor Lho inlornaLion is Lo lo rogardod as
sonsiLivo or noL, luL Lhoso in ossossion ol Lho inlornaLion aro noL lound ly iL, and
havo Lo nalo Lhoir ovn assossnonL as Lo vhoLhor disclosuro ol Lho inlornaLion shall
lo rogardod as doLrinonLal Lo Lho orson in quosLion.
40
Tho oquivalonL aroach
oughL Lo lo alicallo Lo Lho roviov undor discussion.
Tho alsoluLoly docisivo lacLor viLh rogard Lo Lho doLorninaLion ol Lho
dogroo ol violaLion ol orsonal inLogriLy nusL lo Lho issuo ol vho nay gain accoss Lo
Lho inlornaLion. Tho loy issuo Lhoroloro concorns socuriLy in connocLion viLh Lho
rocossing ol daLa. Iron Lho oinL ol viov ol orsonal inLogriLy Lhoro nusL lo a
considorallo dilloronco il only a rosLricLod nunlor ol rosoarchors havo accoss Lo Lho

J8
J9
40
Soo, lor oxanlo, JC 1982/8J, . 22 (Lho IarlianonLary Cnludsnan} and Bohlin, All,
Cjjentlighetsprincipen, 6Lh od., . 18.
143
Ulril von ssen
daLa, conarod viLh Lho siLuaLion in vhich oLhor arLios, such as onloyors or
insuranco conanios, nay also gain accoss Lo iL.
41
Tho oxLonL Lo vhich dilloronL
arLios nay accoss inlornaLion is rogulaLod, as doscrilod in socLion J.2, ly socrocy
logislaLion. Tho socrocy rovisions lay usually a docisivo rolo in Lhis Lyo ol
docisions. In Lho travaux preparatoires concorning Lho rogulaLion ol nodical daLa lilos
and hosiLal rocords, iL is sLaLod LhaL orsonal inLogriLy cannoL lo rogardod as an
alsoluLo criLorion in Lho sonso ol roLocLivo rogulaLions alying viLhouL oxcoLion
or irrosocLivo ol conllicLing inLorosLs. InsLoad, saloguards nusL lo croaLod againsL
acLiviLios LhaL nay lo judgod Lo consLiLuLo inlringononL ol orsonal inLogriLy.
IroLocLion againsL such inlringononLs is rovidod ly noans ol Lho rovisions on
socrocy.
42
\iLh rogard Lo nodical lilos and hosiLal rocords, Lho rovisions ol Lho
Socrocy AcL (and Lho HoalLh and Modical Sorvicos (Irolossional AcLiviLy} AcL},
LogoLhor viLh Lho rovisions ol Lho Modical Rocords AcL concorning inLornal socrocy,
aro LhoughL Lo rovido sullicionL and voll-considorod roLocLion lor
individuals.
4J
Thoro aro good roasons lor alying Lho sano viov Lo Lho caso undor
discussion.
44

Tho discussion alovo indicaLos LhaL il Lho rincial rosoarch rorosonLaLivo
is a public authority, socrocy vill aly Lo Lho inlornaLion in Lho auLhoriLy`s
ossossion concorning individuals. Ivon Lhough Lho socrocy rovisions do noL inly
any uncondiLional rohiliLion Lo discloso inlornaLion, oxaninaLion ol inLogriLy
danago vill, as a rulo, rosulL in iLs non-disclosuro. Sinco orsonal daLa vhich has
loon olLainod and rocossod lor Lho urosos ol rosoarch cannoL in racLico lo
assod on, Lho degree oj personal integrity violation oughL Lo lo considorod as
nodoraLoly rosLricLod. Irovidod LhaL a rosoarch rojocL can lo considorod caallo ol
lurLhoring Lho advancononL ol lnovlodgo, alicaLion ol Lho rovisions ol Lho
ILhical Roviov AcL should nornally load Lo Lho aroval ol Lho rosoarch rojocL
lron Lho oLhical oinL ol viov.
Il insLoad Lho orsonal daLa is in Lho ossossion ol an individual subject, lor
oxanlo, a harnacouLical conany, a rosoarch insLiLuLo or an individual rosoarchor,
no socrocy rovisions aly as a rulo. Il Lho daLa conos lron a ullic auLhoriLy, o.g.
a ullic hoalLh caro insLiLuLion, a rosorvaLion nay lo inosod, sLiulaLing LhaL Lho
inlornaLion nay noL lo assod on (Cha. 14, SocLion 9 ol Lho Socrocy AcL},
vhorouon socrocy vill also aly Lo Lho rivaLo suljocL`s acLiviLios. Such
rosorvaLions aro also assunod Lo lo rogularly inosod vhon individual rosoarchors
roquosL inlornaLion lron nodical daLa lilos.
45
IL should lo noLod LhaL a Board lor
Rosoarch ILhics cannoL inlluonco Lho docision as Lo Lho lorogoing. Cn Lho oLhor
hand, Lho Board lor Rosoarch ILhics nay lay dovn a condition in connocLion viLh iLs
ovn oLhical roviov undor Lho ILhical Roviov AcL, sLiulaLing LhaL no orsonal daLa
shall lo disclosod. Sinco Lho oLhical roviov nusL lo nado loloro Lho rosoarch
connoncos, Lho Board lor Rosoarch ILhics cannoL lnov lor suro LhaL such a roviso
vill lo nado. IL is Lhoroloro jusLiliallo lor Lho Boards lor Rosoarch ILhics Lo rohiliL
dissoninaLion ol Lho inlornaLion as a naLLor ol courso, ly inosing such condiLions.
Il Lhis is indood dono, Lho degree oj violation oj personal integrity can lo considorod

41
Cl. GovornnonL Bill 199/98:108 (Regeringens proposition 1997/98.108), . 48.
42
GovornnonL Bill 199/98:108 (Regeringens proposition 1997/98.108), . 2 and 4.
4J
44
Cl. GovornnonL Bill 199/98:44 (Regeringens proposition 1997/98.44), . 69.
45
144
lairly snall, ovon as rogards rosoarch in rivaLo hands, and Lhoroloro also as
accoLallo lron Lho oinL ol viov ol Lho ILhical Roviov AcL.
IL should lo addod LhaL usually a largo nunlor ol individuals aro includod in
such sLudios, and LhaL rosoarchors aro nornally inLorosLod in Lhoir suljocLs as
nonlors ol a corLain grou, noL as rivaLo individuals. As nonLionod oarlior, Lho
ossililiLy ol idonLilicaLion is sonoLhing vhich, in accordanco viLh Lho travaux
preparatoires, can lo Lalon inLo considoraLion vhon doLornining vhoLhor a givon
rosoarch rojocL shall lo arovod or noL, vhich should nornally soal in lavour ol
aroval in casos nov undor discussion.

4.4 The requirement of information and consent
As nonLionod oarlior, a Board lor Rosoarch ILhics has Lo docido Lho rulos LhaL shall
aly in rosocL ol inlornaLion and consonL. Tho logislaLor has Lhus onLrusLod Lho
Boards viLh Lho Lasl ol vorling ouL suiLallo racLico in Lhis rosocL. IL nusL lo
noLod LhaL Lho Boards lor Rosoarch ILhics nay lay dovn roquirononLs concorning
consonL in rosocL ol rosoarch on liological naLorial only, and noL as rogards rosoarch
onLailing rocossing ol sonsiLivo orsonal daLa lor vhich consonL is noL roquirod.
46

\hon oxanining Lho laLLor, Lho Board nusL only docido vhoLhor Lho rosoarch
rojocL and Lho rocossing ol daLa shall lo arovod or noL, and il aroval is givon,
vhoLhor any roquirononLs shall lo lornulaLod rogarding inlornaLion. Sinco such
rosoarch rojocLs olLon onLail loLh sLudios ol liological naLorial and rocossing ol
orsonal daLa, Lhoso docisions nusL lroquonLly lo Lalon in conjuncLion viLh ono
anoLhor.
IL is inorLanL Lo rononlor Lho lasic roniso ol Lho Biolanls AcL, as voll
as Lho Iorsonal IaLa AcL and Lho ILhical Roviov AcL, sLiulaLing LhaL inorLanL
rosoarch shall not be hampered ly noans ol sLaLuLory rovisions. Tho travaux
preparatoires ol Lho Biolanls AcL sLiulaLo LhaL Lho idoa lohind Lho rulo in quosLion
is LhaL Lho Board lor Rosoarch ILhics shall lo allo Lo nalo doviaLions lron Lho
lundanonLal rincilo roquiring LhaL Lho orsons concornod nusL givo inlornod
consonL. IL shall Lhoroloro lo ossillo also in Lho luLuro, nuch Lho sano as iL is
Loday,
4
Lo rovido inlornaLion in social siLuaLions ly noLico, alying Lho so-callod
oL-ouL rincilo, on Lho assunLion LhaL consonL has loon givon, as long as Lho
arLy concornod givon no indicaLion Lo Lho conLrary.
48

\hon do such `social siLuaLions` aly This quosLion is inorLanL, sinco
ono ol Lho groaL advanLagos ol rosoarch on naLorial lron liolanls is LhaL Lho
rosoarchor gains accoss Lo largo grous ol aLionLs vhich havo loon lollovod u lor a
long Lino, and vhoro Lho orconLago ol droouL casos is vory snall. Il a rosoarchor is
roquirod Lo olLain consonL lron Lho orsons allocLod, his accoss Lo rolovanL naLorial
vill corLainly lo consLricLod Lo a signilicanL dogroo, as a rosulL ol vhich Lho rosoarch
rosulLs vill noL lo oqually voll sulsLanLiaLod, or, aL vorsL, nay lo nisloading. Tho
valuo ol Lho rosoarch vill Lhoroloro soriously dininish il consonL is roquirod in oLhor
Lhan jusL oxcoLional casos. \haL is noro, il consonL has Lo lo olLainod, or, as
sLiulaLod in Lho travaux preparatoires ol Lho Iorsonal IaLa AcL,
49
il noro individual

46
4
48
Soo MIR RoorL 2/2000, . 86.
49
145
Ulril von ssen
inlornaLion has Lo lo givon, Lhis can inoso an unroasonally hoavy, and in corLain
casos rohiliLivo vorlload on Lho rosoarch rorosonLaLivo.
50

Tho only lacLor LhaL should lo Lalon inLo accounL horo is orsonal inLogriLy.
As nonLionod oarlior, a risl ol violaLion ol orsonal inLogriLy vill ariso only vhon
rosoarch also onLails rocossing ol orsonal daLa, luL lor Lhis acLiviLy consonL should
noL lo roquirod. As Lransiros lron Lho oarlior socLions, rosoarch vill nornally lo
conducLod on liological naLorial Lo vhich orsonal daLa nay lo linlod in siLuaLions
vhoro iL is oLhically accoLallo viLh rogard Lo Lho sLricL conlidonLialiLy rovisions
surrounding such rosoarch acLiviLios. In Lhoso casos Lhoro is no roason Lo roquosL
consonL. Nor is Lhoro any roason Lo inoso sLricLor roquirononLs on inlornaLion in
Lhoso casos, oxcoL LhaL iL lo rovidod in a noro gonoral lorn, o.g. in lrochuro lorn
or Lhrough Lho nass nodia. Moro individual inlornaLion or consonL lron orsons
concornod should lo roquosLod only in Lhoso social circunsLancos vhon Lho
rosoarch rojocL iLsoll is conLrovorsial in sono rosocL, and Lho adoquacy ol Lho
oxisLing logal rulos concorning socrocy in ordor Lo roLocL Lho orsonal inLogriLy can
Lhoroloro lo callod inLo quosLion. This concorns casos in vhich, dosiLo Lho saloLy
noasuros involvod, iL is noL cloar LhaL Lho lalancing ol scionLilic valuo and risl vill
load Lo aroval ol Lho rosoarch rojocL.

50
Cl. also GovornnonL Bill 199/98:108 (Regeringens proposition 1997/98.108), . 82.
146
References

Bohlin, All (199}. Cjjentlighet & selretess i myndighets jorslningsverlsamhet (198}.
(RilsarlivoL, RaorL 199:2}. SLoclholn.

Bohlin, All (2001}. Cjjentlighetsprincipen. 6 ul. SLoclholn: NorsLodLs juridil.

IirocLivo 95/46/IC ol Lho Iurooan IarlianonL and Lho Council ol 24 CcLolor 1995 on the
protection oj individuals uith regard to the processing oj personal data and on the jree movement
oj such data. (1995}.

von Isson, Ilril (2002}. Liobanls och Registerjorslning. IrvalLningsraLLslig LidslrilL, halLo
5-6, 2002, . J51-J80.

uropean Convention on Human Rights and Liomedicine IIR/JIR (96} 14.

Halso och sjulvrdslag (198?.7oJ) (HoalLh and Modical Sorvicos AcL} (1982}.

lntegritet Cjjentlighet lnjormationstelnil (199}. SLoclholn: IriLzos (SCI 199:J9}.

JC (IarlianonLary Cnludsnan} 1982/8J . 22.

Lag om biobanler i halso och sjulvrden m.m. (?00?.?97) ( Biolanls (HoalLh Caro}
AcL} (2002}.

Lag om halsodataregister (1998.4J) (HoalLh IaLa RogisLors AcL} (1998}.

Lag om yrlesverlsamhet p halso och sjulvrdens omrde (1998.J1) (HoalLh and Modical
Sorvicos (Irolossional AcLiviLy} AcL} (1998}.

Lag om tgarder i jorslnings eller behandlingssyjte med bejrultade agg jrn mannisla
(1991.11) (IorLilisod Hunan Cva (Moasuros lor Rosoarch and TroaLnonL Iurosos} AcL}
(1991}.

Lagrdsroniss (2002}. tilprvning av jorslning som avser mannislor den ?8 jebruari ?00?
(Iroosal rolorrod Lo Lho Council on LogislaLion lor considoraLion}. SLoclholn.

Modicinsla lorslningsrdoL (2000}. Riltlinjer jr etisl vardering av medicinsl humanjorslning
(MIR raorL 2/2000}. SLoclholn.

atientjournallag (198.o?) (Modical Rocords AcL} (1985}.

ersonuppgijtslag (1998.?04) (Iorsonal IaLa AcL} (1998}.

RadoLzli, Marcus, RadoLzli, Marian & JuLh, Nillas (2002}. Att nyttja genetisl injormation.
SLoclholn: SNS lrlag

Regeringens proposition ?00?/0J.J0 tilprvning av jorslning. (200J} SLoclholn.

Regeringens proposition 1984/8.189 om patientjournallag m.m. (1985} SLoclholn.

Regeringens proposition 1997/98.44 ersonuppgijtslag. (199} SLoclholn
147
Ulril von ssen

Regeringens proposition 1997/98.108 Halsodata och vrdregister. (1998} SLoclholn.

Regeringens proposition ?001/0?.44 Liobanler inom halso och sjulvrdon n.n. (2001}
SLoclholn.

Rynning, IlisaloLh (1998}. Liobanlerna hg tid jr banlinspeltion` IrvalLningsraLLslig
LidslrilL, halLo 6, 1998, . J0J-JJJ.

Samhallets grundlaggande injormation lnventering, Analys (2000}. SLoclholn: IriLzos (Is
2000:J4}.

Selretesslag (1980.100) (Socrocy AcL} (1980}.

Socialtjanstlag (?001.4J) (Social Sorvicos AcL}

Trycljrihetsjrordning (1949.10) (Iroodon ol Lho Iross AcL} (1949}.

\orld Modical AssociaLion. Helsinli Declaration (1964}.

Cnan, Sron & Lindllon, Hans-Clol (2001}. ersonuppgijtslagen. 2 ul. SLoclholn:
NorsLodLs juridil.
148
A Suedish standard jor injormation and consent procedures in biobanl research

7

A Swedish standard for information and consent
procedures in biobank research

Cert Helgesson, hD


The Suedish Liobanls Act jorbids the storage oj human biological samples in biobanls
uithout the patients' injormed consent. This paper suggests a Suedish standard jor in
jormed consent procedures concerning storage and use oj biobanl samples, and argues that
the suggested procedures are recommendable jrom an ethical perspective.

1. Introduction

Indor Lho Svodish Biolanls AcL, vhich onLorod inLo lorco on January 1 200J, iL is
no longor ornissillo Lo sLoro hunan liological sanlos in liolanls viLhouL rior
inlornod consonL lron Lho aLionLs.
1
Tho AcL calls lor nov liolanl inlornaLion
rouLinos and Lho rogisLraLion ol aLionLs` consonL aL hosiLals and caro conLros. Thoso
rouLinos havo Lo nooL loLh logal and oLhical roquirononLs.
In Lhis aor, I suggosL inlornod consonL rocoduros LhaL nooL Lhoso
roquirononLs in a vay vhich is saLislacLory in Lorns ol Lho inLogriLy inLorosLs ol
aLionLs, Lho aliliLy ol Lho Svodish hoalLh caro sysLon Lo rovido high-qualiLy caro,
and rosoarch inLorosLs ol socioLy aL largo, vhilo loing logally accoLallo and
sullicionLly dovn-Lo-oarLh Lo lo racLically loasillo.
A doscriLion ol liolanls and Lho inlornaLion Liod Lo Lhon is givon in
socLion 2 ol Lhis aor, Lho noaning ol inlornod consonL" is discussod in socLion J,
and Lho quosLion ol vhaL valuos aro aL sLalo is addrossod in socLion 4. Tho lind ol
liolanl inlornaLion Lo lo givon Lo oLonLial donors is suggosLod in socLion 5, vhilo
inlornod consonL rocoduros lor liolanling, lasod on Lho valuo considoraLions, aro
rosonLod in socLion 6. Iinally, argunonLs againsL Lho suggosLod rocoduros aro
discussod in socLion .

2. Biobanks and information on individuals
2

Biolanls conLain hunan liological sanlos in various lorns lor oxanlo, vholo
organs, Lunours, arLs ol Lissuos, llood, lasna, colls, INA, or RNA. Tho sLorago

1
Cha. J, SocLion 1 ol Lho Biolanls AcL.
2
I an graLolul Lo Magnus Kaijsor lor hollul connonLs and suggosLions lor Lhis socLion.
149
Cert Helgesson
Lochniquos vary: sanlos nay, lor insLanco, lo sLorod in lroozors or in arallin
llocls, on nicroscoo slidos, or in LosL Lulos.
A vasL najoriLy ol Lho sanlos in Svodish hosiLal liolanls havo loon
collocLod lor diagnosLic urosos, such as cancor scrooning and sorological
oxaninaLions. AarL lron Lhis, sanlos aro collocLod lor naing", lor insLanco ol
oLonLial narrov donors, and lor luLuro clinical urosos. Cno oxanlo ol Lho laLLor
is vhon aLionLs on LranslanL vaiLing lisLs donaLo sorun Lo lo usod lor LosLing
againsL oLonLial organ donors. Iinally, a snall ninoriLy ol Lho liolanl sanlos aro
collocLod oxclusivoly lor rosoarch urosos.
J

Through Lho uso ol sanlos rosorvod in liolanls, a varioLy ol inlornaLion
can lo olLainod, ranging lron curronL and rovious inlocLion sLaLus and llood
cholosLorol lovols, Lo inlornaLion alouL Lho gonoLic codo. This inlornaLion is
rinarily usod in clinical racLico, lor oxanlo in cancor Lhoray, vhoro Lho choico
ol LroaLnonL olLon doonds on vhoLhor Lho cancor is a rolaso or is dovolood do
novo. Ior aLionLs dovoloing cancor a socond Lino, conarisons viLh roviously
collocLod Lunour naLorial aro Lhus ossonLial.
Biolanls havo also rovod Lo lo a valuallo Lool in nodical rosoarch. Ior
oxanlo, rosorvod naLorial lron scrooning lor corvical cancor has loon usod Lo
osLallish Lho oLiological rolo ol hunan aillona virus. In Lho soarch lor disoaso-
causing agonLs such as virusos, lacLoria, or onvironnonLal oxosuro, lor insLanco, Lo
load, cadniun, and osLicidos, llood sanlos collocLod long loloro onsoL ol Lho
disoaso aro olLon insLrunonLal.
To lo usolul lor rosoarch, inlornaLion lron liolanls olLon has Lo lo
conlinod viLh oLhor inlornaLion, such as disoaso sLaLus or oxosuro inlornaLion.
4

To assoss vhoLhor high lovols ol cholosLorol incroaso Lho risl lor ischaonic hoarL
disoaso, a llood sanlo analysis is noL sullicionL. No quosLions can lo ansvorod
viLhouL lnoving vhoLhor Lho aLionL dovolood hoarL disoaso or noL. Sinco a varioLy
ol lacLors, such as sox, ago, and snoling, can allocL loLh cholosLorol lovols and risl
ol hoarL disoaso, Lhis inlornaLion nay also lo noodod. Thus, sono liolanl rosoarch
conLains oLhor inlornaLion Lhan LhaL oxLracLod lron Lho liolanl sanlos
Lhonsolvos. This oLhor" inlornaLion is noL arL ol Lho liolanl, as dolinod in Lho
Biolanls AcL, luL iL nay lo rolovanL vhon consonL is Lo lo olLainod.
A nunlor ol rocauLions aro Lalon Lo rovonL inlornaLion on aLionLs and
rosoarch suljocLs lron goLLing inLo Lho vrong hands, lor oxanlo coding ol Lho
liolanl sanlos and sLricL liniLaLion ol accoss Lo Lhoso sanlos and Lo Lho codo
loys. This is also sLiulaLod ly Lho Biolanls AcL.
5
Iorsonal daLa is roLocLod undor
Lho Iorsonal IaLa AcL and Lho Socrocy AcL.
I Lill nov, sanlos in liolanls havo nainly loon collocLod viLhouL
inlorning aLionLs LhaL Lhoy vill lo sLorod, nor havo aLionLs consonLod Lo Lho
sLorago (sanlos collocLod lor rosoarch loing Lho oxcoLion}. Tho Biolanls AcL
changos Lhis. A sanlo can no longor lo sLorod in a liolanl viLhouL Lho donor`s
inlornod consonL.

J
Kaijsor (200J}. Ior doLailod roloroncos Lo Lho clinical uso ol hunan liological naLorial, soo Lindlorg
(200J}.
4
A nunlor ol oxanlos ol liolanl rosoarch aro rosonLod in Kaijsor (200J}.
5
Cha. 4, SocLion 4 ol Lho Biolanls AcL.
150
3. Informed consent

To consonL Lo sonoLhing noans Lo givo assonL or aroval, Lo agroo Lo sonoLhing and
Lo conly viLh iL. ConsonL is an agroononL as Lo acLion (or oinion}, or an aroval
ol vhaL is dono or roosod.
6

As is olLon oinLod ouL, Lo lo allo Lo givo inlornod consonL a orson nusL
havo a corLain conoLonco. IurLhor, ho or sho nusL undorsLand vhaL Lho consonL is
alouL.

ConsonL is ol liLLlo noral rolovanco il iL is noL sullicionLly inlornod. Ior
oxanlo, il I agroo Lo Lalo arL in an oxorinonL, and Lho rosoarchor doos noL inlorn
no LhaL I an vory liloly Lo goL hurL in iL, luL on Lho conLrary roLonds LhaL ny
arLiciaLion vill lring no groaL orsonal lonoliLs, Lhon I havo loon docoivod. ThaL I
havo consonLod is losido Lho oinL, sinco I havo noL consonLod Lo vhaL acLually Lalos
laco luL Lo vhaL I vas nisloadingly inlornod vould Lalo laco. Sincoro and voll-
inlornod consonL, on Lho oLhor hand, is norally rolovanL, sinco iL noans LhaL Lho
orson consonLing has had a say on Lho issuo aL hand and Lhus has oxorcisod his or
hor auLonony. Moro socilically, Lho orson giving inlornod consonL noans LhaL ho
or sho agroos Lo Lho acLion Lalon, vhaLovor roasons ho or sho nay havo lor doing so.
8

Boing voll-inlornod horo noans having rolovanL and sullicionL inlornaLion
alouL LhaL vhich ono is alouL Lo consonL Lo. Much ol Lho inlornaLion alouL Lho
acLion aL hand nay lo irrolovanL Lo Lho consonL, vhilo sono ol iL is noL. Ior
oxanlo, il I considor loLLing a lriond lorrov ny car Lo do sono grocory shoing,
Lhon I do noL nood Lo lnov vhaL lrand ol coroals ho vill luy, or vhoLhor ho is going
Lo luy LonaLoos, cucunlors, or loLh. BuL I do nood Lo lnov vhoLhor ho is going Lo
drivo carolully and nalo suro LhaL Lho car is roLurnod in good condiLion.
\haL is sullicionL inlornaLion in a corLain siLuaLion is noL alvays cloar, noL
loasL locauso dilloronL orsons nay havo dilloronL viovs in Lho naLLor. \haL is
sullicionL inlornaLion lor ono orson nay lo lar lron sullicionL lor anoLhor. A
racLical consoquonco ol Lhis lor consonL rouLinos concorning liolanls is LhaL
aLionLs and rosoarch suljocLs should lo givon Lho oorLuniLy Lo asl quosLions
ossilly going loyond Lho inlornaLion LhaL is givon Lo ovoryono. To allov lor Lhis is
Lo shov rosocL lor individual dilloroncos.
Inlornod consonL, in Lho conLoxL ol liolanls, concorns a rocoss in vhich a
oLonLial sanlo donor goLs Lho rolovanL inlornaLion and docidos vhoLhor or noL Lo
auLhoriso sLorago and various usos ol Lho sanlo, lasod on LhaL inlornaLion and his
or hor ovn valuos.
9

6
Soo o.g. Longnan IicLionary and Tho Cxlord Thosaurus.
Soo, lor insLanco, Iadon & Boauchan (1986}, . 28294, on conoLonco. ChaLor 9 is nainly
dovoLod Lo a discussion ol undorsLanding. Cn . 155, Lho rincilos ol Lho Nuronlorg Codo aro
discussod. Tho lirsL rincilo ol Lho codo sLaLos LhaL consonL nusL lo volunLary, conoLonL, inlornod,
and conrohonding.
8
Sono ol Lho conloxiLios ol inlornod consonL aro disrogardod horo. Ior a lullor accounL, soo o.g.
Brocl (199J}, Iadon & Boauchan (1986}.
9
Cl. Irilsson (2001}, . 4445.
151
Cert Helgesson
4. Values at stake

\haL valuos aro aL sLalo viLh liolanls Cloarly Lhoro aro loLh osiLivo and nogaLivo
valuos involvod. Tho osiLivo valuos sLon lron Lho usolulnoss ol liolanls lor
diagnosLic, oLhor nodical, and rosoarch urosos. Biolanls havo loon usod lor diag-
nosLic urosos lor nany yoars, and Lho raid dovolononL ol lionodical rosoarch
Lochniquos has incroasod rosoarch inLorosL in liolanl naLorial. Biolanls aro alroady
nov loing usod lor rosoarch, luL a considorallo incroaso in Lhoso acLiviLios can lo
oxocLod. This is liloly Lo load Lo nov lnovlodgo concorning hunan hoalLh and
disoasos, vhich in Lurn nay load Lo nov vays ol inroving hoalLh caro.
Thus, dovolononLs in roconL yoars insiro hoos ol considorallo rogross.
BuL Lhoy also lring loars LhaL Lho nov oorLuniLios, noL loasL Lhoso ol gono
Lochnology, vill lo nisusod or sinly goL ouL ol hand. AarL lron nighLnaro visions
ol ocological disasLors loing causod ly gonoLic naniulaLion ol cros, lanLs, insocLs,
or aninals, Lhoro is a harsh anLiciaLion LhaL gonoLic inlornaLion nay lo usod in
vays LhaL vill havo diro consoquoncos lor socioLy. Ior oxanlo, sono oolo loar
LhaL insuranco conanios and onloyors vill uso iL lor gonoLic discrininaLion, unloss
such inlornaLion is roLocLod ly rigorous rogulaLions.
10

SLoring a sanlo in a liolanl involvos no dirocL hysical risl onco Lho
sanlo is Lalon. BuL having sanlos sLorod in a liolanl involvos a corLain, alLhough
snall, risl ol sonsiLivo inlornaLion onding u in Lho vrong hands and loing usod Lo
Lho disadvanLago ol Lho sanlo donor. This inlornaLion nay lo oiLhor oxLracLod
lron Lho sanlos or Liod Lo Lhon, as is Lho caso vhon liolanl rosoarch is conlinod
viLh rogisLor rosoarch. Tho noro oolo LhaL havo accoss Lo such inlornaLion in an
uncodod lorn, Lho groaLor Lho risl ol such harn, vhich noans LhaL rosoarch on
uncodod liolanl naLorial involvos a corLain risl Lo Lho donors. Il Lho inlornaLion is
voll roLocLod, and noL nisusod, ly liolanl rosoarchors, Lhis risl ronains vory
snall. Sinco inlornod consonL has Lo lo olLainod lron Lho donor in ordor Lo sLoro
Lho sanlo in a liolanl, iL is u Lo LhaL orson Lo judgo vhoLhor Lho rogulaLions and
rouLinos concorning liolanl naLorial, and accordingly Lho risl oxosuro, aro
accoLallo.
AnoLhor cauLionary asocL ol liolanls is LhaL Lhoir uso nay violaLo Lho
donor`s inLogriLy. Solling ouL in doLail vhaL iL Lalos lor sonoono`s inLogriLy Lo lo
violaLod is a conLrovorsial and conlicaLod naLLor, luL aL loasL iL concorns an
inlringononL ol an individual`s orsonal shoro ly noL alloving Lhon Lo docido, or
havo a say, alouL Lhings conLral Lo Lhoir ovn lilo.
11
\haL acLions involvo such

10
Ior an oxanlo, soo Iagons NyhoLor 2002-12-15, . 2. Cl. Korn (1999}, . J1, 4445, J,
RadoLzli, RadoLzli & JuLh (2002}.
11
Sono roadors nay oljocL LhaL I an discussing rivacy, noL inLogriLy. Irivacy" is, lor insLanco, Lho
Lorn usod in Korn (1999}. I loavo Lho Lorninology quosLion asido, including vhaL Lho connocLions aro
loLvoon rivacy and inLogriLy, sinco ny uso ol inLogriLy" is sullicionLly cloar lor rosonL urosos. A
closo connocLion loLvoon Lho Lvo concoLs is indicaLod ly Lhoir uso, lor insLanco, in ArLiclo 21 ol Lho
Helsinli Declaration. Thoro aro also connocLions loLvoon auLonony" and inLogriLy", and loLvoon
Lhoso Lvo concoLs and soll-doLorninaLion". Soo Hansson (1998}, . 18J, vhoro iL is clainod LhaL Lho
valuo ol soll-doLorninaLion is Lho lundanonLal noLivaLion ol rulos alouL olLaining inlornod
consonL". Brocl (199J}, . 28, vriLos: A aLionL`s inLorosL in soll-doLorninaLion rollocLs Lho connon
dosiro Lo nalo inorLanL docisions alouL ono`s lilo onosoll and according Lo ono`s ovn ains and
valuos. Soll-doLorninaLion involvos Lho caaciLios ol individuals Lo lorn, roviso ovor Lino, and ursuo
152
inlringononL is, in arL, lor Lho individual Lo judgo. \iovs on vhaL is a violaLion ol a
orson`s inLogriLy can Lhoroloro lo oxocLod Lo vary lron ono individual Lo anoLhor.
IL is oasy Lo inagino casos in vhich rosoarchors vould lo said Lo go Loo lar in
Lhis rosocL. Ior oxanlo, any doLailod rosoarch, viLhouL consonL, inLo oolo`s
soxual haliLs, roligious loliols, or oliLical alliliaLions vould rolally lo rogardod as
an inLogriLy lroach ly nosL oolo, as vould rosoarch vhoro arLicianLs aro nani-
ulaLod in corLain vays.
12
Hovovor, sinco Lho Biolanls AcL loavos iL Lo Lho oLonLial
sanlo donor Lo considor vhaLovor roasons ho or sho nighL havo lor and againsL
giving consonL, Lhoro is sullicionL roon lor inLogriLy considoraLions a oLonLial
donor linding, say, rosoarch on his sanlos unaccoLallo lron an inLogriLy
orsocLivo can sinly viLhhold consonL. Thus, oolo`s inLogriLy is rosocLod and
roLocLod ly Lho Biolanls AcL.
Sanlo donors havo an inLorosL in rocoiving corLain inlornaLion. Thoy nay
also havo an inLorosL in noL rocoiving corLain inlornaLion. Rocoiving LhaL inlornaLion
anyvay nay lo harnlul and nay involvo a violaLion ol Lho orson`s inLogriLy.
Sinilarly, donors nay havo an inLorosL noL only in having a say alouL corLain Lhings
luL also in not having a say alouL corLain Lhings. This vill sonoLinos nalo iL hard Lo
docido vhoLhor Lo ass on corLain inlornaLion or noL.
1J

Ior Lho salo ol clariLy, loL us roiLoraLo Lho valuo asocLs ol liolanling LhaL
aro nainly ol inLorosL horo. Cn Lho osiLivo sido, Lhoro aro Lho advanLagos ol using
liolanls lor diagnosLic, oLhor nodical, and rosoarch urosos. Cn Lho nogaLivo sido,
Lhoro aro Lho risls ol gonoLic and oLhor orsonal inlornaLion onding u in Lho vrong
hands and harning Lho sanlo donors, and ol sLorago and usos ol sanlos viLhouL
consonL violaLing Lho donors` inLogriLy. In Lho lirsL caso iL is Lho ollocLs ol sonsiLivo
inlornaLion goLLing inLo Lho vrong hands LhaL aro harnlul, in Lho socond caso,
sLorago or uso in iLsoll is harnlul, as an insLanco ol inLogriLy violaLion.
14

\iLh Lhoso considoraLions in nind, loL us soo vhaL inlornaLion is noodod lor
oLonLial sanlo donors Lo lo sullicionLly inlornod, and Lhus caallo ol giving
inlornod consonL.

5. General and specific information

IL is racLical and roasonallo Lo divido inlornaLion Lo lo givon Lo oLonLial donors on
sLorago and uso ol sanlos in liolanls inLo Lvo nain caLogorios: general injormation
and specijic injormation.

5.1. General information
Gonoral inlornaLion raisos asocLs ol liolanls, Lhoir clinical and rosoarch usos, rolo-
vanL lavs and rogulaLions, oLc. LhaL aro ol gonoral rolovanco Lo consonL Lo Lho sLorago
and uso ol individual sanlos in a liolanl.

a lan ol lilo or concoLion ol Lho good." Cl. Hornoron (1999}, . 102. All Lhoso Lorns aro usod in
Lho discussion. In Lho Svodish dolaLo, Lho rolovanL Lorn is integritet".
12
Milgran`s nuch-discussod sLudios ol olodionco in Lho 1960s aro argually an oxanlo ol inLogriLy-
lroaching naniulaLion ol rosoarch suljocLs. Soo Milgran (199}. Ior lurLhor oxanlos, soo Iadon &
Boauchan (1986}.
1J
\ondlor (2002}, . 50.
14
Cl. Irilsson (2001}, . 45.
153
Cert Helgesson
Gonoral inlornaLion oughL rolorally Lo lo rosonLod in roadallo lrochuro lorn.
Briol, vorlal inlornaLion nay lo sullicionL in nany clinical rouLino siLuaLions, and is
also rolorallo lor racLical roasons in nosL casos, iL vould lo lar Loo Lino-
consuning Lo givo oach aLionL doLailod inlornaLion vhon Lho sanlo is Lalon.
Hovovor, in such casos Lho vorlal inlornaLion should lo sulononLod ly vriLLon
inlornaLion. This is vhoro Lho lrochuro conos in handy.
Brochuros conLaining gonoral inlornaLion on liolanls should havo Lho
lolloving conononLs:
vhaL liolanls aro,

hov liolanls aro handlod liolanling racLico,
clinical and rosoarch oinLs ol having liolanls
hov inlornaLion alouL individuals is LroaLod in and, in connocLion viLh liolanls:
vhaL noasuros aro Lalon Lo roLocL Lho inlornaLion, lor oxanlo LhaL Lho
sanlos aro codod, Lho codo loys aro voll roLocLod and can lo accossod only ly
a lov orsons, and inlornaLion dolivorod lron liolanls Lo oxLornal rosoarchors is
nornally codod or doidonLiliod,
LhaL liolanl sanlos nay lo roloasod uncodod il rosoarchors nood Lo connocL
orsonal rocords Lo liolanl inlornaLion so as Lo lo allo Lo roach an inLorosLing
rosulL,
LhaL all rosoarch on liolanls is roviovod lolorohand ly oLhical rosoarch roviov
conniLLoos, Lho uLiliLy ol rosoarch horo loing lalancod againsL ollocLs on
orsonal socuriLy and inLogriLy,
LhaL Lho roviov conniLLoos also docido vhoLhor nov consonL nusL lo olLainod
lor nov usos ol oxisLing liolanls, lor oxanlo nov rosoarch rojocLs,
LhaL sLorago ol sanlos in liolanls is oLional,
LhaL consonL givon roviously can lo viLhdravn aL any Lino, in vhich caso Lho
sanlo nusL lo dosLroyod or doidonLiliod innodiaLoly,
LhaL rosoarch sonoLinos involvos inLornaLional co-ooraLion, LhaL Lhoro nay lo
insLancos vhon liological sanlos lron Svodish ciLizons aro analysod in loroign
laloraLorios, and LhaL sanlos analysod alroad nusL lo roLurnod or dosLroyod
vhon Lho vorl is conloLod,
LhaL liolanl rosoarch nay load Lo Lho dovolononL ol nov noLhods lor
rovonLing and LroaLing various disoasos, and LhaL sono ol Lho discovorios nado
nay nood Lo lo aLonLod lor Lho dovolononL ol nov nodicinos,
Lho ossonco ol vhaL is sLaLod in Lho nosL rolovanL acLs and rogulaLions,
vhoro Lo Lurn in ordor Lo goL noro inlornaLion or uL quosLions dirocLly Lo Lho
auLhoriLios.

5.2. Specific information
Tho socilic inlornaLion concorns a arLicular uroso lor Laling or using corLain
liolanl sanlos, and Lho aLLondanL circunsLancos concorning Lhis, lor oxanlo, Lho
clinical roason lor Laling a corLain sanlo or lacLs alouL a socilic rosoarch rojocL.
\hon a sanlo is Lalon lor rouLino diagnosLic roasons, Lho socilic inlornaLion nay
lo givon vorlally: loloro Laling Lho sanlo, Lho docLor oxlains, in sinlo Lorns,
vhy iL is loing Lalon, and Lho aLionL nay asl quosLions il ho or sho roquiros lurLhor
oxlanaLions.
In consonL siLuaLions concorning Lho uso ol liolanl sanlos lor a arLicular
rosoarch rojocL, Lho socilic inlornaLion should lo in vriLLon lorn Lhoro aro no
154
sLrong racLical roasons againsL having iL Lhis vay, vhilo Lhoro nay lo sono
advanLagos, noL loasL LhaL such inlornaLion should go inLo sono doLail and nay lo
dilliculL Lo conrohond. \riLLon inlornaLion is Lhoroloro liloly Lo nalo Lhings
cloaror. InlornaLion on a socilic rosoarch rojocL oughL Lo lo rosonLod viLh Lho
consonL lorn.
InlornaLion ol Lhis lind should conLain Lho lolloving:

Lho LiLlo ol Lho rosoarch rojocL,
Lho rosoarch grou, univorsiLy doarLnonL, or oquivalonL carrying ouL Lho sLudy,
hov oLonLial arLicianLs havo loon solocLod,
vhaL quosLion or quosLions Lho sLudy is inLondod Lo ansvor and vhy Lhis is
inLorosLing,
vhaL lind ol sanlos vill lo usod,
vhoLhor Lho rosoarchors vish Lo sLoro Lho sanlos vhon Lho sLudy has loon
carriod ouL,
Lho consoquoncos ol arLiciaLing in Lho rojocL aro Lhoro any risls involvod
hov inlornaLion alouL Lho arLicianLs vill lo handlod,
vhoro Lho oLonLial arLicianL nay Lurn lor noro inlornaLion alouL Lho
rojocL.
15

6. Consent

LoL us login horo viLh sono ol Lho considoraLions loading u Lo Lho suggosLod lorns
ol consonL, loloro looling aL Lho lorns Lhonsolvos.

6.1. Consent categories
As vo havo alroady noLod, Lho sanlos in liolanls aro collocLod lor ono ol Lho
lolloving rinary urosos: diagnosLic urosos, luLuro clinical urosos, naing,
or rosoarch. \hilo Lhoro aro lour grounds lor collocLing sanlos in liolanls, iL is
roasonallo Lo sorL Lhon inLo Lhroo dilloronL consonL caLogorios:

1. Sanlos Lalon lor diagnosLic urosos.
2. Sanlos Lalon lor luLuro clinical urosos or lor naing.
J. Sanlos Lalon lor rosoarch urosos.

\hon sanlos aro collocLod and sLorod lor diagnosLic urosos (caLogory 1}, Lho
inlornaLion as voll as Lho consonL nay lo givon vorlally: Lho docLor oxlains Lho
uroso ol Laling Lho sanlo, LhaL Lho liolanl naLorial is voll roLocLod, oLc., and
Lho aLionL Lolls Lho docLor vhoLhor ho or sho consonLs, viLh or viLhouL rosLricLions,
Lo having Lho naLorial sLorod in liolanls and usod in sociliod vays. \hon doing so,
Lho aLionL should havo Lho oorLuniLy ol consonLing, noL only Lo sLorago lor
diagnosLic and oLhor nodical urosos, luL also Lo rosoarch.
IocunonLaLion ol consonL nay lo handlod ly adding iL Lo Lho aLionL`s
nodical rocord. Tho oxacL conLonL ol Lho consonL, including any rosLricLions, nusL lo
cloarly sLaLod. Tho docLor nusL also corLily LhaL Lho aLionL has givon consonL ly

15
Cl. Lhis lisL viLh Lho ono in Boslov oL al (2001}. Sono vriLors go nuch lurLhor and suggosL LhaL
aLionLs should lo inlornod, lor insLanco, ol Lho rosoarchors` orsonal characLorisLics and Lhoir viovs
rolaLivo Lo Lho rosoarch. Soo o.g. \illinson (2001}.
155
Cert Helgesson
signing or iniLialling Lho consonL docunonLaLion. IL is inorLanL lor Lho aLionL`s
consonL sLaLus Lo lo availallo in all Lho circunsLancos vhoro iL is ol rolovanco.
\hon sanlos aro collocLod and sLorod lor luLuro clinical urosos, or
naing, (caLogory 2}, Lho racLical oljocLions Lo olLaining vriLLon consonL aro ol
liniLod inorLanco, sinco Lhis Lalos laco nuch loss lroquonLly Lhan Lho collocLion ol
liolanl sanlos lor diagnosLic urosos. Thoroloro vriLLon consonL should lo
olLainod. Horo again, Lho docLor nay lriolly oxlain, ly vord ol nouLh, Lho
uroso and Lho rocoduros and rouLinos, sulononLing Lhis ly vriLLon inlornaLion
loLh gonoral inlornaLion on liolanling and socilic inlornaLion on Lho uroso
ol Laling Lho sanlo.
Nov consonL is noL alvays noodod lor rosoarch on alroady oxisLing liolanls
iL is u Lo Lho oLhical rosoarch roviov conniLLoos Lo docido. BuL inlornod consonL is
noodod vhon sanlos aro collocLod and sLorod lor rosoarch urosos (caLogory J}, .
In such casos, iL is sLrongly roconnondod LhaL Lho oLonLial donor lo givon cloar and
oasily conrohonsillo vriLLon inlornaLion on Lho socilic rosoarch rojocL lor vhich
Lho sanlos aro loing collocLod, and Lold LhaL Lhoro is an oorLuniLy lor asling
noro doLailod quosLions. Tho inlornaLion should lo rosonLod viLh Lho consonL
lorn. As in rovious casos, a lrochuro viLh gonoral inlornaLion on liolanling
should also lo availallo.
16

6.2. Consent forms
I suggosL Lho lolloving consonL lorns. NoLo LhaL Lho lirsL lorn is Lo lo handlod ly
Lho nodical docLor only, vhilo Lho noxL Lhroo aro Lo lo signod ly Lho sanlo donor.

Form 1: Documentation of consent to storage of biological samples in a biobank for
diagnostic purposes

Documentation of consent to storage of biological samples in a
biobank for diagnostic purposes

Patient

Sample
Date

The patient has been informed of the routines for handling human biological samples in biobanks.
Consent has been given for storage and the following uses:

Care and treatment, and activities associated therewith

Other medical purposes

Biomedical research Exception(s)

Doctors signature or initials:

16
Tho discussion in von Isson (2002} suorLs ny viov LhaL Lho consonL lorns I an alouL Lo suggosL
aro lully accoLallo lron a Svodish logal orsocLivo.
156

Form 2: Consent to storage of samples in a biobank for future clinical use or for mapping
purposes

Consent to storage of samples in a biobank for future clinical
use or for mapping purposes

Concerning storage of (type of sample) in a biobank

I consent to the sample being stored and used for

(purpose)

I consent to the sample being stored and used for

It may also be used for biomedical research
(purpose)

Exception(s)

Date

Patients signature

Anyone who consents to having his or her samples (blood samples, tissue samples, etc.) stored in a
biobank is entitled, under the Swedish Biobanks Act, to withdraw the consent at any time. When
the withdrawal is expressed to responsible authorities, the samples will be deidentified or
destroyed.
17

1
Tho concluding aragrah is oLional, luL roninds Lho donor LhaL consonL can lo viLhdravn laLor.
157
Cert Helgesson
Form 3: Consent to storage and use of samples in a biobank for research purposes

Consent to storage and use of samples in a biobank for
research purposes

To be used when biological samples from humans are collected for research

Consent form for (research project)

I have been informed of the present study and have been given an opportunity to ask
questions.

I consent to
(sample)

being stored and used for
(purpose)

I consent to
(sample)

being stored and used for
(purpose)

and for other kinds of biomedical research

Exception(s)

Date

Patients signature

biobank is entitled, under the Swedish Biobanks Act, to withdraw the consent at any time. When the
withdrawal is expressed to responsible authorities, the samples will be deidentified or destroyed.
18

18
CLional, soo rovious looLnoLo.

158
Form 4: Consent to the use of samples in a biobank for research purposes

Consent to the use of samples in a biobank for research purposes

To be completed when research is to be done on existing biobanks

Consent form for (research project)

I have been informed of the present study and have been given an opportunity to ask
questions.

I consent to
(sample)

being used for
(purpose)

I consent to
(sample)

being used for
(purpose)

and for other kinds of biomedical research

Exception(s)

Date

Patients signature

biobank is entitled, under the Swedish Biobanks Act, to withdraw the consent at any time. When the
withdrawal is expressed to responsible authorities, the samples will be deidentified or destroyed.
19

7. Discussion

Tho consonL lorns LhaL I suggosL shov duo rosocL lor loLh linds ol individually Liod
valuos discussod alovo, sinco Lho aLionL nay lring in any lind ol considoraLion
vhon conLonlaLing vhoLhor Lo consonL Lo Lho sLorago and suggosLod usos ol his or
hor sanlos. ThaL is, il only Lho risl lor orsonal harn is lound Lo lo rolovanL Lo Lho
choico, Lhon only LhaL lacLor vill lo considorod. Il, on Lho oLhor hand, inLogriLy

19
CLional, soo looLnoLo 1.

159
Cert Helgesson
roasons loyond LhaL aro lound Lo lo rolovanL, Lhon Lhoy vill also lo Lalon inLo
considoraLion.
Tho sano alios in casos vhoro a sanlo donor is considoring viLhdraval
ol consonL givon roviously . Sinco Lho righL Lo viLhdrav consonL is indoondonL ol
Lho donor`s roasons, risl ol harn as voll as inLogriLy roasons nay carry any voighL
vhaLovor in Lho docision LhaL Lho donor nalos. IaLionLs concornod only viLh risl ol
harn nay vanL Lo viLhdrav Lhoir consonL oiLhor locauso ol nov lacLs concorning
Lho risl or locauso Lhoy havo ro-ovaluaLod Lho nogaLivo valuo ol Lho ossillo harn,
vhilo Lhoso vho also lind inLogriLy roasons rolovanL nay lind nov lacLs alouL
inLogriLy ollocLs a roason Lo roconsidor Lho consonL.
LoL us nov Lurn Lo considor sono oljocLions Lo Lho consonL rocoduros I
havo roosod.

7.1. Informed consent shall be written
IL nighL lo arguod LhaL consonL shall alvays lo docunonLod in vriLing and signod ly
Lho sanlo donor. This donand goos againsL Lho lirsL consonL lorn suggosLod, vhich
Lho nodical racLiLionor lills in alLor having rocoivod vorlal consonL lron Lho aLionL.

Reply: Iron logal and oLhical orsocLivos, iL nalos no dilloronco hov consonL is
docunonLod. Inloss docLors aro unroliallo, and Laling inLo considoraLion Lho vasL
nunlor ol rouLino sanlos Lalon in ordinary hoalLh caro, Lho suggosLod racLico is
Lho nosL racLical ono.

7.2. Open-ended consent to research is not acceptable
BoLh lavyors and hilosohors havo suggosLod LhaL oon-ondod consonL Lo rosoarch
LhaL is, unsociliod consonL Lo rosoarch in gonoral should noL lo allovod on Lho
ground LhaL iL is unaccoLally lroad.
20
InsLoad, dilloronL linds ol rosoarch should lo
disLinguishod. This vould noan a nunlor ol rosoarch caLogorios, such as cancor ro-
soarch, cardiac rosoarch, rosoarch on arLhriLis, dialoLos, olosiLy, oLc., having Lo lo
rosonLod in Lho consonL lorns. IL has also loon arguod LhaL ono nusL disLinguish
loLvoon dilloronL rosoarch noLhods.
21
According Lo Lhis laLLor viov, iL is noL
accoLallo Lo loL donors consonL, say, Lo cardiac rosoarch, insLoad, consonL nusL con-
corn cardiac rosoarch using Lhis or LhaL noLhod. Ivon il Lhis viov is rojocLod, long
lisLs ol rosoarch Lo vhich vo nay or nay noL consonL vould lo noodod.
22
This vould
givo us consonL siLuaLions quiLo dilloronL lron vhaL I an suggosLing.

20
Thus Hornoron (1999}, . 100, arguos LhaL unsociliod consonL Lo uso llood soLs" lor rosoarch
urosos is Loo gonoral", nainly locauso ol (1} Lho raid dovolononLs in nolocular liology", (2}
Lho inorL and oxorL ol daLa across naLional lordors", and (J} Lho connorcial inLorosLs ol llood
sanlos and oLhor hunan Lissuos lor Lho harnacouLical indusLry".
21
Gran Hornoron roconLly oxrossod Lhis viov in an inLorviov in Svonsla IaglladoL, 2002-12-22, .
1. Soo, o.g., also GusLalsson SLolL (200J}, aor \I. IL nighL lo LhoughL LhaL Lho Helsinli Declaration
roquiros rosoarch noLhods Lo lo sociliod in consonL lorns. IL doos say LhaL in any rosoarch on human
beings, oach oLonLial suljocL nusL lo adoquaLoly inlornod ol Lho ains, noLhods..." (ny iLalics}, luL
rosoarch on liolanl sanlos is noL rosoarch on hunan loings and doos noL involvo nany ol Lho
ossillo risls LhaL rosoarch on hunans doos.
22
CriLics ol oon-ondod consonL Lo rosoarch raroly sLaLo hov socilic Lhoso caLogorios nusL lo in ordor
Lo lo accoLallo, lor insLanco, vhoLhor cancor rosoarch is an accoLallo caLogory or vhoLhor dilloronL
sorLs ol cancor should lo disLinguishod, and il so, Lo vhaL oxLonL (lor insLanco, should Lhoro lo
160
Cno argunonL lor Lhis osiLion is LhaL unloss consonL Lo rosoarch is quiLo sociliod, iL
is noL cloar Lo vhaL ono is oxocLod Lo consonL. Hov can you givo an inlornod
consonL Lo rosoarch LhaL you havo novor loon inlornod alouL is Lho rhoLorical
quosLion raisod ly criLics ol oon-ondod consonL Lo rosoarch. A socond argunonL is
LhaL sanlo donors, lor inLogriLy roasons, should lo allovod Lo havo a say in doLail
alouL lor vhaL linds ol rosoarch Lhoir sanlos aro usod.

Reply: All rosoarch rojocLs aro dilloronL in sono rosocL. Il all inlornaLion alouL ro-
soarch voro rolovanL Lo inlornod consonL, Lhon inlornod consonL could noL lo givon
Lo any rosoarch noL yoL lannod. BuL noL all inlornaLion is rolovanL Lo vhaL is aL
sLalo lor Lho sanlo donor in Lho consonL siLuaLion, nanoly LhaL Lho sLorago and uso
ol Lho sanlos involvo a corLain risl ol harn and nay violaLo his or hor inLogriLy.
Thoso aro Lho asocLs ol liolanls LhaL aro norally rolovanL Lo Lho donor`s consonL.
2J

Thoroloro iL is inlornaLion concorning Lhoso asocLs LhaL Lho donor is onLiLlod Lo. IL is
noL nornally Lho acLual rosoarch conLonL or socilic characLorisLics ol Lho rosoarchors
or Lhoir noLhods LhaL Lho donor should consonL Lo.
CriLics nay oljocL LhaL inLogriLy quosLions concorn noL only hov and Lo
vhaL oxLonL rosoarch inLorloros viLh individual livos having a say on vhaL rosoarch
is carriod ouL on ono`s liological sanlos nay, as such, lo arL ol vhaL inLogriLy is
alouL. Cn Lhis naLLor, I sharo Lho viov Lalon ly Iavid \ondlor:

The ueight oj individuals' claim to a say over uhether they contribute to a particular
research project depends upon hou central maling this contribution is to their lives. ln the
majority oj cases, it seems plausible to assume that it is important jor individuals to
determine uhether their samples are used jor research purposes since doing so allous
sources to decide uhether they contribute to the general project oj increasing medical
lnouledge and helping others. ... lt seems less important, in most cases, jor individuals to
control uhether their samples are used to study one disease or another. Whether l
contribute to medical research at all says something important about my lije, uhether l
contribute to research on arthritis as opposed to research on diabetes says less about my
lije. ... Houever, the specijic nature oj certain research projects can give sources a ueighty
interest in determining uhether their samples are used. or instance, some oppose abortion
and dedicate their lives to ending its provision. Such individuals have a ueighty interest in
controlling uhether they contribute to research projects involving abortion.
?4

\ondlor concludos LhaL individuals can oLhically givo consonL lor luLuro rosoarch
urosos in gonoral viLhouL having Lo lnov alouL and arovo ovory individual uso
ol Lhoir sanlos".
25
Hovovor, sono individuals nay havo roason Lo Lurn Lo local
liolanl auLhoriLios Lo givo noro sociliod consonLs.
Cno nay agroo viLh Lhis luL insisL LhaL noL all rosoarch has Lho sano
inLogriLy ollocLs or involvos sinilar risls Lo sanlo donors. This is corrocL. IL is, lor
insLanco, rolovanL Lo disLinguish loLvoon rosoarch LhaL has accoss Lo uncodod
sanlos and rosoarch LhaL only usos codod sanlos. Bosidos, sono rosoarch Loics aro

dilloronL consonLs Lo dilloronL linds ol cancor in a corLain organ}. Ivon a lisL viLh lroad caLogorios
covoring only our connonosL disoasos vill lo quiLo oxLonsivo.
2J
Tho social valuo ol rosoarch is also aL sLalo lor Lho individual sanlo donor, and noL only Lhoso
asocLs LhaL concorn hin or hor oxclusivoly, luL I disrogard LhaL oinL horo.
24
\ondlor (2002}, . 4950.
25
\ondlor (2002}, . 5J54.
161
Cert Helgesson
noro sonsiLivo Lhan oLhors, lor oxanlo rosoarch concorning vonoroal disoasos and
alcoholisn. Is noL Lhis sullicionL Lo shov LhaL ono cannoL allov oon-ondod consonL
Lo rosoarch
This vould havo loon a corrocL ronarl, had iL noL loon lor Lho oLhical
rosoarch roviov conniLLoos. IL vill lo arL ol Lhoir jol Lo roviov rosoarch rojocLs in
Lorns ol risl oxosuro and inLogriLy ollocLs on sanlo donors. Thoso conniLLoos can
lo oxocLod Lo donand LhaL nov, socilic inlornod consonL is olLainod vhonovor a
lannod rosoarch rojocL involvos highor Lhan nornal risl lor Lho sanlo donors, or
is noro liloly Lhan oLhorviso Lo violaLo Lhoir orsonal inLogriLy.

7.3. Violation of integrity a matter for the individual to judge
IL nay lo arguod LhaL Lhis is Lo niss a vory inorLanL oinL, nanoly LhaL Lho
nonlors ol Lho oLhical roviov conniLLoos cannoL nalo such judgnonLs, locauso iL
is onLiroly u Lo Lho individual Lo judgo vhaL consLiLuLos a violaLion ol inLogriLy.

Reply: This can only lo corrocL il inLogriLy" is usod in such a lroad sonso LhaL iL is no
longor ol any arLicular noral rolovanco. Ivon il Lhoro voro oolo oagor Lo cry ouL
LhaL Lhoir inLogriLy is violaLod oach Lino Lhoy voro noL givon Lho righL Lo voLo any
acLion LhaL sonohov nighL allocL Lhoir livos, Lhis vould givo us no roason Lo agroo
viLh Lhon, il inLogriLy" is usod in iLs ordinary sonso. As I havo sLaLod oarlior,
inLogriLy naLLors aro orsonal naLLors, Lhoy concorn Lhings ol groaL concorn Lo a
orson. NoL ovoryLhing LhaL a orson nay vanL Lo havo a say alouL is ol LhaL lind.
I havo also said in an oarlior socLion LhaL vhaL is Lalon Lo lo a violaLion ol
inLogriLy nay vary loLvoon individuals. Is Lhis viov consisLonL I Lhinl so. This,
lriolly, is hov I soo iL: Sono acLions involvo violaLion ol a orson`s inLogriLy,
rogardloss ol vhoLhor LhaL orson Lhinls so or noL, vhilo sono acLions involvo a
violaLion ol inLogriLy only il Lho orson Lhinls so. CLhor acLions involvo no violaLion
ol inLogriLy ovon il Lho orson Lhinls Lhoy do.
26
Il Lhis is corrocL, sono naLLors ol
inLogriLy violaLion aro u Lo Lho individual, vhilo oLhors aro noL. I soo no roason vhy
oLhical roviov conniLLoos cannoL idonLily vhich casos aro ol vhich lind.

7.4. Specified consents to research are more practical than open-ended consents
Cno nay sLill vish Lo arguo LhaL sociliod consonLs Lo rosoarch aro noro practical
Lhan unsociliod consonLs. Tho lasic assunLion lohind Lhis clain is LhaL oolo, lor
inLogriLy roasons, vill lo unvilling Lo givo oon-ondod consonLs Lo rosoarch, vhilo
consonLs aro nuch noro liloly Lo lo givon il Lho san is noro rosLricLod.

Reply: Cn Lho conLrary, iL is nuch noro racLical Lo uso consonL lorns viLh an oon-
ondod consonL alLornaLivo Lhan lorns viLh rosLricLod consonL alLornaLivos. Thoro aro
aL loasL Lvo roasons lor Lhis. IirsL, il ono asls lor noro rosLricLod consonLs, Lhon a
largo nunlor ol alLornaLivos vill havo Lo lo rosonLod on Lho consonL lorns. This
vill nalo iL dilliculL lor nosL oolo Lo roach a docision, vhich nalos iL noro liloly
LhaL Lhoy vill noL consonL Lo rosoarch aL all. And ovon il Lhoy do consonL Lo rosoarch,
nuch rosoarch vill noL lo consonLod Lo, oiLhor locauso Lhoso alLornaLivos aro noL on
Lho lisL, locauso Lhoy aro lar dovn on a long lisL LhaL nany donors nay noL loLhor Lo
road Lhrough, or undorsLand, or locauso Lhoro vill lo a Londoncy Lo chooso a lov ol

26
Sono ronarls ly Hornoron, (1999}, . 102, lond sono suorL Lo Lhis viov.
162
Lho alLornaLivos jusL locauso Lhoro aro so nany Lo chooso lron. In oLhor vords, Lhoro
is a risl LhaL donors vill consonL Lo Lho rosoarch Lhoy lool nosL sLrongly lor, or lind
oarly on in Lho lisL, insLoad ol Lo all rosoarch LhaL Lhoy havo no oljocLions Lo.
A socond roason vhy oon-ondod consonLs Lo rosoarch aro noro racLical
Lhan narrovor consonLs is LhaL viLh oon-ondod onos Lhoro vill lo lovor occasions
vhon rosoarchors vill havo Lo roLurn Lo sanlo donors Lo asl lor nov consonL. This is
good, sinco Lho scionLilic disadvanLago ol nissing daLa duo Lo non-arLiciaLion nay
lo considorallo.
2
IurLhor, olLaining consonL lron nany donors is oxonsivo. Thoro
is also a considorallo risl LhaL donors viLh oular" sanlos vill ovonLually goL
Lirod ol roading rosoarch inlornaLion and lilling in consonL lorns. Cno can Lhoroloro
oxocL LhaL an incroasing nunlor ol Lhoso donors vill noL ansvor nov roquosLs lor
consonL. Signs ol such an oxhausLion ollocL aro clainod Lo lo soon in Icoland.
28

Tho inlornaLion and consonL rocoduros Lo lo inlononLod doond, in
arL, on Lho aLLiLudos ol oLonLial sanlo donors. CriLics ol oon-ondod consonL
rocoduros arguo as il Lhoy rosuoso a gonoral nogaLivo aLLiLudo, or aL loasL a lacl
ol LrusL, rogarding Svodish nodical rosoarch. I loliovo Lhis onirical assunLion Lo
lo nisLalon. My suggosLions rosL on Lho assunLion LhaL nosL oolo in Svodon
lind nodical rosoarch valuallo and nocossary, and LrusL Lho rosoarch connuniLy and
Lho rogulaLions iL has Lo alido ly.
29
Il Lhis assunLion is corrocL, Lhon Lho suggosLions
nado horo aro loLLor lor all arLs Lhan an alLornaLivo vhoro consonL lorns nusL
socily rosoarch in sono doLail.
AdniLLodly, sono oolo aro liloly Lo donand doLailod inlornaLion, noL
only alouL liolanls in gonoral luL alouL arLicular rosoarch rojocLs, il Lhoy aro Lo
consonL Lo any rosoarch. BuL Lhoro is no orlocL soluLion Lo a siLuaLion vhoro sono
oLonLial donors vanL doLailod inlornaLion alouL ovoryLhing LhaL nighL haon Lo
Lhoir sanlos, vhilo oLhors do noL vanL Lo lo loLhorod viLh inlornaLion and
consonL lorns, or do noL vanL Lo nalo Lho docisions, and Lhoroloro vanL Lo givo
consonL Lo rosoarch onco and lor all. An advanLago ol Lho consonL lorns suggosLod
horo is LhaL Lho inLogriLy ol all donors is rosocLod, sinco Lhoso vho vanL Lo can
roquiro LhaL corLain linds ol rosoarch lo oxcludod lron Lhoir consonL.

References

Boslov, Laura M., \ylio Burlo, Jon I. Morz, IaLricia A. Barr, Sharon Torry, \icLor B.
Ionchaszadoh, Lavronco C. GosLin, MarLa Gvinn & Muin J. Khoury (2001}, Inlornod
ConsonL lor IoulaLion-Basod Rosoarch Involving GonoLics", Health Lau and thics 286:
2J152J21

Brocl, Ian \. (199J}, Inlornod ConsonL", 2154 in Ian \. Brocl, Lije and Death.
hilosophical essays in biomedical ethics, Canlridgo InivorsiLy Iross

Irilsson, SLolan (2001}, Inlornod ConsonL and Biolanls", 4151 in MaLs G. Hansson
(od.}, The Use oj Human Liobanls. thical, Social, conomical and Legal Aspects, Isala
InivorsiLy

2
Cl. Kaijsor (200J}.
28
Iorsonal inlornaLion lron Bjrn Gudljrnsson, nonlor ol Lho NaLional BiooLhics ConniLLoo,
Icoland.
29
Ludvigsson oL al (2002} roorLs a osiLivo aLLiLudo Lovards lionodical rosoarch.
163
Cert Helgesson
Isson, Ilril von, (2002}, ILilrvning av liolanls- och rogisLorlorslning",
rvaltningsrattsligt tidslrijt nr 56: J51J80

Iadon, RuLh R. & Ton L. Boauchan (1986}, A History and Theory oj lnjormed Consent,
Cxlord: Cxlord InivorsiLy Iross

GusLalsson SLolL, Ilrica (200J}, Aspects oj Lioethics Theory and ractice in a reventive
Screening jor Type 1 Diabetes, Iiss., Linling

Hansson, MaLs G. (1998}, Balancing Lho ualiLy ol ConsonL", 1ournal oj Medical thics 24:
18218

Hornoron, Gran (1999}, NoonaLal Scrooning: ILhical AsocLs", Acta aediatrica Sul.
4J2: 9910J

Kaijsor, Magnus (200J}, Ixanlos lron Svodish liolanl rosoarch", . JJ-50 in Hansson
& Lovin (ods.}, Liobanls as Resources jor Health, Isala InivorsiLy

Korn, Iavid (1999}, GonoLic Irivacy, Modical InlornaLion Irivacy, and Lho Iso ol Hunan
Tissuo Socinons in Rosoarch", 168J in Clarisa Long (od.}, Cenetic Testing and the Use oj
lnjormation, \ashingLon I.C.: Tho AII Iross

Lindlorg, Bo S. (200J}, Clinical daLa a nocossary roquirononL lor roalising Lho oLonLial
ol liolanls", . 21-J2 in Hansson & Lovin (ods.}, Liobanls as Resources jor Health, Isala
InivorsiLy

Ludvigsson, Johnny, Ilrica GusLalsson-SLolL, Ior-Iril Liss & Tonny Svonsson (2002},
MoLhors ol Childron in ABIS, a IoulaLion-Basod Scrooning lor IrodialoLos, Ixorionco
Iov ILhical ConllicLs and Havo a IosiLivo ALLiLudo", Annals oj Neu Yorl Academy oj Science
958: J6J81

Milgran, SLanloy (199}, Cbedience to Authority. An xperimental Vieu, London

RadoLzli, Marcus, Marian RadoLzli & Nillas JuLh (2002}, Att nyttja genetisl injormation. Hur
myclet sla jrsalringsbolagen j veta`, SNS

\ondlor, Iavid (2002}, \haL Rosoarch viLh SLorod Sanlos Toachos Is alouL Rosoarch
viLh Hunan SuljocLs", Lioethics 16: JJ54

\illinson, T.M. (2001}, Rosoarch, Inlornod ConsonL, and Lho LiniLs ol Iisclosuro",
Lioethics 15: J41J6J

\orld Modical AssociaLion, Helsinli Declaration, adoLod ly Lho 52nd \orld Modical
AssociaLion Gonoral Assonlly, Idinlurgh, ScoLland, CcLolor 2000

Dagens Nyheter 2002-12-15, IoLor \olodarsli, HoLon noL sjullrsalringon", . 2

Svensla Dagbladet 2002-12-22, AgnoLa LagorcranLz, Ny lag andrar solroglorna lr
liolanlor", KulLur socLion, . 161

Longman Dictionary ol Lho Inglish Languago, 1991, 2nd odiLion

The Cxjord Thesaurus, Cxlord: Clarondon Iross, 199, 2nd odiLion
164
Mapping the debate on injormed consent

8

Mapping the debate on informed consent

Stejan rilsson, ThD


This paper describes the major issues concerning injormed consent that have emerged
during the Suedish debate on biobanls. The process leading to the Liobanls Act and the
debate on each major issue are outlined. May biobanls be collected and used uithout
injormed consent jrom donors` ls there a duty to participate in such research` The extent oj
injormation required in the injormed consent process is outlined, and some complications
are mentioned. Then l ponder questions such as uhen consent is needed jor neu research
on archived specimens, and uhether donors should be able to revole consent. Lastly, an
overvieu is given regarding consent jor specimens talen jrom joetuses, minors, deceased
and noncompetent persons. The discussion shous that the Suedish Liobanls Act leaves a
lot oj the ethical deliberations to the ethics committees, and that some dijjicult questions
remain to be addressed.

1. Introduction

Tho oinL ol sLoring hunan socinons in liolanls is lor inorLanL lnovlodgo Lo lo
roadily availallo lor rosoarch and LroaLnonL, luL aL Lho sano Lino Lho lnovlodgo
nay lo inLinaLo and sonsiLivo, and Lhoroloro vo nusL Lalo caro noL Lo loL individuals
and Lhoir rolaLivos sullor any harn locauso ol such sLorago. Ioolo`s inLogriLy nay lo
saloguardod ly Lhoir socinons and orsonal daLa loing codod, ly a duLy ol
conlidonLialiLy on Lho arL ol onloyoos ol such a lanl, Lhrough Lho oxorciso ol
suorvision and conLrol, and ly various oLhor noans. Cno inorLanL vay ol
roLocLing oolo is ly Lolling Lhon vhaL Lhoy vill lo Laling arL in and loLLing Lhon
docido vhoLhor Lo agroo Lo Lho roLonLion and uso ol Lhoir socinons, i.e. ly using
injormed consent.
IilloronL nodols ol inlornod consonL nay lo usod. Tho lasic varioLy
consisLs ol rosunod consonL viLhouL inlornaLion, inlornod rolusal (or oL-ouL"},
and inlornod consonL roor (oL-in"}. In Lho lirsL caso iL is onough Lo havo roason
Lo loliovo LhaL sonoono uould agroo ij aslod, in Lho socond a orson is inlornod
orsonally or ly osLors, lor oxanlo, LhaL ho or sho vill arLiciaLo unloss rolusing
Lo. In Lhis lasL caso inlornaLion is givon loloro inclusion in a sLudy, and arLiciaLion
is ossillo only alLor a osiLivo docision Lo arLiciaLo. (Thoro is nuch conlusion
alouL Lhoso Lorns in Lho logislaLivo roosals and dolaLo. I havo usod Lho Lorns in
Lho alovo sonso Lo describe Lho osiLions Lalon ly dilloronL dolaLors insLoad ol
roroducing Lho vay Lhoy use Lhon.}
165
Stejan rilsson
In Lhis aor I vill doscrilo Lho najor issuos concorning inlornod consonL LhaL havo
onorgod during Lho Svodish dolaLo on liolanls. Tho rocoss vhich havo lod Lo Lho
Biolanls AcL and Lho dolaLo on oach najor issuo aro ouLlinod. I vill olucidaLo hov
Lho AcL and oLhical rosoarch guidolinos addross Lhoso issuos, sonoLinos viLh
rollocLions on Lho jusLilialiliLy ol Lho soluLions adoLod.
1

2. Short overview of the debate leading up to the Biobanks Act

A liolanl consisLs ol liological naLorial lron ono or noro hunans LhaL is collocLod
and loL indoliniLoly or lor a doliniLo Lino and vhoso origin can lo Lracod Lo Lho
hunan or Lhoso hunans lron vhich Lho naLorial conos.
2
In Svodon liolanls havo
oxisLod lor docados viLhouL arLicular aLLonLion loing aid Lo Lhon. Cno oxcoLion
vas a govornnonLal roorL on gonoLic inLogriLy in 1984.
J
Cno ol Lho lirsL Lo raiso
quosLions again vas Lho oLhicisL Gran Hornoron, e.g. in a coulo ol arLiclos.
4
In May
199 a soninar onLiLlod Hunan liolanls oLhical and social issuos" vas hold in
Icoland ly Lho Nordic Council ol MinisLors, viLh Hornoron Laling arL.
5
In Lho sano
yoar hysician Bo Lindlorg aslod vho ovnod Lho socinons in a liolanl
6
and in
1998 IlisaloLh Rynning rovidod an ovorviov ol curronL logislaLion rolovanL Lo
liolanling and aslod vhoLhor Lho Lino had nov cono lor soLLing u a lanl
insocLoraLo".
AL Lho Lino Rynning had loon Laslod ly Lho rosoarch oLhics

conniLLoo in Isala viLh rovioving a conLracL loLvoon Isala InivorsiLy and a
conany nanod Iurona vhich vanLod Lo uso Lho aLhological liolanl. AL Lhis Lino
noro and noro nodical conanios voro loginning Lo undorsLand Lho ossililiLios ol
liolanling. AaronLly Iurona had alroady had accoss Lo Lho aLhological lanl lor
yoars. Cno ol Lho changos donandod ly Lho conniLLoo and nado ly Iurona vas
LhaL socinon donors voro Lo lo inlornod and Lhoir consonL olLainod. A vorriod
rosoarchor in Lund vroLo a loLLor Lo Lho NaLional Board ol HoalLh and \ollaro
asling alouL Iurona and iLs accoss Lo Lho Isala liolanl.
8

Tho dolaLo gaLhorod lurLhor nononLun vhon Lho Icolandic IarlianonL
docidod Lo givo a conany, doCodo, a liconco Lo uso do-idonLiliod daLa lron
aLionLs, collocLod in Icolandic ullic hoalLh rogisLors, lor rosoarch. doCodo`s lan
vas Lo linl such daLa Lo gonoalogical rogisLors and liolanls, Lhus naling ossillo Lho
collocLion ol gonoLic daLa LhaL nighL oxlain Lho ouLlroal ol disoaso and oinL Lho
vay Lovards nov LroaLnonLs and nodicinos. doCodo loing a connorcial onLorriso,
oLhor conanios nay luy a disosiLional righL Lo such daLa.
9
An iniLiaLivo, in sono

1
Tho so-callod IKI liolanl, lor vhich social rovisions voro nado in Lho AcL, vill noL lo discussod
in Lhis aor. Iloaso noLo LhaL Lho roosod logislaLion rolors sololy Lo liolanls conLaining liological
naLorial vhoso origin is Lracoallo Lo a corLain individual. Non-idonLiliallo socinons and orsonal
daLa aro noL includod in Lho doliniLion ol liolanl, Lho laLLor aro rogulaLod ly Lho Iorsonal IaLa AcL
(SIS 1998:204}.
2
Regeringens proposition ?001/0?.44.
J
Cenetisl integritet 1984, . 21218.
4
Hornoron 199a and Hornoron 199l.
5
Sorsa & Iyljrd ods. 199
6
Lindlorg 199.
Rynning 1998.
8
Tragrdh & Ringnan 1999.
9
I vill noL roLoll Lho dolaLo alouL doCodo horo, luL Lo indicaLo Lho sLrongLh ol oosiLion sullico iL Lo
say LhaL ovon Lho \orld Modical AssociaLion donouncod Lho iniLiaLivo. Soo Iuncan 1999.
166
rosocLs sinilar Lo doCodo`s, vas Lalon in Ino shorLly LhoroalLor, in March 1999,
vhon Lho CounLy Council and Lho InivorsiLy sLarLod a conany, InanGononics,
Lo sLarL oxloiL Lho liolanl vhich Lho InivorsiLy and Lho CounLy Council had loon
ooraLing sinco Lho 80s.
10
IL vas Lo lo ullicly ovnod and all rosulLs voro Lo lo
roLurnod Lo Lho liolanl (Lhoroly loconing ullic donain}.
11
In Lho daily novsaor
VasterbottensKuriren a dolaLo ragod on during Lho sring. IroLagonisLs includod Lho
oliLician Barlro \osLorholn, vho donandod LhaL Lho luLuro ol liolanling lo
invosLigaLod as soon as ossillo and clainod LhaL logislaLion vas ladly noodod.
12

ConcurronLly Lho GovornnonL`s Modical ILhics Advisory Board (SMIR} oinLod ouL
LhaL Lho GovornnonL givo lurLhor considoraLion Lo liolanls aL Lho oarliosL ossillo
oorLuniLy.
1J
Connorcial inLorosLs should noL lo allovod Lo inlringo hunan
inLogriLy. This donand lor an inquiry inLo liolanls had also loon uL lorvard ly a
arlianonLary invosLigaLion inLo rosoarch oLhics, lod ly \osLorholn.
14
Irossuro logan
Lo luild u: in a lacard vhich croaLod a sLir, Lho ovoning novsaor Ajtonbladet
roclainod on Aril 10 1999 LhaL Rosoarchors aro orlorning socroL oxorinonLs
on arLs ol your lody".
15
Tho aor hoavily criLicisod Lho NaLional Board ol HoalLh
and \ollaro lor noL lloving Lho vhisLlo in siLo ol lnoving alouL Iurona`s accoss Lo
hunan liological socinons. In an aoal in Ajtonbladet, a nunlor ol
rorosonLaLivos lron aLionL organisaLions nov also donandod an inquiry.
16

Tho GovornnonL roacLod Lo all Lhis on Juno 1 ly insLrucLing Lho NaLional
Board ol HoalLh and \ollaro Lo roviov quosLions rogarding liolanls and Lo rooso
a nov Biolanls AcL, suosodly as a dirocL consoquonco ol Lho arLiclos ullishod in
Ajtonbladet,
1
alLhough Lho Modical Rosoarch Council had also aslod lor an inquiry.
Social aLLonLion vas Lo lo aid Lo Lho quosLion ol vhoLhor nov consonL vas noodod
vhon old socinons voro Lo lo usod lor a nov uroso". NovorLholoss, nosL
dolaLors vould suroly havo rolorrod a Lhorough and conrohonsivo ollicial
arlianonLary roorL ly a govornnonL connission ol inquiry Lo a svilL ono-nan
inquiry. ThaL vas noL Lo lo, vhich in Lurn holod Lo lring alouL Lho rollons
ouLlinod lolov.
Boloro LhaL inquiry vas linishod, hovovor, noro vorl vas dono olsovhoro.
InsocuriLy had sroad anong scionLisLs. Individual scionLisLs, as voll as
rorosonLaLivos ol Lho harnacouLical indusLry, had lor a vhilo aslod Lho ConniLLoo
lor Rosoarch ILhics aL Lho Modical Rosoarch Council (MRC} lor advico, and rosoarch
oLhics guidolinos lor liolanls voro rosonLod in Juno 1999.
18
In Lhoso guidolinos iL
vas noLod anong oLhor Lhings LhaL individuals havo an inLorosL in rosoarch caallo ol
idonLilying narlors lor disoasos lor vhich sono lorn ol inLorvonLion nay lo
availallo. AnoLhor oinL vas LhaL liolanl naLorial should noL lo allovod Lo lo usod

10
Sinilar iniLiaLivos havo loon Lalon in ILaly (locally in a snall villago}, IsLonia (a hugo liolanl}, and
in Lho Tonga Islands (naLional liolanl as in Icoland}, as voll as in Novloundland. Soo, lor oxanlo,
Grooly 2001.
11
Soo Jons Laago-Hollnan`s lorLhconing lool Commercialization oj Liobanls. A Study oj biotech
companies dedicated to human genetics, lor a lurLhor discussion ol Lho loasililiLy ol Lhoso clains.
12
\osLorholn 1999.
1J
Atgarder lring biobanler 1999. Ior a rosuno, soo Ahlgron 1999.
14
Cod sed i jorslningen 1999, . 212.
15
Tho AlLonlladoL arLiclos voro ullishod loLvoon Aril 10 and 15. Tho journalisLs, Maria
Tradgrdh and Magnus Ringnan, voro laLor avardod Stora 1ournalistpriset lor Lho sorios.
16
Bjrn oL al. 1999.
1
As sLaLod ly Social MinisLor Lars IngqvisL in Ajtonbladet, Aril 15, 1999, . 10.
18
Research ethics guidelines 1999.
167
Stejan rilsson
u. Moanvhilo, Lho Nordic ConniLLoo on BiooLhics organisod an inLornaLional
conloronco in IsLonia (vhich has inauguraLod Lho nosL anliLious liolanl rojocL ol
iLs lind vorldvido, aL loasL unLil Biolanl I.K. vas announcod in 2002}, on Lho
suljocL ol \ho Cvns our Gonos", vhich discussod liolanls in a nunlor ol
rosocLs, noL loasL quosLions ol luying and solling socinons and vholo liolanls.
19

IurLhor conloroncos havo lollovod. Tho Svodish IaLa InsocLion Board, vhich ly
Lhis oinL had rocoivod nany quosLions rogarding liolanls, also soL u an inquiry.
AlLor oxLonsivo liold insocLions, aL Lho Modical Biolanl in Ino lor oxanlo, a
roorL vas ullishod aL Lho loginning ol 2000, indicaLing various dolicioncios in Lho
liolanls invosLigaLod, nosLly Lo do viLh inlornod consonL.
20

Tho NaLional Board ol HoalLh and \ollaro rosonLod iLs roorL in May
2000, alLor alnosL a yoar`s vorl.
21
IL vas roosod LhaL liolanls vhich in a hoalLh
caro soLLing had loon collocLod lron aLionLs or socinon rovidors in ordor Lo roach
a corLain oljocLivo should lo rogulaLod ly Lho Bill. Socondary lanls collocLod lron
such a rinary lanl voro also includod. ConLral osiLions voro alloLLod Lo Lho
oLhical guidolinos lron Lho MRC and Lo Lho rosoarch oLhics conniLLoos. Tho
inlornod consonL rocoduro ondorsod ly an oLhics conniLLoo should aly vhon
sonoono vanLod Lo uso socinons lor rosoarch or lor a clinical Lrial. Tho Board
sLrossod LhaL logislaLion vas noodod and LhaL nany inLorosLod arLios voro asling lor
rogulaLion as soon as ossillo. Tho Bill vas doliloraLoly lroughL as closo as ossillo
inLo lino viLh Lho Council ol Iuroo ConvonLion on Hunan RighLs and
Bionodicino, Lo laciliLaLo sulsoquonL raLilicaLion.
22
A liolanl nay noL lo Lranslorrod
Lo anoLhor counLry, nor shall any Lranslor or roloaso ol naLorial Lalo laco lor
connorcial gain, suggosLions laLor roLainod Lhrough all sLagos ol Lho rocoss Lovards
a nov AcL.
2J
Cno conLrovorsial and sonovhaL uncloar suggosLion nado in Lho Bill
vas LhaL a carogivor in Lho hoalLh caro socLor should lo olligod Lo rovido loLh
Lissuo socinons and orsonal daLa Lo any liolanl soL u in accordanco viLh Lho lav
(suljocL Lo donor consonL}. IL vas suggosLod LhaL social advisory loards should lo
inLroducod, Lo rioriLiso loLvoon rojocLs roquiring accoss Lo socinons in a lanl.
Tho AcL vas noanL Lo cono inLo lorco on July 1, 2001, luL Lho rocoss vas Lo lo
nuch dolayod.
An inorLanL sLaLononL on Lhis roorL vas nado ly Lho Svodish SocioLy lor
Clinical CyLology, vhich drov aLLonLion Lo Lho lacL ol aLhology doarLnonLs
handling and sLoring Lhousands ol socinons ovory day. IL soonod sonovhaL uncloar
vhoLhor Lho NaLional Board ol HoalLh and \ollaro had aL all noLicod LhaL lor nany
rouLino diagnosLic urosos Lho socinons had Lo lo sLorod lor longor Lhan Lvo
nonLhs (Lho liniL lor roLonLion, alLor vhich, in Lho Bills and Lho sulsoquonL AcL, Lho
socinons aro soon as lolonging Lo a liolanl}. GroaL dilliculLios ariso il Lho AcL
alios Lo Lissuo collocLions ol Lhis lind.
24
Il inlornod consonL is noodod as soon as a
socinon has loon loL lor ovor Lvo nonLhs, Lhis vill lo oxonsivo and nay
rolong vaiLing Linos lor diagnosLic rosulLs. Tho socioLy also aslod lor a rovision

19
Who Cuns our Cenes`" 2000.
20
Liobanlers behandling av personuppgijter 2000.
21
Liobanler i halso och sjulvrden m.m. 2000.
22
Convention 199. This convonLion has loon signod ly Svodon luL noL yoL raLiliod, and so is noL
(yoL} logally linding.
2J
BuL Lhis sLaLuLo is sLill loing discussod and challongod in dilloronL vays, soo, lor oxanlo, CsLorlorg
2002.
24
Angende jrslag till lagstijtning 2000.
168
vhoroly socinons Lalon and sLorod lor Lho uroso ol hoalLh caro should only lo
roloasod lor anoLhor uroso il Lhis can lo dono viLhouL conronising Lho aLionL
inLorosL. A aLionL nay lor his or hor vholo lilo havo an inLorosL in using old
socinons lor diagnosLic urosos, lor oxanlo. Sinilar criLicisn onorgod in
connonLs ly sono CounLy Councils, Lho Lund Modical IaculLy and Lho Karolinsla
InsLiLuLo.
25
This vas novor addrossod in Lho sulsoquonL AcL, luL Lho MRC guidolinos
say LhaL il Lho naLorial is collocLod lor clinical urosos |and nay lo ol| signilicanco
lor such urosos in Lho luLuro, Lhoso nusL lo givon rocodonco." Tho roosal LhaL
advisory loards lo inLroducod vas shoL dovn in Lho consulLaLion rocoss, noL loasL
locauso Lho rogular rosoarch oLhics conniLLoos voro alroady suosod undor Lho
nov MRC guidolinos Lo rioriLiso loLvoon rojocLs.
IlisaloLh Rynning criLicisod Lho Bill lor noL including liolanls unconnocLod
viLh hoalLh caro,
26
a criLicisn ochood in nany, nany sLaLononLs,
2
including Lho laLor
roorL ly Lho Rilsdag (IarlianonLary} SLanding ConniLLoo on Social Allairs (soo
lolov}.
28
An inorLanL oinL nonLionod ly Rynning vas LhaL iL is uncloar hov ono
should undorsLand Lho disLincLion, dravn ly Lho NaLional Board ol HoalLh and
\ollaro, loLvoon idonLiliallo and non-idonLiliallo naLorial, or vhoLhor such a
disLincLion vas roally noaninglul.
29

Cn AugusL 2J, 2001 a roosal vas rolorrod Lo Lho Council on LogislaLion
lor considoraLion.
J0
Tho lan nov vas lor Lho nov AcL Lo cono inLo lorco on July 1,
2002. Tho conLrovorsial suggosLion LhaL a carogivor in Lho hoalLh caro socLor should
lo olligod Lo rovido Lissuo socinons Lo any liolanl soL u in accordanco viLh Lho
AcL had ly nov loon drood, as had Lho suggosLion LhaL social advisory loards
should lo croaLod. Tho GovornnonL llunLly sLaLod LhaL Lho AcL should lo vriLLon as
Lo harnoniso viLh Lho ConvonLion on Hunan RighLs and Bionodicino,
J1
and
lurLhornoro LhaL Lho Holsinli IoclaraLion sorvos loLh as Lho rino guidanco lor
lionodical rosoarch in Svodon and as Lho loundaLion lor oLhical roviovs ly rosoarch
oLhics conniLLoos. Tho Biolanls AcL should givo Lissuo socinons Lho sano
roLocLion rogarding Lho individual`s inLogriLy as Lho Iorsonal IaLa AcL.
J2
Tho
GovornnonL doclarod iLs inLonLion ol roLurning Lo Lho quosLion ol liolanls ouLsido
Lho hoalLh caro socLor.
Tho Svodish Council on LogislaLion Lhoroughly rovisod Lho roosal,
JJ
and
nosL ol iLs suggosLions lor inrovononL voro adoLod ly Lho GovornnonL in Lhoir
GovornnonL Bill, daLod Novonlor 29, 2001.
J4
This GovornnonL Bill vas vorlod
ouL in co-ooraLion viLh Lho Svodish LolL and Groon IarLios, vhich nay oxlain
sono ol Lho alLoraLions nado. Nov Lho AcL vas Lo cono inLo lorco on January 1,
200J. Tho Svodish Council on LogislaLion noLod LhaL Lho rolaLionshi loLvoon Lho

25
Soo Lagrdsremiss 2001, socLion 10:2, as voll as Iillnor 2002.
26
Rynning 2000.
2
Regeringens proposition ?001/0?.44, Cvorvagandon och lrslag", socLion 10:J.
28
Socialutslottets betanlande 2002.
29
This vas again lorcolully lroughL Lo our aLLonLion vhon Rynning, viLh SLollan \olin, vroLo yoL
anoLhor conLriluLion Lo Lho dolaLo, soo \olin & Rynning 2002.
J0
Lagrdsremiss 2001.
J1
Ilid., socLion 10:1.
J2
Ilid., socLion 10:2.
JJ
Regeringens proposition ?001/0?.44, Bilaga 5: LagrdoLs yLLrando".
J4
Regeringens proposition ?001/0?.44.
169
Stejan rilsson
Biolanls AcL and oLhor lavs, noLally Lho Iorsonal IaLa AcL, vas uncloar, an
olsorvaLion Lo vhich Lho GovornnonL shovod no rosonso.
J5

Moanvhilo Lho dolaLo ragod on in Lho aors. uiLo a lov nisundorsLandings voro
rovoalod, luL a nunlor ol inorLanL oinLs voro nado. Cno is Lho quosLion ol vhon
rosoarch rosulLs consisLing ol liological naLorial coaso Lo lo liological naLorial"
lron hunans, Lracoallo lacl Lo Lho hunans iL conos lron.
J6
Il such rosulLs voro Lo
lo considorod as naLorial in Lho sonso ol Lho Bill, Lhoy vould havo Lo lo dosLroyod
(or do-idonLiliod, vhich nighL cono Lo Lho sano Lhing} as soon as Lho donor
donandod iL.
AnoLhor inorLanL oinL is hov Lho hugo Lasl ol collocLing inlornod
consonL lor Lho Laling ol aL loasL 2 nillion socinons oach yoar is Lo lo carriod ouL in
racLico viLhouL aLionL socuriLy loing conronisod. To roluso Lho inclusion ol
ono`s socinon in a aLhological lanl vill ronovo Lho ossililiLios ol vorilying
rosulLs, conaring nov socinons viLh old onos, and invosLigaLing ossillo
nisjudgononLs or nix-us.
J
Il insLoad Lho socinons aro Lalon viLhouL consonL,
Lhoy vill havo Lo lo discardod alLor Lvo nonLhs, viLh Lho vory sano consoquoncos.
IL soons as Lhough aLionLs aro alnosL conollod Lo sulniL Lhoir sanlos Lo
liolanls, vhich Lhon nay lo usod lor rosoarch viLhouL aLionLs oxorcising nuch
conLrol. An ansvor lron rorosonLaLivos ol Lho InsLiLuLo lor Bionodical LaloraLory
Scionco (IBL} challongod Lhoso loars. Tho AcL shall lirsL and loronosL saloguard
aLionLs` inLogriLy, noL ronoLo rosoarch. This is in lino viLh Lho HoalLh and Modical
Sorvicos AcL and also viLh Lho oLhical guidolinos lor lionodical laloraLory
LochnologisLs, in vhich aLionL inLogriLy and Lho righL ol soll-doLorninaLion cono
lirsL. Tho vriLors Lhoroloro connondod Lho Bill.
J8

InanGononics in Ino rovolod a dolaLo on iLs ovn.
J9
IharnacouLical
conanios voro rolucLanL Lo nalo doals viLh InanGononics, sinco all rosulLs
locano accossillo Lo conoLiLors (according Lo Lho conany}. InanGononics
vanLod incroasod roLocLion againsL conoLiLors and Lo lo allo Lo oon u Lho
conany Lo noro ovnors vho could conLriluLo risl caiLal, luL Lho roosod
conLracL vas noL accoLod ly Lho CounLy Council.
40
This LhroaLonod Lo drivo
InanGononics lanlruL.
IvonLs lollovod Lhicl and lasL, viLh nov vorsions ol a conLracL loing
rosonLod alnosL daily. Much ol Lho dolaLo concornod vho ovns, conLrols, and shall
lo adninisLraLivoly rosonsillo lor Lho liolanl. Tho rosoarchors vho collocLod Lho
llood socinons lor Lho liolanl lolL LhaL Lhoy voro loing lolL ouL ol Lho icLuro.
RorosonLaLivos ol granLing organisaLions roLosLod LhaL a chango could noan granLs

J5
LaLor, Lho Svodish IaLa InsocLion Board also criLicisod Lho uncloar rolaLionshi loLvoon Lho
Biolanls AcL and Tho Iorsonal IaLa AcL. Tho rincial ol a liolanl nusL considor Lvo dilloronL acLs
aL Lho sano Lino, viLhouL alvays loing cloar alouL hov Lhoy sLand in rolaLion Lo oach oLhor. Soo
\arngrd 2002.
J6
Soo \olin & Iorsson 2001, vho discuss Lho rollon viLh rogard Lo sLon colls. Soo also \olin &
Rynning 2002.
J
Sono oxanlos: Adani 2002, Hodlacl 2002, and Nilsson 2002. Sinilar criLicisn vas voicod ly
sovoral aLionL grous, soo, lor oxanlo, KnilsLrn Nordon 2002.
J8
SilvosLri & Iricson 2002.
J9
As arL ol Lhis rojocL, Jons Laago-Hollnan has sLudiod InanGononics, and a conrohonsivo
ovorviov ol Lho dolaLo is Lo lo lound in his lorLhconing lool Commercialization oj biobanls. A study
oj biotech companies dedicated to human genetics.
40
Soo Ratten till proverna olst 2002 and Lundaprojessor jreslr alternativ lsning 2002, as voll as
Hollnan`s lorLhconing lool.
170
loing usod lor uninLondod urosos. Many lolL iL inorLanL LhaL arL ol Lho naLorial
should lo rosorvod lor ullic rosoarch. Cn Aril 22, alLor nany rovisions, Lho
conLracL vas linally accoLod ly Lho CounLy Council. Nov rosulLs could lo loL
socroL unLil connorcially usod, and ouLsido lorcos could luy inLo Lho conany
(vhich has sinco haonod}.
41
Tho idoa nov vas Lo lind gonos inorLanL lor siclnoss
and hoalLh and Lo sool aLonLs lor Lhon.
Tho conLracL vas noL signod, hovovor, and alouL Lon aoals againsL Lho
docision voro soon lodgod viLh Lho CounLy AdninisLraLivo CourL, lasod on a vholo
array ol dilloronL roasons, noL loasL LhaL donors had had no inLonLion ol suorLing
connorcial inLorosLs vhon donaLing socinons.
42
All aoals voro rojocLod in
CcLolor 2002, a docision noL alLogoLhor saLislacLory lron a logal oinL ol viov.
4J

Irolossor Gisola IahlquisL ol Ino, a nonlor ol Lho oLhics conniLLoo ol Lho
Svodish Scionco Council (lornorly MRC}, vroLo a aor urging ovoryono Lo sLo
arguing alouL ovnorshi. Nov vas Lho Lino Lo nalo suro LhaL liolanls voro
raLionally uLilisod.
44

Tho Rilsdag SLanding ConniLLoo on Social Allairs rocossod Lho
GovornnonL Bill and rosonLod iLs roorL on Aril 25.
45
Tho nain dilliculLy lor Lho
arlianonLary najoriLy vas Lho rovision on hov Lo shuL dovn a liolanl. Tho Bill
vas oLhorviso lolL unchangod, alLhough Lho ConniLLoo ronarlod LhaL iL vas
inorLanL Lo lollov u Lho racLical ouLcono ol Lho AcL, and osocially LhaL Lho
ossililiLy ol oidoniological rosoarch nusL noL lo jooardisod. This vas laLor
ondorsod ly Lho Rilsdag (IarlianonL}. Tho ConsorvaLivo IarLy, as voll as Lho ConLro
IarLy, inLroducod IrivaLo Monlors` Bills Lo oxcludo liolanls usod rinarily lor
hoalLh caro and diagnosLics lron Lho scoo ol Lho AcL, rogardloss ol hov long
socinons aro sLorod, luL voro voLod dovn.
46
In Lho onsuing arlianonLary dolaLo
Lho najoriLy vas accusod ol alnosL asLonishing nonchalanco" locauso ol iLs
rolucLanco Lo aclnovlodgo Lho rollons lacod in Lho aLh ol oidoniology and
rouLino hoalLh caro diagnosLics ly Lhoir roosal.
4
Tho Biolanls (HoalLh Caro} AcL
(SIS 2002:29} vas assod ly Lho Rilsdag on May 16, 2002 in Lho lorn roosod
ly Lho SLanding ConniLLoo on Social Allairs. IL vas suorLod ly Lho Social
IonocraLs, Lho LolL IarLy and Lho Groons.
Tho NaLional Board ol HoalLh and \ollaro Lhon dralLod a rogulaLion and
roconnondaLions vhich voro circulaLod lor connonL in CcLolor 2002 and adoLod
in Ioconlor.
48
Cno oculiar loaLuro ol Lho rogulaLion is iLs doliniLion ol `socinon`.
This includos organs and Lissuo, or arLs Lhorool, colls and coll linos, gonos or arLs
Lhorool, and oLhor lorns ol liological naLorial. Tho quosLion is hov lar on in Lho
rocoss ol rolinononL sonoLhing is Lo lall undor Lho concoL ol liological
naLorial".
49
Cloarly Lho NaLional Board ol HoalLh and \ollaro`s aLLonLion vas dravn
Lo Lhis rollon, sinco Lho linal vorsion includod Lho sLaLononL LhaL a rosulL" lron a

41
Irilsson 2002, and LilllvisL 2002.
42
Soo LvLru 2002a, LvLru 2002l, Dramat om vasterbottningarnas blod jortsatter 2002, and SLaLLin
oL al. 2002.
4J
LvLru 2002c.
44
IahlquisL 2002.
45
Socialutslottets betanlande 2002.
46
Ilid.
4
Snabbprotololl ?001/0?.107, anlrando 20 Loil Carlsson (n}.
48
SCSS ?00?.11 (M).
49
Ior noro on Lhis Loic, soo Rynning`s arLiclo in Lhis voluno.
171
Stejan rilsson
noasuro Lalon viLh a socinon doos noL lall undor Lho rogulaLion. This addiLion uLs
Lho donarcaLion lino oarlior in Lho rocoss, luL a dilliculL inLorroLaLivo Lasl ronains:
vhon does Lho socinon Lurn inLo a rosulL
LasLly, nonLion nusL lo nado ol Lho roosal lor nov oLhical roviov logislaLion in
Svodon. This is inLondod Lo Lalo ollocL on January 1, 2004. Biolanls noL rogulaLod
ly Lho Biolanls AcL vill havo Lo conly viLh Lho rulos laid dovn in Lho nov AcL,
rovidod LhaL Lho donor ol liolanl naLorial is idonLiliallo. IL ronains Lo lo soon
vhoLhor Lho nov AcL vill havo ovon groaLor inacL, naling e.g. Lho rosoarch oLhics
guidolinos rogarding liolanls olsoloLo in corLain rosocLs.
50
Briolly, Lho nov AcL says
LhaL, jusL as viLh liolanls collocLod in a hoalLh caro soLLing, rosoarch using oLhor
liolanls shall lo roviovod ly an oLhics rosoarch conniLLoo, vhich vill docido
aroriaLo rocoduros ol inlornaLion and consonL. An inLorosLing addiLion Lo Lho
rosonL rogulaLion is Lho rovision LhaL il Lho donor sLands in a doondonL
rolaLionshi Lo Lho rosoarchor or has dilliculLios in claining his or hor righLs, as is Lho
caso vhon Lho rosoarchor is also Lho donor`s docLor, or is a sLudonL`s suorvisor,
social considoraLion shall lo givon Lo quosLions ol inlornaLion and consonL during
Lho oLhical roviov.
51

3. Some topics debated during the legislation process

I nov rooso Lo doscrilo sono ol Lho najor oinLs ol discussion vhich havo
onorgod during Lho dolaLo on liolanl rogulaLion in Svodon. I vill also addross
Lhoso issuos and lriolly ovaluaLo Lho noriL ol suggosLod soluLions. Tho conclusion I
cono Lo is LhaL Lho Svodish Biolanls AcL loavos a loL ol Lho oLhical doliloraLions Lo
Lho oLhics conniLLoos, and LhaL sono dilliculL quosLions ronain Lo lo addrossod.

3.1. Consent to the taking and storage of biological specimens
Tho ouLcry in Ajtonbladet had nuch Lo do viLh Lho lacL LhaL oolo voro noL
connonly avaro LhaL Lhoir socinons voro loing loL in liolanls and could lo
usod lor rosoarch. Iornorly, according Lo Lho NaLional Board ol HoalLh and \ollaro
nosL socinons havo loon sLorod viLhouL inlornod consonL.
52
\hon Lho IaLa
InsocLion Board aslod llood lanls alouL Lhoir uso ol llood and alouL Lho
inlornaLion givon Lo llood donors, sono llood lanls adniLLod LhaL lor rosoarch
Lhoy usod llood vhich had loon collocLod lor hoalLh caro only, sonoLinos viLhouL
consonL lron donors.
This has loon connonly rojocLod as a vronglul aroach. \hon socinons
aro Lalon in a hoalLh caro soLLing, connon rincilos rogarding voliLion as voll as
rovisions in LhaL socLor concorning inlornaLion, soll-doLorninaLion and socrocy,
oLc., aro alicallo. Tho sano donands should govorn Lho sLorago, roLonLion and uso
ol socinons Lalon.
5J
Tho sLaLuLory insLrunonL issuod ly Lho NaLional Board ol

50
IurLhor Lo Lhis Loic, soo Ilril von Isson`s conLriluLion Lo Lhis voluno.
51
ThroughouL Lho dolaLo ono quosLion has loon avoidod ly all arLicianLs. Hov long shall Lho
donand lor inlornod consonL aly No ono has discussod Lhis quosLion, iL has only loon said LhaL
perhaps Lho donand nado in Lho ollicial socroLs logislaLion can lurnish guidanco (soo Lagrdsremiss
2001, socLion 10:5}. Thoro iL is said LhaL ullic donain docunonLs conLaining orsonal daLa alouL a
donor ronain socroL lor noL noro Lhan 0 yoars.
52
Liobanler i halso och sjulvrden m.m. 2000, Irord" & Irincior lr inlornaLion och sanLyclo".
5J
Regeringens proposition ?001/0?.44, ChaLor 6: Irincior lr inlornaLion och sanLyclo".
172
HoalLh and \ollaro had as iLs lirsL rulo rogarding inlornod consonL LhaL vhon Lissuo
socinons aro Lalon and collocLod lor a corLain uroso, Lho inlornod donor nusL
havo consonLod Lo Lhis, a rulo vhich has loon alnosL unaninously ondorsod in Lho
laLor discussion. (Iisosal ol old socinons is discussod in socLion J.J.}
NoL ovoryono agroos viLh Lhis rulo, hovovor. Ior oxanlo, LhirLoon
roninonL Svodish scholars vroLo an arLiclo in vhich Lhoy oxrossod Lho convicLion
LhaL iL should noL lo nocossary Lo asl lor consonL Lo sLorago vhon Laling a
socinon.
54
InsLoad consonL nay lo rosunod. To do oLhorviso vould oso a LhroaL
loLh Lo individual and ullic hoalLh. \o nusL guard Lho ossililiLios ol vorilying
individual rosulLs, Lo conaro nov socinons viLh old onos, and Lo invosLigaLo
ossillo nisjudgononLs or nix-us, Lhoy vroLo. IurLhornoro, vo havo a glolal
olligaLion Lo ronoLo rosoarch on Lho Svodish liolanls. IL is only in Lho Nordic
counLrios LhaL vo lind alnosL conloLo liolanls and hoalLh daLa rogisLors anonallo
Lo inLorlinlago. IL vould also lo loLLor Lo uso our rosourcos lor good hoalLh caro
raLhor Lhan Lo collocL inlornod consonL vhoro roviously nono vas noodod. Nov
orhas only voll-Lo-do hosiLals vill loliovo LhaL Lho ond jusLilios Lho cosL, Lhoroly
Lho rincilo ol oqual righL Lo hoalLh caro is LhroaLonod. Tho vriLors concludo LhaL in
ordor Lo do good rosoarch, liolanls nusL lo conloLo, and Lho only vay ol onsuring
LhaL is ly including socinons lron ovoryono.
Thoso argunonLs aro all good roasons vhy liolanls should lo ronoLod.
Tho olvious counLor-argunonL is LhaL noro sLricLly conLrollod liolanls nay havo
highor qualiLy and Lhus nay acLually promote individual and ullic hoalLh. IL is ol
courso hard Lo say aL Lhis oinL vhoLhor Lho nogaLivo or oLinisLic viov is closor Lo
Lho LruLh, nuch doonds on Lho lunds availallo lor liolanl acLiviLios. In Lho travaux
preparatoires iL is said LhaL in nany casos a sLandard, rinLod inlornaLion shooL is
suroly sullicionL Lo onallo a aLionL Lo docido, and LhaL gonoral vriLLon inlornaLion is
suroly sullicionL in nany casos. Thus Lho cosL ol collocLing inlornod consonL vhon a
socinon is Lalon lor hoalLh caro and LroaLnonL nood noL lo as high as sono havo
suggosLod. NovorLholoss, Lho concorn oxrossod ly Lhoso scholars undorlinos vhaL
vas sLaLod ly Lho SLanding ConniLLoo on Social Allairs, nanoly LhaL iL is inorLanL
Lo lollov u Lho racLical ouLcono ol Lho AcL. Il Lho disadvanLagos aro Loo nany, vo
vill nood Lo goL lacl Lo Lho lasic ronisos lor an ollocLivo uso ol liolanls.
Thoro is anoLhor oLhical argunonL lor noL using Lho oL-in nodol ol
inlornod consonL in nodical rosoarch. This olLon Lalos Lho lorn ol an argunonL lor a
gonoral noral olligaLion Lo arLiciaLo in nodical rosoarch. As vo aro callod uon in
nany counLrios Lo sorvo in Lho arny in ordor Lo dolond socioLy againsL niliLary
LhroaLs, so vo should lo callod uon Lo sorvo as rosoarch suljocLs in ordor Lo dolond
us all againsL LhroaLs Lo our hoalLh. \o havo Lo sacrilico sono auLonony and uL
oursolvos Lo sono inconvonioncos lor Lho ullic good. \hon you uso Lho hoalLh caro
sysLon you Lalo advanLago ol Lho vorl dono ly rior gonoraLions. \hy should you
Lalo gain lron Lhis and noL uL sonoLhing lacl in lor luLuro aLionLs Il you oxocL
Lo rocoivo Lho losL ossillo LroaLnonL, you should conLriluLo Lo Lho rocossos ly
vhich such LroaLnonL is osLallishod. Il you don`L, you aro a jree rider".
55
Tho
quosLion, Lhon, is soon Lo lo ono ol jairness. Tho argunonL undoulLodly carrios
considorallo voighL. No sysLon can LoloraLo noro Lhan a corLain nunlor ol lroo
ridors viLhouL lroaling dovn.

54
Adani 2002.
55
Soo Harris & \oods 2001, and viovoinLs Londorod in Committee on thical lssues 1999.
173
Stejan rilsson
Hovovor, as a gonoral argunonL lor Lho righL ol an govornnonL Lo includo ciLizons in
nodical rosoarch, Lhis is oon Lo quosLion. IirsLly, Lho vholo icLuro ol a lroo ridor
nay lo nisguidod. Inirical rosoarch oxisLs vhich suggosLs LhaL arLiciaLion in
nodical Lrials nay acLually lo lonolicial Lo aLionLs.
56
Il so, iL is no lurdon on a
aLionL Lo Lalo arL in clinical rosoarch: on Lho conLrary, Lo roluso Lo do so is Lo
doclino a oLonLial hoalLh lonoliL. BuL suroly, LhaL only sLrongLhons Lho noral
olligaLion In LhoraouLic rosoarch iL nay do so. BuL ovon vhon iL conos Lo
LhoraouLic rosoarch Lhis lino ol roasoning is Loo suggosLivo ol a rocirocal rolaLion
loLvoon Lho hoalLh caro sysLon and Lho individuals vho loLh conLriluLo Lo and uso
iL. Rosoarch is nosL olLon dono ly connorcial onLorrisos. Cl courso, Lhoso
onLorrisos aro nocossary in ordor Lo goL nov nodicinos, luL on Lho oLhor hand Lho
rosoarch suljocL nay lo soon as a rosourco" vho in nany casos von`L lonoliL lron
Lho rosulLs ol rosoarch viLhouL aying lor iL. Iorhas, Lhon, Lho suljocL doos noL lind
hinsoll in a rocirocal rolaLion luL is raLhor in Lho osiLion ol loing a oLonLial
cusLonor vho arLiciaLos as a ossillo cusLonor and connorcial rosourco. And ol
courso iL is noL Loo unconnon Lo lind volunLoors arLiciaLing in rosoarch
rincially lor linancial roasons.
5

Also, such an olligaLion cannoL lo aLLriluLod Lo jusL anyono and ovoryono.
Tho argunonL arisos ouL ol a rodoninanLly vosLorn orsocLivo. Ioolo in Lho
dovoloing vorld nosL olLon havo noL and in nany casos vill noL gain accoss Lo Lho
rosulLs ol nodical rosoarch. This lacL vill sonoLinos lo disLurling ovon in an
allluonL vosLorn counLry lilo Svodon. Ioonding on Lho rolaLionshi loLvoon a
Svodish rosoarch sLudy and Lho inLornaLional rosonco ol Lho drug conany
rosonsillo, an olligaLion nay lo lolL noro or loss sLrongly, or noL aL all. Il, lor
oxanlo, a drug conany von`L nalo a drug as accossillo Lo Third \orld counLrios
as Lo vosLornors, Lhis nay lor oxanlo lo orcoivod ol as a lroach ol Lho IN
ConvonLion on Social, Icononic and CulLural RighLs, vhich rocognisos Lho righL Lo
onjoynonL ol Lho highosL aLLainallo sLandards ol hoalLh. In such a caso oolo havo,
ol courso, no duLy Lo arLiciaLo in such an ondoavour.
\o concludo LhaL a noral olligaLion may carry considorallo voighL lor a
corLain individual aLionL, luL vo cannoL assuno ouLrighL LhaL iL doos and Lhoroloro
in gonoral dro Lho donand lor volunLary arLiciaLion. Tho govornnonL has no
righL Lo inLroduco a univorsal duLy ol arLiciaLion in rosoarch on Lho lasis ol an
assunod noral olligaLion. ThaL olligaLion nay oxisL, luL noL in such a vay as Lo
jusLily lorcing Lho ullic inLo arLiciaLion. RaLhor, Lho argunonL shovs LhaL Lhoro
nay lo casos vhoro alLor joinL oxaninaLion (in an oLhics conniLLoo, LhaL is} vo lind
iL roasonallo lor rosoarch Lo lo dono ovon viLhouL consonL loing olLainod. In ordor
Lo soo vhoLhor such an olligaLion nay lo rosunod, vo nood Lo oxanino oach
arLicular caso on iLs noriLs. \hon liolanl rosoarch in Svodon is concornod, vo
lind loLh a rolaLion loLvoon aLionLs and Lho hoalLh caro sysLon vhich nay lo
arLly doscrilod as rocirocal, and aLionLs vho olLon oxross Lhoir villingnoss Lo
conLriluLo Lo rosoarch lor alLruisLic roasons.
58
\hon socinons aro Lalon lron
aLionLs lor hoalLh caro urosos and, noroovor, nay lo usod lor rosoarch, vo

56
22 sLudios suorLing Lhis conclusion aro nonLionod in Chalnors & Lindloy 2001. Soo also LanLos
1999.
5
\hon Gornans arLiciaLing in rosoarch voro aslod in an anonynous quosLionnairo Lo givo Lhoir
roasons lor doing so, 6' uL linancial noLivos lirsL in Lhoir ansvor. Soo van Goldoron oL al. 199J.
58
Soo, lor oxanlo, GusLalsson SLolL oL al. 2002.
174
undoulLodly havo a rino oxanlo ol a siLuaLion vhoro Lho aLionL gains dirocLly
lron Lhis and aL Lho sano Lino can conLriluLo Lo Lho connon good and Lho luLuro
voll-loing ol oLhors. Thoroloro iL doos noL soon unliloly LhaL vo nay lind such an
olligaLion as doscrilod ly Lho lroo ridor argunonL Lo ossilly oxisL in sono casos.

3.2. The extent of information needed
\haL aro Lho inlornaLion roquirononLs vhon sonoono vanLs Lo collocL socinons
lron donors or aLionLs Tho GovornnonL`s Modical ILhics Advisory Board (SMIR}
criLicisod Lho roorL lron Lho NaLional Board ol HoalLh and \ollaro lor iLs vory
lailuro Lo socily such roquirononLs.
59
Sono cluos aro givon in Lho travaux
preparatoires, vhoro iL is said LhaL in nany casos a sLandard, rinLod inlornaLion
shooL is suroly sullicionL Lo onallo a aLionL docido, and LhaL Lho rocoduro Lo lo
lollovod in a arLicular caso cannoL lo logislaLod on in doLail. Gonoral vriLLon
inlornaLion is suroly sullicionL in nany casos, vhilo sono urosos donand socilic
inlornaLion, adjusLod Lo Lho individual. So iL soons ossillo in nany casos Lo givo
gonoral, vriLLon inlornaLion concorning a lroad uroso.
Tho SCSIS 2002:11 (M} guidolinos and roconnondaLions say LhaL Lho
consonLing arLy should lo inlornod LhaL aroval ly an oLhics conniLLoo is
nocossary in ordor Lo uso a liolanl lor rosoarch or clinical Lrials, LhaL nov inlornod
consonL has Lo lo collocLod il ono`s socinon is Lo lo usod lor anoLhor uroso Lhan
has hiLhorLo loon Lho caso, and LhaL ono`s consonL nay lo viLhdravn aL any Lino (in
vhich caso Lho socinon shall lo dosLroyod or do-idonLiliod il Lho viLhdraval
concorns all uso ol iL}. Tho roconnondaLions sLaLo LhaL Lho inlornod arLy should
considor lor vhaL urosos Lho socinon nay lo Lranslorrod Lo oLhor arLios.
GovornnonL Bill also says LhaL Lho inlornaLion usually givon should noL lo
loss Lhan is roquirod ly SocLion 25 ol Lho Iorsonal IaLa AcL. ThaL socLion rovidos
LhaL inlornaLion shall includo inlornaLion on Lho uso ol orsonal daLa (lor vhich
road: socinons}, luL also LhaL iL shall includo inlornaLion on Lho idonLiLy ol Lho
orson rosonsillo lor Lho orsonal daLa, and all oLhor inlornaLion Lho orson noods
lor Lho assorLion ol his or hor righLs, o.g. vho vill rocoivo Lho daLa and Lho lacL LhaL a
orson is onLiLlod Lo lnov vhaL is loing dono Lo Lhoir daLa. As Rynning ronarls in
Lhis voluno, sinilar donands havo loon nado aL various Linos ly Lho Council ol
Iuroo.
Il orsonal daLa aro rocossod addiLional donands havo Lo lo noL, as
rosonLod in Lho Iorsonal IaLa AcL. In a roconL roorL, Lho IaLa InsocLion Board
rovoalod LhaL in quiLo a lov vays gonoLic rosoarchors aL rosonL do noL soon Lo lully
conly viLh Lho rogulaLivo donands.
60
In Lho roorL Lho lolloving asocLs ol
inlornod consonL voro nonLionod as nandaLory in addiLion Lo Lho onos nonLionod
alovo: consonL shall lo givon Lo a socilic rocossing ol orsonal daLa (Lhis is noL
saLisliod ly a orson consonLing Lo Lho sLudy as such} and Lo a Lranslor ol daLa Lo a
Lhird counLry, and inlornaLion givon should includo Lho olligaLion Lo roloaso daLa,
Lho righL Lo rocLily orronoous daLa, and vhoLhor daLa vill lo Lranslorrod Lo anoLhor
counLry.
61
As nonLionod olsovhoro, il Lho uroso ol rocossing is rosoarch, an oLhics
conniLLoo nay docido uon Lho aroriaLo lovol ol inlornod consonL and nay
vaivo sono ol Lho roquirononLs.

59
Remissyttrande ver Socialstyrelsens rapport 2000.
60
ersonuppgijter i genjorslning 2002.
61
Soo also SCSS ?00?.11 (M), Cha. 4, SocLion 5.
175
Stejan rilsson
In Lho MRC rosoarch oLhics guidolinos iL is said LhaL donors should havo Lho righL Lo
lo Lold hov Lho socinons vill lo sLorod, lor hov long, and hov Lhoy vill ronain
rogisLorod. InlornaLion should includo Lho usos ol Lho socinons LhaL can lo
rodicLod and vhaL vill lo dono Lo rovonL unauLhorisod arLios lron accossing Lho
inlornaLion. Il socinons nay laLor lo usod lor a nov rosoarch uroso, an oLhics
conniLLoo vill roviov and arovo Lho rosoarch and docido Lho roquirononLs lor
inlornod consonL. Tho MRC havo nuch sLrongor donands on hunan suljocLs
rosoarch ol Lho oxorinonLal lind, and so iL soons cloar LhaL a disLincLion is aL vorl
horo loLvoon Lhis lind ol rosoarch and liolanl rosoarch.
Tho MRC also vroLo LhaL iL is inorLanL Lo onsuro Lho individual`s inLorosL il
Lho rosoarch can idonLily a narlor lor a disoaso lor vhich sono lorn ol inLorvonLion
nay lo availallo. Il so, Lhis is a uso" ol Lho socinon vhich roquiros arLicular
aLLonLion: Rogarding rolaLivos, Lhoy vroLo LhaL a rosoarch oLhics conniLLoo nusL
also carolully considor siLuaLions such as vhon gono narlors nay havo individual or
grou inLorosL lor concornod rolaLivos ol Lho orson vho has sulniLLod Lho
socinon. In such casos inlornod consonL should lo olLainod lron anyono vho can
lo dirocLly allocLod ly rosoarch rosulLs."
62
This guidolino vas ondorsod ly Lho
NaLional Board ol HoalLh and \ollaro and Lho GovornnonL.
6J
Tho Loic ronains
highly conLrovorsial and Lho GovornnonL has aoinLod a conniLLoo Lo inquiro e.g.
inLo Lho naLLor ol inlornaLion Lo rolaLivos.
64

Thoro is also a oculiar socLion ol Lho AcL vhich has noL loon dolaLod
hiLhorLo. Cha. 4, SocLion 5 rovidos LhaL il Lho donor consonLs, socinons in codod
lorn nay lo roloasod Lo anoLhor uniL insido or ouLsido Lho counLry lor analysis oLc.
65

So, il you collocL socinons lor a lanl and lan Lo nalo uso ol a laloraLory
sonovhoro olso you vill havo Lo inlorn oach donor ol Lhis vhon Laling ol Lho
socinon, oLhorviso you vill laco a Lronondous Lasl ol ro-conLacLing ovoryono laLor.
This donand soons sonovhaL ovorsLaLod, sinco iL is Lho only ono givon oxliciL logal
lacling in Lho AcL, vhoroas nany oLhor inlornaLion roquirononLs aro usually
orcoivod as noro inorLanL in various oLhical guidolinos.
To concludo, a rogular vorsion ol an inlornaLion shooL should usually
includo Lho lolloving in ordor Lo conly viLh Lho sLandards issuod ly Lho MRC, Lho
NaLional Board ol HoalLh and \ollaro, and Lho GovornnonL:

Ior vhaL usos is Lho naLorial collocLod
\ho is rosonsillo lor Lho liolanl
\ho vill havo accoss Lo or lo rovidod viLh Lho socinon
\ill Lho socinon lo sonL sonovhoro olso (ConsonL undor Cha. 4, SocLion 5
ol Lho Biolanls AcL}
Nov inlornod consonL is Lo lo olLainod il Lho socinon is usod lor anoLhor
uroso.

62
Research ethics guidelines 1999.
6J
Liobanler i halso och sjulvrden m.m. 2000, SocialsLyrolsons vorvagandon och lrslag", socLion 5,
and Lagrdsremiss 2001, socLion 10:6. In a lorLhconing arLiclo, Should rosulLs lron gonoLic rosoarch
lo roLurnod Lo rosoarch suljocLs and Lhoir noxL-ol-lin", I discuss Lhis Loic lurLhor. Soo Lho volsiLo ol
Lho rosoarch rogran lor udaLos on ullicaLions, or ny volsiLo aL
<hLL://vvv.Lool.uu.so/honoago/sLolan_orilsson/ullilaLionor.hLn>
64
Soo Cenetisla underslningar m.m. 2001.
65
Ior a doLailod oxoso, soo Rynning`s arLiclo in Lhis voluno.
176

Il Lho nov uroso is rosoarch, an oLhics conniLLoo vill roviov and arovo Lho
rosoarch and dolino Lho roquirononLs lor inlornod consonL.
Tho ossililiLy ol rovoling ono`s consonL
AddiLional donands occasionod ly Lho rocossing ol orsonal daLa (viLh socilic
consonL}
\hon Lho uroso is rosoarch: Hov vill Lho socinons lo sLorod Ior hov long
Hov vill Lhoy lo rogisLorod
\haL vill lo dono Lo rovonL unauLhorisod arLios lron accossing inlornaLion
gaLhorod in Lho rojocL
May rosoarch rosulLs lo roLurnod il inorLanL lor Lho suljocL`s hoalLh Is consonL
lron rolaLivos noodod

Moro iLons can lo addod Lo Lhis lisL ol courso. Ior oxanlo, iL is inorLanL Lo loo
in nind Lho ongoing discussion ol vhoLhor Lhoro is a nood Lo olLain inlornod
consonL lor Lho Laling ol a socinon, il an invonLion lasod on Lho naLorial Lalon is
laLor Lo lo aLonLod (soo conLriluLions ly Rynning and \ossnan lor noro on Lhis
Loic}.
To concludo Lhis socLion I vill rosonL Lhroo conlicaLions ol Lho discussion
alovo. IirsL, Lho sLaLus and conLonL ol Lho Holsinli IoclaraLion conlicaLo Lhings a
liLLlo. Iroviously Lho doclaraLion vas said Lo consisL ol roconnondaLions". SocLion
nino ol Lho nov 2000 vorsion sLaLos LhaL ovon il rosoarch invosLigaLors should lo
avaro ol oLhical, logal and rogulaLory roquirononLs lor rosoarch on hunan suljocLs in
Lhoir ovn counLrios as voll as alicallo inLornaLional roquirononLs, no naLional
oLhical, logal or rogulaLory roquirononL should lo allovod Lo roduco or olininaLo any
ol Lho roLocLions lor hunan suljocLs soL lorLh in Lhis IoclaraLion." Considor, Lhon,
LhaL in Lho lirsL socLion iL is sLaLod LhaL nodical rosoarch involving hunan suljocLs
includos rosoarch on idonLiliallo hunan naLorial or idonLiliallo daLa". This noans
LhaL Lho alovo disLincLion loLvoon hunan suljocLs oxorinonLaLion and gonoral
liolanl rosoarch doos noL hold. All Lho roquirononLs dolinod concorning
inlornaLion shall aly Lo liolanl rosoarch, vhich noans LhaL oach oLonLial
suljocL nusL lo adoquaLoly inlornod ol Lho ains, noLhods, sourcos ol lunding, any
ossillo conllicLs ol inLorosL, insLiLuLional alliliaLions ol Lho rosoarchor, Lho
anLiciaLod lonoliLs and oLonLial risls ol Lho sLudy and Lho disconlorL iL nay onLail"
(socLion 22}. To Lalo Lhoso roquirononLs soriously vill lo aL odds viLh curronL
racLico in Svodon and viLh Lho various guidolinos rosonLod horo so lar.
66

Tho socond conlicaLion concorns Lho disLincLion also usod in Lho
doclaraLion alovo, LhaL loLvoon idonLiliallo and non-idonLiliallo socinons. IirsL vo
should noLo LhaL Lho IaLa InsocLion Board sav a connon nisconcoLion anongsL
liolanl rincials: Lhoy LhoughL LhaL codod naLorial vas do-idonLiliod. Tho Board
nado cloar LhaL Lhis is noL Lho caso: inlornaLion is do-idonLiliod only vhon Lhoro is
no ossililiLy ol Lracing iL Lo a orson.
6
So according Lo Lho Svodish IaLa InsocLion
Board, a soluLion vhich consisLs in Lho coding ol naLorial is insullicionL e.g. lor
gonoLic naLorial. Such naLorial is a lorn ol orsonal daLa as long as iL is Lracoallo Lo

66
Cno rollon is LhaL Lho guidolinos lron Lho MRC do noL discuss Lho Holsinli IoclaraLion ol 2000,
ovon Lhough Lho MRC rovisod Lho aragrahs alouL liolanls in 2002'
6
Liobanlers behandling av personuppgijter 2000, . 14. Such a nisloading uso ol do-idonLiliod" is
connon, lor oxanlo Lho INISCC InLornaLional BiooLhics ConniLLoo usos Lho Lorn Lo rolor Lo
codod socinons (soo Drajt Report on Collection 2001}.
177
Stejan rilsson
a orson, and vhon iL is rocossod Lhis nalos Lho Iorsonal IaLa AcL alicallo. Thus
nornally noiLhor rosunod consonL, nor an inlornod rolusal, aro accoLallo lor such
rocossing (unloss Lho oxcoLions nado ly Lho Iorsonal IaLa AcL aro alicallo, as
vhon Lho uroso is rosoarch}.
So, vhaL il you goL rid ol Lho codo This doos noL ol nocossiLy inly LhaL
socinons aro do-idonLiliod. Rynning and Lindlorg, anong oLhors, loLh noLo LhaL iL
is ossillo Lo idonLily socinons conLaining gonoLical inlornaLion ovon il Lhoy aro do-
idonLiliod.
68
Il you havo a arLicular gono soquonco, lor oxanlo, and can run iL
againsL idonLiliod gonoLical inlornaLion olsovhoro, you nay idonLily Lho orson Lho
soquonco conos lron. This is lnovn as conuLor roliling". Considor IirocLivo
95/46/IC ol Lho Iurooan IarlianonL and ol Lho Council ol 24 CcLolor 1995 on
Lho roLocLion ol individuals viLh rogard Lo Lho rocossing ol orsonal daLa and on
Lho lroo novononL ol such daLa, vhich says LhaL \horoas Lho rincilos ol
roLocLion nusL aly Lo any inlornaLion concorning an idonLiliod or idonLiliallo
orson, vhoroas, Lo doLornino vhoLhor a orson is idonLiliallo, accounL should lo
Lalon ol all the means lilely reasonably to be used oiLhor ly Lho conLrollor or ly any
other person Lo idonLily Lho said orson." (ny iLalics}.
69
Tho NaLional Board ol
HoalLh and \ollaro also noLod LhaL Lhis vas Lho caso. NovorLholoss Lhoy soonod Lo
assuno LhroughouL Lho roorL LhaL iL vas noaninglul Lo dilloronLiaLo loLvoon
idonLiliallo or codod naLorial on Lho ono hand and do-idonLiliod naLorial on Lho
oLhor, as did Lho GovornnonL in Lho roosal rolorrod Lo Lho Svodish Council on
LogislaLion. BuL Lhis dilloronLiaLion rosLs on shaly loundaLions, as vo soo horo.
Thoro vill rolally lo no nov snarL vay ol do-idonLilying socinons, il
anyLhing Lho oosiLo nay lo Lho caso (Lho invonLion ol nov noans Lo idonLily
socinons}, so I Lhinl Lho only soluLion Lo Lhis dilonna is Lo sLo locusing on Lho
roorLios ol Lho socinon iLsoll. Tho inorLanL Lhing isn`L vhoLhor iL has loon
conloLoly sLriod ol idonLiliors or noL, luL vhoLhor iL vill lo usod in such a vay as
Lo nalo an idonLilicaLion ossillo. Il INA is loL and usod in such a vay LhaL Lho
inlornaLion cannoL lo conarod Lo ouLsido" sourcos ol INA, Lho chancos ol
idonLilicaLion aro vory, vory snall. BuL il Lho socinon is rorosonLod in digiLal
lornaL on Lho InLornoL, Lho risl is considorally highor, ovon il iL is sLill snall. In
oLhor vords, a socilic doscriLion ol vhaL vill lo dono viLh socinons, noL loasL
lron a Lochnological oinL ol viov, is noodod in ordor lor an oLhics conniLLoo Lo
docido on aroriaLo noasuros.
LasLly, Lhoro is a aranounL rollon rogarding Lho lovol ol undorsLanding
on Lho arL ol aLionLs.
0
In a Ironch sLudy, aLionLs vho had consonLod Lo socinons
loing sLorod in a INA lanl vas laLor sonL a quosLionnairo in ordor Lo assoss Lhoir
orcoLions ol sLorago and consonL. Cl Lho aLionLs vho roliod, nono vas avaro
LhaL his or hor sanlos voro loing sLorod in a lanl, and nono rononlorod signing a
consonL lorn.
1
In roconL liLoraLuro on inlornod consonL Lhoro has loon a shilL lron
onhasis on Lho documentation ol inlornod consonL Lo Lho process ol giving
inlornaLion and onsuring conrohonsion.
2
GroaL connunicaLivo slill is noodod il

68
Rynning 1998, and again in Rynning 2000, . 458, Lindlorg 199. Soo also lor oxanlo GosLin
1995, . 494.
69
Ior lurLhor discussion ol Lho dirocLivo, soo Zooga & Andorson 2000.
0
Soo \orl 2002, vhich doscrilos Lho conrohonsion rollon and givos roloroncos Lo sono
onirical sLudios on Lho suljocL.
1
MouLol oL al. 2001.
2
Cn Lhis suljocL, soo lor oxanlo NaLional BiooLhics Advisory Connission 2001.
178
aLionLs aro Lo goL Lho advico and assisLanco Lhoy nood in ordor Lo lo as auLononous
in Lhoir docision as Lhoy can lo. Today`s advancod rosoarch is vory dilliculL lor nany
oolo Lo conrohond, noL loasL sinco nodorn gonoLics is such a conlox ondoavour
and is so lound u viLh rolaliliLios. Il Lho inlornaLion isn`L undorsLood, Lho idoa ol
an auLononous and voll-inlornod docision has raLhor a hollov ring Lo iL. I an noL
suggosLing Lhis nalos Lho consonL invalid, luL I do Lhinl iL uLs loloro us an oLhical
challongo Lo Lry and inrovo aLionL inlornaLion and conrohonsion. NoL loasL
aLionLs vho havo loon sLriclon viLh lad novs nay havo a hard Lino Laling in
inlornaLion and dociding uon Lho ossillo inclusion ol Lhoir socinon in a liolanl.
Il Lhoy say No iL nay rojudico Lhoir luLuro caro, vhich can lo hard lor a orson in
such a sLaLo Lo undorsLand. In ordor Lo inrovo Lho ossililiLy ol Lruo undorsLanding
vhich onallos oolo Lo nalo auLononous choicos, vo nood Lo inlononL sLraLogios
vhich onallo oach arLy Lo Lho inlornod consonL rocoss Lo arLalo in Lhis rocoss
in a lruiLlul nannor. \ory lriolly, sonoLhing along Lhoso linos is callod lor:
ducation policies. Tho gonoral ullic nusL loarn noro alouL ollocLivo hoalLh
caro and rosoarch, as voll as lo oducaLod alouL gonoLics.
rojessional training. Tho gonoral racLiLionor vill olLon lo Lho orson vho
nooLs Lho aLionL and Lhus vill nood a noro Lhorough undorsLanding ol rosoarch and
gonoLics in ordor Lo givo guidanco Lo his or hor aLionLs. Ho or sho nusL also lo
lnovlodgoallo alouL Lho risls, loLh Lo Lho aLionL and Lho aLionL`s rolaLivos,
onLailod ly a docision noL Lo sLoro, lor oxanlo, a cyLological socinon. BoLh gonoral
racLiLionors and qualiliod oxorLs vill nood Lo dovolo Lhoir connunicaLion slills.
J

A sinlo luL ollocLivo Lool lor assossing aLionLs` conrohonsion is Lo asl Lhon Lo
ro-vord Lho inlornaLion givon. GonoLic counsolling nay lo aroriaLo in noro
insLancos Lhan Lhoso lor vhich iL is curronLly rovidod.
Letter instruments. \o nood noro onirical lnovlodgo alouL inlornaLion
roadaliliLy in ordor Lo rosonL inlornaLion in Lho losL ossillo vay. HornonouLics
oxorLs should join lorcos viLh rosoarch rolossionals. IurLhornoro, Lho rocoss ol
inlornod consonL should noL lo considorod as ovor vhon Lho sLaLononL is signod and
Lho socinon has loon sLorod. Ioolo`s roloroncos chango ovor Lino and
undorsLanding sonoLinos Lalos Lino Loo, Lhoroloro inlornaLion should olLon lo
givon on a noro or loss rogular lasis and nov vays dovolood ol suorLing an
ollocLivo ongoing rocoss ol Lvo-vay-inlornaLion. Il a conLacL is nainLainod, iL vill
also lo nuch oasior Lo roLurn rosulLs or Lo ro-conLacL Lho aLionL vhon nov consonL
is noodod lor a nov sLudy.

3.3. The need for consent to new research on existing specimens
Io you nood Lo havo nov inlornod consonL lron donors il Lhoir socinons aro Lo lo
usod lor neu purposes
4
Iurosos rocognisod in Lho lav aro caro and LroaLnonL,
qualiLy assuranco, Loaching, rosoarch, clinical Lrial, noLhod and conoLonco
dovolononL or sinilar ondoavours. BuL vhon Lho uroso is rosoarch, a raLhor
dilloronL noLion ol uroso" conos inLo lay. In rosoarch oLhics Lhoro is a connon
donand LhaL Lho socilics ol oach and ovory rosoarch rojocL lo doscrilod Lo Lho
suljocL loloro ho or sho consonLs Lo iL. AlLhough Lhis noLion is noL sollod ouL in Lho
AcL, iL is oasy Lo soo LhaL iL is rosunod.

J
Soo Hall 2001, lor an inLroducLion Lo Lhis Lhono and lor a conrohonsivo lilliograhy on Lho
suljocL.
4
This quosLion vas lirsL lroachod ly Bo Lindlorg in Lindlorg 199.
179
Stejan rilsson
Rynning, as voll as Lho Svodish Modical Rosoarch Council, ronarls LhaL sinco iL is
dilliculL Lo rodicL vhaL luLuro analysos LhaL vill lo ossillo and dosirallo, iL is hard
Lo asl lor a LradiLional consonL vhoro all circunsLancos aro ouLlinod in doLail.
5
Is iL
Lhon onough jusL Lo consonL Lo Lho socinon loing Lalon lor an unsociliod rosoarch
uroso, jusL as InanGononics iniLially usod an inlornaLion shooL noroly sLaLing
LhaL Lho socinons vould lo usod lor rosoarch concorning rovonLion, diagnosis, and
LroaLnonL ol hoarL aLLacls, sLrolo, and dialoLos, luL also Lo lind ouL alouL Lhoso and
oLhor disoasos, lor oxanlo cancor
6

This rollon is oquivalonL Lo Lho ono alouL old socinons collocLod agos
ago, rolally viLhouL consonL. Nov, vhon noasuros aro Lalon viLh socinons
collocLod loloro Lho acL cono inLo lorco, Lhoy cono undor Lho AcL. So no disLincLion
is nado loLvoon old and nov naLorial in Lhis rosocL. SLill, as noLod ly Rynning, iL
nay lo hard Lo docido vhoLhor a arLicular liolanl is Lo counL as a rinary or
socondary liolanl and vhaL Lho uroso originally vas. IurLhornoro, dilloronL
socinons in Lho lanl nay havo dilloronL origins.
Gisola IahlquisL, chairorson ol Lho MRC aL Lho Lino, hold LhaL Lo noL again
asl donors LhaL onco gavo Lhoir socinons lor luLuro rosoarch, is conLrary Lo Lho
rosoarch oLhics guidolinos in lorco in Svodon. AlLhough Lhoro aro oxcoLions, Lhoy
aro vory sLricL.
Tho guidolinos issuod ly Lho MRC say LhaL inlornod consonL lor
oach nov uroso is Lho nain rulo, vhich noans LhaL gonoral inlornaLion vhoro Lho
aLionL consonLs Lo Lho uso ol collocLod naLorial lor unsociliod luLuro rosoarch
cannoL lo accoLod."
8
Gran Hornoron noLod LhaL ovon il an oL-in or oL-ouL
nodol ol inlornod consonL is rolorallo in nany casos, Lhis has iLs rollons. Many
liolanls aro vory largo and a rosoarch rojocL using nany socinons vould Lhon
nood Lo conLacL so nany oolo LhaL iL vould lo unnanagoallo. Sono liolanls
havo oxisLod lor nany docados and nosL donors aro ly nov docoasod.
9
Tho
sLaLononLs roquiring nov consonL lor oach nov rosoarch rojocL voro ol gravo
concorn Lo scionLisLs. Rosoarchors vorriod, lor oxanlo in Lho rolorral lron Lho
Karolinsla InsLiLuLo,
80
alouL having Lo collocL nov consonL lor ovory changod
analysis, sonoLhing vhich vill lo hard Lo do, vill cosL a loL, and vill causo a high
dro-ouL raLo.
81

Tho NaLional Board ol HoalLh and \ollaro suggosLod in Lho Bill LhaL
socinon donors should consonL Lo oLhor usos" ol Lhoir socinons. BuL il Lho
uroso vas rosoarch Lhon Lho oLhics conniLLoo should docido on aroriaLo
inlornaLion and consonL. This ol courso vas anliguous, as iL can lo Lalon Lo noan
LhaL Lho conniLLoo shall chocl vhoLhor Lho donand has loon saLisliod, or LhaL Lho
Lasl is Lo docido vhoLhor nov inlornod consonL is noodod aL all. Tho lirsL
inLorroLaLion gains suorL lron anoLhor assago vhoro Lho Board soals ol Lho
conniLLoo as dociding hou inlornod consonL shall lo collocLod. BuL in anoLhor
assago Lhoy say LhaL iL is cusLonary lor Lho oLhics conniLLoo Lo oxanino loLh Lho

5
Rynning 1998, . J0, Research ethics guidelines 1999.
6
lnjormation om medicinsla biobanlen 2000.
IahlquisL 1999.
8
Ivon il only Lho aLionL" is nonLionod, MIR also says LhaL Lho guidolinos also aly, vhoro
aroriaLo, vhon liological naLorial is collocLod nainly lor an idonLiliod rosoarch rojocL." (Research
ethics guidelines 1999}.
9
Hornoron 199a, . J1.
80
Lagrdsremiss 2001, socLion 10:8.
81
Ior noro on Lhis Loic, Soo Magnus Kaisor`s conLriluLion Lo Lhis voluno.
180
lovol ol inlornod consonL and uhether it is needed.
82
IL is hard Lo soo vhoLhor Lho
vriLors havo doliloraLoly addrossod Lho rollon.
In Lho roosal rolorrod Lo Lho Svodish Council on LogislaLion, Lho vording
ol Lho socLion had loon changod Lo Lho lirsL alLornaLivo alovo (hov"}. NovorLholoss,
in Lho connonLary Lhoy vroLo LhaL a rosoarch oLhics conniLLoo nay doarL lron
Lho rincilo ol inlornod consonL, sonoLhing vhich is in lino viLh Lho oLhical
guidolinos ol Lho Modical Rosoarch Council. Tho ronarl LhaL iL is cusLonary lor Lho
oLhics conniLLoo Lo oxanino loLh Lho lovol ol inlornod consonL and vhoLhor iL is
noodod vas sLill roLainod in Lho connonLary. Iocisions vould Lhus lo guidod, Lhoy
vroLo, ly Lho oLhical guidolinos ol Lho Modical Rosoarch Council, noL a doLailod
lav.
8J
This vas ondorsod ly Lho GovornnonL.
84
Thus, sono criLics vho arguod LhaL
nov inlornod consonL vas nov Lo lo noodod aL all Linos had nisundorsLood Lho
roosal. To concludo, Lho curronL guidolinos sLaLo LhaL: (a} consonL Lo unsociliod
luLuro rosoarch is conLrovorsial and according Lo Lho MRC cannoL lo accoLod, (l}
inlornod consonL lor oach nov uroso is Lho nain rulo, and (c} Lho oLhics
conniLLoo nay doarL lron Lho rincilo ol inlornod consonL vhon corLain criLoria
aro noL.
IL has long loon cusLonary Lo arovo corLain linds ol rosoarch viLhouL
donors having consonLod Lo socilic urosos. \hilo Lhoro aro nany variaLions on
Lho Lhono, lroadly soaling Lvo nodols nay lo disLinguishod: Lho revieu model and
Lho projessional conduct model. Tho roviov nodol uLs Lho onhasis on roviov ly an
oLhics conniLLoo, an IRB or Lho lilo. Tho conniLLoo shall onsuro LhaL corLain
criLoria aro lullillod loloro aroving a rosoarch rojocL vhoro inlornod consonL is
vaivod. CriLoria usually roquiro anong oLhor Lhings (a} LhaL individuals concornod
nay lo LhoughL Lo givo rosunod consonL, (l} LhaL arLicianLs aro only suljocL Lo
nininal risl, (c} LhaL daLa or socinons aro codod or do-idonLiliod and (d} LhaL
ullic inLorosL in Lho rosoarch cloarly ouLvoighs any harns and risls Lo arLicianLs.
SonoLhing along Lhoso linos is Lho usual rocoduro lor inlornaLion-sonsiLivo
rosoarch, and lasically Lho ono agrood uon in Lho lornor conLracL loLvoon
InanGononics and Ino InivorsiLy/\asLorloLLon CounLy Council, vhoro only
codod or do-idonLiliod socinons and daLa aro suosod Lo lo givon ly Lho liolanl
Lo Lho conany.
85
Tho govornnonLal doarLnonL nonorandun Cenetic lntegrity,
86
as
voll as Lho roorL ly Lho NaLional Board ol HoalLh and \ollaro, liloviso sLrossod
LhaL inlornaLion concorning an individual`s gonos usod lor rosoarch usually should lo
do-idonLiliod (or codod}.
Tho rolossional conducL nodol can lo insLancod viLh Lho BriLish Royal
Collogo ol Ihysicians, vhich sLaLod in iLs guidolinos LhaL noiLhor roviov ly a
conniLLoo, nor inlornod consonL is noodod as long as accoss is olLainod lron Lho
cusLodian ol Lho naLorial, il conlidonLialiLy issuos aro solvod roassuringly, and il Lho
rociionL ol Lho naLorial is a sonior rolossional vho is suljocL Lo an ollocLivo
discilinary codo onlorcod ly his or hor rolossional lody ovor any lroach ol
conlidonLialiLy".
8

82
Liobanler i halso och sjulvrden m.m. 2000, SocialsLyrolsons vorvagandon och lrslag, socLion 8".
8J
84
Regeringens proposition ?001/0?.44, ChaLor 10: Cvorvagandon och lrslag", socLion 10:9.
85
orslnings och utvecllingsavtal 1999.
86
Cenetisl integritet 1996.
8
Cuidelines on the ractice oj thics Committees 1996, Aondix B.
181
Stejan rilsson
BuL Lhoro is anoLhor ossillo osiLion vhich is olLon lasod on Lho noLion ol Lho
digniLy ol Lho hunan loing" lound in Lho ConvonLion on Hunan RighLs and
Bionodicino. This osiLion lasically says LhaL hunan Lissuo cannoL lo LroaLod lilo
oLhor sourcos ol inlornaLion. Hunan Lissuo is an inLrinsic arL ol Lho lody, and Lho
lody is an inLogral arL ol a orson. IL is Lhoroloro lain vrong lor oLhors Lo uso a
orson`s Lissuo viLhouL oxliciL consonL.
88
AnoLhor vay ol uLLing iL is Lo conaro
such a sLudy Lo an inLrudor goLLing inLo a houso vhon no-ono is hono, viLhouL
disLurling anyLhing. Ivon so, Lho houso inhaliLanL has loon vrongod. By Lho sano
Lolon, Lo do rosoarch viLhouL oxliciL consonL is Lo invado your rivacy viLhouL
consonL, vhaL in lav is lnovn as Lrosass,
89
and Lhoroloro should noL lo allovod.
This lind ol osiLion is suorLod ly various guidolinos. Ior oxanlo, in Lho RoorL
on ConlidonLialiLy and GonoLic IaLa nado ly Lho InLornaLional BiooLhics
ConniLLoo (IBC} in 1999, roughly Lho sano idoa is oxoundod.
90
Tho hunan righL
Lo rivacy,
91
so hoavily onhasisod in various hunan righLs insLrunonLs, is aliod
Lhoro Lo Lho uso ol gonoLic daLa, alLhough LradiLionally iL is connocLod lirsL and
loronosL viLh honour and rouLaLion, lanily, hono and corrosondonco. Cno
vorsion ol Lhis argunonL is uL lorvard ly Shoila McLoan, vho says LhaL good
rosoarch should alvays rosocL Lho suljocL ly sooling consonL and Lho giving ol lull
inlornaLion". Any lailuro, sho vriLos, Lo ollor Lhis rosocL is in iLsoll a harn, ovon il
iLs consoquoncos aro noL hysical".
92

Nov, rosoarch oLhics aLLonLs Lo saloguard Lho rivacy and soll-
doLorninaLion ol individuals, luL vho is Lho orson suljocLod Lo an oxorinonL
vhon Lho rosoarch scionLisL sLudios a gonoLic soquonco Ajtonbladet vroLo LhaL
nolody lnovs vho ovns you," luL is iL roally me Lhoy soo in Lho oxorinonL
9J
So
long as a socinon is idonLiliallo, Lhoro is a quosLion ol no loing a suljocL in a noro
alallo sonso. \hon on Lho oLhor hand Lho naLorial lacls any idonLilying
inlornaLion, Lho lacL ronains LhaL I an Lho source or Lho origin ol Lho naLorial, luL iL
soons lar-loLchod Lo say LhaL iL is me Lho oxorinonL is loing orlornod on. In
Icoland, a solosorson lor Lho GovornnonL Bill Lo soL u an Icolandic hoalLh socLor
daLalaso said LhaL rosoarch carriod ouL viLh Lho daLalaso vould noL rorosonL
hunan invosLigaLion and honco Lho Holsinli IoclaraLion sinly did noL aly Lo
daLalaso rosoarch."
94
Svodish rosoarchors roLorLod LhaL nosL oolo can disLinguish
loLvoon Lhonsolvos and, say, a llood socinon'
95

Thoso rosonsos nay ovorsinlily Lhings luL, lor ono Lhing, ono nusL, lilo
Lho IBC, dilloronLiaLo loLvoon linds ol gonoLic daLa. Sono daLa aro connon Lo all
hunaniLy, sono dilloroncos orLain Lo a grou ol oolo, oLhors Lo an individual.
IaLa nay lo linlod Lo an individual or nay noL. To say LhaL all Lissuo is an inLogral
arL ol Lho orson is a gross ovorsLaLononL vhich noglocLs Lho dilloroncos loLvoon

88
This osiLion vas dolondod ly Jacol Iahl RondLorll in Lho lirsL roorL ullishod lron Lhis rosoarch
rojocL, soo RondLorll 2001.
89
Niolson 199, . 12J.
90
Report on Conjidentiality 2000.
91
AlouL Lho concoL ol rivacy: dolinod rolaLionally, iL is Lho vays and circunsLancos undor vhich
oLhor oolo accoss inlornaLion lron no. Iolinod suljocLivoly, iL is Lho righL ol Lho individual Lo
liniL accoss ly oLhors Lo sono asocLs ol Lhoir orsons.
92
McLoan 199.
9J
Soo Ajtonbladet, SaLurday 10 Aril 1999, . 6.
94
As roorLod in Zooga & Andorson 2000, . 41.
95
\olin & Iorsson 2001.
182
culLurally sonsiLivo naLorial and naLorial soon as noro vasLo, loLvoon do-idonLiliod
naLorial and naLorial associaLod viLh an idonLiliallo individual, as voll as Lho
dilloroncos loLvoon naLorial LhaL can lo viovod as an inLrinsic arL ol a arLicular
orson and naLorial LhaL is inLorosLing locauso iL conLains INA vhich is Lho
horiLago ol hunaniLy".
96

This osiLion usos a arLicular inago, in vhich Lissuo is conarod Lo ono`s
hono and loLh can lo suljocLod Lo invasions ol rivacy. This inago, suggosLivo as iL
nay lo, is nisloading. \hon a orson luilds a houso ho Lhoroly luilds a rivaLo
shoro vhich in ono rosocL is an oxLonsion ol his ovn idonLiLy. \o righLly lool LhaL
vo can locl Lho door and LhaL vo do noL havo Lo loL anyono in vho isn`L inviLod. BuL
luilding a liolanl lor rosoarch isn`L roally conarallo Lo Lhis. A noro aroriaLo
inago is LhaL ol oolo LogoLhor luilding a ullic ollico vhich is lor Lho uso ol
ovoryono, and noL an insLrunonL ol ono`s ovn rivacy. \hon Lurning Lo hoalLh caro
vo Lurn Lo a joinLly luilL insLiLuLion and co-ooraLo viLh iL Lo ronoLo hoalLh, ny
ovn as voll as oLhors`. Sono daLa nay nood Lo lo roLocLod ly conlidonLialiLy, ol
courso, luL Lhoro is no logic in assuning LhaL ovory uso ol Lho daLa is LanLanounL Lo
Lrosass. \o can soo LhaL Lho analogy holds in corLain casos, luL iL nay as voll lo
dravn oLhorviso.
ConLrary Lo Lhis icLuro, ono nay hold LhaL Lho inorLanL Lhing isn`L ny
socinon luL Lho vishos I havo rogarding Lho uso Lo vhich iL nay lo uL. Il I
suorL nodical rosoarch and vanL ny socinon Lo lo a conLriluLion Lo iL, having
rosocL lor ny orson nay involvo looing unnocossary conLacL Lo a nininun.
McLoan Lhinls sooling consonL is nocossary in ordor Lo shov rosocL, luL cannoL
avoidanco ol unnocossary conLacLs lo soon as oqually rosocLlul In such a caso iL is
Lho neu conLacL lor consonL vhich nay lo soon as an inLrusion ol rivacy. Also, as
oinLod ouL ly rorosonLaLivos ol Lho Svodish ModoraLo (consorvaLivo} IarLy, a
lurLhor rollon arisos vhon nov consonL is soughL. Moro orsons Lhan roviously
havo Lo lo involvod in conLacLing donors, accordingly sonsiLivo inlornaLion is
oxosod noro Lhan vould oLhorviso lo Lho caso, vhich rosonLs Lho donors viLh an
incroasod risl ol lroachos ol conlidonLialiLy.
9

A largo arL ol Lho conllicL concorning Lho oLhics ol liolanls has iLs origin in
Lho conllaLing ol dilloronL nodols ol rosoarch oLhics. Cn Lho ono hand, Lhoro is Lho
Holsinli IoclaraLion and oLhor sinilar docunonLs on Lho inLogriLy ol Lho
oxorinonLal suljocL, vhich sono havo soon as also valid lor liolanl acLiviLios. Cn
Lho oLhor hand you havo oiLhor Lho sorL ol oLhical considoraLions nado lor
oidoniology and rogisLor rosoarch, or Lho rincilos LhaL aly Lo donaLion.
98
Tho
alsoluLo righL Lo docido lor onosoll and Lo roLocL ono`s inLogriLy is alnosL
indisonsallo in Lho lornor caso, luL soons raLhor ouL ol laco in Lho laLLor. Talo a
rosoarchor vho isn`L inLorosLod in you aL all luL ly survoying daLa lron orhas
Lhousands ol oolo is sooling sLaLisLical rosulLs on a naLional lovol, lor oxanlo.
RogisLor rosoarch is sonoLinos rogulaLod in lav so LhaL arLiciaLion is a logal
roquirononL. Tho individual orson`s inLorosL in soll-doLorninaLion is Lhon givon no
roon aL all.
ArgunonL on Lhoso linos ronains oon Lo Lho oljocLion LhaL uLLing Lho
ullic inLorosL loloro Lho individual righL anounLs Lo jusLilying oxloiLaLion ol

96
The Universal Declaration 199.
9
Soo Socialutslottets betanlande 2002, RosorvaLionor".
98
As noLod in \olin & Iorsson 2001.
183
Stejan rilsson
individuals and ignoro Lho oljocLivo harn LhaL is inllicLod uon Lhon ly disrosocL
lor Lhoir auLonony", or LhaL is Lo onlraco Lho dogna ol scionLilic rogross aL any
rico".
99
BuL Lhoro is a lasic llav Lo such an aLLacl. \hilo iL is Lruo LhaL dilloronL
nodols ol rosoarch oLhics aro conllaLod in Lho dolaLo, Lho righL ol Lho individual
should noL lo auLonaLically viovod in conLradisLincLion Lo Lho ullic inLorosL or Lo
various social rojocLs, lor Lho soll-sano individuals roclainod Lo lo invosLod viLh
righLs can also olLain rovision lor Lhoir inLorosLs indirocLly, Lhrough social
insLiLuLions. Tho rino disLincLion Lo lo nado, Lhoroloro, is loLvoon a dirocL and an
indirocL jorm ol oxorcising individual inLorosLs. An individual can dirocLly assorL his
inLorosLs ly oxorcising his auLonony in various vays, luL ho can also olLain
rovision lor Lhon indirocLly, Lhrough olocLod or aoinLod rorosonLaLivos. \hon a
lav Lhus iningos on his righL as an individual Lo inlluonco a arLicular naLLor, Lhis
nood noL nocossarily lo doonod rojudicial Lo his inLorosLs. AlLor all, as a donocraLic
suljocL ho has (or should havo} olocLod a corLain ordor ol Lhings in ordor Lo lring
alouL logislaLion vhich rovidos loLh lor his ovn inLorosLs and lor oLhor oolo`s.
Thoroloro Lho socond arLiclo ol Lho ConvonLion on Hunan RighLs and Bionodicino,
nonLionod alovo, runs Lho risl ol naling us ovorsinlily our LhoughLs on Lho
naLLor, and all Loo oasily lorgoL LhaL vhaL is in Lho inLorosL ol scionco or socioLy nay
vory voll lo in Lho arLicular orson`s inLorosL Loo.
Tho conllicL loLvoon Lvo dilloronL vays ol undorsLanding orsonal
involvononL in rosoarch runs Lhrough all Lho dolaLos concorning inlornod consonL.
IL soons olvious LhaL roor uso ol Lho AcL ly Lho rosoarch oLhics conniLLoos nusL
lo ainod aL doing jusLico Lo our inLuiLions horo and lirnly nalo roon loLh lor
siLuaLions vhoro orsons aro involvod as oxorinonLal suljocLs, and Lhoso vhoro vo
all vanL scionLisLs and hoalLh caro orsonnol Lo havo ollocLual accoss Lo lroad daLa.
100

3.4. Should the donor be able to revoke his consent?
In Svodon, Tho Modical Rosoarch Council, Lho NaLional Board ol HoalLh and
\ollaro and Lho BioLochnology ConniLLoo
101
all vishod Lo nalo Lho donor lully
onLiLlod Lo rovolo his consonL. Thoir sLandoinL Lallios viLh Lho Holsinli IoclaraLion,
Lho ConvonLion on Hunan RighLs and Bionodicino, and SocLion 12 ol Lho Iorsonal
IaLa AcL vhich sLiulaLos LhaL in casos vhoro rocossing ol orsonal daLa is only
orniLLod vhon Lho orson rogisLorod has givon consonL as Lho AcL rovidos, Lho
orson rogisLorod is onLiLlod aL any Lino Lo rovolo Lho consonL ho has givon. This
rincilo is dorivod lron rosoarch oLhics concorning hunan oxorinonLaLion, vhoro
iL is nandaLory Lo doclaro LhaL oach and ovory suljocL has Lho righL Lo viLhdrav lron
arLiciaLion in an oxorinonL or a sLudy. This is sonoLinos concoivod ol as a
hunan righL. Soaling ol Icolandic aLionLs vho chooso Lo arLiciaLo in Lho hoalLh
socLor daLalaso, Lhoroly ronouncing Lho ossililiLy ol laLor viLhdraval, Zooga and
Andorson vriLo LhaL Lhoy aro roquirod Lo givo u a lundanonLal hunan righL: Lho
righL Lo viLhdrav lron rosoarch sLudios".
102
Tho NaLional Board ol HoalLh and
\ollaro calls iL an uncondiLional righL".
10J

99
Ioyal 199, and Ioyal 1998, rosocLivoly.
100
In a lorLhconing arLiclo (in Svodish} I discuss hov Lo undorsLand and nalo uso ol Lho noLion ol
nov" or oLhor" uroso, soo ol Lho rosoarch rogranno volsiLo lor udaLos on ullicaLions, or ny
volsiLo aL <hLL://vvv.Lool.uu.so/honoago/sLolan_orilsson/ullilaLionor.hLn>.
101
Att spranga granser 2000, SocLion 5 ol dralL onacLnonL on lionodical rosoarch on hunans, . J15.
102
Zooga & Andorson 2000, . 4.
10J
Liobanler i halso och sjulvrden m.m. 2000, SocialsLyrolsons vorvagandon och lrslag, socLion 6".
184
Cn Lho oLhor hand, I havo clainod LhaL a righL ol Lhis lind runs conLrary Lo Lho
osLallishod racLico ol rosoarch oLhics in connocLion viLh rogisLor rosoarch.
104
IirsL, as
noLod alovo, iL is quosLionallo in nany insLancos vhoLhor iL is rolovanL Lo soal ol a
orson Laling arL in a sLudy vhoro oidoniological rosoarch and rogisLor rosoarch
aro concornod. IurLhor, il individuals could rocall Lho daLa/socinons Lhoy havo
suliod Lo rogisLors, Lhis vould doLracL lron Lho scionLilic valuo ol Lho rogisLor
concornod. Il vo uso Lho donaLion nodol, donors aro noL usually allovod Lo asl lor
Lho dosLrucLion ol vhaL Lhoy havo donaLod, as long as iL is usod in Lho vay inLondod
ly Lho donor. Tho dovaluaLion ol Lho rogisLor is noL only nogaLivo in iLsoll: soLLing u
a good-qualiLy liolanl, viLh adoquaLo socuriLy oLc., cosLs largo suns ol nonoy, and
so lailuro Lo uso iL as ollocLivoly as ossillo vould lo a vasLo ol rosourcos. IL should
lurLhor lo noLod LhaL, il Lho socinon has loon nado a suljocL ol rosoarch,
dosLrucLion ol Lho socinon olininaLos Lho ossililiLy ol sulsoquonLly vorilying and
oLhorviso lolloving u Lho rosoarch, vhich viLhouL doulL is a alallo dolicioncy.
Thoso considoraLions havo lornorly guidod Lho croaLion ol rogisLors and
Lissuo lanls in Svodon. Ior oxanlo, in Lho gonoral roconnondaLions ly Lho
NaLional Board ol HoalLh and \ollaro concorning rouLinos lor saving LosL naLorial aL
aLhology doarLnonLs, iL is clainod LhaL LosL socinons do noL lolong Lo aLionLs,
raLhor Lhoy lolong Lo vhoovor has Lalon Lhon. NovorLholoss, Lho NaLional Board ol
HoalLh and \ollaro vroLo in Lhoir Biolanls Bill LhaL il a donor rovolos his or hor
consonL, Lho socinon shall lo dosLroyod. Tho roosal rolorrod Lo Lho Svodish
Council on LogislaLion vonL lurLhor sLill, roquiring Lho socinon Lo lo dosLroyod
immediately. Tho MRC havo had a sinilar idoa: donors nusL lo inlornod ol Lho
ossililiLy LhaL Lhoir socinons nay lo dosLroyod aL any Lino on Lhoir roquosL.
Tho Svodish SocioLy lor Clinical CyLology lound Lhis rovision
unaccoLallo. Sonoono consonLing Lo a socinon loing Lalon lor diagnosLic
urosos should noL lo allovod Lo viLhdrav LhaL consonL: doing so vill jooardiso
Lho ollicioncy ol hoalLh caro lor Lho luLuro.
105
IurLhor criLicisn ol Lho sano lind
cano lron oLhor connonLaLors. Tho idoa lohind Lho Bill vas LhaL il conLinuod
sLorago ol socinons is inorLanL lor hoalLh caro urosos, Lho donor`s docLor
should discuss Lho naLLor viLh Lho aLionL loloro Lho socinon is dosLroyod.
By Lho Lino Lho Bill cano Lo lo onacLod, a chango had occurrod. Nov Lho
rovision vas LhaL alLor sonoono has rovolod consonL, Lho socinon shall lo
dosLroyod or deidentijied. This is no doulL a concossion Lo Lho criLics, luL conos as a
nixod llossing. An AcL in vhich rovocaLion ol consonL includos dosLrucLion ol Lho
Lissuo socinon has Lho ollocL ol osLallishing ly lav Lho donor`s righL Lo havo Lho
socinon dosLroyod, an arrangononL vhich, in Lho lighL ol our rovious discussion,
soons raLhor ill-advisod and oughL noL Lo lo roconnondod. Thoro is no rocodonL
lor any such inalionallo righL. As vo havo alroady soon, iL is alandonod in Lho
sLaLuLory roquirononLs, inLroducod roviously ly Lho NaLional Board ol HoalLh and
\ollaro and oLhor auLhoriLios, concorning Lho suly ol daLa Lo various rogisLors.
Rosoarch viLh Lho aid ol Lhoso rogisLors has loon judgod so valuallo as Lo varranL a
circunscriLion ol Lho individual orson`s righL ol dirocL conLrol ovor his
arLiciaLion. Sinilarly, rosoarch viLh Lho aid ol liolanls aoars Lo lo ol such groaL
inLorosL Lo lroad grous ol aLionLs and Lo socioLy as Lo nalo iL roasonallo lor Lho

104
Irilsson 2001.
105
Angende jrslag till lagstijtning 2000.
185
Stejan rilsson
rosoarchors Lo lo allo Lo do-idonLily Lho socinons in ordor Lo loo Lho liolanl
inLacL.
BuL Lho rovision has a lli sido. Basically, iL rovidos a vay round Lho lav as
oosod Lo a lav having sono logic Lo iL. Il sonoono has loon givon Lho righL Lo
viLhdrav his socinon and usos LhaL righL, LhaL orson nay nov lind LhaL as soon as
Lhoy asl lor Lho socinon Lo lo dosLroyod Lho rosoarchor insLoad do-idonLilios Lho
socinon and rolusos Lo givo iL lacl or Lo dosLroy iL. This nay oasily lo soon as
docoiLlul lohaviour and iL is hard Lo undorsLand hov iL can lurLhor Lho lavgivor`s
ovorriding concorn ol rosorving ullic conlidonco in hoalLh caro and rosoarch,
osocially in lighL ol Lho alovo considoraLions ol vhaL is Lo counL as a do-idonLiliod
socinon in Lho lirsL laco.
106
Tho rosonL rovision Lhus vorls againsL ArLiclo 4 ol
Lho inLornaLional insLrunonL on hunan gonoLic daLa roosod ly Lho InLornaLional
BiooLhics ConniLLoo, calling lor LransaronL rocoduros roviding lor Lho inlornod
arLiciaLion ly socioLy as a vholo" vhon iL conos Lo gonoLic daLa.
10

Thus, insLoad ol Lho sLaLuLo as iL nov sLands, Lho naLuro ol oach uroso
should govorn vhaL is agrood on Lhrough Lho inlornod consonL rocoduro. Cn Lho
sLrongLh ol inlornaLion suliod Lo Lhon concorning Lho valuo ol rogisLors and
rosoarch, as voll as ossillo clinical valuo, Lho najoriLy ol donors hoolully can
accoL Lho assing ol lull conLrol ovor Lho socinons Lo Lho liolanl (alLhough
conlidonLialiLy nusL noL lo conronisod}. Iron an ollicioncy viovoinL Lhis should
lo Lho nornal courso ol Lhings. IL is also orlocLly ossillo Lo anLiciaLo Lhis in Lho
condiLions luL Lo givo anyono vishing Lo do so Lho ossililiLy ol naling a vriLLon
roviso. CLhorviso, ol courso, iL nay sonoLinos only lo ossillo Lo Lalo socinons
lron Lhoso accoLing Lho liolanl`s lull righL ol disosal, viLhouL rojudicing Lho
succoss ol rosoarch. In oLhor casos, orhas Lho ossililiLy ol vorilying rosulLs doos
noL roquiro Lho socinons Lo lo roLainod, and Lho donor`s righL ol rocovoring Lho
socinons or having Lhon dosLroyod can lo arL ol Lho iniLial condiLions. SonoLinos
an agroononL on ossillo do-idonLilicaLion is suiLallo.
In shorL, Lho circunsLancos ol Lho individual caso should lo allovod Lo
docido Lho rocoduro Lo lo lollovod, and a docision on Lhis quosLion should lo
includod in Lho inlornod consonL rocoduro, Lhus naling donors involvod in Lho
docision ol vhoLhor Lo dosLroy or do-idonLily in Lho caso ol rovolod consonL.

3.5. Consent for specimens taken from foetuses, minors, deceased and non-
competent persons
In Lhis lasL socLion vo vill considor social rovisions rogarding inlornod consonL,
lor socinons Lalon lron looLusos and lron docoasod and non-conoLonL orsons.
Tho NaLional Board ol HoalLh and \ollaro vroLo in Lhoir Bill LhaL in Lho caso ol
joetuses Lho noLhor givos consonL. Tho rosoarch oLhics conniLLoo aL Lho Karolinsla
InsLiLuLo suggosLod LhaL Lho laLhor should also havo a say, a viov sharod ly Lho
ModoraLo IarLy nonlors ol Lho Rilsdag SLanding ConniLLoo on Social Allairs. This

106
Soo Lho rolininary lindings ly Ring and KoLLis Lindllad in Lhis voluno, ono ol vhich is LhaL Lho
ullic has groaL LrusL in Lho aliliLy ol univorsiLy-lasod rosoarchors and hoalLh caro orsonnol Lo
ovaluaLo Lho risls and lonoliLs ol gonoLic rosoarch. Tho high lovol ol conlidonco is conlirnod
olsovhoro. In Svodon, 9 oolo ouL ol 10 havo groaL conlidonco in rosoarch and rosoarchors,
according Lo a ullic survoy nado ly TIMC, Svenslen tror p jorslarna 2002.
10
Cutline oj the lnternational lnstrument 2002. NoLo LhaL Lhis ouLlino (in conLrasL Lo Lho auLhor ol Lhis
aor} doos noL uso Lho said arLiclo Lo challongo a righL ol viLhdraval ol consonL, on Lho conLrary,
such a righL is sLrongly acconLuaLod.
186
vas rojocLod ly Lho GovornnonL, hovovor. BuL Lho GovornnonL vas also arisod
ol Lho ossililiLy ol a caso ol vhich no rovision had loon nado: il Lho noLhor dios,
vho vill Lhon docido alouL Lho Laling ol a socinon lron hor looLus Thoroloro
Lhoy includod a rovision sLaLing LhaL a noar rolaLivo" shall givo inlornod consonL
loloro a socinon can logally lo Lalon in such casos.
Tho onhasis uL on Lho noLhor rollocLs connon valuos alouL Lho
vonan`s righL Lo docido concorning hor lody and Lho child sho has carriod. \haL
soons Lo havo loon ovorloolod is LhaL Lho gonoLical inlornaLion oxLracLallo lron a
socinon in oqual noasuro rollocLs Lho gonoLical consLiLuLion ol Lho noLhor and
laLhor and Lhoir lanilios. Tho criLicisn lovollod againsL Lho AcL Lhoroloro soons
rolovanL and orhas ovon jusLiliod. Il Lho socinon is Lo lo usod lor anoLhor
orson`s caro, iL soons accoLallo lor Lho noLhor alono Lo docido, luL il Lho uroso
is gonoLical rosoarch, Lho laLhor`s and his lanily`s inLogriLy soon as inorLanL Lo
saloguard as Lho noLhor`s. Accordingly, Lhis rovision should lo rovisod.
Rogarding specimens jrom deceased orsons, Lho NaLional Board ol HoalLh
and \ollaro suggosLod LhaL Lho AcL should includo a rovision LhaL vhon socinons
aro talen lron disoasod orsons Lhis should lo dono viLh rosocL" lor Lho disoasod.
In Lho discussion on consonL lron rolaLivos Lhoy sLaLod LhaL Lho nodol rogardod as
cusLonary in Lhis siLuaLion vas LhaL ol oL-ouL consonL. SonoLinos consonL nay
ovon lo rosunod. Tho NaLional AssociaLion ol Iisallod Iorsons oljocLod LhaL nosL
oolo aro unavaro LhaL socinons aro Lalon and Lhoroloro consonL cannoL lo
assunod. Thoy vonL on Lo say LhaL rolaLivos nay disagroo anong Lhonsolvos and
LhaL such a siLuaLion had yoL Lo lo addrossod ly Lho Bill.
108
Tho GovornnonL
ansvorod Lho lasL oinL ly sLaLing as Lhoir viov LhaL in such a caso socinons shall
noL lo Lalon (a sLaLononL LhaL orLains Lo Lho noxL socLion as voll}. In Lho
GovornnonL Bill, hovovor, Lho GovornnonL had oniLLod Lho rovision on rosocL"
and nov had only a roloronco Lo Lho AcLs on LranslanLaLion and osL-norLon
oxaninaLions rosocLivoly.
109
This lasically noans LhaL socinons nay lo Lalon il
Lhoro aro grounds lor assuning Lhis Lo lo Lho vill ol Lho docoasod. Il you do noL
lnov vhoLhor Lho docoasod vould havo accoLod Lho ooraLion you nay rocood on
Lvo condiLions: LhaL Lhoro aro no grounds lor assuning LhaL Lho docoasod vas against
such an ooraLion, and LhaL noar rolaLivos havo loon noLiliod and do noL oljocL.
Should rolaLivos disagroo, no socinon can lo Lalon.
110
Il no noar rolaLivo can lo
roachod, an auLosy nay only lo orlornod lor social roasons.
111

Tho rosoarch guidolinos lron Lho Modical Rosoarch Council sLaLo LhaL il you
vanL Lo uso previously collected naLorial lron nov docoasod orsons, Lho rosoarch
oLhics conniLLoo nusL doLornino vhoLhor rolaLivos ol Lho docoasod should lo
inlornod or noL. Tho NaLional Board ol HoalLh and \ollaro, and laLor Lho
GovornnonL, hold Lho viov LhaL consonL lron a rolaLivo may lo ol curronL inLorosL
vhon using such a socinon lor a nov uroso, osocially il Lho rolaLivo`s inLogriLy
nay lo allocLod ly iL. In accordanco viLh Lho oLhical guidolinos, Lho Board
concludod LhaL rolaLivos, vhon iL vas judgod Lo lo nocossary" |ly an oLhics
conniLLoo, LhaL is|, shall lo inlornod and aslod lor consonL in a suiLallo nannor",

108
Remissyttrande ver. Liobanler i halso och sjulvrden m.m. 2000.
109
Regeringens proposition ?001/0?.44, Cha. J, SocLion 4.
110
Soo SS (199.8J1) Lag om transplantation m.m. (Tho TranslanL Surgory AcL}.
111
Soo SIS (199.8J?) Lag om obdultion m.m. (Tho IosL-MorLon IxaninaLions AcL}.
187
Stejan rilsson
il socinons lron a disoasod aro Lo lo usod lor a nov uroso.
112
BoLh Lhoso
oxrossions voro Lo lo doloLod, Lhough. In a suiLallo nannor" vas doloLod aL Lho
suggosLion ol Lho Svodish Council on LogislaLion. InsLoad a nov roloronco Lo Lho
Modical Rocords AcL (SIS 1985:562} vas nado, Lo Lho ollocL LhaL il inlornaLion or
consonL is givon according Lo Lho Biolanls AcL, Lhis shall lo sLaLod in Lho aLionL`s
nodical rocord. In Lho GovornnonL Bill, Lho oxrossion vhon judgod Lo lo
nocossary" vas also alsonL. InsLoad rolaLivos shall havo loon inlornod and noL havo
oljocLod Lo Lho nov uroso. SLill, a rosoarch oLhics conniLLoo nay docido uon Lho
roquirononLs doonod suiLallo vhon Lho nov uroso is rosoarch. \hich is all Lo Lho
good, I Lhinl, sinco rolaLivos nay lind iL ollonsivo Lo lo conLacLod in Lhis naLLor lor
Lrivial roasons.
Tho naLLor ol specimens jrom minors vas rogulaLod ly Lho NaLional Board ol
HoalLh and \ollaro in Lho usual vay: iL is lron Lho cusLodian LhaL vriLLon consonL
nusL lo olLainod, luL Lho ninor shall lo inlornod and havo his or hor say as
doonod suiLallo according Lo ago and naLuriLy. In Lho caso ol an oldor child, iLs ovn
consonL is olLon sullicionL lor Laling and sLoring a socinon in a liolanl, Lho Board
connonLod. Tho sLaLuLo vas hoavily criLicisod. Cn Lho ono hand, Lho rosoarch oLhics
conniLLoo aL Lho Karolinsla InsLiLuLo loliovod Lho ninor`s ovn viov Lo lo
insullicionLly considorod in Lho roosal. Cn Lho oLhor hand, Lho Modical Rosoarch
Council LhoughL loLh aronLs/cusLodians should lo roquirod Lo givo ornission (Lhis
is roquirod undor Lho Codo ol IaronLhood and Guardianshi}. CLhors had sinilar
ronarls Lo nalo. Tho GovornnonL accoLod Lho laLLor oljocLion, LhaL consonL
should lo olLainod lron loLh aronLs or cusLodians.
Tho Svodish Council on LogislaLion lavourod ol Lho lornor suggosLion and
vanLod Lo add a rovision LhaL il ninors ooso Lho Laling ol a socinon Lho
consonL ol cusLodians vill noL lo sullicionL. Hovovor, Lho GovornnonL did noL
accoL any such rovision in Lho laLor GovornnonL Bill. InsLoad Lhoy addod a
rovision vhoroly, ago and naLuriLy orniLLing, Lho ninor hinsoll nay docido. This
is sonovhaL surrising, considoring LhaL Lhoro is a sLrong consonsus" in rolossional
guidolinos againsL carrying ouL rosoarch on an child vho oljocLs ovon il iLs aronLs
consonL.
11J
ILhics conniLLoos nusL docido vhoLhor Lho naLuro ol liolanl rosoarch is
such as Lo varranL a doarLuro lron Lhis rincilo, and nay vory voll lo noro
rolucLanL Lhan Lho lav on Lhis oinL locauso ol connon sLandards in rosoarch oLhics.
Thoro is also an invorso rollon: vhaL il a ninor has a righLlul nood lor a
socinon Lo lo sLorod, lor hoalLh caro urosos, and Lho cusLodian(s} says no
Should Lho ninor`s caro lo conronisod locauso ol Lhis
114
This rollon has yoL Lo
lo solvod oxcoL lor casos vhoro Lho anLiciaLod danago is so sovoro so LhaL Lho Caro
ol Young Iorsons (Social Irovisions} AcL loconos alicallo. uosLions ol caro
asido, a lasic rincilo vhich has ovolvod concorning Lho oLhics ol research on
ninors is LhaL rosoarch should only involvo childron vhon iL is ossonLial lor Lho sLudy
Lo do so and vhon conarallo daLa aro unolLainallo lron adulLs. \hoLhor such a
rosunLion should guido liolanl rosoarch in Svodon has unlorLunaLoly noL loon

112
Liobanler i halso och sjulvrden m.m. 2000, IrlaLLningslrslag", Cha. 2, SocLion 5.
11J
MonLgonory 2001, . 19.
114
As oinLod ouL ly Lho ModoraLo IarLy, soo Socialutslottets betanlande 2002, RosorvaLionor". Cl
courso, in casos ol urgonL nood a sanlo nay sLill lo Lalon undor Lho Caro ol Young Iorsons (Social
Irovisions} AcL (SIS 1990:52}, luL nosL olLon such urgonL noods aro noL ol Lho lind naling Lho
Biolanls AcL alicallo Lo Lho ooraLion, i.e. Lhoro is no nood Lo sLoro Lhon lor noro Lhan Lvo
nonLhs.
188
addrossod hiLhorLo.
115
LasLly, vo nay noLo LhaL in Lho rogulaLion and
roconnondaLions on liolanls iL is said LhaL ninors vho aro noL naLuro onough Lo
docido lor Lhonsolvos vhoLhor a socinon should lo includod in a lanl shall lo
givon Lho oorLuniLy Lo do so as soon as naLuriLy has loon aLLainod.
116

Tho NaLional Board ol HoalLh and \ollaro vroLo LhaL lor noncompetent
persons, a noar rolaLivo or roxy can givo inlornod, vriLLon consonL. Tho NaLional
AssociaLion ol Iisallod Iorsons disagrood: lor Lho nainLonanco ol orsonal inLogriLy,
no ono should havo Lo loavo socinons lor a uroso vhich ho or sho doos noL
undorsLand.
11
Also, Lho vaguo noLion ol `noar rolaLivo` vas criLicisod ly Lho lodios
Laling arL in Lho consulLaLion rocoss. In Lho roosal rolorrod Lo Lho Svodish
Council on LogislaLion Lhoro voro no sLaLuLory rovisions on Lhis naLLor aL all, only a
roloronco Lo Lho Codo ol IaronLhood and Guardianshi. In Lho acconanying roorL,
hovovor, Lho GovornnonL said LhaL a non-conoLonL orson shall hinsoll agroo Lo
Lho donaLion ol a socinon in ordor lor a roxy Lo givo accoLallo consonL. Also,
rolaLivos aro noL orniLLod Lo docido, only a logal LrusLoo or a guardian (sonoono
vho volunLarily acLs as a non-conoLonL orson`s advocaLo} can do so. Il Lho non-
conoLonL orson`s condiLion rovonLs hin lron giving an oinion, a LrusLoo or
guardian nay givo logiLinaLo consonL, rovidod Lhoro aro no roasons lor assuning
LhaL Lho non-conoLonL orson vould disagroo.
118
Tho Svodish Council on
LogislaLion criLicisod Lho inrociso roloronco Lo Lho Codo ol IaronLhood and
Guardianshi and aL Lhoir suggosLion iL vas Lhon vholly oniLLod lron Lho
GovornnonL Bill. In Lho connonLary Lho GovornnonL accordingly sLaLod LhaL il Lho
aLionL or a cusLodian has noL givon inlornod consonL, no socinon can lo Lalon
(lor inclusion in a liolanl}, vhich is in lino viLh Lho Modicinal IroducLs AcL (SIS
1992:859} govorning clinical rosoarch.
Tho rollon is LhaL iL nay lo ol Lho uLnosL inorLanco lor socinons Lo lo
Lalon lron a non-conoLonL orson (a cancor aLionL, say} Lo rovido good qualiLy
hoalLh caro. Thoro is a crucial dissinilariLy horo: vhoroas clinical rosoarch is ol no
criLical inLorosL Lo such a aLionL, Lho Laling and sLorago ol a socinon lor noro Lhan
Lvo nonLhs nay vory voll lo' Tho onission ol Lhis oinL is a naLLor lor gravo
concorn, and vo nusL hoo LhaL Lho Connission on Lho Svodish 1995 guardianshi
rolorn vhich has loon aoinLod ly Lho GovornnonL vill addross Lhoso quosLions
and givo vorlallo guidolinos.
119
In Lho laLor SCSIS 2002:11 (M} rogulaLions and
roconnondaLions, a sLaLononL vas includod Lo Lho ollocL LhaL a socinon nay lo
savod in a liolanl il Lho aLLonding hysician considors iL nocossary in ordor lor salo
hoalLh caro and LroaLnonL ol Lho aLionL. IL is uncloar vhoLhor Lhis rogulaLion is
conaLillo viLh Lho Biolanls AcL.
In all Lho alovo casos, Lho NaLional Board ol HoalLh and \ollaro vroLo, Lho
consonL givon ly a roxy, or il rolovanL, a rolaLivo, nay be revoled il iL is in Lho
inLorosL ol Lho socinon rovidor". SMIR drov aLLonLion Lo a oculiar non-
synnoLrical loaLuro ol Lho rovisions, sinco a rolaLivo or roxy nay say No Lo Lho
inclusion ol a socinon in a liolanl even though such inclusion is in Lho aLionL`s

115
AnoLhor such lasic rincilo vhich has noL loon dolaLod is LhaL rosoarch on oldor childron is
rolorallo Lo rosoarch on young onos.
116
SCSS ?00?.11 (M), Cha. 4, SocLion 5.
11
Remissyttrande ver. Liobanler i halso och sjulvrden m.m. 2000.
118
119
This vas liorcoly dolaLod in Lho Rilsdag loLh on May 16, soo Snabbprotololl ?001/0?.107, and on
May 2, soo Snabbprotololl ?001/0?.11J.
189
Stejan rilsson
losL inLorosL. As in Lho rovocaLion rulo, Lhoy should noL lo allovod Lo do so,
according Lo SMIR. This vas noL ondorsod ly Lho GovornnonL, hovovor. In Lho Bill
rolorrod Lo Lho Svodish Council on LogislaLion Lhoy sinly drood Lho vording
alouL Lho rovidor`s inLorosL, viLh Lho rosulL LhaL Lho righL Lo viLhdrav consonL vas
ovon noro acconLuaLod in Lho rosulLing AcL (a naLLor criLicisod oarlior in Lhis aor}.
LasLly, Lho GovornnonL vriLos LhaL vhon Lho socinons aro Lalon lor
rosoarch, in all Lho casos nonLionod alovo a rosoarch oLhics conniLLoo shall roviov
Lho rosoarch rojocL and docido vhaL roquirononLs ol inlornod consonL aro
nocossary.
120
Also, in Lho roosal lor nov oLhical roviov logislaLion Lhoro aro sono
dilloroncos Lo Lho Biolanls AcL LhaL vill lo ol inorLanco lor liolanls not collocLod
in a hoalLh caro soLLing or dorivod lron such a lanl. Rogarding minors considorod lor
inclusion in rosoarch Lhrough Lho donaLion ol a liological socinon, il Lhoy aro undor
15 and naLuro onough Lo undorsLand Lho rosoarch rojocL and iLs inlicaLions, and
say No Lo iL, Lho socinon shall noL lo Lalon. In Lho caso ol noncompetent orsons,
socinons nay lo Lalon vhon corLain rovisos aro noL and noiLhor Lho non-
conoLonL orson, noar rolaLivos nor a logal LrusLoo or guardian disarovo a noro
saLislacLory soluLion Lhan is lound in Lho Biolanls AcL.

120
Lagrdsremiss 2001, socLion 1J:1, and Regeringens proposition ?001/0?.44, Cha. 1J:
IrlaLLningslonnonLar", Cha. J, SocLion 5.
190
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from the Governments Medical Ethics Advisory Board 1999-03-17.
sterberg, Kerstin (2002). De vill tjna pengar p ditt blod. In Ny Teknik 18 September.
Available at<<http://www.ad.se/> (1/11 2002)
Stefan Eriksson
196
ublic and patient perception oj biobanls and injormed consent

9

Public and patient perception of biobanks and informed consent

Lona Ring, IhI
1
& Asa KoLLis Lindllad, IhI
2

1
Department oj sychology, Royal College oj Surgeons, lreland
2
Department oj harmacy, Uppsala University, Sueden

This chapter provides international examples oj empirical research on public and patient
perception oj research on biobanl material, including procedures oj obtaining injormed
consent. eu such studies have been conducted in the Suedish context, but preliminary
data jrom a pilot study oj the general public in Sueden uill be presented as uell as the
design oj ongoing jullscale studies oj the general public and diabetic patients.

1. Introduction

Tho raid dovolononL ol lioLochnological rosoarch has sLinulaLod Lho
osLallishnonL ol nov liolanls and Lho uso ol oxisLing liolanls. uosLions LhaL loo
coning u, and LhaL havo loon dolaLod in loLh Lho scionLilic and Lho ullic
connuniLy, aro alouL Lho saloLy and risl ol Lho arLicianLs/sanlo donors in Lhis
rosoarch, including issuos concorning inlornod consonL
1
.
Tho lasic rincilo in nodical rosoarch and in rosoarch using hunan
liolanls is LhaL inlornod consonL lron rosoarch suljocLs and sanlo donors should
lo olLainod. Hovovor, Lho rosoarch oLhics conniLLoos can nalo oxcoLions and aro
conniLLod Lo sLrilo a lalanco loLvoon Lho valuo ol rosoarch and Lho roquirononL ol
inlornod consonL. According Lo Lho Svodish Biolanl AcL, Lho rosoarch oLhics
conniLLoos shall solocL aroriaLo inlornaLion and consonL rocoduros alLor Lhis
lalancing and alLor Laling oLhor logislaLion, o.g. Lho Iorsonal IaLa AcL inLo
considoraLion.
Tho challongo lios in hov Lo olLain inlornod consonL lron Lho donors, in a vay LhaL
Lalos nany dilloronL valuos, such as alLruisn, inLogriLy and rosoarch qualiLy, inLo
accounL. IL is inorLanL Lo lalanco Lho inLogriLy/auLonony ol Lho donor and Lho
connon good LhaL nodical rosoarch nay rosulL in. Sono rosoarchors loar LhaL
rosLricLod rogulaLions vill hindor rosoarch in hunan gonoLics viLh highly
doLrinonLal consoquoncos Lo ulLinaLo ullic lonoliL"
2
. CLhors clain LhaL slovod
ovorroLocLion ol suljocLs nay also causo rollons. Cno oxanlo is vhon varnings
in Lho inlornaLion aro goarod Lo gonos LhaL onLail high risl ol dovoloing a disoaso,

1
AshcrolL, 2000, Mcuoon, 1998, Iolias & Marlvard, 2001, Irino oL al., 2000, SLoinlorg, 2001,
\ondlor, 2002, \illians, 2001
2
\adnan, 2000
197
Lena Ring & Asa KettisLindblad
alLhough Lhoso gonos aro rolaLivoly unconnon
J
. Such varnings nay disLracL sLudy
arLicianLs lron oLhor inorLanL inlornaLion and unnocossarily discourago
arLiciaLion in rosoarch sLudios. AddiLionally, inlornod consonL rocoduros and
viLhdravals nay load Lo nissing daLa and Lhoroly jooardizo Lho qualiLy ol Lho
rosoarch
4
. Svodish rosoarchors havo clainod LhaL Lho nov lav is an oxrossion ol an
oxaggoraLod considoraLion lor Lho donors. Isocially, sinco Lhoy havo Lho orsonal
oxorionco LhaL nosL aLionLs` aro villing Lo conLriluLo Lo rosoarch lor Lho connon
good, ovon il Lhoy goL oxosod Lo orsonal risls. This is vhaL Lho rosoarchors loliovo,
luL vhaL is Lho oinion ol Lho oLonLial sanlo donor, i.o. Lho gonoral ullic and
aLionLs Knovlodgo ol oLonLial sanlo donors` orcoLions rogarding Lho uso ol
liolanls is invaluallo in dovoloing aroriaLo inlornod consonL rocoduros lor
uso in clinical racLico and in rosoarch soLLings.

2. Empirical research on the views of the general public and patients regarding
research on biobank material and informed consent procedures an
international perspective

2.1 The publics willingness to contribute to genetic research
Sovoral sLudios indicaLo LhaL Lho ullic`s villingnoss Lo conLriluLo Lo gonoLic rosoarch
is rolaLivoly high. In an Anorican sLudy ol rosocLivo jury nonlors, 60' vould
donaLo a Lissuo sanlo lor gonoLic rosoarch
5
. AnoLhor Anorican sLudy shovod LhaL
42' ol Lho ullic vas in lavor ol llood donaLion and long Lorn sLorago lor gonoLic
rosoarch
6
. Thoso liguros corrosond Lo LhaL lound in a sLudy ol Lho ullic`s
villingnoss Lo arLiciaLo in nodical rosoarch in gonoral, i.o. 46'
. CharacLorisLics ol
Lhoso in lavor ol donaLion includo highor oducaLion and a osiLivo lanily hisLory ol a
gonoLic disordor, a loliol LhaL gonoLic rosoarch vill rovonL disoaso and loliol in
gonoLic doLorninisn
8
. A sLudy ly Malono oL al, lound highor assonL raLos lor aLionLs
agod aL loasL 65 yoars vorsus Lhoso youngor
9
. IL has also loon lound LhaL Lho
villingnoss Lo rovido consonL is groaLor vhon Lho sanlo has loon collocLod in a
rosoarch soLLing raLhor Lhan clinical soLLing
10
. Individuals assossnonLs ol Lho risls and
lonoliLs ol gonoLic rosoarch has loon lound Lo lo unrolaLod Lo Lhoir sLaLod villingnoss
Lo donaLo
11
. Many orsons aoar Lo lo villing Lo donaLo lor rosoarch urosos, ovon
Lhough Lhoy gain noLhing orsonal lron iL
12
. IarLicianLs havo loon lound Lo lo
signilicanLly loss villing Lo arLiciaLo in rosoarch LhaL oxanino sLorooLyical or
oLonLially sLignaLizing LraiLs, as oosod Lo rosoarch LhaL oxanino nodical or
nonLal illnossos
1J
.

J
\ilcox oL al., 1999
4
\ilcox oL al., 1999
5
Morz & Sanlar, 1998
6
\ang oL al., 2001
TrauLh oL al., 2000

8
\ang oL al., 2001
9
Malono oL al., 2002
10
SchvarLz oL al., 2001
11
Morz & Sanlar, 1998
12
ibid
1J
198
Svodish rosoarchors havo also lound LhaL oolos` roadinoss Lo conLriluLo Lo gonoLic
rosoarch is high, aL loasL in Lho lranovorl ol a carolully conducLod sLudy LhaL is voll
lnovn Lo Lho oulaLion
14
. Thoy roorLod acLual daLa on Lho villingnoss Lo givo
consonL lor a nov uroso. Cl iniLial 1494 donors, 1409 (9J'} voro alivo and
ossillo Lo locaLo olovon yoars laLor. Cl Lhoso 1409, 1J45 (95'} rosondod Lo Lho
loLLor sooling inlornod consonL, and 1J11 (9J'} gavo Lhoir inlornod consonL. This
noans LhaL 1J11 ol 1494 (88'} ol Lho original Lissuo sanlos could lo usod.
SLognayr and Aslund concludod LhaL iL is loasillo Lo olLain individual consonL lor
gonoLic rosoarch a docado alLor llood vas donaLod
15
.

2.2 Does the public require informed consent?
Iov sLudios havo oxlorod Lho donor`s orcoLions ol inlornod consonL rocoduros
and Lho rosulLs aro arLially conLradicLory. SLognayr and Aslund lound LhaL a largo
roorLion ol Lho rosondonLs vanLod Lo lo conLacLod loloro ovory nov rosoarch
rojocL in vhich Lhoir llood sanlo is inLondod Lo lo usod
16
. Hovovor, lasod on Lho
viovs ol 504 oldorly rosondonLs in anoLhor sLudy, \ondlor aL al rooso LhaL
consonL is noodod only Lho lirsL Lino sanlos aro usod lor rosoarch urosos,
LhoroalLor, idonLiliod sanlos could lo usod lor lurLhor rosoarch viLhouL socilic
consonL
1
. MosL rosondonLs LhoughL LhaL anonynous sanlos could lo usod lor
rosoarch irrosocLivo ol il inlornod consonL had loon roviously olLainod or noL.
ClayLon oL al
18
also concludo LhaL inlornod consonL is roquirod lor linlallo sanlos
luL noL anonynous sanlos, lasod on a consonsus rocoss involving scionLisLs,
oLhicisLs, lavyors and consunors.
Irolininary lindings lron anoLhor sLudy indicaLo LhaL Lho lay ullic and
nodical rolossionals nay havo dilloronL aLLiLudos Lovards Lho uso ol archivod
inlornaLion and sanlos viLhouL socilic inlornod consonL
19
. This hyoLhosis,
hovovor, is dorivod lron locus grous inLorviovs, and roquiros validaLion Lhrough
rosoarch using a largor sanlo. Tho ullic oxrossod sovoral ossonLial rocondiLions
LhaL had Lo lo noL il rosoarchors voro Lo havo accoss Lo sanlos usod lor rosoarch,
viLhouL olLaining socilic inlornod consonL ol Lho suljocLs. Thoso rocondiLions
includod Lho roLocLion ol a suljocL`s rivacy, nainLaining conlidonLialiLy, and
connunicaLing Lho ouLconos ol sLudios Lo rosoarch suljocLs. AlLhough hysicians
LhoughL LhaL sono lind ol rior ornission lron suljocLs vas dosirallo, Lhoy
oinLod ouL Lho dilliculLios involvod in olLaining individual inlornod consonL in oach
caso.
SchvarLz lound LhaL vriLLon inlornod consonL is rolorrod in gonoLic
sLudios. Ior oxanlo, a survoy ol Jovish individuals alouL Lhoir aLLiLudos rogarding
Lho racLico ol using sLorod INA sanlos lor gonoLic rosoarch, lound LhaL ovorall,
nosL rosondonLs roorLod LhaL vriLLon inlornod consonL should lo roquirod and
LhaL Lhoy vould lo villing Lo rovido such consonL. Tho arLicianLs voro noro
liloly Lo ondorso Lho nood lor olLaining consonL vhon Lho sanlo vas collocLod in a
clinical soLLing
20
. Hovovor, \ondlor and Inanuol roconnond a olicy ol noL

14
SLognayr & Aslund, 2002
15
ibid
16
ibid
1
\ondlor & Inanuol, 2002
18
ClayLon oL al., 1995
19
Asai oL al., 2002
20
199
roquiring consonL Lo nov rosoarch urosos, locauso nosL rosondonLs LhoughL
consonL Lo lo unnocossary
21
.
Tho alovo sLudios givo raiso Lo quosLions such as: Is iL roasonallo LhaL ovory
rosoarch suljocL is givon an oorLuniLy Lo doclino Lo arLiciaLo in any rosoarch
rojocL Ioos ovory rosoarch suljocL considor Lhis oLion as nocossary in all conLoxLs
Can Lhoro lo oxcoLions Lo Lho call lor inlornod consonL Sado raisos Lho lolloving
quosLions: \haL is Lho jusLilicaLion lor ronoving auLononous choico lor Lho
ninoriLy grou \haL sizo najoriLy is noodod Lo ovorrido rosoarch suljocLs` righL Lo
soll-doLorninaLion, LhaL is, Lo dony Lhoir righL Lo say yos or no Lo Lho uso ol Lhoir
lodios, lody arLs, or orsonal inlornaLion in rosoarch
22
. Ho sLaLos LhaL rogardloss il
sanlos aro idonLiliod or anonynizod hunan sanlos or inlornaLion, suljocLs can lo
and should lo locaLod and aslod lor Lhoir consonL Lo roLocL Lho lundanonLal righL
ol soll-doLorninaLion. Rosoarch suljocLs` roasons noL Lo vanL Lhoir liological
naLorials or inlornaLion usod in a sLudy nay lo lausillo or inlausillo, roasonallo
or unroasonallo, in Lho viov ol Lho invosLigaLors. Ho noans LhaL only Lho suljocLs
can voigh Lho sovoriLy ol oLonLial harns Lo Lhonsolvos or Lo Lhoir connuniLios, in
Lorns ol Lhoir ovn valuos, roloroncos, and concorns. Should Sado`s rincilo lo
susLainod no naLLor hov groaL Lho valuo (as orcoivod ly Lho invosLigaLor or a
rosoarch oLhics conniLLoo} ol Lho nov lnovlodgo LhaL nighL lo olLainod lron such
a sLudy Cr should Lho connon good lo considorod An addiLional quosLion is il
Lhoro oxisL Lruly anonynizod sanlos in gonoLic rosoarch Ivory Lissuo sanlo, ovon
Lho snallosL lracLion ol Lhon, can lo usod Lo olLain Lho individuals vholo gonoLic
rolilo.

2.3. Validity of the informed consent
In a sLudy LhaL lollovod u on donors, nono ol Lho aLionLs conLacLod vas avaro LhaL
Lhoy had sanlos sLorod in a INA lanl, LhaL gonoLic analysos had loon undorLalon
or rononlorod LhaL Lhoy had signod a consonL (vhich indood oxisLod}
2J
. AnoLhor
sLudy shovod LhaL only a ninoriLy ol Lho donors rocallod LhaL sanlos nighL lo usod
lor luLuro rosoarch and LhaL Lho roloaso ol rosoarch rocords could allocL Lhoir
insuranco sLaLus
24
. Cno roason nighL lo LhaL consonL lorns olLon aro vriLLon aL a
highor roading lovol Lhan is aroriaLo lor Lho inLondod oulaLion
25
.
This inlios LhaL Lho validiLy ol a givon consonL is doulLod. Il Lho
inlornaLion is noL undorsLandallo ly Lho aLionLs, iL is quosLionallo vhoLhor Lho
docision-naling is voll inlornod. Tho lindings also sLross Lho inorLanco ol
sLraLogios Lo hol suljocLs rononlor vhon lorgoLLing inorLanL asocLs ol Lhoir
rosoarch arLiciaLion
26
.

2.4. The donors whish for feedback of results
uosLions concorning loodlacl ol rosoarch inlornaLion cannoL lo noglocLod,
alLhough cunlorsono Lo carry ouL. Ioodlacl ol rosoarch rosulLs nay lo a noLivaLing
lacLor lor sono oolo. MorLz oL al. lound LhaL 9' ol Lho arLicianLs indicaLod a

21
\ondlor & Inanuol, 2002
22
Sado, 2002
2J
MouLol oL al., 2001
24
\ondlor oL al., 2002
25
Cgloll & CLLo, 1991
26
\ondlor oL al., 2002
200
dosiro Lo rocoivo rosoarch rosulLs undor a linlod nodol
2
. Hovovor, Iullor oL al noan
LhaL roviding gonoLic inlornaLion Lo suljocLs nay onLail signilicanL risls and causo
orronoous conclusions LhaL could rosulL in hysical, sychosocial, or ocononic
harns. Il gonoLic rosoarch rosulLs aro Lo lo givon Lo Lho suljocLs, Lho roLocol nusL
rovido lor counsoling loloro and alLor Lho LosL. Thoy concludo LhaL il a olicy
nandaLing roLurn ol clinically noaningloss daLa voro inlononLod, associaLod cosLs
and orsonnol nighL rovido an olsLaclo Lo doing Lho sLudy. Thus, in Lho alsonco ol
clinical validiLy Lhoro should noL lo an alsoluLo roquirononL lor daLa Lo lo roLurnod
Lo suljocLs. Ior rosoarch in vhich daLa aro noL rovidod Lo suljocLs, Lho rosoarchor
should dononsLraLo alsonco ol clinical validiLy, a rosoarch oLhics conniLLoo should
lo roquirod Lo roviov and arovo Lho oxcoLion, and Lho inlornod consonL
docunonL should sLaLo oxliciLly LhaL Lho daLa vill noL lo roLurnod Lo Lho rosoarch
suljocL
28
.

2.5 Recommendations for obtaining adequate informed consent in genetic studies
ClayLon oL al havo dovolood roconnondaLions lor olLaining adoquaLo inlornod
consonL vhon gaLhoring Lissuo sanlos LhaL nay lo usod lor gonoLic sLudios
29
. Thoir
roconnondaLions voro arLially lasod on oinions oliciLod lron Lho gonoral ullic.
Thoy concludo LhaL (1} inlornod consonL is roquirod lor all gonoLic rosoarch using
linlallo sanlos unloss condiLions lor liniLaLion or vaivor aro noL, (2} inlornod
consonL is noL roquirod lor gonoLic rosoarch using anonynous sanlos luL nay lo
considorod il idonLiliors aro Lo lo ronovod lron curronLly linlallo sanlos, (J}
insLiLuLional roviov loards could usolully roviov all roLocols LhaL rooso Lo uso
sanlos lor gonoLic rosoarch, and (4} lurLhor vorl rogarding Lhoso issuos is
varranLod.
RoconnondaLions as Lo hov Lho consonL lorn can lo dosignod has loon
rosonLod ly Boslov oL al. Thoy havo croaLod an inlornod consonL LonlaLo lor
oulaLion-lasod sLudios using Lissuo sanlos
J0
and rovido doLailod suggosLions
rogarding Lho languago Lo lo usod and vhaL inlornaLion Lo givo rosocLivo
arLicianLs
J1
. Hovovor, alongsido Lho dovolononL ol lorns, Lhoro is a nood Lo
rolorn Lho inlornod consonL and locus noro on Lho rocoss iLsoll Lhan Lho lorn, i.o.
Lo onsuro LhaL arLicianLs roally havo givon Lhoir volunLary inlornod consonL
J2
.

3. The Swedish publics perceptions of research using biobanks and informed
consent procedures a pilot study

Tho ain ol our sLudy is Lo idonLily orcoLions ol Lho gonoral ullic and aLionLs
rogarding: (1} rosoarch involving sLorago and uso ol hunan Lissuos lron vhich
gonoLic naLorials nay lo dorivod and, (2} rocoduros ol inlornod consonL in rolaLion
Lo Lho uso ol naLorial lron liolanls

2
Morz & Sanlar, 1998
28
Iullor oL al., 1999
29
ClayLon oL al., 1995
J0
Boslov oL al., 2001
J1
ibid
J2
Annas, 2001
201
3.1 Methods
Tho daLa vill lo collocLod ly noans ol a soll-adninisLraLod quosLionnairo. Tho
dovolononL ol Lho quosLionnairo vas a donanding rocoss givon Lho conloxiLy ol
Lho Loic. SLorod Lissuo sanlos, gonoLic rosoarch, inlornod consonL, and inLogriLy
aro issuos LhaL Lho avorago ciLizon hardly rolaLos Lo on a daily lasis. MosL oolo aro
liloly Lo lo unavaro ol sovoral ol Lhoso concoLs or only havo a vaguo orcoLion ol
Lhon. Ivon oolo viLh oxorionco in Lhis liold lind iL dilliculL Lo Lalo sidos againsL
or viLh dilloronL liolanling issuos.
Tho conLonL validiLy and Lho loasililiLy ol Lho quosLionnairo vas onsurod ly
loLLing dilloronL oxorLs (rosoarchors, hysicians, oLhicisLs, and lay non} soo il any
inorLanL aroas voro nissod, and suggosL rovision or doloLion ol irrolovanL or uncloar
quosLions. This rocoduro vas rooaLod alLor ovory rovision ol Lho quosLionnairo. \o
also carriod ouL an oxLonsivo iloL sLudy Lo allov ovaluaLion ol Lho quosLions,
idonLilicaLion ol nisinLorroLaLions and analysis ol Lho disLriluLion ol ansvors. In Lho
iloL sLudy, vo also ovaluaLod Lho quosLionnairo iLsoll ly adding sono quosLions aL
Lho ond ol Lho quosLionnairo, lor oxanlo, vhoLhor Lho quosLions voro dilliculL Lo
undorsLand or il Lhoy lolL irrolovanL. Tho local rosoarch oLhics conniLLoo arovod
ol Lho sLudy and Lho quosLionnairo.
Tho iloL sLudy consisLod ol a soll-adninisLorod quosLionnairo sonL Lo a
randon sanlo (n=500} ol Lho gonoral ullic in Svodon in May 2002. Tho
laclground daLa includod inlornaLion LhaL vo hyoLhosisod had an inacL on Lho
aLLiLudo Lovards gonoLic rosoarch and liolanling, o.g., ago, gondor, oducaLion,
hoalLh sLaLus, and ovorall oxorioncos ol Lho hoalLh caro sysLon. Tho quosLionnairo
also includod quosLions on: gonoLic disoasos in Lho lanily, vhoLhor Lho rosondonL
had ovor loon a llood donor, aLLiLudos Lovards gonoLic rosoarch and LrusL in
dilloronL auLhoriLios caaliliLy Lo ovaluaLo Lho risls and lonoliLs ol gonoLic rosoarch,
aLLiLudos Lovards gonoLic rosoarch, villingnoss Lo donaLo a llood sanlo lor rosoarch,
roloroncos lor inlornod consonL rocoduros, lood-lacl ol rosoarch rosulLs and
oLonLial oxcoLions lron Lho call lor inlornod consonL. A hyoLhoLical quosLion
vas consLrucLod Lo asl alouL Lho rosondonLs` villingnoss Lo donaLo a llood sanlo
lor rosoarch urosos.
All daLa voro codod and analysod viLh Lho SISS solLvaro rogran. Bolov
vo rosonL sono rolininary rosulLs lron Lho iloL quosLionnairo.

3.2 Preliminary results from the pilot study
3.2.1 Response rate and representativeness
Tho rosonso raLo vas J0' (n=154} viLh no ronindors. A sinilar sLudy, carriod ouL
in Lho norLhorn arL ol Svodon during Lho sring ol 2002, had a rosonso raLo ol
59.6' alLor Lhroo ronindors
JJ
. Conarod Lo Lho gonoral ullic, vonon and
rosondonLs ovor 45 yoars ol ago voro slighLly ovor-rorosonLod anong Lho
rosondonLs. Hovovor, Lho lovol ol oducaLion anong Lho rosondonLs rollocLod LhaL
ol Lho gonoral Svodish oulaLion.

3.2.2 Evaluation of the questionnaire itself
A najoriLy ol Lho rosondonLs LhoughL LhaL iL vas inorLanL Lo havo a say in Lhoso
naLLors (9'}, i.o. LhaL Lhoy arociaLo LhaL Lho ullic is lisLonod Lo ly inviLing

JJ
Klaus Hyor, IhI-sLudonL, Ino InivorsiLy, Svodon, o-nail, January 24, 200J.

202
Lhon Lo survoys. A najoriLy LhoughL LhaL Lho quosLions voro oasy Lo undorsLand
(95'} and LhaL Lho nunlor ol quosLions vas alouL righL (82'}. MosL ol Lho
rosondonLs also lolL LhaL Lho quosLions voro rolovanL Lo Lhon (8'}. This is
surrising givon Lho conloxiLy ol Lho Loic. Hovovor, iL is inorLanL Lo loo in
nind LhaL 0' ol Lho rosondonLs choso noL Lo rosond, and LhaL ono roason nighL
lo LhaL Lho quosLionnairo vas Loo dilliculL, long and irrolovanL Lo Lhon.

3.2.3. Perceptions of genetic research
A ninoriLy ol Lho rosondonLs (2J'} voro avaro ol LhaL sono ol Lhoir Lissuo sanlos
nay lo sLorod. A najoriLy ol Lho rosondonLs had a osiLivo aLLiLudo Lovards gonoLic
rosoarch concorning naing ol Lho gonono (8'}, assossing risl lor disoaso (89'},
diagnosLics (92'} and LroaLnonLs (94'}. In Lho oon-ondod quosLions sovoral
rosondonLs noLod LhaL Lhoy vhoro ro nodical gonoLic rosoarch, as long as iL did noL
involvo any IranlonsLoin" Londoncios, such as aLLonLs Lo croaLo Lho orlocL hunan
loing. \hon aslod alouL Lhoir LrusL in dilloronL auLhoriLios caaliliLy Lo ovaluaLo Lho
risls and lonoliLs ol gonoLic rosoarch, univorsiLy-lasod rosoarchors (80'} ranlod
highosL vhilo local hoalLh caro oliLicians (2'} voro lound aL Lho loLLon.

3.2.4 Willingness to contribute to genetic research
A najoriLy ol Lho rosondonLs (89'} vould consonL Lo donaLo an oxLra llood sanlo
lor rosoarch urosos. Cl Lhoso, a najoriLy (68'} arovod ol Lhoir sanlo loing
usod lor gonoLic rosoarch. Tho nosL connon noLivo vas lor Lho lonoliL ol luLuro
aLionLs. Sono 16' ol Lhoso vho consonLod Lo givo an oxLra llood sanlo said LhaL
Lhoir docision vould lo inlluoncod ly Lho linancial sourco ol Lho rosoarch. Hovovor,
Lho najoriLy (66'}, voro indilloronL ol Lho linancial sourco and dologaLod Lho
docision Lo Lho rosoarch oLhics conniLLoo.

3.2.5 Requirement for informed consent
\onon and Lhoso in highor agos voro signilicanLly noro liloly Lo vanL Lo lo aslod
lor Lhoir consonL il Lhoir sanlo vas Lo lo usod in rosoarch. Hovovor, alnosL hall
(46'} ol Lho rosondonLs oxrossod no nood Lo lo aslod lor inlornod consonL in
rolaLion Lo nov rojocLs, il Lho rosoarch oLhics conniLLoo had arovod ol Lho
rojocL. AnoLhor 18' vanLod Lo lo aslod lor inlornod consonL il Lho uroso is
onLiroly dilloronL lron Lho original uroso. Thoy also vanLod oral or vriLLon
inlornaLion. YoL anoLhor 18' callod lor Lho sLricLosL inlornod consonL rocoduro.
Thoy vanLod Lo lo aslod lor inlornod consonL lor all nov rojocLs, and Lo lo valid,
Lho consonL has Lo lo signod ly Lho donor. Thoy also vanLod oral or vriLLon
inlornaLion alouL Lho rojocL.
Il aslod lor inlornod consonL in rolaLion Lo ovory nov rojocL a najoriLy ol
Lho rosondonLs vould lool rosocLod (68'}, sono 25' vould Lhinl LhaL iL is a
vasLo ol rosourcos LhaL should lo invosLod in rosoarch, alouL 8 orconL vould lool
indilloronL alouL loing aslod, and 9 orconL vould lool LhaL Lhoy goL unnocossary
inlornaLion. Cnly 6 orconL vould lo ronindod alouL illnoss and vorriod alouL
Lhoir hoalLh
AlouL hall (52'} ol Lho rosondonLs` LhoughL LhaL sanlos lron docoasod
donors nighL lo usod il Lho rosoarch oLhics conniLLoo arovos. Hovovor, J
orconL LhoughL LhaL rolaLivos havo Lo nalo Lho docision.
203
Many (5J'} ol Lho rosondonLs Lhinl LhaL Lhoro aro siLuaLions vhon Lho rosoarch
oLhics conniLLoo can arovo ol rosoarch using sLorod sanlos viLhouL olLaining
inlornod consonL lron Lho donor or rolaLivos. IxcoLions Lo Lho call lor inlornod
consonL vas duo il rior consonL has loon givon (46'}, il iL is an old sanlo LhaL has
loon givon in rolaLion Lo caro/LroaLnonL (J4'} or il Lho rosoarch oLhics conniLLoo
Lhinls LhaL asling lor consonL vill vorry Lho donor (29'} or il Lho donor is doad and
rolaLivos havo Lo lo aslod (20'}. Hardly anylody (<1'} LhoughL LhaL roducod
rosoarch qualiLy duo Lo nissing daLa or incroasod cosLs lor lollov-u vould
logiLinaLo oxcoLion lron inlornod consonL

3.2.6 Relative importance of information
Tho nosL inorLanL inlornaLion Lo lo givon vhon aslod Lo donaLo a sanlo vas
il caro and LroaLnonL vill lo allocLod ly Lho rosoarch rosulLs (86'}, vhilo Lho righL
Lo viLhdrav Lho consonL and goL Lho sanlo dosLroyod vas lound Lo lo Lho rolaLivoly
loasL inorLanL inlornaLion (62'}.
Sono J9 orconL vould lilo Lo goL loodlacl ol rosoarch rosulLs and Lo goL
inlornaLion alouL Lhoir risl lor horodiLary disoasos. AnoLhor 44 orconL vanLod Lo
havo Lhis inlornaLion only il Lho disoaso vas rovonLallo or ossillo Lo LroaL. Cnly
sono 6 orconL vould rolor noL Lo goL inlornod aL all. Hall ol Lho rosondonLs
vanLod Lo docido Lhonsolvos vhoLhor Lhoir rolaLivos should lo inlornod alouL LhaL
Lho rosondonL carrios a risl lor a horodiLary disoaso. AlouL J0' rolorrod LhaL Lho
hoalLh caro orsonnol should nalo Lhis docision

3.2.7 Conclusion
This iloL sLudy has rovoalod sono LonLaLivo lindings, aarL lron sorving Lho uroso
ol lurLhor validaLing Lho quosLionnairo lor Lho lull-scalo sLudios. Thoso rolininary
rosulLs indicaLo, LhaL Lho gonoral ullic soons Lo suorL Lho uso ol sLorod sanlos.
Tho LrusL in rosoarchors, and nosL oLhor auLhoriLios, is high and Lho rosondonLs aro
rolaLivoly rono Lo dologaLo docisions alouL Lho uso ol Lhoir sanlos Lo Lho rosoarch
oLhics conniLLoo. Hovovor, duo Lo Lho lov rosonso raLo iL is inossillo Lo
gonoralizo our rosulLs, Lho risl lor solocLion lias is aaronL. ConsoquonLly, rosulLs
lron Lho lull-scalo sLudios vill lo noodod Lo conlirn Lhoso rosulLs. Tho Lvo lull-scalo
sLudios vill also rovido onough sLaLisLical ovor, Lo allov lor nulLivariaLo rogrossion
analysos Lo idonLily lacLors LhaL inlluonco, lor oxanlo, Lho villingnoss Lo donaLo a
sanlo and Lho roloronco lor dilloronL consonL rocoduros.

3.3 The full-scale studies of the Swedish public and diabetic patients
BoLh lull-scalo sLudios onloy Lho nodiliod vorsion ol Lho soll-adninisLorod
quosLionnairo usod in Lho iloL sLudy. IL vas sonL Lo a randon sanlo (n=6000} ol
Lho gonoral ullic in Svodon in laLo CcLolor 2002. Tho rosonso raLo has roachod
50' alLor Lvo ronindors (Lho lirsL ronindor viLh a loLLor only, and Lho socond viLh a
nov quosLionnairo and onvoloo}, and vill hoolully incroaso lurLhor alLor Lho Lhird
and lasL ronindor (loLLor only} LhaL vas sonL in nid January 200J. Analysis vill lo
conducLod during Lho sring 200J. In arallol, a socond lull-scalo sLudy is running in
vhich Lho sano quosLionnairo is usod Lo idonLily dialoLic aLionLs orcoLions. In
Lhis sLudy, dialoLic aLionLs visiLing Lho dialoLic clinic aL a najor hosiLal in Svodon
aro consocuLivoly aroachod unLil a saLislying nunlor ol aLionLs havo accoLod Lo
arLiciaLo. Tho analysis ol Lhoso daLa vill lo carriod ouL during Lho lall ol 200J. Tho
204
rosulLs lron loLh lull-scalo sLudios vill lo ullishod in oor-roviovod inLornaLional
scionLilic journals.

References

Annas, G.J. (2001}. Rolorning inlornod consonL Lo gonoLic rosoarch. 1AMA, \ol. 286:18,
. 2J26-2J28.

Asai, A., Chnishi, M., Nishigali, I., SolinoLo, M., Iuluhara, S. & Iului, T. (2002}.
ALLiLudos ol Lho Jaanoso ullic and docLors Lovards uso ol archivod inlornaLion and
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LMC Med thics, \ol. J: 1, . 1.

AshcrolL, R. (2000}. Tho oLhics ol rousing archivod Lissuo lor rosoarch. Neuropathol Appl
Neurobiol, \ol. 26: 5, . 408-411.

Boslov, L.M., Burlo, \., Morz, J.I., Barr, I.A., Torry, S., Ionchaszadoh, \.B., GosLin,
L.C., Gvinn, M. & Khoury, M.J. (2001}. Inlornod consonL lor oulaLion-lasod rosoarch
involving gonoLics. 1AMA, \ol. 286: 18, . 2J15-2J21.

ClayLon, I.\., SLoinlorg, K.K., Khoury, M.J., Thonson, I., Androvs, L., Kahn, M.J.,
Koolnan, L.M. & \oiss, J.C. (1995}. Inlornod consonL lor gonoLic rosoarch on sLorod
Lissuo sanlos. 1AMA, \ol. 24: 22, . 186-192.

Iullor, B.I., Kahn, M.J., Barr, I.A., Biosoclor, L., Crovloy, I., Garlor, J., Mansoura, M.K.,
Murhy, I., Murray, J., Ihillis, J., RoLhonlorg, K., RoLhsLoin, M., SLolor, J., Svorgold, G.,
\olor, B., Collins, I.K. & Hudson, K.L. (1999}. Irivacy in gonoLics rosoarch. Science, \ol.
285: 54J2, . 1J59-1J61.

Malono, T., CaLalano, I.J., CÌvyor, I.J. & GianLonio, B. (2002}. High raLo ol consonL Lo
lanl liologic sanlos lor luLuro rosoarch: Lho IasLorn CoooraLivo Cncology Grou
oxorionco. 1 Natl Cancer lnst, \ol. 94:10, . 69-1.

Mcuoon, M.J. (1998}. ILhical and logal issuos in Lho rocurononL, sLorago and uso ol
INA, Clin Chem Lab Med. \ol. J6: 8, . 545-549.

Morz, J.I. & Sanlar, I. (1998}. INA Banling: An Inirical SLudy ol a Iroosod ConsonL
Iorn. I \oir, R.I. (Ids}. Stored Tissue Samples. thical, Legal, and ublic olicy lmplications,
Iova CiLy: InivorsiLy ol Iova Iross. . 198-225.

MouLol, G., do MonLgollior, S., Moningaud, J.I. & Horvo, C. (2001}. Bio-lilrarios and INA
sLorago: assossnonL ol aLionL orcoLion ol inlornaLion. Med Lau, \ol. 20: 2, . 19J-204.

Cgloll, J.R. & CLLo, R.K. (1991}. Aro rosoarch arLicianLs Lruly inlornod RoadaliliLy ol
inlornod consonL lorns usod in rosoarch. thics Lehav, \ol. 1:4, . 2J9-252.

Iolias, M.K. & Marlvard, N.J. (2001}. Novlorn scrooning, inlornod consonL, and luLuro
uso ol archivod Lissuo sanlos. Cenet Test, \ol. 5: J, . 19-185.

Irino, \., Solol, M.I. & HorringLon, C.S. (2000}. ILilizaLion ol hunan Lissuo in lroasL
cancor rosoarch, Lreast Cancer Res. \ol. 2: 4, . 2J-240.
205

Sado, R.M. (2002}. Rosoarch on sLorod liological sanlos is sLill rosoarch. Arch lntern Med,
\ol. 162: 1J, . 14J9-1440.

SchvarLz, M.I., RoLhonlorg, K., Josoh, L., Bonlondorl, J. & Lornan, C. (2001}. ConsonL
Lo Lho uso ol sLorod INA lor gonoLics rosoarch: a survoy ol aLLiLudos in Lho Jovish
oulaLion. Am 1 Med Cenet, \ol. 98: 4, . JJ6-J42.

SLognayr, G. & Aslund, K. (2002}. Inlornod consonL lor gonoLic rosoarch on llood sLorod
lor noro Lhan a docado: a oulaLion lasod sLudy. LM1, \ol. J25, . 6J4-6J5.

SLoinlorg, K.K. (2001}. ILhical challongos aL Lho loginning ol Lho nillonniun. Stat Med,
\ol. 20: 9-10, . 1415-1419.

TrauLh, J.M., Musa, I., Sininoll, L., Jovoll, I.K. & Ricci, I. (2000}. Iullic aLLiLudos
rogarding villingnoss Lo arLiciaLo in nodical rosoarch sLudios. 1 Health Soc olicy, \ol. 12:
2, . 2J-4J.

\adnan, M. (2000}. GonoLicisLs ooso consonL ruling. Nature, \ol. 404: 64, . 114-
115.

\ang, S.S., Iridingor, I., Shoody, K.M. & Khoury, M.J. (2001}. Iullic ALLiLudos rogarding
Lho IonaLion and SLorago ol Blood Socinons lor GonoLic Rosoarch. Community Cenet, \ol.
4: 1, . 18-26.

\ondlor, I. (2002}. \haL rosoarch viLh sLorod sanlos Loachos us alouL rosoarch viLh
hunan suljocLs. Lioethics, \ol. 16: 1, . JJ-54.

\ondlor, I. & Inanuol, I. (2002}. Tho dolaLo ovor rosoarch on sLorod liological sanlos:
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\ondlor, I., Irasad, K. & \illond, B. (2002}. Ioos Lho curronL consonL rocoss nininizo
Lho risls ol gonoLics rosoarch. Am 1 Med Cenet, \ol. 11J: J, . 258-262.

\ilcox, A.J., Taylor, J.A., Shar, R.R. & London, S.J. (1999}. GonoLic doLorninisn and Lho
ovorroLocLion ol hunan suljocLs. Nat Cenet, \ol. 21: 4, . J62.

\illians, I.I. (2001}. Inlornod consonL in gonoLic rosoarch. Croat Med 1, \ol. 42: 4, .
451-45.
206
lntellectual property and biobanls

10

Intellectual property and biobanks

Asa Hellstadius, LLM, Sanna Woll, LLM & Richard Wessman, LLD

Department oj Lau, Stoclholm University

The exploitation oj biobanls creates interactions betueen various legal disciplines. The
rights to injormation, consent and uithdraual, established by the recent Suedish
legislation on biobanls and granted to protect the patient's or donor's integrity uhen
supplying the biobanl uith material, are contrasted uith the rights oj the proprietor or
user oj a biobanl. The latter include intellectual property rights acquired as a result oj
biobanlrelated research and development and possible commercialisation. Such
proprietary rights are clearly needed in order to create incentives jor companies to invest
in research, but their application may collide uith other types oj rights and interests. ln
the intellectual property context, biobanls are regarded as protectable compilations, i.e.
databases. Hence, biobanls may be protected by intellectual property in the jorm oj
copyright or sui generis protection. The extent and the practical ejjects oj protection oj
biobanls are oj importance to proprietors and users oj biobanls, researchers, patients and
others, since the rights holder may prevent certain acts uith the samples contained in the
biobanl. The ounership oj intellectual property in biobanls and related materials
resulting jrom scientijic research is therejore oj special interest. The intellectual property
rights oj researchers employed at Suedish universities are governed by the socalled
teacher exception. This specijic system concerns academic research, and is a both
statutory and a traditional system giving university teachers ounership title to their
patentable copyrightable uorls. lt is therejore recommended that the intellectual property
rights be properly regulated by contracts, just as any other right to the material (i.e. right
to disposition, use etc.) in a biobanl needs to be regulated.

1. Introduction

As a rosulL ol lioLochnological dovolononLs, collocLions ol lioLochnological
naLorial aro ol olviously groving valuo and inorLanco lor rosoarch and
dovolononL urosos. In arLicular againsL Lho lacldro ol Lho svilL
lioLochnological dovolononL, liolanls nusL lo considorod as inorLanL and
valuallo assoLs. In such a orsocLivo, quosLions ol ovnorshi, righLs in and conLrol
ol Lho naLorial as such aro ol suddon and crucial inLorosL.
Tho sysLon ol inLollocLual roorLy lav ollors corLain ossililiLios lor
croaLors ol liolanls Lo onjoy an oxclusivo righL Lo Lho sLrucLuro ol Lho lanl, as voll
as roLocLion againsL oxLracLions or ro-uLilisaLion ol Lho daLa. In Lho ovonL ol
connorcialisaLion ol liolanls and Lhoir conLonL oiLhor as daLa or as collocLions ol
daLa (daLalasos}, Lho inorLanco ol Lradonarl or Lrado nano roLocLion should noL
lo lorgoLLon as anoLhor oxanlos ol valuallo oxclusivo righLs. \horo Lho righLs
207
Asa Hellstadius, Sanna Woll & Richard Wessman
holdor is an onloyoo ol a connorcial conany, iL doonds on Lho onloynonL
conLracL vhoLhor Lho oxclusivo righLs in a liolanl sLrucLuro or Lho collocLion aro
Lranslorrod Lo Lho onloyor. In rincilo, hovovor, Lhis is noL Lho caso vhon Lho
croaLor ol a liolanl sLrucLuro is acLivo as a univorsiLy Loachor, as social rulos ly lav
and LradiLion aly in Lho univorsiLy onvironnonL. In loLh casos rollons nay occur
LhaL donand considoraLion ol Lho siLuaLion ainod lor, and conLracLual rogulaLion is
olLon ol viLal inorLanco Lo rovonL logal rollons or disagroononLs occurring laLor
on.
AlLhough inLollocLual roorLy righLs in Lho lighL ol roconL yoars`
Lochnological dovolononLs havo loon inLonsoly dolaLod in nany loruns, naLionally
and inLornaLionally, inLollocLual roorLy quosLions in rolaLion Lo liolanls havo as
yoL loon liLLlo discussod. Tho lolloving sunnary ol sono nov sLudios on liolanls
and inLollocLual roorLy ains Lo lill LhaL ga. IL is olvious LhaL Lho oxisLonco ol
oxclusivo righLs in liolanl sLrucLuros, or righLs Lo lorlid oxLracLion lron or ro-
uLilisaLion ol Lho collocLion in a liolanl, or Lo hold a liolanl Lradonarl or Lrado
nano Lo an oxclusivo lasis alvays rosLricLs Lho accoss ol oLhor arLios Lo Lho
roLocLod oljocLs. This is vhy inLollocLual roorLy righLs aro sonoLinos quosLionod
and can novor lo rogardod in isolaLion, i.o. viLhouL also Laling duo accounL ol
conoLiLion sLrucLuros and Lho lalancing ol righLs. Tho sysLon as such oxisLs Lo
ronoLo socially lonolicial dovolononLs ol various linds and Lo insiro
conoLiLion.
To undorsLand Lho lull ollocLs ol inLollocLual roorLy righLs as jusL
nonLionod in Lhis socilic liolanl conLoxL, a liLLlo noro oxlanaLion ol Lho sysLon as
such is noodod. To sLarL viLh, inLollocLual roorLy is Lho arL ol Lho logal univorso
LhaL rogulaLos Lho roLocLion ol arL and liLoraLuro, scionco and Lochnology, indusLrial
dosigns, Lradonarls and oLhor disLincLivo signs and rolaLod suljocLs. BuL all Lhoso
oljocLs havo Lo lo Lalon in a lroad sonso Loday. LiLorary should lo undorsLood as
noroly doscriLivo" and vhaL nodorn arL sLands lor is nuch noro Lhan Lho classical
vorls, a visiL Lo any nodorn arL oxhiliLion vill nalo Lhis cloar. A Lradonarl is noL
only a vord or a icLorial lalol, iL nay ovon consisL ol a snoll.
Tho noLion ol InLollocLual IroorLy is Lhus lairly oxrossivo ol vhaL iL is all
alouL. Tho logal roLocLion givon rosonllos rorioLary righLs Lo Langillo oljocLs in
nany rosocLs, luL concorns non-Langillo naLLors, vorls ol Lho nind. An
inLollocLual roorLy righL is noL a righL Lo a hysical oljocL, luL raLhor an alsLracL
honononon ol Lho nind. Hovovor, Lho righL nusL lo nanilosLod in hysical
oljocLs vhich luncLion as carriors ol Lho inLollocLual roducL. Ior insLanco, a liLorary
vorl or an invonLion can lo olsorvod in iLs concroLo lorn, luL Lho oljocL ol
roLocLion is Lho vorl as such. Tho inLollocLual roorLy sysLon conlors, lor
oxanlo, on Lho auLhor a coyrighL, on Lho invonLor a aLonL righL or on Lho Lrador a
Lradonarl righL, oLc., vhich is a Lyo ol nonooly. Tho oxclusivo righL can lo
Lranslorrod as a vholo or arLly (undor liconco} Lo oLhors in a sinilar vay Lo oLhor
oljocLs ol ovnorshi.
Ivon il logislaLion is naLional or Loday Lo a corLain oxLonL rogional viLhin
Iuroo, as lor oxanlo viLh Lradonarl and dosign righLs oxisLing on a naLional as
voll as a rogional lasis, roLocLion can Lranscond naLional lordors, Lhanls Lo a sysLon
ol inLornaLional convonLions. Iuo Lo Lho social characLor ol inLollocLual roorLy,
ollocLivo inLornaLional agroononLs and sysLons ol roLocLion aro arLicularly
inorLanL, and Lhanls Lo harnonisaLion aL loLh Iurooan and glolal lovol, such
208
righLs can Lo a largo oxLonL lo onjoyod in a sinilar vay lron counLry Lo counLry. Tho
oljocL, suljocL, scoo and duraLion ol roLocLion dillor according Lo Lho various
righLs, and Lo a corLain oxLonL aL loasL Lho scoo ol roLocLion nay dillor lron
counLry Lo counLry. This is osocially Lruo ouLsido Iuroo.
InLollocLual IroorLy Lav has LradiLionally loon closoly connocLod viLh
Lochnical dovolononLs, and nornally, vhoro Lhoro is a nov Lochnology, raid
adaLaLion ol Lho inLollocLual roorLy sysLon Lalos laco, in addiLion Lo nov Lyos
ol righLs loing dovolood. This is noL loasL Lho caso vhoro considorallo invosLnonLs
aro involvod. InLollocLual roorLy lav in our days has novod Lovards a sysLon lor
roLocLion ol invosLnonLs. NovorLholoss, vhon inLroducing inLollocLual roorLy
righLs in novol onvironnonLs and surroundings, nov siLuaLions and rollons nay
ariso. Cno such oxanlo is Lho inLroducLion in socioLy ol inlornaLion Lochnology,
digiLalisaLion and Lho InLornoL, vhoro inLollocLual roorLy righLs havo had Lo lo
adaLod Lo vorl in nov soLLings. Tho oxisLonco ol such righLs in lioLochnology and
gono Lochnology rosoarch is naLural and a consoquonco ol Lho LradiLional nuLual
doondonco ol Lho inLollocLual roorLy sysLon and scionLilic and socioLal
dovolononL.

2. The biobank, the market and the law

Thoro aro nany nov and inLorosLing logal quosLions concorning Lho uso and
oxloiLaLion ol liolanls. IilloronL Lyos ol righLs oxisL in and around Lho collocLions
ol hunan liological naLorial. Sono ol Lhoso nay noroly soon Lo conllicL viLh oach
oLhor, oLhor acLually do so. BuL lasically, Lho righLs oxisL on dilloronL lovols, lor
insLanco, Lho righLs ol Lho aLionL or donor Lo lo inlornod ol Lho rosorvaLion ol Lho
sanlo and Lo consonL Lo iLs rosorvaLion, Lho righLs ol rorioLors or Lho usors ol a
liolanl Lo nalo uso ol Lho sanlos, Lho coyrighL roLocLion ol Lho liolanl as such,
and Lho aLonLing ol invonLions rosulLing lron uso ol sanlos in rosoarch.
Tho logal donarcaLions vhich soonor or laLor havo Lo lo nado loLvoon Lho
righLs ol dilloronL orsons (in arLicular loLvoon, on ono hand, Lho donors ol hunan
naLorial and, on Lho oLhor, Lho ovnors or usors ol liolanls} aro aL Lho rosonL Lino
lar lron cloar or rociso. In Lhis arLicular conLoxL, iL is inorLanL Lo dolino cloarly
Lho righL ol Lho aLionL or donor Lo lo inlornod ol Lho rosorvaLion ol Lho sanlo, Lo
consonL Lo Lhis rosorvaLion and Lo viLhdrav a consonL roviously givon.
1
Tho
osLallishnonL ol such righLs nay noL only allocL Lho collocLion and uso ol sanlos in
liolanls, luL also Lho ossililiLy Lo assign or Lranslor a liolanl Lo anoLhor arLy,
2

and Lho ossililiLy ol aLonLing invonLions vhich aro dorivod lron Lho uso ol
liolanls.
J
IurLhornoro, quosLions rogarding Lho righLs ol Lho rorioLors or Lho usors
ol Lho liolanls aro ol groaL inorLanco. Tho connorcially inorLanL ossililiLy ol
doriving valuallo inLollocLual roorLy righLs lron Lho uso ol liolanls has Lo lo
considorod. In Lhis conLoxL noL only aLonL lav, luL also coyrighL lav and
Lradonarl lav, aro inorLanL.

1
Cha. J, SocLions 1 and 6 ol Lag (?00?.?97) om biobanler l halso och sjulvrden m.m.
2
lbid, Cha. 4, SocLion .
J
Boylovold 2000, . 1 and SLorclx 1998 . 12J.
209
Tho uso ol liolanls in rosoarch and dovolononL nay rosulL in invonLions LhaL aro
aLonLallo.
4
In Lho liolds ol lioLochnology and gonoLic onginooring, Lho ossililiLy ol
acquiring an oxclusivo righL Lhrough Lho rulos ol aLonL lav sorvos as an inorLanL
inconLivo lor invosLnonL in rosoarch. Tho sysLonaLic aroach Lalon ly Lho liolanl
rorioLor in Lho conilaLion and adninisLraLion ol Lho liolanl nay olLon lo
oligillo lor roLocLion undor coyrighL lav, or cono undor social roLocLion lor
conilaLions.
5

IurLhornoro, Lho rorioLor nay aLLonL Lo socuro Lho goodvill or
rouLaLion ol Lho liolanl ly rogisLoring iLs nano as a Lradonarl. Tho Lradonarl nay
sorvo Lo guaranLoo Lho liolanl`s rolialiliLy and qualiLy.
Tho Lrado nano or Lradonarl ol Lho liolanl nay lo roLocLod in various
vays. Il iL loconos voll lnovn in Lho rolovanL ullic socLor or in Lho arLicular
liold ol Lrado, iL nay lo roLocLod undor Lho Svodish Tradonarls AcL, rogardloss ol
rogisLraLion. IL nusL aL rosonL lo considorod uncloar vhoLhor Lho narl has Lo lo
voll lnovn anong rosoarchors and nodical racLiLionors in Lho liold ol liolanl
rosoarch or anong Lho aLionLs or donors sulying Lho liolanl viLh naLorial.
NovorLholoss, duo osocially Lo Lho lurdon ol rool in a oLonLial
inlringononL rocooding, rogisLraLion is Lo lo rolorrod undor nornal condiLions. In
ordor Lo acquiro a Lradonarl righL in Svodon ly vay ol rogisLraLion, ono nay
rogisLor Lho Lradonarl on oiLhor a naLional lasis
6
or a Iurooan lasis
. In Lho laLLor
caso, Lho Lradonarl is roLocLod in Lho Iurooan Inion in iLs onLiroLy. Tho
rogisLraLion ol Lho Lrado nano in accordanco viLh Lho Svodish Trado Nanos AcL vill
roLocL Lho Lrado nano lron loing usod ly oLhors as a Lrado nano or Lradonarl in
Svodon.
Tho ain ol sLrongLhoning Lho goodvill ol Lho rorioLor ol Lho liolanl,
rorosonLod ly iLs Lrado nano or Lradonarl, nay in iLsoll rogardloss ol logal
olligaLions lo a sullicionL inconLivo Lo inrovo oLhical asocLs. ILhical quosLions
aro no doulL inorLanL in Lho liold concornod. Cnly il a liolanl collocLs and
handlos iLs naLorial in an oLhically roor vay, vill iL lo viovod in a osiLivo lighL ly
rosoarchors and donors. Tho rollocLion ol Lho oLhical sLandards in Lho Lrado nano or
Lradonarl vill sorvo as an ocononic inconLivo lor invosLnonLs in inlornaLion and
qualiLy conLrol.
In Lhis conLoxL, viLh a viov Lo Lho connorcial oxloiLaLion ol liolanls, an
inorLanL disLincLion nusL lo nado loLvoon, on Lho ono hand, liolanls croaLod
viLhin Lho lrano ol ullic hoalLh and nodical sorvicos, and on Lho oLhor, Lhoso
croaLod ly rivaLo conanios, o.g. liolanls ovnod ly harnacouLical conanios.
Tho Svodish Biolanls AcL alios only Lo liolanls viLhin Lho socLor ol ullic
hoalLh and nodical sorvicos,
8
and logislaLion rohiliLing Lho oxloiLaLion ol a
liolanl lor connorcial gain, or rovonLing Lho assignnonL ol a liolanl Lo anoLhor
arLy, nay allocL Lho valuo ol a liolanl Lo iLs rorioLor or usor.

4
Marll 2002, . 1, Holzalol/Schnoidor 2001, . 860, Ng-Loy \oo Loon 2002, . J9J and Sona
1999, . J1.
5
See SocLion J Ixclusivo righLs Lo Biolanls".
6
Tho alicaLion should lo nado Lo Lho IaLonL and RogisLraLion Cllico (IR\} in Sdorhann.
Tho alicaLion is nado Lo Cllico lor HarnonizaLion ol Lho InLornal MarloL in AlicanLo or via Lho
IR\ in roLurn lor an addiLional chargo.
8
Cha. 1, SocLion J.
210
A dividing lino nay lo dravn loLvoon Lho righLs ol Lho orson sulying Lho
liolanl viLh iLs naLorial, o.g. a aLionL or a donor, and Lho righLs ol Lho orson vho
is Lho rorioLor ol Lho liolanl or is using iL lor rosoarch and dovolononL. \hilo
Lho rorioLor ol Lho liolanl nay acquiro oxclusivo righLs Lo Lho lanl as such or iLs
nano or dovolo aLonLallo roducLs, Lhoro is no sharing ol lonoliLs viLh Lho aLionL
or donor. \iLh Lhis dividing lino in nind and viLh an oyo Lo oLonLial conllicLs ol
inLorosL loLvoon Lho orsons siLuaLod on dilloronL sidos ol Lho lino ono nay, on Lho
ono hand, considor Lho inLogriLy ol Lho aLionL or donor and Lho righL a orson has
ovor his ovn lody and naLorial collocLod lron iL, and on Lho oLhor, Lalo inLo
accounL Lho nood Lo suorL and oncourago rosoarch and dovolononL, ly Lho uso ol
liolanls, in Lho liolds ol lioLochnology and gonoLic onginooring.
Tho conllicL jusL nonLionod is, hovovor, aL loasL Lo sono oxLonL illusory.
Tho aLionL or donor, in oLhor vords Lho orson vho sulios naLorial, o.g. a llood
sanlo, Lo Lho liolanl, is noL only a sulior" in Lho narloL in quosLion. Ho is aL
Lho sano Lino a consunor" ol Lho ond roducL, o.g. a harnacouLical, rosulLing
lron lioLochnological rosoarch nado ossillo ly Lho uso ol a liolanl. Cno nay in
Lhis sonso soal ol a dual rolo. Tho aLionL or donor nay lo soon noL only as a
roducor ol rav naLorial lor a arLicular liolanl, luL also as a oLonLial consunor
ol roducLs sLonning lron Lho rosoarch nado ossillo ly Lho liolanl in quosLion.
\hon doLornining vhoLhor or noL Lho logislaLion is ollicionL ono cannoL avoid Laling
Lhis dual rolo" inLo accounL. In doing so, iL has Lo lo considorod LhaL an
ovorroLocLivo viov ol Lho aLionL/donor, rosulLing in an unlalancod onhasis on
righLs ol inlornaLion, consonL and viLhdraval, nay on Lho vholo load Lo nogaLivo
ollocLs, noL only lor Lho rorioLors or usors ol liolanls luL also lor Lho
aLionLs/donors Lhonsolvos, in Lhoir caaciLy as consunors ol harnacouLicals and
oLhor roducLs rosulLing lron liolanl-rolaLod rosoarch and dovolononL.
IirsLly, such ovorroLocLion nay voalon Lho inconLivos Lo invosL in liolanl-
rolaLod rosoarch and dovolononL. Tho nood Lo inlorn and acquiro consonL, in
addiLion Lo Lho risl ol a laLor viLhdraval ol a consonL alroady givon, nay load noL
only Lo a riso in dovolononL cosLs luL also Lo insocuriLy as Lo Lho rosonL and luLuro
caaciLy and valuo ol a arLicular liolanl. \hon dociding vhoLhor or noL Lo invosL
in a liolanl, Lho invosLor nusL considor Lho cosLs ol inlorning and acquiring consonL
and lurLhornoro Lho insocuriLy rolaLod Lo Lho risl ol luLuro viLhdravals ol consonL.
Socondly, oxcossivo roLocLion ol Lho aLionL/donor nay incroaso
LransacLion cosLs. In ordor Lo inlorn and olLain consonL, Lho rorioLor ol a liolanl
has Lo Lalo corLain noasuros, o.g. inlornaLion anhloLs suliod Lo Lho
aLionL/donor, social inlornaLion acLiviLios anong Lho sLall and lorns socuring
consonL. Tho cosL ol adninisLraLivo noasuros, in ocononic Lorns LransacLion cosLs
nay lo so signilicanL as Lo rovonL LransacLions vhich in Lhonsolvos vould havo
loon ollicionL.
Tho Biolanls AcL oughL Lo lo viovod againsL Lho lacldro ol Lho alovo
argunonL concorning Lho dual rolo ol Lho aLionL/donor. IL roquiros Lho rorioLor ol
Lho liolanl Lo inlorn Lho aLionLs/donors and olLain Lhoir consonL, luL Lho closor
inLorroLaLion ol Lhoso roquirononLs, is, aL loasL Lo a corLain oxLonL, lolL lor Lho courLs
or corLain oxorL conniLLoos
9
Lo docido. Cloarly, Lho roquirononLs cannoL lo
consLruod in an ovorly sLricL nannor, sinco Lhis vould losson Lho inconLivos Lo invosL
in liolanls and incroaso Lho LransacLion cosLs involvod in croaLing Lhon.

9
Cha. 1 SocLion 2 and Cha. 2 SocLion J ol Lho Biolanls AcL.
211

\hon a liolanl is croaLod ouLsido Lho aroa ol ullic hoalLh and caro sorvico, o.g. a
rivaLo liolanl ovnod and adninisLorod ly a harnacouLical conany, Lho
Biolanls AcL is noL alicallo. BuL Lhoro is sLill a roquirononL ol consonL, in Lho
sonso LhaL Lho rorioLor ol Lho rivaLo liolanl nusL olLain Lho consonL ol Lhoso
vho suly Lho liolanl viLh sanlos. Nornally, Lhis vill lo adninisLorod ly vay ol
social agroononLs Lhrough vhich consonL is socurod. Indor corLain condiLions, o.g.
vhon a conany usos sanlos lron onloyoos in iLs ovn liolanl, Lho dilliculL
donarcaLion ol Lho roquirononLs ol inlornaLion and consonL, nonLionod alovo, nay
sLill havo Lo lo nado.
Ivon il iL lollovs lron Lho Biolanls AcL LhaL a aLionL/donor nay viLhdrav
consonL alroady givon, iL is noL cloar vhoLhor a righL ol viLhdraval oxisLs in rolaLion
Lo rivaLoly ovnod liolanls ouLsido Lho aroa ol hoalLh and nodical sorvicos.
Nornally, Lhis nusL lo Lalon Lo hingo on Lho inLorroLaLion ol Lho agroononL
loLvoon Lho aLionL/donor and Lho rorioLor ol Lho liolanl. IndoulLodly, Lhis
rorosonLs an inorLanL dilloronco loLvoon Lho rogulaLion ol liolanls viLhin ullic
hoalLh and nodical sorvicos and liolanls croaLod rivaLoly, lor oxanlo ly
harnacouLical conanios. Such a dilloronco nay lo jusLiliod ly dilloroncos in Lho
vay in vhich naLorial is collocLod.

3. Exclusive rights to biobanks

Tho croaLor/roducor ol a liolanl has olLon invosLod Lino and nonoy in iLs croaLion,
and Lhoroloro vishos inLollocLual roorLy roLocLion ol Lho rosulLs. \haL ho has
achiovod in Lho inLollocLual roorLy sonso is rolally a daLalaso". Sinco a liolanl
nay consLiLuLo a daLalaso, Lho rincilos lor Lho roLocLion ol daLalasos undor
inLollocLual roorLy lav aro oxaninod rogarding Lhoir alicaLion in Lho donain ol
liolanls.

Tho inLollocLual roorLy righLs ol inLorosL lor a daLalaso roducor aro coyrighL
and/or sui generis
10
roLocLion. Gonorally, Lvo Lyos ol roLocLion aro concoivallo:

Tho daLalaso is roLocLod indoondonLly ly , on accounL ol Lho
ol Lho daLalaso, vhich is roLocLod as an original vorl undor SocLion 1
ol Lho CoyrighL AcL.
Tho daLalaso is roLocLod ly Lho so-callod undor SocLion 49 ol
Lho CoyrighL AcL, on accounL ol Lho involvod in Lho croaLion ol Lho
daLalaso.
11

A conlinaLion ol Lhoso righLs is ossillo, doonding on originaliLy and Lho
invosLnonLs nado in Lho conilaLion and Lho sLrucLuro ol Lho naLorial. IL should lo
noLod LhaL also, Lho rogisLors aurLonanL Lo Lho liolanls, viLh inlornaLion ol Lho
sanlos, nighL lullil Lho roquirononLs lor coyrighL or sui generis roLocLion.

10
LiLorally, ol iLs ovn lind".
11
SocLion 49 ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl.
212
\horo a liolanl is roLocLod, Lho croaLor/roducor ol a liolanl is roLocLod againsL
unauLhorisod uso ol Lho roLocLod oljocL (i.o. Lho lanl}. uosLions ariso as Lo vhaL
consLiLuLos inlringononL ol Lho righL. Can Lho uso ol sanlos in Lho liolanl inlringo
such a righL, o.g. Lho roloaso ol sanlos lor rosoarch urosos Tho ansvor doonds
on vhich Lyo ol righL roLocLs Lho naLorial. Il Lho lanl is oligillo lor coyrighL, Lho
arrangononL ol naLorial vill lo roLocLod againsL coying, ullic disLriluLion or
dislay. Il on Lho oLhor hand iL is noroly sonoLhing LhaL corrosonds Lo Lho
roquirononLs ol a sui generis right, Lho roLocLion rovonLs againsL Lho oxLracLion
and/or ro-uLilisaLion ol Lho vholo or a sulsLanLial arL ol a conilaLion`s conLonLs,
luL noL noro.

3.1 Biobanks as Databases
Tho logal doliniLion ol a liolanl" is biological material jrom one or several humans
that is collected and stored [.]".
12
According Lo Lho Biolanls AcL, Lho naLorial nood
noL lo sLorod in a corLain sLrucLuro. Hovovor, Lho sanlos nusL lo conLainod
viLhouL risl ol dosLrucLion. IurLhornoro, unauLhorisod orsons nusL lo rovonLod
lron accossing Lho naLorial. Tho sano goos lor Lho aurLonanL rogisLors.
ConsoquonLly, Lho arrangononL ol sanlos in a corLain ordor is a roroquisiLo lor Lho
luncLionaliLy and Lho lullilnonL ol Lho logal roquirononLs ol a liolanl.
Tho logal concoLion ol a daLalaso" rolors Lo Lho sLorago ol inlornaLion
usually olocLronic in a nonory. Hovovor, Lho vord daLa" is ly no noans liniLod
Lo conuLorisod sLorago ol inlornaLion. Tho noLion ol daLa" only rolors Lo
inlornaLion conLainod. This viov is rollocLod in Lho IC IirocLivo`s doliniLion ol a
daLalaso:

Database' shall mean a compilation oj independent uorls, data or other materials
arranged in a systematic or methodical uay and individually accessible by electronic
means."
1J

According Lo Lho logal doliniLion, a daLalaso is a conilaLion ol indoondonL daLa
viLh individually accossillo olononLs. So iL nood noL lo olocLronic. Tho inLollocLual
roorLy roLocLion ol daLalasos covors ovory conilaLion ol naLorial sLorod ly any
noans. Tho usor ol a laso nusL lo allo Lo lind rolovanL inlornaLion ly using
individual soarch criLoria, and should noL havo Lo soarch Lhrough Lho vholo
collocLion ol inlornaLion Lo lind Lho inlornaLion ho or sho vanLs.
14

IroLocLion is noL doondonL on Lho sizo ol Lho laso. Ivon a snall collocLion
ol naLorial is a daLalaso qualilying lor roLocLion undor Svodish lav. \iLh rogard Lo
liolanls, a lanl viLh a liniLod nunlor ol sanlos is jusL as oligillo lor roLocLion as
a lanl conLaining Lhousands ol iLons. As a gonoral rulo, liological naLorial sLorod in
a corLain sLrucLuro is a daLalaso, viLh duo rogard lor Lho sLrucLuring ol Lho naLorial,
and Lho noans ol soarching Lho conilaLion.
In ordor Lo onjoy coyrighL roLocLion a daLalaso nusL lullil Lho criLoria ol
originaliLy" and individualiLy" Lo lo a vorl" viLhin Lho noaning ol coyrighL lav.

12
Cha. 1, SocLion 2 ol Lag (?00?.?97) om biobanler i halso och sjulvrden m.m. (Lho Biolanls AcL},
Regeringens proposition ?001/0?.44, Liobanler i halso och sjulvrden m.m. (GovornnonL Bill
2001/02:44} . 21.
1J
ArL. 1(2}, IirocLivo 96/9/IC.
14
Andorson 2001, . 40J oL soq.
213
Tho roLocLion allordod undor Lho sui generis righL dillors in sono rosocLs lron
roLocLion undor coyrighL. A daLalaso roLocLod undor Lho sui generis righL doos noL
ossoss Lho nocossary dogroo ol originaliLy lor coyrighL roLocLion.
Tho doliniLaLion loLvoon Lho Lvo linds ol roLocLion doonds on an
ovaluaLion ol Lho vorl laid dovn in Lho daLalaso ol inLorosL. CoyrighL roLocLs
inLollocLual croaLiviLy in Lho solocLion or arrangononL ol Lho conLonLs ol a daLalaso,
vhilo Lho sui generis righL roLocLs invosLnonLs in Lho olLaining, vorilicaLion or
rosonLaLion ol a daLalaso`s conLonL. Tho righLs luncLion oiLhor soaraLoly or
conlinod.
15

3.2 Copyright
CoyrighL, as Lho Lorn suggosL, is a righL Lo rovonL oLhors lron coying a liLorary or
arLisLic vorl. Tho roLocLion undor coyrighL lav ol collocLions ol liological
naLorial can lo soon as an oxLonsion ol Lho oljocLs LradiLionally roLocLod. CoyrighL
originaLod in Lho oighLoonLh conLury, viLh auLhors and arLisLs sooling roLocLion lor
Lhoir liLorary and arLisLic vorls. BuL ovor Lho lolloving conLurios nov noods havo
loon lolL, and nodorn coyrighL has dovolood Lovards a lroad righL lor a varioLy ol
individual oxrossions LhaL aro sonoLinos quiLo connonlaco. Today coyrighL in
liLorary and arLisLic vorls should lo Lalon in a vory lroad sonso. Tho dovolononL ol
nov Lochnologios, noL loasL, has roloundly allocLod Lho logal lranovorl. Cl courso,
LradiLional vorls lilo novols, nusical conosiLions and ainLings aro sLill covorod,
luL so Loo aro various nodorn and Lochnologically rolaLod hononona such as
conuLor rograns, and daLalasos.
As a rosulL ol Lhis dovolononL, coyrighL has cono Lo lay an inorLanL
rolo in Loday`s socioLy, as inLollocLual roorLy roLocLion ol Lochnical oquinonL
and roducLs is crucial. Tho roLocLion ol daLalasos, noL loasL, is inorLanL lron an
ocononic orsocLivo. Iurooan as voll as naLional logislaLion has Lhoroloro loon
onacLod in Lhis donain. Svodish logislaLion on Lho roLocLion ol daLalasos is
harnonisod viLh LhaL ol Lho oLhor IC counLrios undor IirocLivo 96/9/IC, Lho
IaLalaso IirocLivo.
CoyrighL roLocLion is rogulaLod in Lho CoyrighL AcL ol 1960.
16
This righL
is choa Lo adninisLor and oasy Lo accoss. CoyrighL roquiros no lornal rogisLraLion.
Cn Lho conLrary, lornal roquirononLs lor coyrighL roLocLion aro rocludod ly
inLornaLional lav. Tho righL arisos as soon as a vorl is croaLod. CoyrighL roLocLs,
noL idoas luL Lho lorn in vhich an idoa is oxrossod. Tho idoas nood noL lo nov luL
Lho lorn lo iL liLorary or arLisLic nusL lo an original croaLion, o.g. noL a coy ol
sonolody olso`s vorl. Thus, Lho lasic criLorion lor roLocLion is originaliLy.
IroLocLion doonds noiLhor on Lho qualiLy ol Lho vorl nor on Lho uroso ol iLs
croaLion. BuL a qualiliod originaliLy, in Lho sonso ol Lho vorl dilloring lron vhaL vas
roviously lnovn or vhaL could lo oxocLod, vill oarn such a vorl noro oxLonsivo
scoo ol roLocLion.
Cno roroquisiLo ol coyrighL roLocLion is LhaL Lho auLhor`s vorl originaLos
lron hin orsonally. IL nusL havo iLs origin in Lho auLhor`s lalour, and nusL lo Lho
rosulL ol a orsonal inLollocLual croaLion. Thoro is no novolLy roquirononL, iL sullicos
LhaL Lho vorl onanaLos lron Lho auLhor and is nov Lo hin or hor. Thus, Lho
suljocLivo sLaLo ol Lho individual auLhor is docisivo. This noans aL loasL in Lhoory

15
KolLvodgaard/Lovin 2000, . 9J.
16
Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl (Lho CoyrighL AcL}.
214
LhaL Lvo orsons vho croaLo Lvo idonLical vorls indoondonLly aro loLh onLiLlod Lo
coyrighL roLocLion, i.o. roLocLion againsL coying. In roal lilo, vorls aro raroly
idonLical, luL Lhoy nay lo sinilar. This is Lruo noL loasL ol vorls LhaL aro noro
luncLional in characLor, o.g. liolanls and oLhor daLalasos.
\horoas a logal orson nay acquiro coyrighL ly Lho Lranslor ol righLs lron
a naLural orson, iL is alvays Lho auLhor or croaLor ol a vorl, Lho naLural orson, vho
is also Lho iniLial ovnor ol Lho coyrighL in Lho vorl.
1
Nor nay nachinos lo holdors
ol coyrighL.
18
Il a vorl is croaLod ly a grou ol orsons joinLly, Lho oxclusivo righLs
shall lo ovnod joinLly.
19
In addiLion Lo LradiLional coyrighL roLocLion, iL is also
ossillo Lo roLocL corLain lind ol oljocLs undor vhaL aro callod noighlouring
righLs.
20
Tho sui generis righL alroady nonLionod is jusL such a noighlouring righL
undor vhich daLalasos and oLhor conilaLions nay lo roLocLod.
As nonLionod oarlior, Lho coyrighL roLocLion conlorrod concorns Lho
daLalaso`s sLrucLural olononLs, i.o. Lho inhoronL organisaLion ol Lho sanlos in a
liolanl. Sinilarly, an oncycloaodia nay lo roLocLod as such lor Lho choico and
sLrucLuro ol iLs conLonL, vhoroas a liolanl is roLocLod lor Lho solocLion and
arrangononL ol sanlos. A liolanl is roLocLod ovon Lhough iLs conLonL (Lho
sanlos} consisLs ol non-roLocLod naLorial. Tho liological sanlos can novor
qualily as vorls" viLhin Lho noaning ol coyrighL lav, and aro noL roLocLod as
such undor coyrighL. ConsoquonLly, Lho roLocLion rolaLos only Lo Lho (original}
sLrucLuro ol Lho liolanl, noL iLs conLonLs.
Ior roLocLion ol a liolanl, iLs sanlos should lo solocLod and arrangod
according Lo a corLain noLhod ol sLrucLuro. Tho organisaLional sLrucLuro noods Lo lo
original and croaLivo. In addiLion, iL nusL lo Lho auLhor`s ovn inLollocLual croaLion,
viLh rogard Lo Lho solocLion and disosiLion ol Lho naLorial. A liolanl viLh Loo
sinlo a vay ol organising Lho sanlos, viLhouL any individual rincilo ol solocLion
or arrangononL ol Lho naLorial, vill noL onjoy coyrighL roLocLion.
21

Tho righLs losLovod ly lav on Lho ovnor ol coyrighL in a roLocLod vorl
aro oxclusivo righLs Lo uso Lho roLocLod vorl, or auLhoriso oLhors Lo uso iL.
CoyrighL nay lo soaraLod inLo Lvo arLs: ocononic righLs", and noral righLs".
22

1
SocLion 1 ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl. Tho logal righL nay lo
Lranslorrod Lhrough conLracLs. Thoro aro also rulos govorning Lho onloyor`s righL Lo Lho vorls or
invonLions ol onloyoos, see ibid SocLion 40(a}. See jurther \oll, socLion 4.
18
Lindlorg/\osLnan 2001, . 24.
19
SocLion 6 ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl.
20
Tho noighlouring righLs roLocL inter alia Lho righLs ol roducors and orlornors and non-arLisLic
hoLograhs.
21
See Regeringens proposition 199o.111, Rattsligt slydd jr databaser m.m. (GovornnonL Bill
1996/9:111} . 28. See also ArL. 2(5} ol Lho Borno ConvonLion, ArL. 10(2} ol Lho TRIIS AgroononL,
and ArL. 5 ol Lho \IIC CoyrighL TroaLy.
22
Tho noral righLs" aro indoondonL ol Lho ocononic righLs and cannoL lo Lranslorrod. Tho noral
righLs consisL lirsLly in an auLhor`s righL Lo lo nanod, vhon Lho vorl is loing roroducod or nado
availallo Lo Lho ullic. Socondly, Lho auLhor has a righL Lo oljocL Lo Lho vorl loing usod in a vay LhaL
vould lo rojudicial Lo Lho auLhor`s rouLaLion.
Tho noral righLs aro lound in SocLion J ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga
verl. An oxcoLion Lo Lho rincilo ol non-Lranslor ol noral righLs is vhon a conuLor rogran is
croaLod ly an onloyoo in Lho oxocuLion ol his duLios or on Lho insLrucLions ol his onloyor, Lho
laLLor shall lo onLiLlod, unloss oLhorviso rovidod ly a conLracL, Lo oxclusivoly oxorciso all ocononic
righLs in Lho rogran so croaLod. (SocLion 40(a} ol Lag (19o0.7?9) om upphovsratt till litterara och
lonstnarliga verl}.
215
Tho ocononic righLs aro liniLod Lo roroducLion ol Lho vorl and naling Lho vorl
availallo Lo Lho ullic. Thoso righLs aro covorod in Lho lolloving acLs:

Lho naling ol coios ol Lho vorl,
Lho disLriluLion ol coios Lo Lho ullic,
Lho ullic orlornanco ol a vorl,
Lho ullic dislay ol a vorl.
2J

A coy is orcoivod as oach nodiun in vhich Lho vorl is lixaLod, no naLLor ly vhaL
Lochniquo. Tho lixaLion ol a vorl nusL lo indoondonL lron Lho original vorl.
Coios and oLhor roroducLions ol Lho vorl aro rogardod as sanlos ol Lho original
vorl, ovon il Lhoy aro noL idonLical viLh Lho original. ToLal idonLiLy is noL roquirod.
Tho scoo ol roLocLion lor a roLocLod vorl corrosonds Lo iLs originaliLy. Il Lho
vorl is highly original, Lho scoo ol roLocLion vill accordingly lo assossod quiLo
lroadly, and vico vorsa. Tho ossililiLios ol croaLivo variaLion aro liniLod in corLain
conLoxLs, duo Lo Lho naLorials, luncLions oLc. ol Lho vorl. Ior insLanco, Lho oLions
lor sLrucLuring a liolanl aro gonorally quiLo liniLod, and consoquonLly Lho scoo ol
roLocLion lor liolanls vill lo quiLo narrov.
Tho scoo ol coyrighL roLocLion includos noL only Lho naling ol idonLical
coios ol a vorl, luL also Lho vorl in an alLorod lorn, in LranslaLion, adaLaLion,
arrangononL and any oLhor alLoraLion, in anoLhor liLorary or arLisLic lorn or ly oLhor
Lochnical noans. Ior inlringononL Lo lo osLallishod, Lho rolaliliLy nusL lo shovn
ol Lho inlringing vorl loing dorivod (coiod} lron Lho roLocLod vorl. AssossnonL
ol Lho scoo ol roLocLion is lasod on Lho doliniLaLion loLvoon adaLaLions ol Lho
vorl, vhich aro conrisod in Lho scoo ol roLocLion, and oLhor lrooly connocLod
vorls, vhich lall ouLsido Lho coyrighL roLocLod donain.
24
Il Lho sLrucLural
olononLs ol a liolanl aro coyrighL roLocLod, coying ol Lho sLrucLuro is noL
allovod. CoyrighL inlringononL nay occur ovon il only a arL ol Lho sLrucLuro is
coiod, rovidod LhaL Lho arL conLains Lho original, roLocLod sLrucLuro.
Tho socond arL ol Lho ocononic righLs conlorrod ly coyrighL consisLs in
naling Lho vorl availallo Lo Lho ullic. A vorl is nado availallo in Lhroo vays: ly
Lho disLriluLion ol coios Lo Lho ullic, ly Lho ullic orlornanco ol a vorl, and ly
Lho ullic dislay ol a vorl.
Tho ullic orlornanco ol a vorl is ol inorLanco Lo nalors ol nusic,
lilns and lays. IL consisLs ol Lho righL Lo lay, road or LransniL Lho vorl Lo Lho
ullic, luL could in Lhis conLoxL lo rolovanL Lo scroon dislays Lo an unlnovn
audionco. Tho disLriluLion righL is a righL Lo disLriluLo a vorl Lhrough salo, ronLal or
londing. Tho ullic dislay ol a vorl is a righL Lo shov Lho original vorl, or a coy
ol iL, in ullic.
Cnly acLs Laling laco viLhin Lho ullic shoro aro roLocLod undor
coyrighL. Tho vorl nay lo dislayod viLhin Lho rivaLo shoro, or viLhin a liniLod
circlo ol orsons, viLhouL auLhorisaLion lron Lho righLs holdor. A roroquisiLo is LhaL
Lho circlo ol orsons should consisL ol a liniLod uniL viLh a concroLo, individual

2J
SocLion 2 ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl. See also ArLs. 2-4 ol
IirocLivo ?001/?9/C oj the uropean arliament and oj the Council oj ?? May ?001 on the
harmonisation oj certain aspects oj copyright and related rights in the injormation society.
24
See KolLvodgaard/Lovin 2000, . 14J oL soq.
216
connocLion loLvoon iLs nonlors, o.g. a conany`s onloyoos, sLudonLs aL a school,
dologaLos aL a conloronco or nonlors ol an associaLion.
CoyrighL is liniLod ly a nunlor ol oxcoLions. IL is noL oLornal, luL is
Loday lairly long-lasLing, and rolally nuch longor Lhan noodod lor nosL ol Lho
vorls roLocLod: 0 yoars lron Lho auLhor`s doaLh yoar. CLhor oxcoLions aro
coying lor rivaLo uso and oxhausLion ol Lho righL ly Lho narloLing ol a roducL
viLh Lho consonL ol Lho coyrighL holdor.
25
Cno inorLanL cavoaL in Lhis conLoxL,
hovovor, is LhaL a digiLal daLalaso nay noL lo coiod Lo a digiLal lornaL, ovon
rivaLoly.
26

3.3 Sui generis protection of biobanks
As nonLionod oarlior, Lho righL sui generis oxisLs irrosocLivo ol ossillo coyrighL (or
oLhor} roLocLion ol a daLalaso. As has also loon nonLionod, Lho IaLalaso dirocLivo
has loon Lransosod Lo Svodish Lav ly anondnonLs Lo Lho CoyrighL AcL. Tho sui
gonoris righL is lound in SocLion 49, and Lho IirocLivo is an inorLanL sourco lor
inLorroLaLion ol Lho rulos. Tho roLocLod conilaLions aro noL vorls" in Lho
noaning ol Lho CoyrighL AcL. Tho sui generis righL rovidod undor Lho IirocLivo
roLocLs noL only Lho conilaLion ol naLorial luL also Lho daLa conLonLs ol Lho laso.
Thus, Lho dilloronL arLs ol Lho daLalaso aro roLocLod as voll as Lho vholo daLalaso
as such.
In Lhis conLoxL, Lho docisivo criLorion lor roLocLion is Lho rosonco ol a
(qualiLaLivoly and/or quanLiLaLivoly} sulsLanLial invosLnonL in Lho olLaining,
vorilicaLion or rosonLaLion ol Lho conLonLs ol a conilaLion. Tho concoLion ol
sulsLanLial invosLnonL" is dolinod noiLhor in Lho CoyrighL AcL nor in Lho IaLalaso
IirocLivo. \hon assossing Lho criLorion ol sulsLanLial invosLnonL, ocononic as voll
as oLhor invosLnonLs aro ovaluaLod.
2
Tho doloynonL ol linancial rosourcos and/or
Lho oxondiLuro ol Lino, ollorL and onorgy in Lho naling ol Lho liolanl/daLalaso aro
soon as invosLnonLs in Lho Lorns ol Lho IirocLivo.
28

Tho sui generis righL roLocLs Lho nalor ol a liolanl/daLalaso lron
oxLracLion and/or ro-uLilisaLion ol Lho vholo or a sulsLanLial arL ol iLs conLonLs. Tho
Lorn oxLracLion" noans Lho ornanonL or Lonorary Lranslor ol all or a sulsLanLial
arL ol Lho conLonLs ol a conilaLion Lo anoLhor nodiun ly any noans or in any
lorn. Ro-uLilisaLion" noans any lorn ol naling availallo Lo Lho ullic all or a
sulsLanLial arL ol Lho conLonLs ol a daLalaso ly Lho disLriluLion ol coios, ly
ronLing, ly on-lino or oLhor lorns ol Lransnission.
29
Thus Lho dilloronco loLvoon
oxLracLion" and ro-uLilisaLion" is LhaL Lho lornor rolors Lo Lho righL Lo nalo coios
ol Lho daLalaso vhilo Lho laLLor concorns Lho righL ol naling iL availallo Lo Lho
ullic.
AarL lron sulsLanLial" loing usod as a criLorion lor roLocLion, Lho
concoL is also ol ivoLal inorLanco lor assossing inlringononL ol Lho righL. Cnly
Lho uso ol sulsLanLial arLs ol a conilaLion is rogardod as an inlringononL. IL has

25
Tho liniLaLions aro conLainod in Cha. 2 ol Lag (19o0.7?9) om upphovsratt till litterara och
lonstnarliga verl. See KolLvodgaard/Lovin 2000, . 112 oL soq.
26
SocLion 12 ara 2 no. J ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl.
2
Regeringens proposition 199o/97.111, Rattsligt slydd jr databaser m.m. (GovornnonL Bill
1996/9:111} . 55.
28
RociLal 48 ol IirocLivo 9o/9/C.
29
ArL. (2} ol IirocLivo 9o/9/C.
217
loon roosod in Lho logal liLoraLuro LhaL Lho Lorn sulsLanLial" viLh rogard Lo Lho
inLorroLaLion ol oxLracLion" and ro-uLilisaLion" could noan Lho uso ol noro Lhan
50 ' ol Lho conilaLion. Hovovor, an inLorroLaLion ol Lho Lorns ly a conoLonL
courL, such as Lho Iurooan CourL ol JusLico, is noodod Lo osLallish Lho oxacL
conLonL ol Lho Lorn sulsLanLial".
Tho righLs holdor is Lho nalor" or roducor" ol a daLalaso.
J0
Tho nalor ol
a daLalaso is Lho orson vho Lalos Lho iniLiaLivo and Lho risl ol invosLing.
SulconLracLors, hovovor, aro socilically oxcludod lron Lho doliniLion ol nalor.
Tho roducor could lo a hysical as voll as a juridical orson (lor insLanco a
conany}. Tho conilaLion nood noL lo Lho rosulL ol a croaLivo, inLollocLual ollorL.
InsLoad Lho vorl laid dovn is roLocLod.

IroLocLion undor sui generis righL ol daLalasos nay lo sunnarisod as lollovs:

Lho sui generis righL alios Lo all conilaLions, vhaLovor Lhoir lorn, rovidod
Lhoy aro conilaLions ol indoondonL vorls, daLa or oLhor naLorials arrangod in
sysLonaLic or noLhodical vay and individually accossillo ly olocLronic or oLhor
noans,
iL roLocLs only conilaLions vhoro Lhoro has loon a sulsLanLial invosLnonL in
oiLhor Lho olLaining, vorilicaLion or rosonLaLion ol Lho conLonLs ol Lho daLalaso,
iL roLocLs againsL unauLhorisod oxLracLion and/or ro-uLilisaLion ol Lho vholo or ol
a sulsLanLial arL ol Lho conilaLion, and
iL is availallo only lor conilaLions vhoso nalors or righLs holdors aro IIA
(Iurooan Icononic Aroa} naLionals or cororaLions.
J1

Tho Lorn ol sui generis roLocLion is lilLoon yoars lron Lho daLo ol conloLion ol Lho
naling ol Lho conilaLion. A sulsLanLial chango ol Lho conLonLs ol Lho daLalaso
qualilios Lho rosulLing daLalaso lor iLs ovn Lorn ol roLocLion. In racLico, Lho Lorn
ol roLocLion can Lhus lo rolongod quiLo oasy ly sulsLanLial nov invosLnonLs. BuL
Lho liniLaLion viLh rogard Lo digiLal coying also alios Lo non-coyrighLallo
conilaLions ol daLa .

3.4 Practical implications
Il a liolanl is roLocLod undor oiLhor coyrighL or sui generis roLocLion or undor
loLh righLs in conlinaLion corLain acLs consLiLuLo inlringononL. Tho holdor ol Lho
righLs nay rovonL Lhoso acLs. Considoring LhaL conllicLing inLorosLs nay oxisL
rogarding a liolanl, Lho oxisLonco and oxorciso ol inLollocLual roorLy righLs is
corLainly inorLanL.
A liolanl is coyrighL roLocLod il iLs sLrucLuro lullils Lho criLoria ol
solocLion and originaliLy noodod lor coyrighL. Tho sLrucLuro could lo visualisod in
Lho lorn ol a so-callod nind-na. Il Lho liological sanlos aro sLrucLurod in
accordanco Lo a corLain sysLon and viLh a solocLion ol sanlos, coyrighL roLocLion
nay aly. Hovovor, Lho conilaLion ol sanlos nusL noL lo Loo sinlo or ol a
rouLino naLuro. RogisLors conLaining orsonal daLa aro also oligillo lor coyrighL
roLocLion according Lo Lho sano criLoria, luL sLrucLuring in chronological or
consocuLivo ordor nay noL lo doLailod onough lor roLocLion. Iilloring lovols ol

J0
ArL. 8 ol IirocLivo 9o/9/C.
J1
ArL. 11 ol IirocLivo 9o/9/C.
218
sanlos, or a corLain schono lor idonLilicaLion ol sanlo nunlors, nalo Lho
sLrucLuro noro advancod and should onhanco iLs oligililiLy lor roLocLion. Iuo
rogard nusL, ol courso, lo had Lo Lho racLical ossililiLios ol nunloring and
narling Lho sanlos.
Tho Biolanls AcL conLains sLandards lor Lho lalolling ol sanlos in a
liolanl. Tho naLorial nusL alvays lo Lracoallo lacl Lo a corLain individual.
Hovovor, Lho sanlos roloasod lor rosoarch nusL lo codod.
J2
A coding sysLon lor Lho
liolanl and iLs rogisLors is Lhoroloro noodod Lo lullil Lho inLogriLy donands in Lho
Biolanls AcL. Such a coding sysLon nay also qualily lor coyrighL or sui generis
roLocLion.
Coios ol Lho vorl can only lo nado il Lho sLrucLuro ol Lho liolanl is
coiod and usod, lor insLanco in Lho naling ol anoLhor liolanl. Tho issuing ol
sanlos lron a liolanl is noL an acL ol coying. InsLoad, Lhoir roloaso nay consLiLuLo
acLs ol naling Lho roLocLod vorl availallo Lo Lho ullic, vhich is also rosorvod lor
Lho coyrighL holdor.
Ior an issuing ol sanlos Lo lo rogardod as an acL ol naling Lho roLocLod
sLrucLuro availallo Lo Lho ullic, a coy ol Lho roLocLod vorl noods Lo lo oiLhor
disLriluLod or dislayod. Tho roloaso ol sanlos gonorally concorns only arLs ol Lho
vholo liolanl. Hovovor, iL is noL nocossary lor Lho roLocLion Lo aly LhaL Lho
vholo vorl is disLriluLod or dislayod. As sLaLod alovo, iL is Lho sLrucLuro LhaL is
roLocLod undor coyrighL. IL is sullicionL lor only a arL ol Lho liolanl Lo lo usod, il
LhaL arL conLains Lho roLocLod sLrucLuro. Thus, il Lho sanlos roloasod lron a
liolanl sullico Lo lorn Lho roLocLod sLrucLuro, Lho roloaso ol Lho lornor nay
consLiLuLo disLriluLion ol Lho laLLor. In such casos Lho righLs holdor`s ornission nusL
lo olLainod loloro Lho roloaso.
Iullic as oosod Lo rivaLo dislay ol Lho vorl is concoivallo il Lho
roLocLod sLrucLuro is nado availallo lor olsorvaLion ly Lho ullic. Tho vorl Lho
roLocLod sLrucLuro nood noL lo in original lorn. A hoLograh shoving Lho
sLrucLuro ol Lho liolanl nay lo onough. Il Lho ullic has accoss Lo Lho liolanl, so
LhaL Lho roLocLod sLrucLuro is availallo lor ovoryono Lo soo, Lhon Lho lanl is
dislayod Lo Lho ullic, and Lho acL roquiros Lho righLs holdor`s ornission.
Hovovor, iL could lo dilliculL lor Lho ullic Lo assinilaLo Lho roLocLod sLrucLuro
jusL ly visiLing Lho liolanl as such. IL is noro a naLLor ol shoving Lho sLrucLuro in
Lho lorn ol nind-nas and Lho lilo.
Ior roLocLion according Lo Lho righL sui generis a sulsLanLial invosLnonL
ocononic or ly oLhor noans is roquirod. Tho collocLion ol naLorial and daLa lor
nosL liolanls nay lo onough Lo qualily Lhon lor Lho sui generis roLocLion.
Tho uso ol sanlos in a sui generis roLocLod liolanl could lo soon as oiLhor
oxLracLion or ro-uLilisaLion ol Lho lanl. Tho assossnonL ol inlringononL is lasod on
vhoLhor Lho arL oxLracLod is sulsLanLial or noL. Hovovor, Lho nunlor ol sanlos
issuod in nosL liolanls nay noL lo largo onough Lo saLisly Lho criLorion ol
sulsLanLial arL". A conlononLary roLocLion is lound in Lho IaLalaso IirocLivo.
Tho rooaLod and sysLonaLic oxLracLion and/or ro-uLilisaLion ol insulsLanLial arLs ol
Lho conLonLs ol Lho daLalaso nay also consLiLuLo inlringononL. Thus a
conlononLary roLocLion nay lo alicallo in nosL casos. Hovovor, Lhoso acLs

J2
See Cha. 4, SocLion 4 ol Lag (?00?.?97) om biobanler l halso och sjulvrden m.m., Regeringens
proposition ?001/0?.44 om biobanler i halso och sjulvrden m.m. (GovornnonL Bill 2001/02:44} .
46 oL soq.
219
nusL lo rovod Lo conllicL viLh a nornal oxloiLaLion ol LhaL daLalaso, or
unroasonally rojudico Lho logiLinaLo inLorosLs ol Lho nalor ol Lho daLalaso. This
could lo dilliculL, sinco Lho sanlos aro uniquo, and aro roloasod nainly lor rosoarch.
Tho rulo is cloarly dosignod lor digiLal daLalasos, and Lho rollons ol alying such
rulos Lo non-olocLronic daLalasos aro alundanLly visillo in Lhis conLoxL.

4. Who owns the biobank?

Sinco Loday onloyoos aro rosonsillo lor a largo roorLion ol croaLivo vorl in
gonoral, and nosL invonLions, iL is inorLanL and inLorosLing Lo lnov vho loconos
Lho ovnor ol Lho inLollocLual roorLy righLs in a liolanl LhaL is croaLod in Lho
courso ol onloynonL. BuL Lhoro is no rociso ansvor Lo Lhis quosLion.
Svodish inLollocLual roorLy lav rovidos LhaL Lho croaLors ol
coyrighLallo vorls, aLonLallo invonLions or roLocLallo indusLrial dosigns havo Lho
iniLial LiLlo Lo Lho inLollocLual roorLy righLs.
JJ
Thoroloro, Lho sLarLing oinL is LhaL
an onloyor nay only olLain coyrighL, aLonL or dosign righLs ly a conLracLual
assignnonL in conLracL or ly lav. This is osocially Lruo in a univorsiLy onvironnonL.

4.1 Ownership of employees copyright
In Svodon Lhoro is no oquivalonL Lo Lho Anglo-Saxon contracts oj service" or Lho
Anglo-Anorican uorls made jor hire", vhoroly Lho coyrighL gonorally lolongs Lo
Lho onloyor. Thoro is lasically only ono oxcoLion Lo Lhis rincilo, lolloving lron
Lho Iurooan IirocLivo 91/250/IIC on Lho Logal IroLocLion ol ConuLor
Irograns, vhich is includod in SocLion 40(a} ol Lho CoyrighL AcL. ThaL SocLion
doals viLh conuLor rograns croaLod viLhin Lho scoo ol onloynonL, or vhon
lolloving insLrucLions givon ly an onloyor.
J4
IL Lolls us LhaL, in Lho alsonco ol any
agroononL Lo Lho conLrary, Lho coyrighL in such conuLor rogrannos is
Lranslorrod Lo Lho onloyor, and as a consoquonco ol SocLion 40(a} ol Lho CoyrighL
AcL Lho onloyor holds loLh Lho ocononic and Lho noral righLs in a conuLor
rogran.
J5

Ior vorls oLhor Lhan conuLor rogrannos Lhoro aro no oxliciL rovisions
govorning coyrighLs in onloynonL rolaLionshis. Tho Svodish coyrighL LradiLion
lollovs Lho conLinonLal Iurooan sysLons, and an onloyor nay only lo onLiLlod Lo
onloyoos` coyrighL ly an agrood Lranslor.
J6
Hovovor, ovon il no Lranslor ol righLs
has loon oxliciLly agrood, an agroononL loLvoon Lho arLios nay lo inlorrod. Tho
gonoral rulo is LhaL Lho onloyor nay oxloiL onloyoos` vorls viLhin his nornal
liold ol acLiviLios.
J

JJ
See SocLion 1(1} ol Lag (19o0.7?9) om upphovsratt till litterara och lonstnarliga verl, SocLion 1(1} ol
atentlag (19o7.8J7) and SocLion 1(2} ol Mnsterslyddslag (1970.48).
J4
Soo ArL. 2(J} ol IirocLivo 91/?0/C. Cj. ArL. 1J(J} ol Lho Regulation (C) o/?00? on
Community Design.
J5
See SocLion J.5.1 CoyrighL roLocLion".
J6
See jurther SvonsaLor, . JJ1 oL soq.
J
See Svodish Lalour CourL caso 2002 No. 8.
220
4.2 Ownership of employees patentable inventions
IaLonLallo invonLions occurring in Lho courso ol onloynonL aro rogulaLod in Lho
Inloyoo`s InvonLions (InLiLlononL} AcL (1949:J45}.
J8
This AcL is nainly non-
nandaLory and iLs nain rovisions can lo and aro in Lho rivaLo socLor
ovorriddon ly collocLivo agroononLs. Tho AcL alios Lo aLonLallo invonLions nado
ly onloyoos in Lho courso ol Lhoir rivaLo or ullic onloynonL, SocLion 1(1}.
Ioonding on Lho onloyoos` duLios in rolaLion Lo Lho invonLions nado, Lho AcL
dolinos Lhroo dilloronL caLogorios ol invonLions, Lo vhich an onloyor has a groaLor
or lossor righL, SocLion J. BuL ovon vhoro Lho lav sLiulaLos a LoLal Lranslor ol Lho
invonLion Lo Lho onloyor, Lho onloyoo has a nandaLory righL Lo a roasonallo
rocononso lor Lho righLs Lranslorrod Lo Lho onloyor, SocLion 6(1}. Tho anounL ol
ronunoraLion is Lo lo docidod ly Lho arLios involvod. Tho valuo ol Lho invonLion,
Lho scoo ol Lho righLs LhaL Lho onloyor acquiros, Lho Lorns ol onloynonL and Lho
signilicanco LhaL Lho onloynonL nay havo had in Lho naling ol Lho invonLion aro
lacLors Lalon inLo considoraLion vhon dociding Lho ronunoraLion.

4.3 Ownership of intellectual property rights by university employees
Tho Inloyoo`s InvonLions (InLiLlononL} AcL, hovovor, is noL alicallo Lo
invonLions nado ly Loachors onloyod aL univorsiLios or oquivalonL insLiLuLions
(teacher exception}, SocLion 1(2}.
J9
Inloyod Loachors ovn Lho righLs in Lhoir
aLonLallo invonLions and aro onLiLlod such invonLions as Lhoir rivaLo roorLy,
unloss oLhorviso rovidod ly conLracL.
40
Sinilarly, Lho inliod agroononL aliod Lo
coyrighLs viLhin Lho onloyor` s nornal liold ol acLiviLios in oLhor onvironnonLs
Lhan Lho univorsiLy has no loaring on univorsiLy Loaching sLall. As rogards vorls
nado ly non-Loaching sLall, Lho univorsiLy nay variously clain Lho aLonL or
coyrighL Lo oljocLs dovolood in Lho courso ol Lhoir duLios in Lho sano vay as lor
onloyoos in gonoral.
Tho undorlying concoL ol Lho Loachor oxcoLion is acadonic lroodon. IL
should lo noLod LhaL Lho quosLion ol ovnorshi is noL allocLod ly vhoLhor Lho
univorsiLy`s rosoarch lunding conos lron indusLry, a lunding rosoarch council or
sono oLhor sourco.
As an ollocL ol Lho Loachor oxcoLion, vhoro a daLalaso, lor insLanco a
liolanl, is roLocLod as a liLorary vorl undor SocLion 1 ol Lho CoyrighL AcL, and iL
has loon nado ly a univorsiLy rosoarchor or a grou ol such Loachors, Lho sLrucLuro
lolongs Lo Lho croaLors ol Lho laso, i.o. Lho univorsiLy Loachors. IL should lo
onhasisod LhaL inLollocLual roorLy lavs, ol courso, do noL roLocL Lho hunan
liosanlos as such in LhaL daLalaso and Lho naLorial is noL covorod ly Lho
oxcoLion.
41

J8
See jurther Ionnonarl 1950 and Jacolsson/Torsnodon/TrnroLh 1980, . 6J0 oL soq.
J9
In Svodon Lhoro is an ongoing discussion rogarding righLs and vrongs ol Lho Loachor oxcoLion, see
jurther GovornnonL Cllicial RoorLs 1996:0, GovornnonL Bill 2000/2001:J . 195 and
GovornnonL Bill 2001/2002:2 . 4 oL soq. Cj. Lho Ianish AcL J4/1999 on invonLions aL ullic
rosoarch insLiLuLions, SocLion 42 ol Lho Gornan Lav on Inloyoo InvonLions ol 195, as anondod
.2.2002, SocLion 12(J} ol Lho NoLhorlands IaLonLs AcL ol 1995 and Cha. 1, SocLion 1 ol Lho Ironch
Iocroo on Inloyoos InvonLions ol 199. See also SocLion 24
lis
ol Lho ILalian Lav on IaLonLs lor
InvonLions, Royal Iocroo ol 19J9, as anondod 18.10.2001.
40
AlouL Lho Loachor oxcoLion in Lho Nordic CounLrios see Andorson 2000, . 602 oL soq. Bruun
2000, . 611 oL soq. and Lund 2002, . 618 oL soq.
41
See jurther Lho Norvogian caso lron Aslor og Brun horrodsroLL, judgononL 29.9.1999.
221

\hon sovoral orsons havo collocLod hunan liosanlos lor a liolanl, only Lhoso
vho havo nado a croaLivo conLriluLion Lo Lho consLrucLion ol Lho liolanl`s
sLrucLuro can onjoy coyrighL in Lho vorl. An assisLanL Lo Lho croaLion ol such a
daLalaso vill noL lo a holdor ol Lho coyrighL. BuL, adniLLodly, iL is noL alvays oasy
Lo drav a disLincLion loLvoon auLhorshi and assisLanco.
Il on Lho oLhor hand a liolanl has no original sLrucLuro, and is roLocLod as
a daLalaso only undor Lho social rovision in SocLion 49 ol Lho CoyrighL AcL (sui
generis righL}, Lho holdor ol Lhis noighlouring righL is Lho nalor ol Lho daLalaso,
gonorally Lho invosLor.
42
In sono siLuaLions Lho invosLor nay lo a univorsiLy
rosoarchor or a grou ol rosoarchors, and in oLhors iL is Lho univorsiLy doarLnonL or
a lunding arLy. Ivon co-ovnorshi ol a liolanl is ossillo, o.g. ly univorsiLy
onloyoos and Lho univorsiLy.
\horo Lhoro is an ovorla ol roLocLion lor a liolanl, o.g. Lho rulos on lull
coyrighL and sui generis roLocLion aro loLh alicallo, and Lho croaLors and Lho
nalor/invosLor aro dilloronL orsons, Lho croaLors` individual righLs havo rioriLy and
liniL Lho daLalaso nalor`s righL sui generis. Tho daLalaso nalor nay only oxorciso
his righL viLh Lho coyrighL ovnor`s consonL, vhilo Lho coyrighL ovnor`s righLs Lo a
vorl aro in no vay liniLod ly Lho sui generis righL.
Thoroloro, and as a consoquonco ol Lho Loachor oxcoLion, iL is inorLanL
lor univorsiLios, conLriluLors oLc. Lo dolino (oarly on} Lho rolaLionshi loLvoon Lho
arLios in a rojocL, and osocially Lo soLLlo quosLions LhaL nay ariso concorning
ovnorshi ol inLollocLual roorLy. \iLhouL such agroononLs, or oxliciL
ronunciaLion ol Lho righLs ly Lho Loaching sLall involvod in Lho croaLion ol liolanls,
Lho laLLor vill locono Lho holdors ol Lho coyrighL.

42
See also Cha. III ol IirocLivo 9o/9/C on the legal protection oj databases.
222
5. Summary

e^kaifkd lc fkqbiib`qrî molmboqv ofdeqp fk _fl_^khp

Copyright protection: Sui generis protection:

What is protected? What is protected?

Tho sLrucLuro in vhich Lho sanlos
aro organisod in Lho lanl.
Tho invosLnonL in Lho naling ol Lho
liolanl.

Who is the rights holder? Who is the rights holder?

Tho croaLor (hysical orson} ol Lho
sLrucLuro in Lho liolanl.
Tho nalor/roducor/invosLor ol Lho
liolanl.

Which acts may the rights holder
prevent?
Which acts may the rights holder
prevent?

Maling a nov liolanl viLh an
idonLical sLrucLuro.

Roloasing sanlos in Lho lorn ol Lho
roLocLod sLrucLuro.

Iislaying Lho liolanl`s sLrucLuro
Lo Lho ullic.

Iislaying Lho sLrucLuro on a scroon,
lor Lho ullic Lo soo.
Tho unauLhorisod oxLracLion/ro-
uLilisaLion ol Lho conLonLs ol Lho lanl,

i.e..

Roloasing sanlos lron Lho lanl.
Iislaying Lho liolanl Lo Lho ullic.

Recommendations in employment
relations?
Recommendations in employment
relations?

AgroononLs on Lranslor ol righLs aro
roconnondod. Tho gonoral rulo is
LhaL Lho onloyor nay oxloiL
onloyoos` vorls viLhin Lho
onloyor`s nornal liold ol acLiviLios.
Il no Lranslor ol righLs has loon
oxliciLly agrood, an inliod
agroononL loLvoon Lho arLios nay
lo considorod Lo oxisL.

InivorsiLy onloyoos aro suljocL Lo
Lho Toachor IxcoLion. AgroononLs
on Lranslor ol righLs aro
roconnondod.
AgroononLs on Lranslor ol righLs aro
roconnondod. Tho invosLor is Lho
righLs holdor and in gonoral LhaL is Lho
onloyor. In univorsiLy onvironnonLs,
in sono siuLaLions Lho invosLor nay lo
a univorsiLy rosoarchor or a grou ol
rosoarchors, and iL oLhors iL is Lho
univorsiLy.

223

References

Agreement on TradeRelated Aspects oj lntellectual roperty Rights (TRls) (1995}

Andorson, Mads Brydo, (2001}. lTretten. 1 od., Konhann: IorlagoL IT-roLLon.

Andorson, Mads Brydo, (2000}. InivorsiLoLslorslning og innaLorialroLLighodor i Iannarl,
NIR 2000 . 602.

Arbetsdomstolen, AD ?00? nr 87 (2002}

Asler og Lrum herredsrett, dom ?9.9.1999 (1999}

Lerne Convention jor the rotection oj Literary and Artistic Worls (1886}.

Boylovold, Iorycl (2001}. Why Recital ?o oj the .C. Directive on the legal protection oj
Liotechnological inventions should be implemented in National Lau. InLollocLual IroorLy
uarLorly, 2000:1, . 1-26.

Bruun, Nillas, (2000}. Hgslolejorslning och immaterialratt. NIR 2000 s. 611

Council Directive 91/?0/C oj 14 May 1991 on the legal protection oj computer programs
(1991}

Council Regulation (C) No o/?00? oj 1? December ?001 on Community Designs (2002}

Decret relatij aux inventions de salaries, N
0
79797 du 4.9.1979 (Iranco} (199}

Ionnonarl, Sigurd, (1950}. Cm ratten till arbetstagares uppjinningar. SLoclholn: I.A.
NordsLodL & Snors lrlag

Directive ?001/?9/C oj the uropean arliament and oj the Council oj ?? May ?001 on the
harmonisation oj certain aspects oj copyright and related rights in the injormation society (2001}

Council Directive 91/?0/C oj 14 May 1991 on the legal protection oj computer programs
(1991}

Directive 9o/9/C oj the uropean arliament and oj the Council oj 11 March 199o on the
legal protection oj databases (1996}

Cesetz ber Arbeitnehmererjindungen vom 197 (Gornany} (195}

Holzalol, Honril, Schnoidor, Michaol (2001}. Wem Cehrt das Menschliche Cenom.
Govorllichor RochLsschuLz und IrholorrochL InLornaLionalor Toil, 2001:10, . 860-86J.

Jacolsson, Mns, Torsnodon, Iril, TrnroLh, LonnarLh, (1980}. atentlagstijtningen en
lommentar. SLoclholn: I.A. NordsLodL & Snors lrlag

KolLvodgaard, Mogons, Lovin, Marianno (2000}. Larobol i immaterialratt. 6 od., SLoclholn:
NorsLodL Juridil

Lag (?00?.?97) om biobanler i halso och sjulvrden m.m.(2002}
224
Lag (1949.J4) om ratten till arbetstagares uppjinningar. (1949}

Lag (19o0.7?9) om upphovsratt till litterara eller lonstnarliga verl. (1960}

Loi N
0
9?97 du 1
er
juillet 199? relative au code de la propriete intellectuelle (Iranco} (1992}

Lov J47/1999 om opjindelser ved ojjentlige jorslningsinstitutioner (Ionnarl} (1999}

Lindlorg, Agno, \osLnan, Ianiol (2001}. raltisl lT-raLL. J od., SLoclholn: NorsLodL
Juridil

Lund, AsLri M. (2002} lmmaterialretten og jorslningen ved universiteter og hysloler. NIR
2002 . 618

Marll HulorL (2002}. Who Cuns the Human Cenome` InLornaLional Roviov ol IndusLrial
IroorLy and CoyrighL Lav, 2002:1, . 1-5.

Mnsterslyddslag (190:485}. (190}

Ng-Loy \oo Loon (2002}. atenting oj Cenes A Closer Lool at the Concepts oj Utility and
lndustrial Applicability. InLornaLional Roviov ol IndusLrial IroorLy and CoyrighL Lav,
2002:4, . J9J-414.

atentlag (19o7.8J7) (196}

atents Act oj 1977 (SLorlriLannion} (19}

Regeringens proposition 199o/97.111, Rattsligt slydd jr databaser m.m. (199}

Regeringens proposition ?000/01.J, orslning och jrnyelse. (2000}

Regeringens proposition ?001/0?.?, oU och samverlan i innovationssystemet. (2001}

Regeringens proposition ?001/0?.44, Liobanler i halso och sjulvrden m.m. (2001}

Regio Decreto ?9.o.19J9 N. 11?7, Testo aggiornato delle disposizioni legislative in material di
brevetti per invenzioni industriali (ILaly} (19J9}

Rijlsoctrooiuet (NoLhorlands} (1995}

Sona, Giusoo (1999}. Directive on Liotechnological lnventions. atentability oj Discoveries,
lnternational Revieu oj lndustrial roperty and Copyright Lau. 1999:, . J1-J8.

SCI 1996:0 Sanvorlan nollan hgslolan och naringslivoL. HuvudloLanlando av NYICR-
KonniLLon (1996}

SLorclz, Sigrid (1998}. Sono ILhically IrollonaLic AsocLs ol Lho Iroosal lor a IirocLivo
on Lho Logal IroLocLion ol BioLochnological InvonLions. uropean lntellectual roperty Las
Revieu, 1998:4, . 12J-128.

SvonsaLor, LonnarL (1991}. Anstallning och upphovsratt. SLoclholn: NorsLodLs Juridillrlag.

WIPO Copyright Treaty (1996)
225

226
Cijts and donations

11

Gifts and donations

Associate rojessor Annina H ersson

Department of Law, Stockholm University

Sometimes the only uay oj treating certain serious illnesses or physical injuries is by
organ or tissue transplant. ln the context oj organ and tissue transplantation, the
jollouing concepts are ojten used. maling a gijt oj or donating organs or tissue, gijts,
donations, malers oj gijts and donors. Sueden is home to a number oj biobanls, in
uhich millions oj samples oj blood, tissue and cells are stored. These biobanls are under
either private or public management and the material stored may have been talen jrom a
patient, jor example in order to male a diagnosis, treat the patient himselj or jor other
medical purposes, e.g. research. The sample may also have been talen in order to
clinically test pharmaceuticals or other medical products. The stored samples are talen
jrom living, deceased or as yet unborn persons. Hou, then, does the recipient tale
possession oj the material` ls it a question oj gijt or donation in this context too` The aim
oj this presentation is to lool into these tuo concepts, donations and gijts, jrom a civil lau
perspective, and above all to see uhether the civil lau rules jor gijts can be applied to legal
issues regarding donations oj human material.

1. Introduction

SonoLinos Lho only vay ol LroaLing corLain sorious illnossos or hysical injurios is ly
organ or Lissuo LranslanL. In Lho conLoxL ol organ and Lissuo LranslanLaLion, Lho
lolloving concoLs aro olLon usod: naling a gilL ol or donaLing organs or Lissuo, gilLs,
donaLions, nalors ol gilLs and donors. Svodon is hono Lo a nunlor ol liolanls,
1
in
vhich nillions ol sanlos ol llood, Lissuo and colls aro sLorod. Thoso liolanls aro
undor oiLhor rivaLo or ullic nanagononL and Lho naLorial sLorod nay havo loon
Lalon lron a aLionL, lor oxanlo in ordor Lo nalo a diagnosis, LroaL Lho aLionL
hinsoll or lor oLhor nodical urosos, o.g. rosoarch.
2
Tho sanlo nay also havo loon
Lalon in ordor Lo clinically LosL harnacouLicals or oLhor nodical roducLs. Tho
sLorod sanlos aro Lalon lron living, docoasod or as yoL unlorn orsons. Hov, Lhon,
doos Lho rociionL Lalo ossossion ol Lho naLorial Is iL a quosLion ol gilL or donaLion
in Lhis conLoxL Loo
Tho ain ol Lhis rosonLaLion is Lo lool inLo Lhoso Lvo concoLs, donaLions
and gilLs, lron a civil lav orsocLivo, vhoro Lho concoL ol a gilL aL loasL is logally

1
A liolanl can lo a Lissuo lanl or a collocLion ol llood sanlos, or Lho inlornaLion, vhich has loon
olLainod lron such a lanl. Cl. Cha. 1, SocLion 2 ol Lho Biolanls (HoalLh Caro oLc.} AcL (SIS
2002:29}, Iro. 2001/02:44 . 1, . 6, . 21 and . 6.
2
Soo Rynning, I., Biolanlorna hg Lid lr lanlinsolLion 1998, IrvalLningsraLLslig LidslrilL,
1998, halLo 6, . J05.
227
Annina H ersson
Lochnically liniLod. Tho donaLion ol liological sanlos is rogulaLod ly sLaLuLo in Lho
liold ol hoalLh and nodical caro lav. Thoso sLaLuLos, lor oxanlo Lho TranslanL
Surgory AcL,
J
aro ol a ullic lav, raLhor Lhan a civil lav, characLor. Tho TranslanL
Surgory AcL rovidos, lor oxanlo, Lho condiLions undor vhich organs nay lo
ronovod lron Lho lody ol a living or docoasod orson lor LranslanL or oLhor
nodical urosos. Hovovor, Lho AcL doos noL rogulaLo Lho logal rolaLionshi
loLvoon Lho donor and Lho donoo.
4
Tho quosLion is, Lhoroloro, vhoLhor Lho civil lav
rulos lor gilLs can lo aliod Lo logal issuos rogarding donaLions ol hunan naLorial,
vhich aro noL govornod ly Lho TranslanL Surgory AcL or oLhor ullic lav
logislaLion. \haL aro Lho Lorninological sinilariLios and dilloroncos loLvoon Lho
Lvo Is Lho naling ol a gilL an acLivo giving and LhaL ol a donaLion a assivo giving
Can Lho Lvo concoLs noan Lho sano Lhing in corLain conLoxLs and dilloronL Lhings
in oLhors IurLhor, vhaL aro Lho sinilariLios and dilloroncos loLvoon a donor ol a gilL
in iLs gonoral conLoxL and sonoono vho donaLos hunan liological naLorial \haL
aro Lho sinilariLios and dilloroncos loLvoon a donoo in iLs gonoral conLoxL and a
donoo ol hunan liological naLorial \haL logiLinaLos a gilL LransacLion in iLs logal
sonso Can Lho civil lav rulos rogarding gilLs in gonoral lo aliod Lo donaLions ol
hunan liological naLorial

2. Terminology

LoL us login ly considoring Lho Lorninological sinilariLios and dilloroncos loLvoon
Lho concoLs ol gilLs and donaLions. In iLs gonoral conLoxL, a gilL is dolinod as a
Lranslor ol roorLy viLhouL ronunoraLion.
5
Tho classic oxanlo is vhon sonoono
givos sonoLhing avay viLhouL rocoiving any sorvico in roLurn (i.o. considoraLion},
o.g. a rosonL. Logally, unlilo urchaso and oxchango, a gilL is a lonolicial agroononL
sinco Lranslor is nado viLhouL ronunoraLion.
6
Tho roroquisiLos lor a gilL aro as
lollovs: 1} a Lranslor ol roorLy
, 2} nado volunLarily
8
and J} a lonolicial inLonLion
on Lho arL ol Lho donor lor a gilL Lo lo nado.
9
Tho naling ol a gilL nusL lo soon Lo
lo an acL ol gonorosiLy or such-lilo.
10
IL can lo hard Lo drav Lho lino loLvoon
lonolicial and onorous
11
agroononLs on Lho ono hand, and gilLs and oLhor logal

J
Soo Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}, Lag (1995:8J2} on
oldulLionor n.n. (Lho IosL-MorLon IxaninaLions AcL}. Cl. also Halso och sjulvrdslag
(1982:6J}(Lho HoalLh and Modical Sorvicos AcL} and Lag (1998.J1) om yrlesverlsamhet p halso
och sjulvrdens omrde (Lho HoalLh and Modical Sorvicos (Irolossional AcLiviLy} AcL}.
4
Soo SCI 1989:98 . 255.
5
Soo Bonniors sLora loxilon, Gan-Hon,1986. Soo also SLora Svonsla Crdlolon, 1996, BongLsson, B.,
Sarslilda avLalsLyor I, 191, . 20.
6
Cl. BorgsLrn, S. & Iol, H. & HsLad, T. & Lindllon I H., Juridilons Tornor, 8Lh odiLion., 199J.
Tho donoo shall lo onrichod aL Lho donors oxonso. Soo BongLsson, B., Cn gvologrooL i
civilraLLon, SvJT 1962 . 694.
8
Tho Lranslor ol voalLh shall noL lo nado ly roason ol a logal duLy. Soo BongLsson, B., o. ciL. SvJT
1962 . 694.
9
Soo BongLsson, B., Sarslilda avLalsLyor I, 191, . 21 and Lho sano auLhor in o. ciL. SvJT 1962 .
694. Tho gilL concoL doos noL includo Lranslors ol voalLh viLh no considoraLion, vhoro Lho
LransacLion is cloarly dicLaLod ly lusinoss inLorosLs.
10
Soo BongLsson, B., Sarslilda avLalsLyor I, 191, . 22.
11
An onorous agroononL is ono in vhich a lurdon is inosod on loLh arLios, o.g. a urchaso. Soo
BorgsLrn, S. oL al., Juridilons Lornor, 8Lh odiLion, 199J.
228
Cijts and donations
concoLs on Lho oLhor. AgroononLs vhich lornally soon Lo lo lonolicial can, in lacL,
olLon involvo considoraLion.
12
Cno oxanlo is an agroononL (lnovn as a
ronunoraLory gilL} vhoroly an undorLaling has loon givon locauso a donoo has
carriod ouL corLain sorvicos on lohall ol Lho donor, in siLo ol no logal clain Lo
ronunoraLion having loon nado. IurLhor, a gilL Lo an hoir can lo considorod an
advanco on his inhoriLanco.
1J

Tho Svonsla Aladonions CrdlisLa (sLandard Svodish dicLionary} dolinos
Lho vorl Lo donaLo" as Lo givo ly dood ol gilL lor urosos Lo Lho lonoliL ol
ovoryono".
14
AnoLhor roloronco lool dolinos a donaLion as a largor gilL, usually nado
in a logal lorn, o.g. in a vill.
15
A donaLion can Lhoroloro lo a gilL ly dood ol gilL
Lo an auLhoriLy or loundaLion, lor oxanlo.
16
Tho alovo doliniLion ol donaLion is
rolaLivoly connon in dicLionarios,
1
luL Lho vord can also lo said Lo lo usod noro
gonorally, arLicularly in nodical conLoxLs".
18
Torninologically, Lhoro doos noL
aoar Lo lo any dilloronco loLvoon a gonoral donaLion and Lho donaLion ol hunan
liological naLorial. Hovovor, Lho lorns and logal consoquoncos ol Lho Lvo can dillor
doonding on Lho uroso and oljocL ol Lho donaLion.
IurLhornoro, iL is also inorLanL Lo doLornino Lho arLios involvod in Lho
dilloronL logal rolaLionshis. As rogards a gilL in a gonoral conLoxL, Lhoro is a logal
rolaLionshi loLvoon a donor and donoo. IarLios on oiLhor sido nay lo naLural or
logal orsons. Tho gilL LransacLion olLon Lalos laco viLhouL Lho involvononL ol any
inLornodiary, and Lho gilL is gonorally Lranslorrod dirocLly lron Lho donor Lo Lho
rociionL. InsLoad ol Lho oljocL ol Lho gilL loing LransniLLod dirocLly Lo Lho rociionL,
Lho donor can also rovido Lho rociionL viLh a ronissory noLo, in vhich ho
undorLalos Lo Lranslor Lho roorLy.
19
Tho oljocL ol Lho gilL nay also lo in Lho hands
ol a Lhird arLy. In Lhis caso, Lho donor can inlorn Lho Lhird arLy LhaL Lho roorLy
shall nov lo aL Lho disosal ol Lho rociionL.
20
A gilL lron a naLural orson can only
lo nado ly a living donor, in oLhor vords, a gilL vhich can only lo valid on Lho
donor`s doaLh and vhich cannoL lo classod as loing loquoaLhod undor a vill, is in
rincilo invalid.
21
Cl courso, a donor can loavo a gilL Lo sonoono alLor his doaLh, luL
in ordor lor Lho rociionL Lo lo allo Lo validaLo Lho gilL on Lho donor`s doaLh, Lho gilL
nusL lo loquoaLhod undor a vill. IL vill Lhoroloro no longor lo a quosLion ol a gilL,

12
Soo Hollnor, J., Socioll avLalsraLL II, KonLralLsraLL, J ul., 1 halLoL, sarslilda avLal, 1996, . 2J4.
1J
Soo 6:1 Arvdaball (InhoriLanco Codo, SIS 1958:6J}.
14
Soo Svonsla aladonions ordlisLa vor svonsla srloL, 1998.
15
Soo Bonniors sLora loxilon, Chr-In, 1985.
16
Soo Irllarado Crd 1960. Conaro donationsjrordning (SS 1998.140} vhoro donaLion is dolinod
as any Lranslor ol roorLy Lo a ullic auLhoriLy Lhrough gilL or LosLanonLary rovision and vhich
doos noL roquiro any quid ro quo or sLaLus as a lonoliciary and vhoro Lho roorLy doos noL
consLiLuLo a loundaLion.
1
Soo SLora svonsla ordlolon, 1996, Bonniors svonsla ordlol, nya slolulagan, 1992. Cl. Svonsla
ord - nod uLLal och lrllaringar, 2 ul., 199J, . 1J2, vhoro donaLion is dolinod as ollicially giving
sonoLhing avay".
18
Soo SLora svonsla ordlolon, 1996.
19
20
21
Soo 1:J Arvdaball (InhoriLanco Codo, SIS 1958:6J}. Soo also \alin, G., KonnonLar Lill
arvdalallon, Iol 1 (1-1 Ka} 5 ul., 2000, . 419. Cl. . 20J. Soo also BorgsLrn, S. oL al.,
Juridilons Tornor. 8Lh odiLion, 199J.
229
Annina H ersson
luL ol a LosLanonLary doviso.
22
A sinilar siLuaLion alios Lo gonoral donaLions, Lho
dilloronco loing LhaL Lho donor nay lo living or docoasod vhon Lho donaLion is
ollocLod, sinco Lho donaLion is oiLhor nado ly vay ol dood ol gilL during Lho donor`s
liloLino or in Lho lorn ol a vill il iL is nado alLor Lho donor`s doaLh.
As nonLionod alovo, hunan liological naLorial can lo Lalon lron a
living, docoasod or as yoL unlorn orson. As rogards Lho logal rolaLionshi loLvoon
Lho arLios, Lho donor is cloarly a naLural orson. In hunan liological Lorns, Lho
donor is dolinod in Lho sano vay as a nalor ol a gilL, o.g. a llood donor, sorn
donor or a orson lron vhon organs aro ronovod on LranslanL.
2J
Hovovor, Lho
rociionL can lo a naLural or a logal orson. SonoLinos Lho donaLion LransacLion is
carriod ouL ly a logal inLornodiary, in siLo ol a naLural orson loing inLondod as Lho
ulLinaLo rociionL ol Lho naLorial, o.g. vhon hunan liological naLorial is Lalon lor
LranslanL viLhouL loing Lranslorrod dirocLly Lo Lho rociionL. Tho naLorial is insLoad
sLorod aL Lho rolovanL nodical insLiLuLion lor a shorL oriod unLil such Lino as Lho
righL rociionL can rocoivo iL. This is noL unconnon.

3. Who donates human biological material?

Tho TranslanL Connission`s inLorin roorL
24
includod a discussion ol hov Lo
dolino Lho Lorn `donor`. IL vas concodod LhaL iL is dilliculL Lo lind an adoquaLoly
nouLral Lorn Lo doscrilo Lho orson vho undorgoos an ooraLion in ordor lor anoLhor
orson Lo rocoivo an organ lor LranslanL. \horo a living orson vas involvod, iL vas
lolL Lo lo cloar LhaL LhaL orson should lo callod Lho nalor ol a gilL or donor.
Hovovor, vhoro a docoasod orson vas involvod, Lhoso concoLs noL viLh sono
dilliculLios, sinco in rincilo Lhoso vords vould roquiro Lho rulos rogarding consonL
Lo lo such LhaL organs could only lo ronovod il a osiLivo doclaraLion ol consonL Lo
LhaL ollocL had loon givon during Lho docoasod orsonss liloLino. Tho Connission
vonL on Lo say LhaL iL vas quosLionallo vhoLhor such a doclaraLion ol consonL could
ovon sullico in ordor lor a orson Lo lo roasonally characLorisod as Lho nalor ol a
gilL or as a donor.
25
Tho Connission lound LhaL Lhoro should lo a corLain linguisLic
dilloronco loLvoon a gilL in iLs roal sonso and noro accoLanco or consonL, luL iL
lailod Lo cono u viLh any oLhor suiLallo gonoral Lorn, vhich could lo usod
irrosocLivo ol Lho lorn ol Lho rulos ol consonL. Tho Connission Lhoroloro
doLorninod Lo onloy Lho Lorn `donor` in rosocL ol loLh living orsons and
docoasod orsons lron vhon an organ is ronovod, irrosocLivo ol vhoLhor Lhoy had
or had noL during Lhoir liloLino osiLivoly nado lnovn Lhoir inLonLion Lo nalo a gilL
or in any oLhor vay indicaLod LhaL Lhoir organs voro Lo lo ronovod. IurLhor, Lho
Connission doLorninod Lo onloy Lho Lorn òrgan donaLion` Lo donoLo Lho Laling
ol organs in a lroad sonso, and Lhus noL only Lo siLuaLions in vhich Lho docoasod, or
his surviving rolaLivos, cloarly nalo iL lnovn LhaL Lhoy aro donaLing organs as gilLs
alLor doaLh or vhoro Lhoy oLhorviso oxrossly consonL LhoroLo.

22
Soo 11:10 Arvdaball (InhoriLanco Codo, SIS 1958:6J}. BoquosL rolors Lo a arLicular lonoliL
granLod ly a vill, such as socilic Langillo roorLy or a socilic ocuniary sun or a righL ol uso in Lho
roorLy or a righL Lo onjoy Lho inLorosL Lhoroon or Lho rocoods Lhorool.
2J
Soo Bonniors sLora loxilon, Chr-In, 1985.
24
Soo SCI 1989:98 . J9. CLhor logislaLivo roosals ly Tho TranslanL Connission aro SCI
1989:99, SCI 1991:42 and SCI 1992:16.
25
Cl. SCI 1984:9 . JJ.
230
Cijts and donations

As indicaLod alovo, Lho quosLion ol vho can lo dolinod as a donor is linlod Lo Lho
rulos on consonL Lo Lho donaLion ol hunan liological naLorial. Tho curronL rulos in
Lho aroa ol hoalLh and nodical caro lav aro rolaLivoly rociso as rogards vhich
siLuaLions roquiro consonL and also concorning Lho Lyo ol naLorial involvod.
ConsonL can oiLhor lo vriLLon or oral, doonding on Lho siLuaLion. Svodish lav
curronLly considors LhaL nodical sLos can only lo Lalon onco consonL has loon givon
ly Lho rolovanL orson. Il Lho hunan liological naLorial is arL ol a aLionLs nodical
LroaLnonL,
26
Cha. 2, SocLion 1 ol Lho HoalLh and Modical Sorvicos Irolossional
AcLiviLy AcL (1998:5J1} rovidos LhaL Lho aLionL shall lo rovidod viLh carolul
oxorL hoalLh and nodical caro in accordanco viLh scionLilic racLicos and racLical
oxorionco.
2
As lar as is ossillo, a caro rogranno shall lo dosignod and uL inLo
racLico in consulLaLion viLh Lho aLionL, vho shall also lo shovn considoraLion and
rosocL.
Il Lho liological naLorial is noL Lalon as arL ol Lho nodical LroaLnonL ol
Lho aLionL hinsoll, luL lor sono oLhor uroso, o.g. LranslanL surgory, nodical
rosoarch or harnacouLical roducLion, Lho rincilo rulo as sLaLod in Lho lirsL lino ol
SocLion 6 ol Lho TranslanL Surgory AcL (1995:8J1} is LhaL organs or oLhor such
liological naLorial coning undor Lho AcL shall noL lo ronovod lron living donors
viLhouL consonL.
28

Il Lho organ or naLorial vhich is Lo lo Lalon cannoL lo rocroaLod or il Lho
ooraLion is liallo Lo causo considorallo harn Lo or dilliculLios Lo Lho donor, Lho
socond sonLonco, in SocLion 6 ol Lho sano AcL, roquiros consonL Lo lo in vriLing.
IurLhor, Lho ooraLion nay only lo carriod ouL il Lhoro is no sorious risl Lo Lho
donor`s lilo or hoalLh (SocLion 5}. As rogards Lho LranslanL ol naLorial, vhich
cannoL lo rocroaLod, Lho donor is roquirod Lo lo a rolaLivo ol Lho roosod rociionL,
or oLhorviso Lo lo arLicularly closo Lo hin (SocLion }. CLhorviso, socilic roasons
aro roquirod loloro Lho ooraLion can lo orlornod on oLhor orsons. Il Lho naLorial
is noL rocroaLod or il Lho ooraLion nay oLhorviso involvo considorallo harn Lo or
dilliculLios lor Lho donor, ornission lron Lho NaLional Board ol HoalLh and \ollaro
is also roquirod SocLion 9}, il Lho naLorial is Lo lo Lalon lor nodical urosos oLhor
Lhan lor LranslanL. Socilic rulos also aly as rogards naLorial Lalon lron ninors
and lron nonLally disallod orsons.
29

\horo Lho donor ol organs or Lissuo is docoasod, his viovs on ronoval ol
liological naLorial rior Lo doaLh vill lo docisivo. Thoroloro, undor SocLion J (1} ol
Lho TranslanL Surgory AcL, liological naLorial inLondod lor LranslanL or sono
oLhor nodical uroso nay lo Lalon lron a docoasod il ho has agrood Lo Lho
ooraLion or il iL can oLhorviso lo shovn LhaL such a sLo vould havo loon in

26
IL should lo noLod LhaL Lho TranslanL Surgory AcL is noL alicallo Lo liological naLLor oxcisod lor
Lho uroso ol LroaLing Lho orson uon vhon Lho incision vas orlornod. Soo SocLion 2 (2} ol Lag
(199.8J1) om transplantation m.m. (Tho TranslanL Surgory AcL}.
2
Cl. also SocLions 2, 2a, and 2l ol Halso och sjulvrdslag (1982:6J}(Lho HoalLh and Modical
Sorvicos AcL}.
28
Soo Lho sLaLuLory LoxL and Iro. 1994/95:148 . J1, . 9. Cl. SCI 199:154 . 422, Rynning,
I., SanLyclo Lill nodicinsl vrd och lohandling, In raLLsvoLonslalig sLudio, 1994, . 125. SCI
1989:98 . 198.
29
Soo SocLions 8 and 9 (2} ol Lag (199.8J1) om transplantation m.m. (Tho TranslanL Surgory AcL}.
Soo also Iro. 1994/95:148 . J4, . 81.
231
Annina H ersson
accordanco viLh Lho docoasod`s viovs.
J0
Iornission can lo inlorrod, o.g. lron
inlornaLion in a vill or a donor`s card. IL should lo noLod LhaL ornission nood noL
lo vriLing. IurLhor, il Lho donor has noL oxrossod any viovs Lo Lho conLrary, his
consonL vill lo doonod Lo havo loon givon. Hovovor, liological naLorial nay noL lo
ronovod vhoro Lho docoasod has in vriLing oxrossod LhaL ho is againsL such an
ooraLion or vhoro Lhoro aro oLhor roasons Lo loliovo LhaL such an ooraLion vould
lo conLrary Lo Lho docoasod`s vishos, (SocLion J (2}}. Il Lhoro is conllicLing
inlornaLion as Lo Lho docoasod`s oinL ol viov on Lhis naLLor, or il Lhoro is any oLhor
arLicular roason vhy such an ooraLion should noL rocood, Lho ooraLion nusL noL
lo orlornod (SocLion J (J}}. Iinally, orsons closo Lo Lho docoasod nay also
rohiliL Lho ooraLion il Lho vishos ol Lho docoasod aro noL lnovn (SocLion 4}.
Hovovor, iL can also lo noLod LhaL organs and oLhor naLorial nay lo Lalon undor
Lho IosL-MorLon IxaninaLions AcL, should Lho uroso ol Lho osL norLon roquiro
iL.
J1

Il Lho liological naLorial is Lissuo lron an alorLod looLus, Lho vonan vho
carriod Lho looLus nusL givo hor consonL il Lho Lissuo lron Lho looLus is Lo lo usod lor
nodical urosos, SocLion 11 ol Lho TranslanL Surgory AcL.
J2
Tho Lorn nodical
urosos" noans LhaL Lho Lissuo is Lo lo usod lor LroaLing illnossos or injurios or
nodical rosoarch.
JJ
Iornission lron Lho NaLional Board ol HoalLh and \ollaro is also
roquirod in ordor lor Lho Lissuo Lo lo Lalon, and LhaL ornission can only lo givon
vhoro Lhoro aro social roasons lor doing so. Such roasons vill lo lound vhoro Lho
alicaLion lor consonL is nado lor oxLronoly urgonL urosos such as Lho LroaLnonL
ol sorious illnossos, o.g. Iarlinsonss disoaso. Social roasons can also lo lound vhoro
osLallishod noLhods involving sorious sido ollocLs can lo avoidod or vhoro Lhoro aro
no alLornaLivo noLhods availallo.
J4
\hon Lho ooraLion is orlornod, Lho vonan
can doLornino vhoLhor Lho Lissuo lron Lho looLus nay only lo usod lor sono
socilic uroso. Sho can Lhoroloro oxcludo corLain usos ol Lho naLorial and so has
Lho iniLial righL ol disosal ovor Lho naLorial. Il Lho vonan has consonLod Lo Lho
naLorial loing usod in a corLain vay, sho cannoL laLor lay dovn lurLhor condiLions as
Lo hov Lho Lissuo is Lo lo usod.
ConsonL is also roquirod il Lho liological naLorial is Lo lo usod lor
rosoarch inLo or LroaLnonL ol lorLilisod oggs.
J5
Tho consonL ol Lho ogg and sorn
donors is roquirod, luL iL doos noL havo Lo lo in vriLing.
J6
IL should lo noLod LhaL Lho
TranslanL Surgory AcL doos noL aly Lo Lho LranslanL ol ganoLos or organs

J0
Soo Lho sLaLuLory LoxL and Iro. 1994/95:148 . 2J, . 5.
J1
Soo Lag (199.8J?) om obdultion m.m. (Lho IosL-MorLon IxaninaLions AcL}. Soo also SocLion 21
ol Lho sano AcL rogarding anaLonical dissocLion lor urosos ol rosoarch or Loaching. Soo Iro.
1994/95:148 . 100 and SCSS 199o.?8 om llinisla obdultioner m.m .( Clinical auLosios oLc. } .
11.
J2
Soo Iro. 1994/95:148 . 41, . 84. Cl. SCI 1991:42 . 69.
JJ
Soo SCSS 1997.4 Socialstyrelsens jreslrijter om organ och vavnadstagning jr transplantation eller jr
annat medicinslt andaml (Irovisions ol Lho NaLional Board ol HoalLh and \ollaro on Lho collocLion
ol organs and Lissuo lor LranslanL surgory or oLhor nodical urosos}, . 16.
J4
Soo SCSIS 199:4 . 16.
J5
Soo SocLions 1 and 2 ol Lag (1991.11) om tgarder i jorslnings eller behandlingssyjte med bejrultade
agg jrn mannisla (Lho IorLilisod Hunan Cva (Rosoarch or TroaLnonL Moasuros} AcL}.
J6
Soo SocLion 1 ol Lag (1991.11) om tgarder i jorslnings eller behandlingssyjte med bejrultade agg
jrn mannisla (Lho IorLilisod Hunan Cva (Rosoarch or TroaLnonL Moasuros} AcL}. Soo also Rynning,
I, SanLyclo Lill nodicinsl vrd och lohandling, 1994, . 125.
232
Cijts and donations
roducing ganoLos.
J
Thoso aro rogulaLod inter alia ly Lho InsoninaLion AcL (SIS
1984:1140} and Lho IorLilisaLion CuLsido Lho Body AcL (SIS 1988:11}.
J8
Sunning
u, curronL logislaLion rovidos LhaL a living, docoasod or as yoL unlorn orson can lo
a donor. In gonoral Lorns, all hunan liological naLorial can lo donaLod Lo dilloronL
rociionLs lor dilloronL urosos.

4. Who receives human biological material?

As indicaLod alovo, a donor ol hunan liological naLorial can rovido LhaL naLorial
lor dilloronL urosos. Tho socilic uroso lor vhich Lho naLorial is rovidod is
doLorninod ly Lho idonLiLy ol Lho inLondod rociionL. Il sonoono rovidos an organ
or Lissuo lor LranslanL, Lho rociionL is anoLhor naLural orson, luL Lho LransacLion
rocoss vhoroly Lho donaLion is nado is olLon carriod ouL ly a logal inLornodiary,
LhaL is Lo say Lho nodical insLiLuLion vhoro Lho ooraLions aro orlornod on Lho
donor and Lho donoo. Il Lho liological naLorial is ronovod lron a orson in ordor,
lor oxanlo, Lo nalo a diagnosis or LroaL Lho aLionL hinsoll and Lho sanlo is Lhon
sLorod, Lho rociionL is Lho logal orson vhoro Lho LroaLnonL is givon/vhoro Lho
sanlo is sLorod.
J9
IaLhology doarLnonLs in hosiLals around Lho counLry sLoro coll
sanlos and Lissuo sanlos vhich aro usod Lo diagnoso aLionLs` illnossos. Tho Lissuo
sanlos aro olLon sLorod lor uso, lor oxanlo, as a lasis lor conarison vhon nov
sanlos aro Lalon.
40
Tho liological naLorial nay also havo loon ronovod lron a
orson lor nodical urosos oLhor Lhan Lhoso nonLionod alovo, o.g. lor LranslanL
41

or rosoarch. As rogards Lho laLLor, Lho sanlo nay havo loon Lalon ly rosoarchors aL
rosoarch insLiLuLos vhich aro oiLhor undor rivaLo or ullic nanagononL. In Lhoso

J
Soo SocLion 2 ol Lag (199.8J1) om transplantation m.m. (Tho TranslanL Surgory AcL}.
J8
Soo SCSS 1987.o Socialstyrelsens jreslrijter och allmanna rd om inseminationer (Irovisions and
gonoral guidolinos ol Lho NaLional Board ol HoalLh and \ollaro on insoninaLion} . 14, and SCSS
1989.J Socialstyrelsens jreslrijter och allmanna rd om bejrultning utanjr lroppen m.m. (Irovisions
and gonoral guidolinos ol Lho NaLional Board ol HoalLh and \ollaro on IorLilisaLion CuLsido Lho
Body} . 5.
J9
Soo SocLions J and 18 ol Halso och sjulvrdslag (198?.7oJ}(Lho HoalLh and Modical Sorvicos AcL}.
Soo SCSS ?001.8 Socialstyrelsens allmanna rd om jrsiltighetsmtt vid hantering och marlning av
sdant biologislt avjall som lan medjra olagenhet jr mannislors halsa enligt miljballen (Gonoral
guidolinos ol Lho NaLional Board ol HoalLh and \ollaro on cauLion vhon handling and narling
liological vasLo oLc.}, SCSS 1999.?7 Socialstyrelsens jreslrijter och allmanna rd om hantering av
smittjrande avjall jrn halso och sjulvrden (Irovisions and gonoral guidolinos ol Lho NaLional Board
ol HoalLh and \ollaro on handling inlocLious vasLo lron Lho hoalLh and nodical socLor}, SCSS
1989.J8 Socialstyrelsens jreslrijter om blodgivning, blodtransjusioner m.m. (Irovisions ol Lho NaLional
Board ol HoalLh and \ollaro on llood Lranslusions oLc.), SCSS 1990.8 Socialstyrelsens allmanna rd
rrande omhandertagande av joster ejter abort (Gonoral guidolinos ol Lho NaLional Board ol HoalLh and
\ollaro rogarding caro ol alorLod looLus}, SCSS 199o.?8 Klinisla obdultioner m.m.(Clinical
auLosios oLc.}, SCSS 199o.?9 Socialstyrelsens jreslrijter och allmanna rd. Vissa tgarder inom
halso och sjulvrden vid ddsjall (Irovisions and gonoral guidolinos ol Lho NaLional Board ol HoalLh
and \ollaro: IoaLh and docoasod orsons corLain noasuros in Lho hoalLh and nodical socLor}.
40
Soo SCSS 199.9 Socialstyrelsens allmanna rd. rutiner jr bevarande av provmaterial vid
patologavdelningar m.m. (Gonoral guidolinos ol Lho NaLional Board ol HoalLh and \ollaro on rouLinos
lor rosorving Lissuo sanlos aL aLhology doarLnonLs oLc.}.
41
Soo SCSS 1997.4 Socialstyrelsens jreslrijter och allmanna rd avseende organ och vavnadstagning
jr transplantation eller jr annat medicinslt andaml (Irovisions ol Lho NaLional Board ol HoalLh and
\ollaro on Lho collocLion ol organs and Lissuo lor LranslanL surgory or oLhor nodical urosos}, . 15
rogarding insLiLuLions and oLhor uniLs vhoro incisions can lo orlornod.
233
Annina H ersson
circunsLancos, Lho rociionLs nay lo naLural as voll as logal orsons. Sanlos nay
also lo Lalon in ordor Lo clinically LosL harnacouLicals or oLhor nodical roducLs. In
Lhis caso, Lho rociionL nay lo a rosoarchor viLh a harnacouLical conany or a
conany as a logal orson.

5. Gifts

Tho logal concoL ol a gilL is rogulaLod ly sovoral dilloronL sLaLuLos,
42
ono ol vhich is
Lho CorLain IndorLalings in rosocL ol GilLs AcL (SIS 19J6:8J} (`GilLs AcL`}.
Hovovor, Lhis AcL govorns only ono arLicular issuo, nanoly Lho condiLions undor
vhich an undorLaling Lo nalo a gilL has logal ollocL.
4J
CLhor AcLs onconassing
rulos on gilLs includo Lho Land Codo
44
(Cha. 4, SocLions 29-J1}, Lho Air Trallic
AcL
45
(Cha. 9}, and Lho Trading Conanios AcL,
46
luL Lhoso sLaLuLos aro noL
arLicularly doLailod as rogards rulos on gilLs. CLhor logislaLion govorning onorous
agroononLs, o.g. Lho Salo ol Goods AcL,
4
nusL Lhoroloro lo consulLod in ordor Lo
doLornino vhaL doos noL aly Lo gilLs in any givon caso.
48
Il Lhoro is any uncorLainLy
as Lo vhoLhor an agroononL is ol a lonolicial naLuro, iL should lo doLorninod
vhoLhor Lho nalor ol Lho gilL did indood havo such an inLonLion. Il Lho nalor ol a
gilL oxrossly undorLool Lo nalo a gilL, no arLicular rollons ariso,
49
luL il Lho
rociionL cannoL roly on any such undorLaling iL loconos nocossary Lo inLorroL Lho
agroononL and lool in arLicular Lo Lho circunsLancos surrounding Lho agroononL as
voll as Lo cusLon.
50
Tho gonoral rincilos ol inLorroLaLion, validiLy and anondnonL
aly vhon doLornining vhoLhor an agroononL is lonolicial or noL, luL alicaLion
nay dillor il an agroononL is lound Lo lo lonolicial. \hon inLorroLing Lho inLonLion
ol Lho arLios, lor oxanlo, Lho inLonLion and vishos ol Lho nalor ol Lho gilL vill lo
docisivo, vhoroas Lho rociionLs inLonLion vill lo irrolovanL.
51
Il an undorLaling Lo
nalo a gilL has logal ollocL, Lho nalor ol Lho gilL can lo logally roquirod Lo lullil his
olligaLions and nalo Lho gilL. Il Lho nalor ol a gilL roLains Lho righL Lo disoso ol
sonoLhing onconassod ly Lho gilL conLrary Lo Lho undorLaling Lho gonoral logal
rincilos on Lho illogal rosolling ol goods aro Lho only rocourso oon Lo Lho nalor ol
a gilL.
52

SocLion 1 (1} ol Lho GilLs AcL rovidos LhaL an undorLaling Lo nalo a gilL ol
a chaLLol is invalid il Lho gilL is noL conloLo, as long as Lho undorLaling has noL loon

42
Tho lolloving is lasod on \alin, G., Lagon on sluldolrov, 2 ul., 199, . 2JJ, Hosslor, H.,
Allnan salraLL, 19J, . 5J2, Hollnor, J, Socioll avLalsraLL II, KonLralLsraLL, J od., 1 halLoL, sarslilda
avLal, 1996, . 2J4, BongLsson, B., Sarslilda avLalsLyor I, 191, . 20. Ior a hisLorical roLrosocL ol
Lho logal insLiLuLo ol gilL, soo Ischolsson, I, Cn logrooL glva onligL svonsl raLL, 189, and Lho
sano auLhor in: IulllordandoL av glva al ls ogondon onligL svonsl raLLsraxis., Isala, 1906.
4J
Soo \alin, G., Lagon on sluldolrov, 2 ul., 199, . 2JJ.
44
Soo 1ordaball, SIS 190:994.
45
Soo Lujtjartslag (SIS 195:29}(Civil AviaLion AcL}.
46
Soo Lag (1980.110?) om handelsbolag och enlla bolag (LiniLod IarLnorshis AcL}. Cl. NJA 1986 .
402.
4
Soo Kplag, SIS 1990:9J1.
48
Soo Hollnor, J., Socioll avLalsraLL II, KonLralLsraLL, J ul., 1 halLoL, sarslilda avLal, 1996, . 2J5.
49
Soo Hollnor, J., o. ciL. . 2J5.
50
Soo Hollnor, J., o. ciL. . 2J5.
51
Soo Hollnor, J., o. ciL. . 244.
52
234
Cijts and donations
nado in a ronissory noLo or oLhor vriLLon docunonL vhich has loon handod Lo Lho
rociionL.
5J
An undorLaling Lo nalo a gilL can also lo nado orally. Should Lho
circunsLancos surrounding Lho origin ol Lho gilL lo such LhaL Lho oral undorLaling
vas inLondod Lo lo nado gonoral lnovlodgo, iL nay lo linding.
54

Tho rulo soL ouL in SocLion 1 (1} ol Lho GilLs AcL alios only Lo Lho
conLracLual ollocL ol Lho gilL agroononL, i.o. Lho rolaLionshi loLvoon Lho nalor ol a
gilL and rociionL. Hovovor, SocLion1 (2} ol Lho GilLs AcL rogulaLos Lho ollocL ol Lho
gilL agroononL on Lhird arLios, i.o. vhoLhor iL vill havo ollocL againsL Lho crodiLors
ol Lho nalor ol a gilL, lor oxanlo, in Lho ovonL ol lanlruLcy. This socLion rovidos
LhaL il Lho gilL is noL conloLo iL cannoL lo onlorcod againsL Lho nalor ol a gilL`s
crodiLors, in siLo ol Lho lacL LhaL Lho roquirononLs in SocLion 1 (1} ol Lho GilLs AcL
nay havo loon lullillod. Cn Lho oLhor hand, iL is ossillo Lo Lurn Lhis rulo on iLs hoad
and assorL LhaL il Lho gilL is conloLo iL is innaLorial as rogards Lho validiLy ol Lho gilL
vhoLhor ono has acLod in accordanco viLh Lho lornal roquirononL soL ouL in
sulsocLion ono.
55
In Lho lirsL insLanco, Lho rociionL doos noL ovon havo Lho righL Lo
nalo an unrivilogod clain in Lho nalor ol a gilL`s lanlruLcy. In gonoral, Lho GilLs
AcL also rovidos LhaL an undorLaling Lo nalo a gilL is noL ovon conLracLually
linding vhoro Lho gilL is inconloLo. Tho rulo in SocLion1 Lhoroloro ains Lo
doLornino Lho oinL aL vhich a linding undorLaling ly Lho nalor ol a gilL loconos
valid as againsL Lhird arLy crodiLors so LhaL Lho LransacLion cannoL lo rondorod
voidallo oxcoL, lor oxanlo, undor Lho rulos on rocovory as laid dovn in Lho
BanlruLcy AcL.
56

Tho oljocL ol a gilL LransacLion can lo dilloronL Lyos ol chaLLol. Tho GilLs
AcL, hovovor, is noL inLondod Lo rogulaLo all Lyos ol gilL, only Lhoso vhich havo as
Lhoir oljocL nonoy, Langillo chaLLols, oral or vriLLon clains and corLain Lyos ol
sharos or socuriLios.
5
GilLs ol roal roorLy aro govornod ly Cha. 6, SocLion 4 ol Lho
Housing AcL.
58
Tho lorn ol Lho oljocL ol Lho gilL LransacLion is ol inorLanco as
rogards Lho oinL aL vhich Lho gilL is Lo lo considorod conloLo. Tho crodiLors ol Lho
nalor ol a gilL aro gonorally roLocLod onco Lho gilL conos inLo Lho rociionLs
ossossion. Indor SocLion 2 (1} ol, lino 1 ol Lho GilLs AcL, a gilL such as nonoy or a
Langillo chaLLol is noL conloLo unLil iL conos inLo Lho rociionLs ossossion. Cn Lho
oLhor hand, Lho gilL nay lo considorod conloLo in anoLhor vay, sinco Lho sulsLanco
ol Lho Lranslor roquirononLs dillors doonding on Lho Lyo ol roorLy concornod.
Tho rincilo rulo rovidos LhaL Lho nalor ol a gilL can chango his nind
righL u unLil Lho Lino vhon Lho gilL or dood ol gilL has loon Lranslorrod. Cnco Lho
gilL is conloLo, hovovor, iL cannoL lo viLhdravn unloss Lho gilL docunonL is invalid
in sono vay, soo lor oxanlo Cha. J ol Lho ConLracLs AcL.
59
Hovovor, il, alLor Lho
undorLaling has loon nado, Lho linancial osiLion ol Lho nalor ol a gilL has
doLorioraLod Lo such a dogroo LhaL, ovon Laling inLo accounL Lho rociionL`s siLuaLion,

53
See Walin, G., op. cit.. p. 233.
54
See Walin, G., op. cit. p. 233. See also Lagberedningens frslag till Lag om skuldebrev m.m., 1935, p. 132,
NJA II 1936 p. 141.
55
See Walin, Lagen om skuldebrev, 2 uppl., 1997, p. 234.
56
See Lagberedningens frslag till Lag om skuldebrev m.m., 1935, pp. 131, NJA II 1936 p. 146. See also
Konkurslag (SFS 1987:672)(Bankruptcy Act).
57
See Lagberedningens frslag till Lag om skuldebrev m.m., 1935, pp. 130 and Walin, G., Lagen om
skuldebrev, 2 uppl., 1997, p. 228.
58
See Bostadsrttslag (SFS 1991:614). Cf. NJA 1993 p. 560.
59
See Lag (SFS 1915:218) om avtal och andra rttshandlingar p frmgenhetsrttens omrde.
235
Annina H ersson
Lho donand lor Lho gilL is unroasonallo, Lho gilL can lo roducod or viLhdravn in
accordanco viLh SocLion 5 (1} ol Lho GilLs AcL. Tho gilL can also lo viLhdravn
undor SocLion 5 (2} ol Lho GilLs AcL il, alLor Lho undorLaling is nado luL rior Lo
conloLion, Lho rociionL soriously vrongs Lho nalor ol a gilL.
60
In Lhis caso Lho
nalor ol a gilL nusL noLily Lho rociionL ol Lho viLhdraval viLhin ono yoar ol Lho
vrong coning Lo his lnovlodgo.
A gilL nay lo suljocL Lo insLrucLions as Lo hov iL is Lo lo onloyod.
61

Thoso insLrucLions nay consLiLuLo condiLions
62
, i.o. a Lranslor lan or oLhor
LosLanonLary clauso concorning Lho handling ol rocoivod roorLy.
6J
Tho logal
osiLion rogarding such insLrucLions is raLhor oaquo in corLain aroas,
64
luL lron a
conLracLual orsocLivo, iL is osLallishod lav LhaL Lhoso condiLions nay lo doclarod
invalid il Lhoy aro conLrary Lo good and accoLod racLico or aro unroasonallo undor
SocLion J6 ol Lho ConLracLs AcL.
65
IurLhor, as rogards Lhird arLios iL is osLallishod
LhaL a Lranslor lan, lor oxanlo, can lo valid againsL Lhon as rogards gilLs,
66
luL
invalid on urchaso.
6
A Lranslor lan ol a nixod lonolicial and onorous characLor is
considorod Lo lo valid againsL Lhird arLios il Lho Lranslor is cloarly a gilL LransacLion.
68

6. Object of gifts

Indor Lho GilLs AcL Lho oljocL ol a gilL LransacLion can lo dilloronL Lyos ol chaLLol,
including Langillo chaLLols, luildings on anoLhor`s land, sharos and oLhor socuriLios,
inLollocLual roorLy righLs oLc. Aninals aro also considorod Lo lo Langillo chaLLols,
LhaL is Lo say, Lhoy aro logal suljocLs.
69
Hovovor, Lhoro ronains Lho quosLion as Lo
vhoLhor hunans/Lho hunan lody can lo Lho oljocL ol a gilL viLhin Lho noaning ol
Lho GilLs AcL. This quosLion can only lo ansvorod lirsL ly analysing vhoLhor iL is
ossillo Lo ovn ono`s ovn lody and iLs arLs, sinco no ono can roally givo avay
sonoLhing LhaL doos noL lolong Lo Lhon. LiLoraLuro on Lho suljocL Lalos as a sLarLing
oinL Lho lacL LhaL ovory orson is a suljocL ol Lho lav.
0
A orson, Lhoroloro, cannoL

60
Marllig oratt in Svodish. Soo NJA 1961 . 105, vhoro Lho donoo conniLs a sorious crino againsL
Lho donor. Cl. also NJA 19 . 1.
61
Soo Hollnor, J., Socioll avLalsraLL II, KonLralLsraLL, J ul. 1 halLoL, sarslilda avLal, 1996, . 246.
62
SulsLanLivo lav sonoLinos nalos a sysLonic disLincLion loLvoon dilloronL roorLy righLs, such as
ovnorshi, righL ol clain, arLiciaLion righL or social righL. Tho lasL nonLionod grou can conriso
Lhroo lorns, nanoly righLs ol usor, righLs ol socuriLy and qualilicaLion (betingelse}. Tho lasL ol Lhoso
donoLos a ovor ol sono lind ovor anoLhor orsons roorLy vhich doos noL cono undor Lho oLhor
caLogorios ol social righL. Thoro aro various linds ol betingelse, nanoly righLs qualilicaLions (righL ol
rourchaso, oLions oLc.}, nogaLivo qualilicaLions (rohiliLion ol Lho Lranslor or granL ol corLain
roorLy} and urosivo rovisions.
6J
Soo Hosslor, H., Allnan salraLL, 19J, . 26, . 54, 446.
64
Soo, lor oxanlo, Surono CourL JusLico BongLssons ridor in NJA 1990 . 18.
65
Soo Hollnor, J., Socioll avLalsraLL II, KonLralLsraLL, J ul. 1 halLoL, sarslilda avLal, 1996 . 246.
66
Soo NJA 1986 . 16, NJA 1989 . 696 och NJA 199J . 529.
6
Soo NJA 194 . J6 and NJA 199J . 468.
68
Soo NJA 1998 . 1J5 and NJA 1991 . J6.
69
Soo MalnsLrn, A. & Agoll, A., CivilraLL, 16 ul., 1999 . 59, 6.
0
Soo MalnsLrn, A. & Agoll, A., CivilraLL, 16 ul., 1999 . 59, Ingor, G., RaLLon vor ogoL liv och
vor ogon lro, Kungl. HunanisLisla \oLonslas-SanlundoL i Isala, Arslol 1985, . 9. Soo
also SCI 1989:98 . 68.
236
Cijts and donations
lo Lho oljocL ol anoLhor`s ovnorshi.
1
This is also Lruo ol docoasod orsons.
2
Ivory
hunan loing has logal orsonaliLy, lron Lho nononL ol lirLh unLil doaLh, luL on
doaLh, a hunan loing is no longor considorod Lo lo a suljocL ol Lho lav and
Lhoroloro losos his logal orsonaliLy. Tho docoasod can Lhoroloro no longor acquiro
any righLs. Thoso righLs vhich Lho docoasod had during his liloLino aro Lranslorrod Lo
anoLhor or aro oxLinguishod conloLoly.
J
Hovovor, iL should lo noLod LhaL Lho lacL
ol Lho docoasod no longor loing a logal suljocL doos noL nalo hin a logal oljocL.
IurLhor, Lho docoasod`s rolaLivos/osLaLo cannoL clain LiLlo Lo his corso or any arLs ol
iL. A corso cannoL lorn arL ol an osLaLo and iL should noL lo ossillo Lo soL a rico
on iL linancially.
4
A corso cannoL lo considorod Lo lo an oljocL logally soaling,
and Lhoroloro sonoono vho ronovos a corso viLhouL ornission cannoL lo said Lo
havo conniLLod a crino againsL roorLy.
5
This vould also aly vhoro sonoono
ronovod arLs ol a corso.
6
Hovovor, iL nusL lo concodod LhaL during his liloLino
Lho individual can docido Lo a groaL oxLonL hov his lody vill lo doalL viLh on his
doaLh. This is Lruo loLh ol arrangononLs as Lo his lunoral as voll as ossililiLios ol
ronoving organs ly vay ol LranslanL ooraLions and osL norLons. AlLornaLivoly,
Lho docoasod`s rolaLivos vill also lo allo Lo doLornino Lhoso issuos, luL Lhoy cannoL
òvn` a corso. Musouns and nodical insLiLuLions, hovovor aro caallo ol ovning
an onLiro corso.

\haL, Lhon, is Lho siLuaLion as rogards ovnorshi ol arLs ol a hunan
lody IL is said LhaL arLs ol a living hunan (hair, loards oLc} lolong Lo Lho orson
lron vhon Lhoy havo loon Lalon, as long as LhaL orson has noL givon Lhon u. Tho
sano should also lo Lruo ol oLhor naLorials such as llood and inLornal organs vhich
havo loon ronovod on Lho ooraLing Lallo".
8
Cl docoasod orsons iL is said LhaL in
Lho sano vay as a living orson`s hair, loard oLc. can lo assod on Lo anoLhor, Lho
sano cannoL lo said as rogards Lho sano Lyo ol liological naLorial lron a
docoasod".
9

As indicaLod alovo, gilLs aro gonorally lonolicial agroononLs and aro lasod
on Lho roniso LhaL Lho nalor ol Lho gilL has Lho logal righL Lo Lranslor. Alying Lhis
concoL Lo Lho hunan lody, Lho quosLion arisos as Lo vhoLhor Lho ovnor can givo
avay his lody or any arL ol iL.
80
IocLrino rovidos LhaL ovon il iL is noL ossillo Lo

1
Sooo SCI 1989:98 . 68. Cl. Aloxius, K., NgoL on agandoraLL, angro ogon raLLsslar och on
ovonLuoll lrininalisoring av rosLiLuLion, SvJT 1995 . 599, arguing LhaL a orsons righL Lo Lhoir ovn
lody, gonorally soaling, is rolally ol a sinlo lind, i.o. a non-Lranslorallo righL ol ovnorshi,
unacconaniod ly any uncondiLional righL ol disosal ovor Lho oljocL.
2
Soo SCI 1989:98 . 0.
J
Soo SCI 1989:98 . 69.
4
Soo Ingor, G., RaLLon vor ogoL liv och vor ogon lro, Kungl. HunanisLisla \oLonslas-
SanlundoL i Isala, Arslol 1985, . 9. Soo also SCI 1992:16 . 66.
5
Cl. ChaLor 8, SocLion 8 ol Lrottsball (Lho Ional Codo, SIS 1962:00}. Soo also HolnqvisL, L., &
Loijonhulvud, M., Traslnan, I C., \onnlorg, S., BroLLslallon. In lonnonLar. Iol 1 (1-12 la.} .
J6, Jarolorg, N., BroLLon, andra halLoL, IrngonhoLslroLLon, 2 ul., 1986, . 42, 82, 122.
6
Soo SCI 1992:16 . 66.
Soo Jarolorg, N., BroLLon, andra halLoL, IrngonhoLslroLLon, 2 ul., 1986, . 49. Thoro vould
noL, hovovor, aoar Lo lo any inodinonL Lo rivaLo orsons occuying sloloLal arLs. Soo il., . 49.
8
Soo SCI 1989:98 . 68. Soo also Jarolorg, N., BroLLon, andra halLoL, IrngonhoLslroLLon, 2
ul., 1986, . 49.
9
Soo SCI 1989:98 . 0.
80
Cl. Sgangor, J., Crganhandol, Krosdolar Lill salu, 1994, . 80.
237
Annina H ersson
ovn sonoono`s lody or arLs ol iL, Lho orson in quosLion doos havo Lho righL Lo
disoso ol iL viLhin corLain aranoLors.
81

Svodish lav includos sovoral sLaLuLos govorning vhaL can lo dono viLh a
hunan lody rosocLivoly in lilo and in doaLh.
82
MosL ol Lho rolovanL logislaLion
locusos on nodical rocoduros such as LranslanL,
8J
osL norLon
84
, criLoria lor
doLornining vhoLhor sonoono is doad,
85
insoninaLion,
86
rosoarch on lorLilisod oggs
8

oLc. So vhaL can ono do viLh a corso Cn Lhis arLicular oinL Lho logislaLion only
says Lhan LhaL corLain rocoduros rogarding corsos aro rohiliLod.
88
Tho ossililiLios
ol using Lho corso lor dilloronL urosos aro liniLod, as long as Lho ooraLion is noL
onLronchod in an acL or oLhor sLaLuLo.
89
Tho oxacL siLuaLion ouLsido Lho logislaLod
liolds, hovovor, is raLhor uncloar.
Io Lho lody and iLs arLs lorn arL ol Lho ovnor`s osLaLo as assoLs and
Lhoroloro consLiLuLo a lasis lor Lhoso lialiliLios vhich ho sulsoquonLly Lalos on
Iron vhaL has loon sLaLod alovo, Lho ansvor Lo LhaL quosLion oughL, prima jacie, Lo
lo no. Cn Lho oLhor hand, Lhoro is no doulL LhaL a orson can cuL oll his hair and
soll iL lor a socilic sun ol nonoy Lo a vignalor.
90
Argually, Lhon, iL should lo
ossillo lor a lody arL soaraLod lron Lho lody Lo lo givon avay in Lho sano vay
as oljocLs in gonoral. Tho travaux preparatoires, hovovor, soons Lo disLinguish
loLvoon lody arLs vhich can lo rocroaLod, such as llood and hair, and arLs vhoso
ronoval vould lo Lo Lho ornanonL doLrinonL ol Lho individual. As rogards Lho
laLLor caso, iL aoars LhaL voro an agroononL Lo soll a lidnoy Lo cono undor Lho
scruLiny ol a courL, Lho courL vould rolally lind Lho agroononL ouL ol looing
viLh good racLico and Lhoroloro doclaro iL invalid. As Lo Lho quosLion ol vhoLhor a
lody arL is an assoL ol Lho orson vho ovns iL, Lho ansvor vill doond on Lho lody
arL in quosLion.
Tho travaux preparatoires ol Lho TranslanL Surgory AcL discuss hov Lo
doal viLh agroononLs on lody arLs vhoro Lho agroononL has loon nado loloro Lho
lody arL has loon ronovod lron Lho lody. Iiscussion also locusos on hov Lho
orson onLiLlod Lo Lho lody arL can onlorco orlornanco ol such an agroononL. As
rogards Lho logal analysis, iL should hovovor lo noLod LhaL iL nalos no dilloronco
vhich lody arL is involvod. Should Lho orson onLiLlod Lo Lho hair sold onlorco
orlornanco hinsoll, i.o. cuL oll Lho ovnor`s hair viLhouL his consonL, ho vill havo
conniLLod lodily harn and nay lo liallo lor laLLory. Cl courso, Lho sano vill lo

81
Soo Machado, N., Ising Lho lodios ol Lho doad, SLudios in CrganizaLion, Lav and Social Irocoss
RolaLod Lo Crgan TranslanL, 1996, . 10.
82
Soo Machado, N., Ising Lho lodios ol Lho doad, SLudios in CrganizaLion, Lav and Social Irocoss
RolaLod Lo Crgan TranslanL, 1996, . 166.
8J
Soo Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}.
84
Soo Lag (199.8J?) om obdultion m.m. (Lho IosL-MorLon IxaninaLions AcL}.
85
Soo Lag (1987.?o9) om lriterier jr bestammande av mannislans dd (Lho Hunan IoaLh CriLoria ol
IoLorninaLion AcL). Soo ro. 1986/8:9.
86
Soo Lag (1984.1140) om insemination. (InsoninaLion AcL}.
8
Soo Lag (1991.11) om tgarder i jorslnings eller behandlingssyjte med bejrultade agg jrn mannisla
(Lho IorLilisod Hunan Cva (Rosoarch or TroaLnonL Moasuros} AcL}.
88
Soo SCI 1989:98 . 0.
89
Soo, lor oxanlo. begravningslag (SS 1990.1144}(Lho Burials AcL}, begravningsjrordningen
(1990.1147}(Lho Burials Crdinanco}, Lag (199.8J?) om obdultion m.m. (Lho IosL-MorLon
IxaninaLions AcL}. Soo also SCI 1989:98 . 1 and SCI 1992:16 . 60.
90
Ior Lho lolloving Lhroo arLs, soo SCI 1992:16 . 58-59.
238
Cijts and donations
Lruo as rogards oLhor lody arLs. Iorlornanco should noL lo onlorcoallo ly coorcivo
noans.
Tho only ossillo conclusion is LhaL Lho gonoral civil lav rulos on gilLs aro
noL vory orLinonL Lo Lho donaLion ol hunan liological naLorial. Tho oljocL ol a gilL
in gonoral dillors lron a donaLion ol hunan liological naLorial. Tho lirsL caso
concorns an oljocL roorLy or a `Lhing` vhich on Lranslor is Lho suljocL ol a
Lranslor ol roorLy. Tho socond caso concorns a logal suljocL or, aL all ovonLs,
sonoLhing vhich is noL Lo lo considorod an oljocL ol Lho lav. Thoro is no quosLion
horo ol any Lranslor ol roorLy. Gonorally, a gilL is an assoL loLh Lo Lho nalor ol Lho
gilL and Lho rociionL. Hovovor, Lho lody and iLs arLs cannoL lo considorod Lo lo an
assoL lorning arL ol Lho ovnor`s roorLy, Lhoroly croaLing olligaLions incunlonL
uon hin.
91

7. Donations

Tho Lorn `donaLion` gonorally involvos a orson giving avay an oljocL or nonoy lor a
uroso LhaL lonoliLs ovoryono. Cno oxanlo could lo vhoro sonoono loavos a
donaLion ol 20 nillion SIK Lo a univorsiLy lor a nov sLudonL union luilding, anoLhor
vhoro a donaLion ol ainLings or oLhor vorls ol arL is lolL Lo a nusoun. A orson
vho donaLos hunan liological naLorial doos so ly alloving Lho ronoval ol llood,
colls, Lissuo or organs, lor oxanlo, and Lho roason lor doing so nay lo Lo onallo Lho
docLor Lo nalo a diagnosis or LroaL Lho aLionL. MaLorial nay also lo ronovod lor
oLhor nodical urosos, o.g. rosoarch.
92
Cr again, Lho sanlo nay lo rovidod lor
uso in Lho clinical LosLing ol harnacouLicals or oLhor nodical roducLs.
As nonLionod alovo, Lho donaLion ol liological naLorial is govornod ly
sLaLuLo in Lho aroa ol hoalLh and nodical caro. Thoso sLaLuLos, o.g. Lho TranslanL
Surgory AcL,
9J
aro ol a ullic lav, as oosod Lo a civil lav, naLuro. Tho TranslanL
Surgory AcL, lor oxanlo, dolinos Lho condiLions undor vhich organs nay lo
ronovod lron a living or docoasod orson`s lody in ordor Lo lo usod lor LranslanL
or oLhor nodical uroso. Hovovor, Lhis AcL doos noL rogulaLo Lho logal rolaLionshi
loLvoon Lho donor and donoo.
94

Tho donaLion ol liological naLorial is in rincilo noL nado lor
ronunoraLion,
95
and ono could Lhoroloro characLoriso Lho agroononL as a lonolicial
agroononL. BuL is Lho agroononL noro in lino viLh an agroononL Lo nalo a gilL or a
donaLion in gonoral Tho inLorin roorL ol Lho TranslanLs ConniLLoo
96
indicaLos
LhaL ovon il an organ donaLion voro Lo lo characLorisod as a gilL, Lho donor`s oxross

91
Soo, rogarding ovnorshi ol hunan liological naLorial, \osLorlund, L., & Iorsson., H. A.,
CivilraLLsliga rollolLionor anvandningon av nanslligL liologislL naLorial, 2000, . 2J.
92
Soo Rynning, I., Biolanlorna hg Lid lr lanlinsolLion IrvalLningsraLLslig LidslrilL, halLo 6,
1998, . J05.
9J
Soo Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}, Lag (199.8J?) om
obdultioner m.m. (Lho IosL-MorLon IxaninaLions AcL}. Conaro also Halso och sjulvrdslag
(1982:6J}(Lho HoalLh and Modical Sorvicos AcL} and Lag (1998.J1) om yrlesverlsamhet p halso
och sjulvrdens omrde (Lho HoalLh and Modical Sorvicos (Irolossional AcLiviLy} AcL}.
94
Soo SCI 1989:98 . 255.
95
IL should lo noLod LhaL a Lolon sun ol nonoy is givon Lo Lho donor in connocLion viLh donaLion ol
llood.
96
Soo SCI 1989:98 . 150.
239
Annina H ersson
(acLivo} consonL is noL roquirod in ordor lor Lho LranslanL ooraLion Lo lo carriod
ouL. IurLhor, il a orson during his liloLino has assod on an organ Lo anoLhor, ho has
Lhoroly nado a considorallo sacrilico and such a donaLion viLhouL ronunoraLion
can corLainly lo characLorisod as a gilL". Hovovor, should Lho donaLod organ noL lo
clainod unLil Lho doniso ol Lho nalor ol Lho gilL, Lho siLuaLion is sonovhaL
dilloronL: In Lhis caso, iL is noL as naLural Lo rogard Lho surrondor ol Lho organ as a
sacrilico on Lho arL ol Lho nalor ol Lho gilL. Ho no longor roquiros iL, and il iL is noL
usod lor LranslanL, iL vill sLill lo dosLroyod LogoLhor viLh Lho rosL ol Lho lody oiLhor
on cronaLion or during Lho docaying rocoss. Thoso roasons vhich, as rogards a
living orson, load ono Lo concludo LhaL ho did noL vish Lo donaLo an organ in Lho
alsonco ol his oxross consonL Lo do so do noL havo Lho sano lorco onco Lho
roosod donor has diod".
9

Tho alovo assago can lo usod as a lasis lor discussing Lho lolloving
roosiLions: lirsL, LhaL Lho lonolicial characLor ol donaLions as a concoL rogarding
hunan liological naLorial nay chango, doonding on vhoLhor Lho nalor ol a gilL
rovidos Lho naLorial on his doaLh or vhoLhor ho rovidos iL during his liloLino, and
socond, vhoLhor Lho donaLion ol hunan liological naLorial can lo lacod on an
oqual looLing, lron a logal orsocLivo, viLh a gilL or donaLion in gonoral.
Addrossing Lho lirsL quosLion, I doulL LhaL Lho lonolicial naLuro ol Lho
donaLion arisos only vhoro Lho donor has rovidod Lho naLorial during his liloLino.
Conaring Lhis siLuaLion viLh LhaL ol gilLs in gonoral, iL is arguallo LhaL an
agroononL should noL in lacL lo considorod lonolicial sinly locauso iL vas noL
linlod viLh a sacrilico on Lho arL ol Lho nalor ol a gilL. Tho lacL LhaL Lho surrondor
ol Lho oljocL doos noL involvo any arLicular loss sullorod ly Lho nalor ol a gilL can
hardly lo said Lo chango Lho sulsLanco ol Lho agroononL. A orson can vish Lo givo
avay sonoLhing lor vhich ho no longor has any uso, luL vhich in Lho oyos ol Lho
rociionL has considorallo valuo. In Lhis caso Lhoro is noLhing Lo suggosL LhaL Lho
agroononL cannoL lo considorod Lo lo a gilL. Conaring donaLions in gonoral, Lho
nalor ol a gilL can lo a living or docoasod aL Lho orlornanco ol Lho donaLion. Il Lho
donaLion is nado during Lho liloLino ol Lho nalor ol a gilL, iL is ollocLod ly dood ol
gilL. Il iL is nado alLor doaLh, iL is ollocLod in Lho lorn ol a vill.
In Lho laLLor caso, iL is cloar LhaL Lho donaLion doos noL involvo any
sacrilico on Lho arL ol Lho docoasod. Hovovor, Lho donaLion is considorod Lo havo a
lonolicial characLor sinco Lho nalor ol Lho gilL is giving avay a noans or oljocL lor a
orson Lo Lho lonoliL ol ovoryono insLoad ol loLLing iL lall Lo Lho rolaLivos ol Lho
docoasod. Tho lacL LhaL a docoasod no longor roquiros Lho liological naLorial doos
noL, iL is sulniLLod, havo sullicionL lorco any noro Lhan in Lho alovo casos Lo
chango Lho lonolicial characLor ol Lho donaLion LransacLion. ThaL a orson, u unLil
his doaLh and his rolaLivos LhoroalLor can roluso Lo rovido liological naLorial lor
Lho lonoliL ol anoLhor, sorvos only Lo undorin Lho lacL LhaL vhon a donaLion is in
lacL nado, iL is an acL (alloiL assivo}
98
ol a cloarly lonolicial characLor.
As rogards Lho socond quosLion vhoLhor Lho donaLion ol hunan
liological naLorial can lo oquaLod viLh an agroononL on gilLs or donaLions in
gonoral, Lho ansvor is no. As nonLionod alovo, in ordor lor Lhoro Lo lo a gilL in Lho
lirsL laco, Lhoro nusL lo a Lranslor ol roorLy lron Lho nalor ol a gilL Lo Lho
rociionL. Indor SocLion 15 ol Lho TranslanL Surgory AcL, hunan liological

9
Soo SCI 1989:98 . 150.
98
Soo lurLhor doLails alouL Lhis quosLion undor Lho sulhoading Conclusions".
240
Cijts and donations
naLorial nay noL lo rovidod, rocoivod or rocurod lor linancial gain, and Lhis
rovision rocludos Lho salo or urchaso ol such naLorial in roLurn lor aynonL,
vhich in Lurn nalos iL vory dilliculL Lo uL a linancial valuo on such naLorial. Sinco
hunan liological naLorial doos noL havo any linancial valuo, Lhoro vill lo no Lranslor
ol roorLy vhon Lho naLorial assos lron Lho nalor ol a gilL Lo Lho rociionL.
99

GilLs in gonoral and donaLions ol hunan liological naLorial aro Lhoroloro noL on an
oqual looLing. Conaring Lho donaLion ol hunan liological naLorial viLh donaLions
in gonoral, Lho vholo uroso ol Lho laLLor LransacLion is lor Lhoro Lo lo a Lranslor ol
roorLy lron Lho nalor ol a gilL Lo Lho rociionL. Boaring Lhis in nind, noiLhor
donaLions in gonoral nor donaLions ol hunan liological naLorial aro conarallo,
sinco in Lho laLLor caso, as nonLionod alovo, Lhoro is no Lranslor ol roorLy aL all.
\iLhin Lhis conLoxL, hovovor, iL nay lo inLorosLing Lo considor anoLhor
Lyo ol agroononL, nanoly LhaL ol a doosiL. This quosLion is arLicularly orLinonL
as rogards sanlos vhich havo loon sLorod lor Lho caro ol Lho aLionL hinsoll. Is iL
Lho caso LhaL vhon Lho liological naLorial is handod ovor Lo Lho rociionL, Lho acL ol
handing ovor can lo characLorisod as a doosiL A doosiL gonorally rolors Lo an
agroononL vhoroly an oljocL is lolL in Lho caro ol anoLhor.
100
In Lho conLoxL ol a
gonoral doosiL, Lho orson vho loavos Lho oljocL in Lho caro ol anoLhor loos
his/hor ovnorshi ol LhaL oljocL.
101
IurLhor, uso ol Lho oljocL is gonorally noL
orniLLod. Tho naLuro ol a doosiL is LhaL Lho oljocL is noroly hold lor salo-looing,
and Lhoro is no quosLion ol Lho roorLy changing hands or loing usod. Il Lhis doos
haon, Lho orson holding Lho oljocL nay lo liallo in danagos. A doosiL
agroononL doos noL havo Lo conly viLh any lornaliLios in ordor Lo lo valid. Tho
arLios nay nalo an agroononL LhaL ronunoraLion nay lo rovidod in roLurn lor
sLorago (agroononL ol an onorous characLor}, luL Lho agroononL nay also lo ol a
lonolicial naLuro. Tho nosL sLriling characLorisLic ol a doosiL is LhaL Lho orson
sLoring Lho roorLy Lalos Lho roorLy in Lho inLorosLs ol Lho orson naling Lho
doosiL. IL doonds on Lho uroso lor vhich Lho naLorial vas rovidod as Lo
vhoLhor ono can soal ol a doosiL ol liological naLorial. Il Lho liological naLorial
vas ronovod, lor oxanlo in ordor Lo nalo a diagnosis or LroaL Lho aLionL hinsoll,
and Lho sanlo is laLor sLorod, ono can say LhaL a doosiL has loon ollocLod. Tho
naLorial is handlod, lor oxanlo, ly a aLhology doarLnonL in Lho aLionL`s ovn
inLorosLs. \iLh LranslanLs ol liological naLorial, hovovor, Lhoro can lo no quosLion
ol a doosiL. Il Lho conLrary voro Lho caso, Lho rociionL ol, say an organ vould
sinly lo sLoring iL lor Lho donor and Lho donor could Lhoroloro rocovor iL vhonovor
ho dosirod. Biological naLorial rovidod lor rosoarch urosos cannoL lo said Lo
consLiLuLo doosiLs oiLhor, sinco in LhaL caso Lho rosoarchor vould noL lo allo Lo uso
Lho naLorial.
Having rogard Lo Lho alovo, Lhoroloro, a LransacLion involving LranslanL
or rosoarch on liological naLorial cannoL lo characLorisod as a doosiL. Cno should
Lhoroloro avoid characLorising as a doosiL an agroononL loLvoon a donor and
rociionL ol such naLorial. Hovovor, iL is ossillo Lo uso Lho Lorn `doosiL` vhoro iL
is sinly a quosLion ol sLoring Lho sanlo in Lho inLorosLs ol Lho aLionL.

99
Soo lurLhor doLails undor Lho sulhoading RociionLs ol gilLs and donoos".
100
Soo BorgsLrn, S. oL. al., Juridilons Tornor, 8Lh od., 199J.
101
Tho lolloving is lasod on BongLsson, B., Sarslilda avLalsLyor I, 191, . 80, MalnsLrn, A &
Agoll, A., CivilraLL, 16 ul., 1999, . 12J, Holldon, M. & MillqvisL, G., KrodiLraLL, Svorigos Rilos
Lag, LaglolslonnonLaron, 2000, . 241.
241
Annina H ersson
8. Object of donations

Tho oljocL ol a gonoral donaLion, as sLaLod alovo, is usually nonoy or a chaLLol. As
rogards Lho donaLion ol liological naLorial Lho oLonLial oljocLs dillor doonding on
vhoLhor iL is Lalon lron a living or docoasod orson. Tho oljocL ol a donaLion lron a
living orson can lo a lidnoy or a lung or ossilly arL ol Lho livor. As a rulo Lhoro is
a sLrong connocLion loLvoon Lho donor and rociionL in Lho sonso LhaL Lho Lvo aro
rolaLod ly llood.
102
A living nalor ol a gilL can ol courso also donaLo Lissuo, llood,
oLhor lodily lluids, colls, lroasL nill and LooLh.
As rogards a docoasod nalor ol a gilL Lhoro aro sovoral ossillo oljocLs ol
donaLion. A docoasod nalor ol a gilL can donaLo all Lyos ol hunan liological
naLorial as long as iL is Lochnically loasillo. IurLhor, sonoono nay noL vanL Lo
donaLo sinly a singlo organ or socilic Lissuo luL his vholo lody lor nodical
rosoarch. In Lhis caso, social rulos aly.
10J

9. Comparison between gifts and donations

Tho dilloronco loLvoon a gonoral gilL and a donaLion ol liological naLorial can lo
sunnarisod as lollovs: Lho nalor ol a gonoral gilL can chango his nind alouL
naling LhaL gilL righL u unLil Lho nononL LhaL Lho gilL or dood ol gilL is handod
ovor Lo Lho rociionL. Hovovor, onco Lho gilL is conloLo, iL cannoL lo viLhdravn
unloss Lho gilL docunonL is invalid in sono vay. CLhorviso, Lho dood ol gilL is
linding loLh on Lho nalor ol a gilL and on oLhors arLios. A gonoral gilL vill locono
conloLo, in Lho caso ol Langillo chaLLols, lor oxanlo, vhon Lho roorLy conos
inLo Lho rociionL`s ossossion. As indicaLod alovo, hovovor, Lho gilL nay lo
viLhdravn il Lho gilL docunonL is invalid in sono vay. This is Lruo ovon vhoro Lho
gilL is conloLo. \hon is Lho donaLion ol liological naLorial doonod conloLo
\hon Lho liological naLorial is ronovod lron Lho lody Il ono assunos LhaL Lho
donaLion ol Lho liological naLorial loconos conloLo in ronoval lron Lho lody, iL is
nocossary Lo disLinguish loLvoon dilloronL siLuaLions as rogards Lho righL Lo viLhdrav
Lho donaLod naLorial.
Il Lho liological naLorial has loon rovidod lor LranslanL and Lho nocossary
ooraLion has loon orlornod so LhaL Lho rolovanL organ is alroady in Lho rociionL`s
lody, iL vill noL lo ossillo Lo viLhdrav Lho donaLion on Lho lasis LhaL, lor oxanlo,
Lho nalor ol a gilL can shov LhaL Lho donaLion docunonL vas sonohov invalid duo
Lo orror, inrudonco oLc.
Il liological naLorial is rovidod lor rosoarch urosos, Lho gonoral rulo is
LhaL Lho donor can roquiro Lho sanlo Lo lo dosLroyod il lor sono roason ho no
longor vishos Lo lo involvod in Lho rosoarch rojocL. IurLhor, Lho donor can roquiro
LhaL Lho naLorial lo roLurnod il iL is noL Lo lo usod lor Lhoso urosos lor vhich Lho
nalor ol a gilL rovidod iL. Il Lho donor, duo Lo orror, inrudonco or sono sinilar

102
Soo SocLion ol Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}. Soo also
Iro. 1994/95:148 . 80. Soo also SCSS 1997.4 Socialstyrelsens jreslrijter och allmanna rd
avseende organ och vavnadstagning jr transplantation eller jr annat medicinslt andaml (Irovisions ol
Lho NaLional Board ol HoalLh and \ollaro on Lho collocLion ol organs and Lissuo lor LranslanL surgory
or oLhor nodical urosos}, . 12.
10J
Soo SocLion 21 ol Lag (199.8J?) om obdultioner m.m. (Lho IosL-MorLon IxaninaLions AcL}.
242
Cijts and donations
roason, has noL undorsLood Lho uroso lor vhich Lho naLorial vas Lo lo usod, ho is
orniLLod Lo roquiro iLs roLurn. Thoro should, Lhoroloro, lo a righL in loLh casos Lo
viLhdrav liological naLorial vhich has loon rovidod lor rosoarch urosos, ovon
Lhough Lho donaLion nusL lo considorod Lo lo conloLo. Hovovor, corLain Lochnical
rollons nay ariso vhoro Lho donor vanLs Lho sanlo Lo lo dosLroyod. Suoso ono
nanagos Lo dorivo a nov roducL lron LhaL sanlo. \haL is iL LhaL Lho donor can
roquiro Lo lo dosLroyod JusL Lho sanlo iLsoll or Lho nov roducL as voll Cha. J,
SocLion 6 ol Lho Biolanls (HoalLh Caro oLc.} AcL (SIS 2002:29} rovidos LhaL a
orson vho has givon his consonL Lo Lho uso ol a Lissuo sanlo nay viLhdrav his
consonL aL any Lino. Il Lho viLhdraval alios Lo all usos Lho Lissuo sanlo shall lo
dosLroyod or doorsonalisod viLh innodiaLo ollocL. Tho GovornnonL Bill on Lho
AcL
104
sLaLos LhaL Lho orson vho givos his consonL Lo sLoring Lho sanlo in a liolanl
lor corLain urosos shall havo Lho unqualiliod righL Lo viLhdrav LhaL consonL. This
righL also oxLonds Lo Lhoso orsons vho havo Lho logal righL Lo rorosonL LhaL orson.
Tho consoquonco ol a viLhdraval vhich loars uon all usos ol Lho sanlo is, as
highlighLod alovo, LhaL Lho Lissuo sanlo vill oiLhor lo dosLroyod or doorsonalisod.
Tho lill indicaLos LhaL il Lho viLhdravn consonL loars only on Lho uso ol a sanlo lor
ono ol sovoral urosos, Lho sanlo should noL lo dosLroyod in iLs onLiroLy. InsLoad
aroriaLo noasuros should lo Lalon, o.g. social narlings Lo onsuro LhaL Lho
sanlo is noL usod aL varianco viLh Lho donors consonL. IurLhor, as rogards
viLhdraval ol consonL lor sanlos vhich havo loon Lalon lor rosoarch urosos, iL
should lo Lho acLual Lissuo sanlo rovidod lor Lho rosoarch LhaL is Lo lo dosLroyod,
and noL Lho rosulLs ol LhaL rosoarch. Tho quosLion as Lo vhaL is Lo lo dosLroyod il a
nov roducL is dorivod lron rosoarch involving Lho Lissuo sanlo is noL cloar lron
Lho Biolanls AcL. Hovovor, iL is sulniLLod LhaL in Lhis caso Lhoro should lo a LosL
vhoroly dilloronL inLorosLs aro roasonally lalancod, LhaL is Lo say Lho nalor ol a
gilL`s righL Lo viLhdrav consonL and Lho rosoarchor`s righL Lo oxloiL naLorial lor
vhich consonL vas givon in Lho nano ol rosoarch. Convorsoly, a rulo LhaL doos noL
Lalon inLo accounL Lho rosoarchor`s inLorosLs as voll as Lho inLorosLs ol Lho nalor ol a
gilL nay havo sorious consoquoncos lor rosoarch and largo rojocLs nay cono Lo
noLhing or havo Lo lo sLarLod again lron scraLch.

10. A comparative analysis of deeds of gift and donors forms

Thoro aro sinilariLios in lorn loLvoon a dood ol gilL and a donaLion lorn lor
liological naLorial, as rogards a donaLion lorn conloLod ly a living donor, Lho
inLonLion Lo donaLo can oiLhor lo oral or lo lound in a vriLLon docunonL.
105
Ior
oxanlo, Lho LoxL ol a vriLLon donaLion lorn lor llood or Lissuo rovidod ly a living
donor can lo lornod in such a vay LhaL Lho donor consonLs Lo givo Lho sanlo Lo a
socilic rociionL lor rosoarch urosos.
106

104
Soo Iro. 2001/02:44 . 9, . 44, . 5.
105
Cl. SocLions 69 ol Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}, Cha. 2,
SocLion 1 ol Lag (1998.J1) om yrlesverlsamhet p halso och sjulvrdens omrde (Lho HoalLh and
Modical Sorvicos (Irolossional AcLiviLy} AcL}, SocLions 2, 2a and 2l ol Halso och sjulvrdslag
(1982:6J}(Lho HoalLh and Modical Sorvicos AcL}.
106
This oxanlo is Lalon lron a donaLion lorn - issuod ly Lho Modical Biolanl aL Norrland
InivorsiLy HosiLal and Ino InivorsiLy, 2000.
243
Annina H ersson
As rogards docoasod donors, an inLonLion Lo donaLo can lo oxrossod in a vriLLon
docunonL, o.g. a donor`s card, or can lo oral, o.g. ly inlorning a closo rolaLivo ol
LhaL dosiro
10
or ly signing u viLh Lho NaLional Ionors` RogisLor.
108
InlornaLion
givon oiLhor on a donor`s card or on Lho NaLional Ionors` RogisLor can lo anondod
aL any Lino and as nany Linos as is dosirod. \hoLhor Lho donor usos a card or Lho
rogisLor is innaLorial, sinco Lhoro is no dilloronco in `valuo` loLvoon Lhoso Lvo
lorns" ly vhich Lho donor can nalo lnovn his osiLion rogarding hunan liological
naLorial.
109
IrrosocLivo ol hov Lho donor nalos lnovn his sLandoinL, iL vill lo Lho
inlornaLion rovidod nosL roconLly LhaL vill lo usod Lo doLornino Lho donor`s
vishos rogarding donaLion and vill Lhoroloro `lind` loLh Lho donor and Lhird arLios.
Tho dood ol gilL nusL havo loon nado in vriLing, in Lho lorn ol a
ronissory noLo or oLhor vriLLon docunonL dravn u lor Lho socilic uroso ol
shoving LhaL Lho rolovanL undorLaling has loon nado.
110
IurLhornoro, a linding
undorLaling can lo inliod vhoro a orson indicaLos in a nornal loLLor LhaL ho
inLonds Lo loavo a gilL, il iL is cloar lron Lho circunsLancos LhaL Lho loLLor-vriLor has
inLondod LhaL Lho rociionL should lo allo Lo roly on Lho loLLor as rool ol an
undorLaling ol a gilL. In Lhis caso, Lho loLLor is doonod Lo consLiLuLo a dood.
111
An
undorLaling Lo nalo a gilL nay also lo oral il, lor oxanlo, Lho nalor ol a gilL has
nado lnovn his inLonLion Lo a grou or associaLion ol a nunlor ol orsons.
112
Indor
corLain circunsLancos a gilL nusL also lo rogisLorod in ordor Lo lo valid (cl. Cha. 8,
SocLion 1 ol Lho Marriago Codo, SIS 198:2J0}.
Sunning u, Lhon, iL aoars, prima jacie, LhaL donaLion lorns and doods
ol gilL aro sinilar in lorn, luL Lho Lvo Lyos ol docunonL havo vory dilloronL logal
consoquoncos. Il an undorLaling Lo nalo a gonoral gilL has logal ollocL, Lhon logal
avonuos nay lo ursuod in ordor Lo hold Lho nalor ol a gilL Lo his olligaLions
rogarding LhaL gilL. A orson vho nalos lnovn a dosiro or a rolusal Lo donaLo
hunan liological naLorial is doonod Lo havo oxrossod a nanilosLaLion ol vill, and
noL a oinL ol viov".
11J
\ill such a nanilosLaLion ol vill rovidod in a vriLLon
agroononL a doclaraLion givon Lo Lho rociionL, LhaL a donaLion is Lo lo nado lo
linding In siLo ol Lho donaLion having loon nado Lhrough a vriLLon docunonL, iL
is unliloly Lo lo onlorcod on civil lav grounds vhoro iL is considorod aL varianco viLh
rincilos ol good racLico.
114
IurLhornoro, Lhis vould conllicL viLh Lho rovisions ol
Lho TranslanL Surgory AcL on consonL and any such undorLaling should Lhoroloro
lo doclarod invalid.
115
Having rogard Lo Lhoso lacLs, a dood ol gilL and a donaLion
lorn/donor`s card can hardly lo said Lo lo on an oqual looLing, ovon Lhough Lho
loLLor can lo adducod as vriLLon rool ol Lho dosiro ol Lho nalor ol a gilL Lo givo
avay" liological naLorial.

10
Cl. SocLion J ol Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}.
108
\ollaro on Lho collocLion ol organs and Lissuo lor LranslanL surgory or oLhor nodical urosos}, . 6.
109
Soo SocialsLyrolson (NaLional Board ol HoalLh and \ollaro}, IonaLion av organ och vavnador:
Irgor och svar, 2000, . 2J.
110
111
Soo \alin, o. ciL. . 2JJ.
112
Soo Laglorodningons lrslag Lill Lag on sluldolrov n.n. 19J5, . 1J2, NJA II 19J6 . 141.
11J
Soo SCI 1989:98 . 220.
114
Soo o. ciL. . J9 . 69.
115
Cl. SCI 1989:98 . 58.
244
Cijts and donations
Thoro aro lurLhor dilloroncos loLvoon a gonoral dood ol gilL and a donaLion lorn lor
liological naLorial. As rogards gonoral gilLs, Lhoro is, in rincilo, alvays a socilic
rociionL. Iocoasod donors ol hunan liological naLorial can novor indicaLo on Lhoir
donor`s card LhaL a socilic organ nusL lo donaLod Lo a socilic idonLiliod rociionL.
Hovovor, a docoasod orson doos havo Lho righL Lo docido vhich naLorial nay lo
Lalon and lor vhaL urosos. Living donors nay docido on a socilic idonLiliod
rociionL ol Lhoir LranslanLod naLorial. Il Lho nalor ol a gilL rovidos hunan
liological naLorial lor oLhor nodical urosos ho nay, in Lho sano vay as a
docoasod donor, dirocL vhich naLorial nay lo Lalon and lor vhaL urosos iL shall
lo usod. A living nalor ol a gilL is also allo Lo doLornino vhoLhor Lho naLorial
should lo donaLod Lo a socilic rociionL lor rosoarch urosos.
116
Socondly, a dood ol
gilL nay lo linlod viLh ronunoraLion lron Lho rociionL Lo Lho donor, o.g. Lho
rociionL ol Lho gilL nusL rovido Lho nalor ol a gilL viLh a ronissory noLo ol X
SIK. In rincilo, Lho donaLion ol liological naLorial should novor lo nado in
roLurn lor ronunoraLion Lo Lho donor. Thirdly, a dood ol gilL nay havo Lax
inlicaLions lor Lho rociionL, sonoLhing vhich is noL ossillo vhon donaLing
liological naLorial. IourLhly, il a orson loconos a donor or donoo, LhaL inlornaLion
vill lo roLocLod ly conlidonLialiLy,
11
vhoroas Lho conLrary is Lruo ol gonoral gilLs.
As rogards gilLs, Lhoro aro rulos on ullicaLion, vhoroly in ordor Lo lo valid againsL
Lhird arLios, Lho gilL vill only locono valid on rogisLraLion. Il, lor oxanlo, a nan
vishos Lo nalo a gilL ol sonoLhing Lo his vilo, Lhon oiLhor Lho rulos alying Lo Lho
conloLion ol gilLs in gonoral havo Lo lo conliod viLh, or olso Lho gilL nusL lo
rogisLorod in vhaL is lnovn as Lho NaLional Marriago RogisLor. CLhorviso Lho gilL
vill noL lo valid as loLvoon Lho arLios, Cha. 8, SocLion 1 (1} ol Lho Marriago Codo
(SIS 198:2J0}. Ior roLocLion againsL Lho donors crodiLors, Lho gilL has Lo lo
rogisLorod in Lho NaLional Marriago RogisLor, Cha. 8, SocLion 1 (2} ol Lho Marriago
Codo. Any crodiLors vill Lhon lo arisod ol Lho gilL, sinco Lho rogisLor onLry is
ullishod in Lho ollicial journal IosL- och Inrilos Tidningar and in local novsaors.

11. Makers of gifts and donors

A conarison ol Lho sinilariLios and dilloroncos loLvoon Lho nalor ol a gilL and a
donor ol liological naLorial loads Lo Lho lolloving conclusions. As rogards gonoral
lonolicial agroononLs, in rincilo Lho ovnor has Lho logal righL Lo disoso ol his
assoLs as ho dosiros. Ho can Lhoroloro hand Lhon ovor Lo vhonsoovor ho vishos in
Lho lorn ol a gilL. In Lho caso ol a donaLion, Lho nalor ol a gilL also has Lho logal
righL Lo docido vhaL should haon Lo his lody and iLs arLs. Hovovor, il a nalor ol
a gilL consonLs Lo liological naLorial loing donaLod alLor his doaLh, ho can noiLhor
rohiliL nor roquiro iL Lo lo usod lor Lho lonoliL ol a socilic orson or grou ol

116
Cl. donaLion lorn, issuod ly Lho Modical Biolanl aL Norrland InivorsiLy HosiLal and Ino
InivorsiLy. Tho donaLion lorn cloarly sLiulaLos LhaL Lho liological naLorial is givon Lo LhaL arLicular
liolanl. IurLhornoro, iL is sLiulaLod in Lho donaLion lorn LhaL Lho liological naLorial vill noL lo
sold.
11
Soo, lor oxanlo, Selretesslag (1980.100} (Lho Socrocy AcL}, ersonuppgijtslag (1998.?04}(Lho
Iorsonal IaLa AcL}.
245
Annina H ersson
orsons ol a corLain naLionaliLy or arLicular oLhnic origin, sinco Lhis vould acL as an
olsLrucLion Lo Lho ooraLion.
118

Tho nalor ol a gonoral gilL can lay dovn insLrucLions Lo Lho rociionL as Lo
hov Lho gilL should lo onloyod. Tho quosLion is, hovovor, vhoLhor ono can soL
condiLions lor Lho uso ol a donaLion ol liological naLorial in Lho sano vay. As has
alroady loon shovn, corLain Lyos ol condiLion can lo inosod, lor oxanlo Lho
donor nay sLiulaLo LhaL Lho liological naLorial nay noL lo usod lor anyLhing oLhor
Lhan a socilic uroso, or LhaL only a corLain Lyo ol liological naLorial nay lo
Lalon.
119

In rincilo, anyono can lo a donor ol hunan liological naLorial. A living
nalor ol a gilL should lo allo Lo rovido hunan liological naLorial irrosocLivo ol
ago. Biological naLorial nay also lo Lalon lron as yoL unlorn or docoasod orsons.
Hovovor, corLain donors aro oxcludod lron donaLing organs or Lissuo Lo anoLhor
orson vhoro Lho rociionL is in risl ol inlocLion or illnoss.
Tho GilLs AcL doos noL laco any arLicular roquirononLs on Lho nalor ol
a gilL. Hovovor, Lho gilL nay lo null and void oving Lo a lornal dolocL vhoroly Lho
nalor ol a gilL, oving Lo lacl ol logal caaciLy, has no ossililiLy ol orlorning Lhis
logal acL, Lho roason loing LhaL 1} Lho nalor ol a gilL is a ninor,
120
2} Lho nalor ol a
gilL is undor guardianshi,
121
J} Lho nalor ol a gilL is nonLally disLurlod.
122
Tho
nalor ol a gonoral gilL connoncos Lho gilL LransacLion. This is also Lho caso vhoro
hunan liological naLorial is donaLod, ly Lho donor oxrossing his vill Lo nalo a
donaLion.

12. Recipients of gifts and donees

A lurLhor quosLion roquiring analysis is LhaL ol Lho sinilariLios and dilloroncos
loLvoon Lho rociionL ol a gonoral gilL and Lho donoo ol hunan liological naLorial.
Tho docLrino on gonoral gilLs discussos Lho concoL ol Lho roquirononL ol accoLanco
ly Lho rociionL.
12J
Tho gonoral rulo is LhaL acLual accoLanco ly Lho rociionL is noL
roquirod, as long as Lho gilL doos noL inoso any olligaLions on Lho rociionL.
IosiLo Lhoro loing no roquirononL ol accoLanco, Lhoro nusL lo sono sorL ol co-
ooraLion ly Lho rociionL in ordor lor Lho gilL Lo lo considorod linal, oiLhor
inliciLly or assivoly ly rocoiL ol Lho roniso ol a gilL or Lho conloLion ol Lho
gilL. Thoro is no roquirononL lor Lho rociionL Lo Lalo rocoiL ol Lho gilL. This noans
LhaL Lho roniso ol a gilL nay lo inooraLivo ovon Lhough Lho roniso ol a gilL is

118
\ollaro on Lho collocLion ol organs and Lissuo lor LranslanL surgory or oLhor nodical urosos}, .
12.
119
Soo alovo undor sulhoading CljocL ol donaLions".
120
Soo Cha. 9 ol Lho Codo ol IaronLhood and Guardianshi (raldraball}(SIS 1949:J81, rorinLod
SIS 1995:94}.
121
Soo Cha. 11 ol Lho Codo ol IaronLhood and Guardianshi (raldraball}(SIS 1949:J81,
rorinLod SIS 1995:94}.
122
Soo, lor oxanlo Lag (19?4.J?J) om verlan av avtal som slutits under pverlan av psylisl strning
(IllocLs ol ConLracL vhon Concludod undor Lho Inlluonco ol MonLal IisLurlanco AcL}.
12J
Soo Hollnor, J., Socioll avLalsraLL II, KonLralLsraLL, J ul., 1 halLoL, sarslilda avLal, 1996 . 240.
BongLsson, B., Sarslilda avLalsLyor 1, 191, . 25. Cl. HsLad, TjansLor uLan udrag, 19J, .
224.
246
Cijts and donations
linding on Lho nalor ol a gilL il Lho gilL is noL accoLod ly Lho rociionL. Inlilo
gonoral gilLs, as a rulo Lhoro should lo oxross accoLanco ly Lho rociionL as rogards
donaLing hunan liological naLorial, lor oxanlo, vhoro a LranslanL roquiros a
nodical ooraLion, iL is cloar LhaL Lho rociionL nusL havo oxrossod his dosiro Lo
rocoivo Lho organ/Lissuo. Il Lho naLorial is Lalon lor rosoarch urosos, iL soons
naLural Lo concludo LhaL Lho rociionL having aslod Lho nalor ol a gilL vhoLhor ho
has consonLod Lo Lho naLorial loing usod lor LhaL uroso has oxrossly nado
lnovn his dosiro Lo rocoivo Lho naLorial. Il Lho sanlo is Lalon in ordor Lo nalo a
diagnosis ol or LroaL Lho aLionL hinsoll, iL should lo inliciL lron Lho HoalLh and
Modical Caro AcL LhaL Lho sanlo is Lo lo usod lor Lho lonoliL ol LhaL aLionL.
124

As indicaLod alovo, a gonoral gilL can lo viLhdravn il, having givon Lho
undorLaling, Lho linancial siLuaLion ol Lho nalor ol a gilL doLorioraLos Lo such a
dogroo LhaL, also Laling inLo accounL Lho rociionL`s condiLions, Lho onlorcononL ol
Lho gilL is cloarly unroasonallo. Tho gilL nay also lo viLhdravn undor SocLion 5 (2}
ol Lho GilLs AcL vhoro Lho rociionL, alLor Lho undorLaling luL rior Lo conloLion,
doos Lho nalor ol a gilL considorallo (signilicanL} vrong.
125
This rovision is noL
arLicularly suiLallo lor alicaLion Lo Lho donaLion ol hunan liological naLorial
oiLhor. In Lho lirsL laco, hunan liological naLorial, viLh Lho oxcoLion ol llood,
hair, lroasL nill and LooLh, nay noL lo sold or rovidod Lo Lho nalor ol a gilL in
roLurn lor aynonL,
126
nor nay Lho rociionL rocoivo or LransniL liological naLorial
lron a living, docoasod or alorLod looLus lor linancial gain.
12

Sinco liological naLorial doos noL havo a linancial valuo, iL loconos
orLinonL Lo asl Lho signilicanco in Lhis conLoxL lor Lho nalor ol a gilL ol a righL ol
viLhdraval as rovidod in SocLion 5 (1} ol Lho GilLs AcL. As rogards Lho socond
oxcoLion, nanoly Lho viLhdraval ol Lho roniso ol a gilL on Lho lasis LhaL Lho
rociionL doos Lho nalor ol a gilL signilicanL vrong, iL can lo said LhaL Lho nalor ol a
gilL ol liological naLorial nusL alvays lo allo Lo chango his nind. Tho nalor ol a
gilL vho has consonLod Lo donaLo liological naLorial has Lho righL Lo chango his
nind, irrosocLivo ol vhoLhor or noL Lho rociionL has signilicanLly vrongod hin. Il a
orson has undorLalon Lo donaLo, say, Lissuo Lo a rosoarch rojocL, ho is onLiLlod Lo
chango his nind u unLil Lho oinL LhaL Lho Lissuo is acLually donaLod. Moroovor, Lho

124
Soo SocLions J and 18 ol Halso och sjulvrdslag (1982:6J} (Lho HoalLh and Modical Sorvicos
AcL}. Cl. also SCSS ?001.8 Socialstyrelsens allmanna rd om jrsiltighetsmtt vid hantering och
marlning av sdant biologislt avjall som lan medjra olagenhet jr mannislors halsa enligt miljballen
(Gonoral guidolinos ol Lho NaLional Board ol HoalLh and \ollaro on cauLion vhon handling and
narling liological vasLo oLc.}, SCSS 1999.?7 Socialstyrelsens jreslrijter och allmanna rd om
hantering av smittjrande avjall jrn halso och sjulvrden (Irovisions and gonoral guidolinos ol Lho
NaLional Board ol HoalLh and \ollaro on handling inlocLious vasLo lron Lho HoalLh and Modical
SocLor}, SCSS 1989.J8 Socialstyrelsens jreslrijter om blodgivning, blodtransjusioner m.m. (Irovisions
ol Lho NaLional Board ol HoalLh and \ollaro on llood Lranslusions oLc.), SCSS 1990.8
Socialstyrelsens allmanna rd rrande omhandertagande av joster ejter abort (Gonoral guidolinos ol Lho
NaLional Board ol HoalLh and \ollaro rogarding caro ol alorLod looLus}, SCSS 199o.?8 Klinisla
obdultioner m.m. (Clinical auLosios oLc.}, SCSS 199o.?9 Socialstyrelsens jreslrijter och allmanna
rd. Vissa tgarder inom halso och sjulvrden vid ddsjall (Irovisions and gonoral guidolinos ol Lho
NaLional Board ol HoalLh and \ollaro: IoaLh and docoasod orsons corLain noasuros in Lho HoalLh
and Modical SocLor}.
125
Soo \alin, G., Lagon on sluldolrov, 2 ul., 199, . 248.
126
Soo SocLion 15 ol Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}. Soo Iro.
1994/95:148 . 8.
12
Soo SocLion 15 ol Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}.
247
Annina H ersson
nalor ol a gilL can also viLhdrav Lho Lissuo sanlo alLor donaLion il Lho sanlo is
noL onloyod in a vay lor vhich consonL vas givon or Lho nalor ol Lho gilL has
changod his/hor nind rogarding arLiciaLion in Lho rosoarch rojocL. A signilicanL
vrong" should novor lo allo Lo ariso rogarding Lho donaLion ol organs Lalon lron a
docoasod, locauso Lho ond rociionL and Lho nalor ol a gilL do noL gonorally lnov
oach oLhor. Boaring in Lhis in nind, iL is unliloly LhaL Lho rociionL can do Lho nalor
ol a gilL signilicanL vrong" in a vay LhaL could lo consLruod as Lho nalor ol a gilL
no longor vishing Lo donaLo his organ Lo LhaL orson. Il Lho nalor and rociionL ol a
gilL aro rolaLod or acquainLod, or oLhorviso lnov oach oLhor and Lho rociionL is said
Lo havo dono Lho nalor ol a gilL signilicanL vrong, Lho rulo nusL also aly LhaL Lho
nalor ol a gilL can chango his nind righL u unLil Lho ooraLion and alLor Lho
ooraLion il Lho naLorial is noL usod in Lho vay vhich ho consonLod Lo.

13. Conclusions

Tho lolloving conclusions can lo dravn lron Lho alovo. Tho lirsL conclusion nusL
lo LhaL Lho GilLs AcL and oLhor gonoral civil lav rulos on gilLs oLc. aro noL roally
suiLallo Lo lo aliod Lo Lho donaLion ol liological naLorial.
128
Socondly, loLh
gonoral gilLs and donaLions ol liological naLorial Lalon lron living orsons consLiLuLo
acLs ol acLivo giving. Crgan donaLions lron docoasod orsons could ossilly lo
consLruod as an acL ol acLivo giving. SocLions J and 4 ol Lho TranslanL Surgory AcL
rovido LhaL, in Lho alsonco ol any indicaLion Lo Lho conLrary ly Lho nalor ol a gilL,
consonL Lo donaLo vill lo rosunod as long as rolaLivos do noL roluso Lo go ahoad
viLh Lho ooraLion.
129
IL is Lhoroloro rosunod LhaL Lho docoasod vanLod Lo hol a
lollov hunan loing in nood ol organs and LhaL Lho donor vould Lhoroloro havo loon
in lavour ol Lho donaLion.
1J0
In Lhis rosocL Lho acL ol giving can lo doonod Lo lo
assivo. Thirdly, a donaLion lorn/donor`s card rogarding liological naLorial and a
gonoral dood ol gilL do noL ranl oqually in a logal orsocLivo. In rincilo, gonoral
gilLs alvays havo a socilic, idonLiliod rociionL, vhoroas docoasod donors ol hunan
liological naLorial can novor indicaLo on Lhoir donor`s card a socilic, idonLiliod
rociionL Lo vhon a arLicular organ should lo donaLod. Hovovor, a docoasod
orson doos havo Lho righL Lo doLornino vhich naLorial nay lo Lalon and lor vhaL
urosos. Living donors should also lo allo Lo doLornino LhaL Lho naLorial should lo
donaLod Lo socilic rociionLs lor rosoarch urosos. IourLhly, Lho concoLs do noL
havo Lho sano Lorninological sulsLanco. Thoro is gonorally considorod Lo lo no
dilloronco loLvoon Lho concoLs ol gonoral gilLs and donaLions ol hunan liological
naLorial. Il Lhoro is any dilloronco, iL is only logislaLivo, i.o. dilloroncos loLvoon Lho
GilLs AcL and Lho TranslanL Surgory AcL, and in ovoryday sooch donaLions aro
rolorrod Lo as gilLs. AnoLhor inLorroLaLion is LhaL Lho concoLs aro usod dilloronLly
doonding on vhoLhor iL is a donor or donoo LhaL is rolorrod Lo. A naLural orson
vho rocoivos hunan liological naLorial rocoivos a gilL. Such a orson rocoivos a gilL
viLhouL olligaLions and Lho naLorial Lhon lolongs Lo hin. Tho Lorn `donaLion` rolors
Lo Lho orson vho givos avay Lho gilL. Tho alsonco ol Lorninological disLincLion
loLvoon Lho concoLs ol gilL and donaLion is noL arLicularly sorious in iLsoll, luL iL

128
Cl. SCI 1989:98 . 69.
129
Soo sLaLuLory LoxL and Iro. 1994/95:148 . 2J, . 5.
1J0
Soo SocialuLsloLLoLs loLanlando 1994/95:SoI21 TranslanLaLionor och oldulLionor n.n. . 1J.
248
Cijts and donations
nay givo riso Lo sono conlusion loLvoon Lho Lvo logal concoLs in a logal
orsocLivo. AuLhoriLios, organisaLions or oLhor lodios roviding inlornaLion Lo Lho
gonoral ullic should Lhoroloro nalo iL quiLo cloar LhaL Lho donaLion ol liological
naLorial is noL linlod, in logal Lorns, Lo gilLs in gonoral. IilLhly, gilLs dillor lron
donaLions doonding on Lho osiLion ol Lho nalor ol a gilL and Lho donor. Tho
dilloroncos includo vho can lo, rosocLivoly, Lho nalor ol a gilL, and Lho donor.
SixLhly, Lho sinilariLios loLvoon a donoo and Lho rociionL ol a gonoral gilL aro noL
arLicularly sLriling oiLhor, il anyLhing Lho oosiLo alios. In shorL, vo nay
concludo LhaL Lho GilLs AcL cannoL lo aliod Lo oaquo logal quosLions rogarding
Lho donaLion ol liological naLorial.

249
Annina H ersson
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HsLad, Torgny (19J}. Tjanster utan uppdrag. ersattning och behrighet vid s.l. negotiorum
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Halso och sjulvrdslag (198?.7oJ)(Lho HoalLh and Modical Sorvicos AcL}

Ingor, Gran (1986} Ratten ver eget liv och ver egen lropp. Kungl. HunanisLisla \oLonslas
SanlundoL i Isala, Arslol 1985. . 9-105. Isala: AlnqvisL & \ilsoll.

Jarolorg, Nils (1986). Lrotten. Hajte ?. rmgenhetsbrotten. 2 ul. SLoclholn: NorsLodL.

1ordaball (SS 1970.994) (Lho Land Codo}

Konlurslag (SS 1987.o7?) (BanlruLcy AcL}.

Kroppen ejter dden (1992}. SluLloLanlando av LranslanLaLionsuLrodningon. SLoclholn:
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Kplag (SS 1990.9J1) (Lho Salo ol Goods AcL}

Lagberedningens jrslag till lag om sluldebrev m.m. (19J) Laglorodningon. SLoclholn: Nord.
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Lag angende vissa utjastelser om gva (19J6}. NyLL juridislL arliv. Avd. 2. TidslrilL lr
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Lag (19Jo.8J) angende vissa utjastelser om gva (Lho GilLs AcL}

Lag (191.?18) om avtal och andra rattshandlingar p jrmgenhetsrattens omrde (Lho
ConLracLs AcL}

Lag (19?4.J?J) om verlan av avtal som slutits under pverlan av psylisl strning (IllocLs ol
ConLracL vhon Concludod undor Lho Inlluonco ol MonLal IisLurlanco AcL}

Lag (1980.110?) om handelsbolag och enlla bolag (LiniLod IarLnorshis AcL}

Lag (1984.1140) om insemination (InsoninaLion AcL}

Lag (1987.?o9) om lriterier jr bestammande av mannislans dd (Lho Hunan IoaLh CriLoria
ol IoLorninaLion AcL}
251
Annina H ersson

Lag (199.8J?) om obdultioner m.m. (Lho IosL-MorLon IxaninaLions AcL}

Lag (199.8J1) om transplantation m.m. (Lho TranslanL Surgory AcL}

Lag (1998.J1) om yrlesverlsamhet p halso och sjulvrdens omrde (Lho HoalLh and
Modical Sorvicos (Irolossional AcLiviLy} AcL}

Lag (1991.11) om tgarder i jorslnings eller behandlingssyjte med bejrultade agg jrn
mannisla (Lho IorLilisod Hunan Cva (Rosoarch or TroaLnonL Moasuros} AcL}

Lujtjartslag (SS 197.?97) (Civil AviaLion AcL}

Machado, Nora (1996}. Using the bodies oj the dead. studies in organization, lau and social
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ol Sociology, Iniv.

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MalnsLrn, SLon, Gyrlin Irono, Sjgron, IoLor A. & Hodin, Mario-Louiso, Lonniers
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sjulvrdspersonalens uppjattningar och erjarenheter. MargaroLa Sannor, raorL uLgivon av
LranslanLaLionsuLrodningon. SLoclholn: Allnanna lrlagoL. (SCI 1989:99}

atienten har ratt (199}. IolloLanlando av KonniLLon on halsooch sjulvrdons
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ersonuppgijtslag (1998.?04) (Lho Iorsonal IaLa AcL}

Regeringens proposition 198o/87.79 med jrslag till lag om ddens intrade, m.m.
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Regeringens proposition 1994/9.148. Transplantationer och obdultioner m.m. (1995}
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Regeringens proposition ?001/0?.44. Liobanler inom halso och sjulvrdon n.n. (2001}
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Rynning, IlisaloLh (1994} Samtycle till medicinsl vrd och behandling. en rattsvetenslaplig
studie. Iiss. Isala. Isala: IusLus.

Rynning, IlisaloLh (1998}. Liobanlerna hg tid jr banlinspeltion` IrvalLningsraLLslig
LidslrilL, halLo 6, 1998, . J0J-JJJ.

Selretesslag (1980.100) (Lho Socrocy AcL}

SCSS (1987.o) Socialstyrelsens jreslrijter och allmanna rd om inseminationer.
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252
Cijts and donations
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m.m. SocialsLyrolsons lroslrilLor och allnanna rd losluLado don J0 novonlor 1989.
SocialsLyrolsons lrlaLLningssanling. SLoclholn: SocialsLyrolson.

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SocialsLyrolsons lroslrilLor losluLado don 14 doconlor 1989. SocialsLyrolsons

SCSS (1990.8) Socialstyrelsens allmanna rd rrande omhandertagande av joster ejter abort.
SocialsLyrolsons allnanna rd losluLado don J1 naj 1990. SocialsLyrolsons lrlaLLningssanling.
SLoclholn: SocialsLyrolson.

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SCSS (199o.?8) Socialstyrelsens jreslrijter och allmanna rd om llinisla obdultioner m.m.
SocialsLyrolsons lroslrilLor och allnanna rd losluLado don 1 doconlor 1996.

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sjulvrden vid ddsjall. SocialsLyrolsons lroslrilLor och allnanna rd losluLado don 1
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transplantation eller jr annat medicinslt andaml. SocialsLyrolsons lroslrilLor och allnanna
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\oLonslalig lodaro: SLuro Allon, vriga nodarloLaro: Asa Alolin. SLoclholn: NorsLodLs.

Svensla alademiens ordlista ver svensla sprlet (1998). 12 ul. SLoclholn: NorsLodLs
ordlol.

Svensla ord med uttal och jrllaringar. ?800 ord (199J}. 2 ul. ILarloLando av
ordlolsLoxLon och Lillaggon Lill andra ulagan. InsLiLuLionon lr srlvoLonslalig
daLalohandling (SrldaLa}, GLolorgs InivorsiLoL: MarLin GollorsLan, KorsLin Noron och
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NorsLodL.

253
Annina H ersson
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\alin, GsLa (199}. Lagen om sluldebrev. gvolagen, rantelagen, deposition, ddning. 2 ul.
SLoclholn: NorsLodLs juridil.

\alin, GsLa (2000}. Kommentar till arvdaballen, Del 1 (117 lap), Arv och testamente. 5
ul. SLoclholn: NorsLodLs juridil

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manslligt biologislt material. SLoclholn: Juridisla lalulLoLon, Iniv.: Juro

Altenslapsball (1987.?J0) (Lho Marriago Codo}

Arvdaball (SS 198.oJ7) (InhoriLanco Codo}

Court cases

NJA (NyLL juridislL arliv. Avd 1.}

NJA 1961 . 105
NJA 194 . J6
NJA 19 . 1
NJA 1986 . 16
NJA 1986 . 402
NJA 1989 . 696
NJA 1990 . 18
NJA 1991 . J6
NJA 199J . 468
NJA 199J . 529
NJA 199J . 560
NJA 1998 . 1J5

254
`~ ~ ~ ~ ~ ~~

NO

Commercial engagement and public research
in the biomedical area
1

r~ _~I iijI p i

Department of Law, Uppsala University.

Anong Lho nany logal asocLs ol Lho lionodical aroa, Lho connorcial onos aro ol
social inLorosL Lo Lhoso ongagod in rosoarch vorl, i.o. Lho scionLisLs, Lho hosiLals
and hosiLal auLhoriLios as voll as Lho univorsiLios, Lho crucial quosLion loing LhaL ol
Lho ossililiLios and liniLs Lo naling a roliL ouL ol Lho scionLilic rosulLs. Tho nov
Svodish Biolanl AcL (2002:29} addrossos Lho rollon, luL a nunlor ol quosLions
ronain unansvorod.
Briolly, naLional as voll as inLornaLional lavs lirnly discounLonanco any
linancial gain ouL ol Lho hunan lody and iLs arLs as such, a connorcial narloL lor
such naLorial is unvanLod lor sovoral roasons, rincial anong Lhon loing hunan
digniLy. Hovovor, naLional as voll as inLornaLional lavs also nalo oxcoLions lor
discardod Lissuos" (ITS 199/164, arL. 21} or ovon lor llood (SocLion 15 ol Lho
Svodish TranslanLs AcL}. Cn Lho oLhor hand, Svodon`s nov Biolanl AcL lays dovn
LhaL Lissuos or arLs ol Lissuos LhaL aro loL in a liolanl undor iLs rovisions nusL
noL lo sold or oLhorviso Lranslorrod lor linancial gain (Cha. 4, SocLion 8}. As Lho
nov AcL rolors Lo Lho oldor TranslanLs AcL vhon iL conos Lo Lho sancLions againsL
illogal conducL, iL ronains uncorLain vhoLhor llood roally is oxcoLod or noL.
Iolining Lho dilloronL hunan naLorials in Lhis conLoxL and also linancial gain" is
Lhoroloro a najor logal Lasl.
In Lhis rocoss iL should lo noLod LhaL Lho Svodish logislaLion also liniLs Lho
aliliLy ol ullic insLiLuLions as such Lo Lalo arL in roliL-naling lusinoss, vhaLovor
Lho conLoxL. As Lho univorsiLios as voll as ullic nodical caro insLiLuLions, hosiLals
oLc. aro nornally arL ol Lho ullic sysLon undor Lhis olligaLion, a lurLhor
inodinonL Lo linancial roliL is nado ovidonL.
IL should also lo noLod LhaL, according Lo Svodish lav, a scionLisL, ovon il ho
or sho is on Lho ayroll ol an univorsiLy, is granLod Lho oxclusivo inLollocLual righL Lo
dovolo Lho invonLion or discovory rosulLing lron his or hor rosoarch-vorl.
An inLorosLing caso is nov onding loloro Lho AdninisLraLivo CourL ol
Aoal in Sundsvall. Tho CourL is oxocLod Lo doal viLh Lho quosLions vhoLhor or
noL Lho \asLorloLLon CounLy Council, as nandaLor ol Lho hosiLal in Lho univorsiLy
Lovn ol Ino in Lho norLh ol Svodon, a} lrolo Lho lasic rohiliLion in Lho Local

1
An Inglish sunnary ol h ~ ~ ,
lorLhconing, 200J

255
r~ _~
GovornnonL AcL ol linancial suorL Lo a rivaLo onLorriso, or ovon l} lrolo Lho
sano AcL`s rohiliLion ol linancial gain in a lody coning undor Lho AcL, Lho CounLy
Council loing such a lody, vhon Lho CounLy Council, as ono ol Lho arLios lorning
a rivaLo onLorriso, Inan Gononics AB (Lho InivorsiLy ol Ino loing ono oLhor
arLy}, granLod Inan Gononics AB a lavourod osiLion lor using Lho hunan
naLorial in a liolanl collocLod aL CounLy Council-run Ino HosiLal. Tho
AdninisLraLivo CourL ol lirsL insLanco in Ino (Ion i LansraLLon i \asLorloLLons
lan 2002-10-04, nl nr 668-02} did noL lind Lho chargos nado ly CounLy rosidonLs
rovod, luL vo aro sLill avaiLing Lho docision ly Lho CourL ol Aoal.

In ny ous I roconnond LhaL

Lho CounLy Council in chargo ol a liolanl loo iL and run iL according Lo Lho
Biolanls AcL and noL shov lavour Lo any usor,

scionLisLs lron all univorsiLios lo givon oqual righLs Lo uso Lho naLorial undor Lho
lav viLhouL gaining any nonooly sLaLus,
Lho rosoarch lo oonly lundod, vhoLhor ly Laxayors` nonoy, socially
oarnarlod, or ly Lho nodical indusLry on a connission lasis,
scionLisL dovolo Lhoir rosulLs lrooly undor Lho lav.

256
Agreements concerning biological material

1J

Agreements concerning human biological material

Urban aulsson, Advocate & Rebecla risl, LLM

Lird & Lird

This article addresses some oj the more critical legal issues that arise in connection uith
the negotiation and drajting oj commercial agreements jor access to and research on
human biological material stored in biobanls. Nou that Sueden has enacted a lau
regulating the handling oj biobanls uithin healthcare organizations, uhich clarijies the
legal situation regarding commercial use oj the biobanl material, it is expected that the
number oj collaborations betueen companies and academia in respect oj the biobanls
uill increase. When negotiating and drajting the collaboration agreements there are a
number oj critical legal issues that need to be considered. The legal issues specijic to
biobanl research collaboration are. (i) the prohibition oj deriving projit jrom handling
donated human biological material, (ii) the requirement oj patient consent to donation oj
material, and (iii) the requirement oj ethics committee approval jor research on human
biological material. These issues and their impact on the ley clauses in a commercial
agreement regarding access to and research on human biological material are discussed in
this article. The ley clauses that are addressed concern. (i) considerations paid under the
agreement, (ii) rights to research material and results, and (iii) the content oj the
research.

1. Background

Iuo Lo Lho raid dovolononL ol lionodical rosoarch and gonoLic onginooring loLh
in Svodon and inLornaLionally, inLorosL in collocLions ol hunan liological naLorial
has dranaLically incroasod during roconL yoars. Ivory day liological naLorial is Lalon
lron hunans in Lho lorn ol socinons lor dilloronL roasons and lor dilloronL
urosos. \aluallo inlornaLion, lor oxanlo rogarding disoaso nochanisns and
gonoLic causos, can Lhon lo oxLracLod lron Lhis liological naLorial. Thoroloro Lho
liological naLorial onallos rosoarch LhaL vas noL ossillo Lo carry ouL loloro,
rosoarch LhaL nighL load Lo nov noLhods ol LroaLnonL and nov drugs. In Lhis vay
Lho liological naLorial also acquiros a connorcial valuo vhich inols rosoarch
conanios Lo onLor inLo agroononLs viLh univorsiLios and counLy councils concorning
accoss Lo hunan liological naLorial in liolanls.

2. General overview agreements and scope of article

By vay ol laclground, iL should lo onhasisod LhaL an agroononL rogarding accoss
Lo liological naLorial is in nany rosocLs no dilloronL lron agroononLs viLhin oLhor
257
Urban aulsson & Rebecla risl
aroas. Tho agroononL is luilL uon Lho rosunLion LhaL Lvo or noro arLios agroo
on a suiLallo lorn ol collaloraLion and lron Lhis Lry Lo roach a roasonallo
disLriluLion ol righLs and olligaLions. Many dilloronL arLios nay onLor inLo
agroononLs rogarding liological naLorial. Tho agroononLs nay lo oral or in vriLing,
shorL-livod or long-Lorn.
In Lhis arLiclo vo vill locus on Lho issuos LhaL vill surlaco vhon a
connorcial onLiLy and a univorsiLy/counLy council aro alouL Lo onLor inLo a vriLLon
agroononL concorning accoss Lo and rosoarch on liological naLorial lron a liolanl.
IL should lo noLod LhaL gonoral conLracLual issuos vill noL lo discussod any lurLhor.
Tyically, loLh univorsiLios and counLy councils nighL lo Lho oLhor arLy Lo Lho
connorcial agroononL, luL lor Lho salo ol sinliciLy vo vill horoalLor only rolor Lo
univorsiLios, ovon Lhough counLy councils nighL also lo involvod.
Tho arLicular rollons viLh agroononLs concorning hunan liological
naLorial in liolanls LhaL vo inLond Lo discuss in Lhis arLiclo aoars in rolaLion Lo a
nunlor ol sLaLuLory rovisions doscrilod lolov, nanoly:

Tho rohiliLion undor Lho TranslanLs AcL (1995:8J1} and Lho Biolanls AcL
(2002:29}, ol doriving roliL lron Lho handling ol donaLod hunan liological
naLorial
Tho rulos ol oLhical aroval.
Tho roquirononL ol aLionL consonL and Lho ollocL ol viLhdraving consonL.

Thoso rovisions and Lhoir ollocLs on Lho conLonL ol Lho agroononL dolino Lho scoo
ol Lhis arLiclo.

2.1 The prohibition of deriving profit
SocLion 15 ol Lho TranslanLs AcL conLains a rohiliLion ol doriving roliLs LhaL
covors handling ol hunan liological naLorial lor roliL urosos. Indor Lho lav iL is
a crininal ollonco Lo Lalo, dolivor, rocoivo or handlo liological naLorial lron a living
or docoasod hunan loing or Lissuo lron an alorLod looLus viLh Lho inLonL ol doriving
roliL. All hunan liological naLorial is includod, viLh Lho oxcoLion ol llood, hair,
noLhor`s nill and LooLh, and Lho rohiliLion is inLondod lor unrocossod liological
naLorial.
Cno inorLanL oxcoLion Lo Lho rohiliLion concorns rolinod or rocossod
hunan liological naLorial LhaL is includod in a roducL, lor oxanlo a drug, and LhaL
loconos an oljocL ol salo or oLhor assignnonL lor a considoraLion. This rocossod
liological naLorial is noL covorod ly Lho rohiliLion.
1

Tho logal acLs LhaL aro covorod ly Lho rohiliLion aro lirsL ol all urchaso or
salo ol Lho naLorial. BuL Lho rohiliLion is gonoral in naLuro and is noL liniLod Lo
corLain arLios or siLuaLions. In Lho travaux roaraLoiros iL is sLaLod LhaL Lho
rohiliLion doos noL havo any liniLaLion concorning Lho uroso ol Lho handling, luL
LhaL a vido lornulaLion vas usod Lo covor all lorns ol Laling, dolivory, rocoiL or
nodiaLion ol liological naLorial lor Lho uroso ol doriving roliL.
2

1
Iro. 1994/95:148 . 88 and Ionoij, HunanliologislL naLorial och vinningslrlud. 2001 .5.
2
Iro. 1994/95:148 . 52, 8 l. Soo Ionoij, HunanliologislL naLorial och vinningslrlud. 2001 .
8 ll.
258
Tho Biolanls AcL, vhich cano inLo lorco on 1 January 200J,
J
rohiliLs Lho gainlul
assignnonL and disLriluLion ol Lissuo socinons sLorod in liolanls.
4
Cha. 4, SocLion
ol Lho sano AcL lays dovn a rulo naling Lho assignnonL ol a liolanl as such
ossillo, vholly or arLly, and locusing on Lho siLuaLion vhoro a liolanl is assignod
rinarily lor, say, organisaLional roasons. To nalo such an assignnonL ossillo,
social circunsLancos aro roquirod and Lho NaLional Svodish Board ol HoalLh and
\ollaro has Lo givo ornission. Hovovor, such assignnonL nay noL lo undorLalon
lor gain.
Tho lacL LhaL Svodish lav rohiliLs Lho handling ol hunan liological
naLorial lor roliL urosos should causo any arLy dosiring Lo onLor inLo an
agroononL concorning LhaL lind ol naLorial Lo carolully considor Lho arLicular
rollons LhaL ariso and Lho inacL on conLracL Lorns, such as Lho sLrucLuro ol
aynonL and cosL calculaLion nodols usod in Lho agroononL. \o vill lo roLurning Lo
Lhoso quosLions rosonLly.

2.2 Ethical approvals
Boloro giving iLs aroval Lo a arLicular rojocL, a rosoarch oLhics conniLLoo shall
oxanino Lho rojocL lron a scionLilic as voll as lron a gonoral oLhical oinL ol viov.
5

Any condiLions inosod ly Lho conniLLoo shall lo ovidonL lron Lho docision.
Tho rosoarch oLhical oxaninaLion rolors Lo Lho scionLilic duraliliLy ol Lho
rojocL and Lho oLhical rollons LhaL Lho rojocL osos. IL also oxaninos Lho
adoquacy ol Lho rocoduros lor collocLing aLionLs` consonL and Lho inlornaLion
rovidod Lo Lho aLionLs. Tho rosoarch oLhics conniLLoos shall nalo a risl/roliL
osLinaLo and in doing so ascorLain LhaL Lho rojocL concorns an ossonLial quosLion
vhich can lo aroriaLoly ansvorod Lhrough Lho roosod rosoarch.
6

Tho oLhics conniLLoos considor alicaLions loloro Lho rosoarch logins, luL
cannoL oxanino Lho orlornanco ol Lho rosoarch as such. Tho scionLisL involvod in
Lho rosoarch is Lhoroloro olligod Lo lollov Lho rojocL doscriLion LhaL has loon givon
aL Lho Lino ol alicaLion and Lo roorL any changos in Lho rojocL as voll as
conlicaLions and nov inlornaLion viLh a loaring on Lho risl assossnonL. Iinally,
Lho scionLisLs havo Lo roorL Lho rosulL ol Lho rojocL. Tho oLhics conniLLoo shall
lurLhor arovo ossillo nodilicaLions ol Lho rojocL loloro Lhoy aro carriod ouL.

IL is also inorLanL Lo noLo LhaL, ursuanL Lo Lho onding logislaLion on
oLhical aroval lor rosoarch, rosoarch LhaL lalls viLhin Lho scoo ol Lho roosod lav
roquiros oLhical aroval in ordor Lo lo ornissillo. To carry ouL such rosoarch
viLhouL Lho rolovanL aroval has loon nado a crininal ollonco. IurLhor, iL is a
condiLion lor aroval undor Lho lav LhaL Lho rosoarch lo carriod ouL or suorvisod
ly an aroriaLoly qualiliod rosoarchor. As has alroady loon shovn, a rosoarch

J
Lag (?00?.?97) om biobanler i halso och sjulvrden (Lho Biolanls AcL}.
4
Cha. 4, SocLion 8 ol Lag (?00?.?97) om biobanler i halso och sjulvrden (Lho Biolanls AcL}.
5
Rosoarch oLhics conniLLoos araiso and judgo rosoarch oLhical quosLions. BoLh Lho gonoral ullic
and Lho rosoarch connuniLy shall lo rorosonLod on such a conniLLoo. Isually Lho conniLLoo is
alliliaLod Lo a univorsiLy or a collogo, or Lo sono oLhor auLhoriLy roninonLly concornod viLh lunding
Lho rosoarch. Soo Cha. 1, SocLion 2 ol Lag (?00?.?97) om biobanler i halso och sjulvrden (Lho
Biolanls AcL}. According Lo Cha. 2 , SocLion J ol Lho Biolanls AcL, a rosoarch oLhics conniLLoo
shall LosL and arovo Lho osLallishnonL ol a liolanl il iL shall lo usod lor Lho uroso ol rosoarch or
clinical LosLing. Soo also Cha. J , SocLion 5 (J}.
6
Iro 2002/0J:50, . 95 ll.
ibid.
259
collaloraLion agroononL viLh a univorsiLy vill nood Lo addross issuos rolaLing Lo Lho
scionLilic orsonnol involvod in Lho rosoarch and nochanisns lor olLaining Lho
roquisiLo aroval.
8
\o vill roLurn Lo Lhis quosLion lolov.

2.3 The patients consent
Biological naLorial nay lo Lalon lron a living hunan loing lor Lho uroso ol
rosoarch only il ho or sho has consonLod. Tho consonL shall lo lrooly givon and can lo
givon oiLhor vorlally or in vriLing. ConsonL onco givon nay aL any Lino lo
viLhdravn. Tho consonL shall lo socilic and cloarly sLaLo Lho rosoarch LhaL is Lo lo
carriod ouL viLh Lho naLorial and, in Lho ovonL ol nov aroas ol uso loing lound lor
Lho naLorial in quosLion, nov consonL shall lo olLainod. Tho rosoarch oLhics
conniLLoo doLorninos Lho roquirononLs LhaL vill lo alicallo lor inlornaLion and
consonL in ordor lor Lho Lissuo socinon Lo lo usod lor Lho nov uroso.
9

IL lollovs lron Lho alovo LhaL Lho rosoarch aroa sociliod in Lho aLionL`s
consonL vill consLiLuLo Lho lrano lor Lho rosoarch LhaL can lo conLracLod. IL is also Lo
lo noLod LhaL a viLhdraval ol consonL only rolaLos Lo Lho donaLod naLorial as such.
Thus, iL doos noL allocL Lho rosoarch rosulLs LhaL havo loon gonoraLod viLh Lho uso ol
Lho naLorial. In LhaL conLoxL, iL ronains Lo drav Lho lino loLvoon Lho liolanl
naLorial and Lho rosoarch rosulLs. \o vill roLurn Lo Lhis lolov.

3. Key clauses

Boloro dralLing an agroononL lor accoss Lo and rosoarch on liolanl naLorial, iL is
inorLanL Lo carolully Lhinl Lhrough all Lho dilloronL issuos LhaL nay ariso loLvoon
Lho arLios in Lho luLuro. Tho noro issuos LhaL aro addrossod lolorohand in Lho
conLracL, Lho noro liloly iL is LhaL Lho co-ooraLion vill vorl ouL. Tho sLaLuLory
rovisions doscrilod lriolly alovo olviously allocL Lho dralLing ol a nunlor ol loy
clausos in Lho agroononL. In Lhis connocLion, vo havo olocLod Lo conlino Lho rosonL
arLiclo Lo discussing Lhoir inacL on Lho conLracL rovisions LhaL aro Lyically Lho loy
clausos lor a connorcial onLiLy. Thoso loy clausos addross:

compensation,
rights to biobank material and research results, and
Lho conLonL ol Lho rosoarch.

3.1 Compensation clauses
Tho arLios nay violaLo Lho alovo doscrilod rohiliLion ol linancial gain vhon
dralLing Lho cononsaLion clausos.
10
A arLy inLonding Lo onLor inLo an agroononL
concorning accoss Lo liolanl naLorial should invosLigaLo Lho lolloving Lvo quosLions
in arLicular:

(i) what is the compensation intended to cover and
(ii) how is the compensation to be calculated?

8
Is 2001:62 ILilrvning av lorslning son avsor nannislor, . 95 ll.
9
Chap. 3 , Sections 1 and 6 of Lag (2002:297) om biobanker i hlso- och sjukvrden (the Biobanks Act).
Prop. 2001/02:44, pp. 24 f, 35 ff.
10
See Chap. 4, Section 8 of Lag (2002:297) om biobanker i hlso- och sjukvrden (the Biobanks Act).
260

To sLarL viLh, ono can osLallish LhaL co-ooraLion loLvoon acadonic and connorcial
onLiLy nay conLain sovoral dilloronL linds ol cononsaLion nochanisns. Tho nosL
lroquonL cononsaLions aro:

(i) compensation for the handling by the universities of the biobank and
distribution of material,
(ii) compensation for contract research carried out by the university scientists on the
biobank material on the companys behalf,
(iii) unrestricted research grants to the university, which may or may not fall due for
payment at agreed milestone events, and
(iv) compensation, primarily royalties, the size of which depends on the commercial
success of the products developed by the commercial entity from the biobank
material.

Boloro going inLo Lhoso quosLions in doLail vo vould lilo Lo noLo Lho liniLod caso lav
in Svodon on Lho suljocL., \iLh Lho oxcoLion ol Lho roconL judgnonL ly Lho counLy
adninisLraLivo courL in \asLorloLLon concorning Inan Gononics AB, caso lav, Lo
Lho losL ol our lnovlodgo, is non-oxisLonL.
11
Addod Lo vhich, Lho docLrino in Lhis
liold is noagro.
12

CononsaLion lor conLracLual rosoarch, iLon (ii} alovo, is noro soldon
rollonaLic. Tho rohiliLion ol roliL is ainod aL aynonLs lor Lranslor ol Lho
liological naLorial.
1J
Tho cononsaLion in iLon (ii) rolors Lo a rosoarch sorvico
suliod ly Lho univorsiLy and noL accoss Lo liological naLorial.
IaynonLs undor iLons (i), (iii) and (iv) alovo nay, hovovor, causo groaLor
rollons, doonding on hov Lho cononsaLion is consLrucLod.
Rogarding cononsaLion lor Lho handling ol liolanls and disLriluLion ol
naLorial, i.o. iLon (i) alovo, Lho rovisions havo Lo lo LransaronL onough lor iL Lo lo
cloar LhaL Lho cononsaLion doos noL conLain any narl-u luL is calculaLod on Lho
lasis ol Lho acLual cosLs ol Lho univorsiLios. In Lhis conLoxL iL is inLorosLing Lo noLo
LhaL viLhin Lho univorsiLy vorld Lhoro is a sLoady Lrond Lovards, as iL is hood,
alandonnonL ol Lho lixod orconLago-lasod loos lor adninisLraLion, ronisos and
oLhor cosLs, LhaL havo so lar has loon aliod Lo oxLornally lundod rosoarch. InsLoad,
nany univorsiLios vanL Lo roach a soluLion vhoro an ovorall rico is aliod vhich
nay includo a roliL olononL. Such a nodol nay lo loss suiLallo Lo aly in
agroononLs concorning liolanl naLorial, sinco Lho ovorall rico quoLod nay voll
oxcood dirocL and indirocL cosLs Lo Lho univorsiLy.
Iroosod vording ol a cononsaLion clauso lor handling ol liolanls is
givon lolov:

The company shall compensate the University jor its costs and expenses as a result oj
storage, handling and administration oj the biobanl. The scope oj the compensation and
other payment terms are shoun in Appendix [ ]. At the same time, the University
conjirms that the compensation paid by the Company jor the uorl oj the University, as
stated above, to no extent comprises any projit to the University."

11
Caso No. 668-02, lansraLLon in \asLorloLLons lan.
12
Ionoij, HunanliologislL naLorial och vinningslrlud. 2001. . J ll.
1J
Cha. 4 , SocLion 8 ol Lag (?00?.?97) om biobanler i halso och sjulvrden (Lho Biolanls AcL}.
Iro. 2001/02:44 . 56 l.
261
\hoLhor or noL rosoarch granLs in agroononLs rogarding accoss Lo liolanls, i.o. iLon
(iii) alovo, aro consisLonL viLh Lho lav vill, Lo a groaL oxLonL, doond on vhoLhor or
noL Lho aynonL is connocLod in any vay viLh Lho handling ol Lho liolanl. Il, lor
insLanco, a conany undorLalos in an agroononL concorning liolanls Lo ay a
rosoarch granL, Lho sizo ol vhich is doondonL on Lho quanLiLy ol liological naLorial
LhaL Lho conany gains accoss Lo, Lhoro is an ovidonL risl ol Lho univorsiLy loing
considorod Lo havo disLriluLod Lho naLorial lor Lho uroso ol gain.
Liloviso, iL should lo dilliculL Lo undorLalo Lo ay a rosoarch granL aL a
corLain raLo lor ovory yoar LhaL Lho liolanl agroononL is in lorco. An oxanlo ol
such a clauso is givon lolov:

or the duration oj this agreement, the Company undertales to support the research oj
the University uithin the area [ ] at a rate oj SK [ ] annually and the University
undertales to allocate the said grant jor such research."

Il on Lho oLhor hand Lho rosoarch granL is aid as a rovard lor succosslul conLracLual
rosoarch carriod ouL ly Lho univorsiLy, vhoro ossilly also inLollocLual roorLy
righLs havo loon Lranslorrod, iL is loss rolallo LhaL Lho rohiliLion ol roliL vill lo
considorod Lo havo loon violaLod. Ivon il Lho liolanl naLorial has nado conLracLual
rosoarch ossillo, Lho connocLion loLvoon Lho Lvo is diluLod. IL is horo rolovanL Lo
noLo Lho oxcoLion sLaLod in Lho TranslanLs AcL concorning rocossod liological
roducLs. Tho diluLod connocLion, coulod viLh Lho lacL LhaL Lho rohiliLion ol
roliLs should as onal logislaLion lo inLorroLod rosLricLivoly, should load Lo Lho
conclusion LhaL Lho lasL nonLionod lorn ol conLriluLion lalls ouLsido Lho rohiliLion
aroa. An oxanlo ol such a clauso is givon lolov:

As a reuard to the University jor successjul contract research, the Company undertales
to support the research oj the University uithin the area [ ] by the amounts set out belou,
to be paid out on the milestone events set out belou, and the University undertales to
allocate the said amounts jor research in the said area.

(i) SK [ ] at the initiation by the Company oj clinical trial in phase lll uith the
jirst product resulting jrom the contractual research,
(ii) SEK [ ] at the grant to the Company of all necessary regulatory approval
required for the commercial sale of products referred in i) above in the first
country or region of either the EU or the U.S.

Iinally Lho quosLion ronains vhoLhor a univorsiLy can agroo Lo cononsaLion lasod
on Lho connorcial succoss ol Lho conany viLh roducLs dovolood lron Lho
liolanl naLorial. In accordanco viLh Lho alovo, vo loliovo Lhis quosLion should lo
ansvorod in Lho nogaLivo il Lho surrondor ol liological naLorial is Lho sun LoLal ol
Lho InivorsiLy`s orlornanco. Tho cononsaLion in LhaL caso cannoL roasonally lo
considorod Lo rolaLo Lo anyLhing luL Lho acLual Lranslor ol liological naLorial.
Cn Lho oLhor hand, il royalLios or nilosLonos aro granLod in roLurn lor
succosslul conLracL rosoarch acconlishod ly Lho univorsiLy, vhoro in nany casos
valuallo inLollocLual roorLy righLs aro also croaLod, Lho rohiliLion ol roliL should
noL roasonally aly. Tho oxcoLion sLaLod in Lho TranslanLs AcL lor liological
roducLs should also lo noLod in Lhis rogard.

262
Summary: the prohibition of profit

Tho rohiliLion ol roliL LargoLs Lranslors ol Lho naLorial lor Lho uroso ol
linancial gain.
Tho agroononL has Lo lo LransaronL, so LhaL dilloronL sorvicos and Lho ricing ol
Lho sano aro cloar.
CononsaLion viLh an olononL ol roliL" should lo ossillo insolar as iL rolaLos
Lo oLhor orlornanco ly Lho univorsiLy Lhan Lho handling and disLriluLion ol
naLorial lron Lho liolanl.
Tho rohiliLion ol roliLs consLiLuLos onal logislaLion and shall Lhoroloro lo
inLorroLod rosLricLivoly.

3.2 Ownership and use of biological material
Tho rollons LhaL a dralLor ol an agroononL is conlronLod viLh concorning roorLy
righLs Lo hunan liological naLorial rosulL lron Lho uncloar logal siLuaLion in
Svodon.
14
Thoro aro lovor uncorLainLios rogarding liological naLorial LhaL
consLiLuLos rosoarch rosulLs, and noL liolanl naLorial. Ior Lhis roason, noL loasL, iL is
suiLallo vhon sLrucLuring an agroononL Lo divido Lho naLorial inLo Lvo caLogorios,
i.o. liolanl naLorial and liological naLorial LhaL consLiLuLo rosoarch rosulLs,
rosocLivoly.

Ixanlos ol such doliniLions aro givon lolov:

_~ ~~ shall mean the donated human biological material that is made
available under this Agreement jor the Research."

o ~~ shall mean the human biological material and other material that
has been created in the Research and uhich is derived jrom the Liobanl material"

Rogarding liolanl naLorial Lho docLrino aoars unaninous in LhaL ovnorshi
cannoL lo usod as a logal concoL. Tho righL ly vhich a univorsiLy or a scionLisL
ossossos a donaLod hunan liological naLorial is raLhor a righL ol disosal, Lho oxLonL
ol vhich is largoly doLorninod ly Lho conLonL ol Lho aLionL`s consonL and Lho oLhical
aroval LhaL has loon givon lor Lho rosoarch on Lho naLorial.
15

Iron a conLracLual oinL ol viov iL is inorLanL Lo onsuro:

(i) LhaL Lho conLonL ol Lho rosoarch LhaL is inLondod Lo lo oxocuLod viLh Lho
donaLod naLorial is voll dolinod in Lho agroononL and LhaL iL is consisLonL
viLh Lho rosoarch LhaL has loon sociliod in Lho oLhical aroval and
aLionL`s consonL, rosocLivoly,
(ii) LhaL Lho loy scionLisLs vho aro Lo carry ouL Lho rosoarch in quosLion aro
sociliod in Lho agroononL and LhaL Lho same scionLisLs havo loon sociliod
in Lho oLhical alicaLion,

14
Soo, lor oxanlo, \osLorlund/Iorsson, CivilraLLsliga rollolLionor anvandningon av nanslligL
liologislL naLorial. 2000 . 2J ll, J2, 62. Iro. 2001/02:44 . 25 l.
15
\osLorlund/Iorsson, CivilraLLsliga rollolLionor anvandningon av nanslligL liologislL naLorial.
2000 . 2J ll.
263
(iii) LhaL iL is cloar lron Lho agroononL vhoLhor Lho donaLod naLorial is
surrondorod Lo scionLisLs in codod lorn, vhich nalos iL roLracoallo, or in
an un-idonLiliod lorn LhaL doos noL nalo iL Lracoallo lacl Lo a donor.

Tho oxLonL ol Lho righL ol disosal ol Lho liolanl naLorial is allocLod ly vhaL has
loon agrood concorning:

(i) vhoLhor Lho liolanl naLorial is Lo lo surrondorod in codod or an un-
idonLiliod lorn and
(ii) Lho consoquoncos ol a viLhdraval ol aLionL`s consonL, alying only Lo
codod naLorial

IL is cloar lron Cha. 4, SocLion 4 ol Lho Biolanls AcL LhaL Lho liolanl naLorial,
vhon surrondorod Lo scionLisLs, shall lo in oiLhor codod or un-idonLiliod lorn. Ior
Lissuo socinon in a liolanl Lo lo covorod ly Lho Biolanls AcL Lho naLorial nusL
lo Lracoallo lacl Lo Lho donor. ConsoquonLly, Lho AcL vill noL covor un-idonLiliod
naLorial. IL should lo noLod LhaL a donor has an unrosLricLod righL Lo, aL any Lino,
viLhdrav consonL. \iLhdraval ol consonL shall load Lo dosLrucLion ol Lho Lissuo
socinon LhaL has loon donaLod lor rosoarch. \hon consonL is viLhdravn, iL nay lo
docidod LhaL Lho Lissuo socinon, insLoad ol loing dosLroyod, shall lo un-idonLiliod,
vhorouon Lho Biolanls AcL coasos Lo lo alicallo. IL is inorLanL Lo olsorvo LhaL
Lho viLhdraval ol consonL doos noL includo Lho rosulL ol Lho rosoarch on Lho
naLorial. Thus, aroriaLo vording is inorLanL in Lhis conLoxL, and Lho vording
nusL lo adaLod Lo Lho nood lor disosal, also in Lho ovonL ol Lho donor viLhdraving
consonL. IilloronL vordings ol Lho conLracL and ol aLionLs` consonL can lo usod Lo
rogulaLo Lho scoo ol Lho righL ol disosal.

Concorning Lho liological naLorial LhaL consLiLuLos rosoarch rosulLs lron Lho uso ol
Lho liolanl naLorial, dolinod as RosulLing MaLorial" alovo, a nunlor ol quosLions
nood Lo lo considorod in Lho conLracL, lor oxanlo:

(i) hov Lo drav Lho lino loLvoon Lho liolanl naLorial and Lho naLorial
consLiLuLing rosoarch rosulLs, and
(ii) hov Lo allocaLo Lho righLs Lo Lho liological naLorial consLiLuLing rosoarch
rosulLs.

IirsLly, as rogards iLon (i), Lho dolaLod onlryonic sLon coll rosoarch nay sorvo as an
oxanlo. Tho sLon colls, vhich aro Lho adaLallo rinordial colls ol Lho lody, can
lo isolaLod lron a donaLod onlryo. Thon, ly alying a nunlor ol Lochniquos,
nodia and Lools, Lhoso isolaLod colls can lo nado Lo divido Lhonsolvos viLhouL
changing characLor. AL Lhis oinL a sLon coll lino is considorod Lo lo osLallishod.
Tho quosLion Lhon is aL vhaL oinL in Lhis rocoss sLon colls aro Lranslornod
lron donaLod naLorial Lo a rosoarch rosulL. Tho ansvor Lo Lhis quosLion vill docido
vhich righLs can lo olLainod Lhrough an agroononL lor Lho rosocLivo naLorial. In
our oinion, Lho LransiLion lron donaLod naLorial Lo rosoarch rosulL Lalos laco vhon
Lho onlryonic sLon colls havo loon isolaLod and nado Lo nulLily ouLsido Lho
onlryo. IL is vorLh noLing LhaL noiLhor Lho Biolanls AcL or iLs travaux preparatoires
lurnish any guidanco on Lhoso quosLions, loyond saying LhaL Lho liolanl naLorial
264
doos noL includo rosoarch rosulLs.

Hovovor, iL aoars lron Lho travaux preparatoires
ol Lho TranslanLs AcL LhaL a corLain lovol ol rocossing ol Lho liological naLorial is
nocossary in ordor lor Lho naLorial Lo consLiLuLo a roducL and Lhus lo oxcoLod
lron Lho AcL`s rohiliLion ol roliL. A sinilar viov is sLaLod ly Lho IMIA
(Iurooan Agoncy lor Lho IvaluaLion ol Modical IroducLs}, in Lhoir
roconnondaLions lor a doliniLion ol a hunan sonaLic coll Lhoray roducL.
16

Thoro aro sono lairly conlicaLod quosLions LhaL Lho auLhor ol Lho
agroononL noods Lo considor, noL loasL vhon Lho conLracL doals viLh naLorial LhaL
nulLilios Lhrough coll division.
\hon Lho donarcaLion is nado in Lho agroononL, vhich ol courso
rosuosos doLailod discussions viLh scionLilically iniLiaLod orsons, Lho arLios can
agroo on Lho righLs Lo Lho rosulLing rosoarch naLorial. As lar as vo undorsLand, Lho
sano rulos aly lor liological rosoarch naLorial as lor oLhor, noro LradiLional,
rosoarch rosulLs, i.o. Lhoy can lo ossossod viLh lull roorLy righLs lor Lho
rorioLor.
Hovovor, vhoLhor such a roorLy righL iniLially lolongs Lo Lho univorsiLy
or Lho univorsiLy scionLisLs vho havo croaLod Lho rosulL, in our oxanlo alovo Lho
sLon coll lino, is a soaraLo quosLion. Insolar as aLonLallo invonLions, and noL
Langillo rosulLs, aro concornod, iL lollovs lron Svodish lav LhaL Lho aLonLallo
invonLion is ovnod ly Lho univorsiLy scionLisLs.
1

\hon iL conos Lo Lho acLual Langillo rosulL, Lho issuo is noL rogulaLod in
Svodish lav. Tho quosLion ol Lho righL Lo liological rosoarch naLorial has loon
oxaninod ly a Norvogian disLricL courL.
18
Tho caso concornod a disuLo loLvoon
Lvo hosiLals alouL Lho righL ol disosal ol rosoarch naLorial, anong oLhor Lhings in
Lho lorn ol llood LosLs, INA oxLracLs and orsonal inlornaLion rolaLing Lo Lho
socinon. Tho courL osLallishod LhaL in Lho alsonco ol dirocLly alicallo rulos, an
ovorall assossnonL had Lo lo nado ol Lho circunsLancos in Lho caso. Tho sLarLing
oinL ol Lho courL`s assossnonL vas Lho aLionL inLorosL.
Sinco Lho courL lound LhaL Lho aLionL inLorosL, as iL had loon oxrossod in
Lho consonL, vas Lo lo saLisliod rogardloss ol vho had Lho righL Lo Lho naLorial, Lho
quosLion vas docidod ly lalancing Lho inLorosLs ol Lho arLios. In Lhis lalancing ol
inLorosLs, Lho courL lound LhaL Lho dogroo ol connocLion ol oach arLy Lo Lho rojocL
and Lho disuLod naLorial vould lo docisivo and iL rulod in Lho lavour ol Lho
scionLisL. In iLs judgnonL Lho courL considorod anong oLhor Lhings vho had nanagod
Lho linancing ol Lho rojocL and Lho conLacL viLh Lhird arLios vho suliod and
conLrollod rosourcos lor Lho rojocL as voll as Lho inLonLions ol Lho arLios.
Sinco iL soon Lo lo uncloar in Svodish lav vhoLhor liological rosoarch
rosulLs iniLially lolong Lo Lho scionLisL or Lo Lho univorsiLy, our advico Lo an ouLsido
conLracLing arLy, lor oxanlo a conany, is Lo onsuro LhaL ovnorshi is assignod ly
loLh Lho univorsiLy and Lho scionLisL.

16
IoinLs Lo considor on nanulacLuro and qualiLy conLrol ol hunan sonaLic coll Lhoray nodicinal
roducLs. AdoLod ly Lho conniLLoo lor IrorioLary Modicinal IroducLs (CIMI}, May 2001, . J.
1
Soo SocLion 1 (2} ol Lag (1949.J4) om ratten till arbetstagares uppjinningar (Lho Inloyoos`
InvonLions (InLiLlononL} AcL}.
18
Aslor and Baorun HorrodsroLL, NordislL InnaLoriollL RaLLsslydd (NIR}. 2000, . 688.
265
Summary: ownership and right of use
IilloronL rulos aly, rosocLivoly, Lo liolanl naLorial and liological naLorial
consLiLuLing rosoarch naLorial.

Iso carolul doliniLions in Lho agroononL Lo drav Lho lino loLvoon Lhoso
caLogorios ol liological naLorial.
Sinco iL is uncorLain in Svodish lav vhoLhor liological rosoarch rosulLs lolong Lo
Lho univorsiLy or Lho scionLisL, an ouLsido arLy should socuro righLs lron loLh.

3.3 The research content
As rogards Lho conLonL and orlornanco ol Lho rosoarch, Lho aLionL`s consonL and
oLhical aroval consLiLuLo Lvo liniLing lacLors. In an agroononL rogarding accoss Lo
and rosoarch on liolanl naLorial, Lhoroloro, Lho conLonL ol Lho rosoarch lan, vhich
is nornally aLLachod Lo Lho agroononL, nusL lully corrosond Lo Lho aLionL`s
consonL and Lho oLhical aroval. Sinco Lho uroso ol Lho Biolanls AcL is Lo roLocL
Lho inLorosLs ol aLionLs and noL loasL Lho aLionLs` inLogriLy, vo roconnond LhaL Lho
aLionL inlornaLion cloarly sLaLo vhaL can lo oxocLod in Lorns ol rosulLs and Lhoir
oLonLial uso in Lho luLuro.

Tho lolloving should also lo rogulaLod in Lho agroononL:

(i) vhich aroriaLoly qualiliod univorsiLy rosoarchor is Lo carry ouL or
suorviso Lho rosoarch,
(ii) vho is rosonsillo lor olLaining nov oLhical arovals and aLionL
consonLs as a rosulL ol changos in Lho conLonL ol Lho rosoarch,
(iii) Lho consoquoncos ol non-conlorniLy loLvoon Lho arovod sociliod
rosoarch and Lho rosoarch acLually carriod ouL, and consoquoncos il no
aroriaLoly qualiliod rosoarchor is availallo Lo carry ouL or suorviso Lho
rosoarch.

Also concorning Lho conLonL and oxocuLion ol Lho rosoarch, iL is inorLanL Lo
disLinguish cloarly loLvoon Lho liolanl naLorials on Lho ono hand and Lho liological
rosoarch rosulLs on Lho oLhor. Tho liniLaLions LhaL lollov lron Lho oLhical aroval
and Lho aLionL consonL aro Lyically rolaLod Lo Lho donaLod naLorial and noL Lho
rosoarch rosulLs. IurLhor rosoarch on Lho hunan liological naLorial LhaL consLiLuLo
rosoarch rosulLs nighL donand nov oLhical arovals, luL LhaL is a dilloronL issuo.

Sunnary: the research content
Tho oLhical aroval and Lho aLionL consonL consLiLuLo Lho lranovorl lor Lho
rosoarch LhaL Lho agroononL nay covor.
Tho aroriaLoly qualiliod rosoarchor conducLing or suorvising Lho rosoarch
should lo idonLiliod in Lho agroononL.
RosonsililiLy lor olLaining nov oLhical arovals and/or aLionL consonLs in Lho
ovonL ol changod rosoarch and rosonsililiLy lor onsuring LhaL an aroriaLoly
qualiliod rosoarchor is availallo Lo carry ouL or suorviso Lho rosoarch, nood Lo lo
rogulaLod in Lho agroononL.

266
4. Conclusion

Tho onacLnonL ol Lho Svodish Biolanls AcL has holod Lo clarily sono ol Lho
roviously uncloar logal issuos LhaL Lho conLracLing arLios nood Lo considor vhon
onLoring inLo an agroononL lor accoss Lo and rosoarch on donaLod hunan liological
naLorial sLorod in a liolanl hold ly a hoalLh caro organisaLion. In arLicular, loy
clausos doaling viLh i} righLs ol uso and LiLlo Lo Langillo rosoarch rosulLs, and ii} Lho
sLrucLuro ol aynonLs undor Lho agroononL, nay nov lo dralLod viLh a highor
dogroo ol logal corLainLy Lhan in Lho asL.

267
References

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<vvv.onoa.ou.inL/dll/hunan/lv/4145098on.dl>

Ionoij, BongL (2001}. Humanbiologislt material och vinningsjrbud, Juridisl LidslrilL 2000-
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roposition ?00?/0J.0, tilprvning av jorslning. SLoclholn

Lag (?00?.?97) om biobanler i halso och sjulvrden (Lho Biolanls AcL}

Lag (199.8J1) om transplantationer och obdultioner m.m. (Lho TranslanLs AcL}

Lund, AsLri M. (2000}. lmmaterialretten og jorslningen ved universiteter og hoysloler, NordislL
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Regeringen proposition 1994/9.148. Transplantationer och obdultioner m.m. (1995}
SLoclholn

Regeringens proposition ?001/0?.44. Liobanler inom halso och sjulvrden m.m. (2001}
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\osLorlund, Li, Iorsson, Annina H. (2000}. Civilrattsliga rejleltioner p anvandningen av
manslligt biologislt material. SLoclholn: Juridisla lalulLoLon, Iniv.:Juro

Court cases

Ml nr 668-02, (2002-10-04} lansraLLon i \asLorloLLons lan

268
m~ ~ ~

NQ

Publications and activities

1. Project Reports

Hansson, M.G. (od.}, q r e~ _~K b~I p~I b~ ~
i~ ^. RoorL I, Isala InivorsiLy, 2001, ISBN 91-506-142-X, including:
~K Jonsson, L., Landogron, I., SLoring and Ising Biolanls lor Rosoarch, . 1-8.
K SundsLrn, C., Tho Biolanl Rosourcos in AnaLonical IaLhology, . 9-14.
K Laago-Hollnan, J., Tho IndusLrial Iso ol Biolanls in Svodon: an Cvorvoiv, .
15-J4.
K Hansson, M.G., In Lho InLorosLs ol Illicioncy and InLogriLy, . J5-40.
K Irilsson, S., Inlornod ConsonL and Biolanls, . 41-52.
K Lundlorg, L., KoLLis Lindllad, A., Inirical Rosoarch on Inlornod ConsonL and
Biolanls, . 5J-54.
K RondLorll, Iahl, J., Biolanls and Lho RighLs Lo Lho Hunan Body, . 55-60.
K \osLorlund, L., Iorsson, A.H., Civil Lav RollocLions on Lho Iso ol Hunan
Biological MaLorial, . 61-82.
K Ionoij, B., IrohiliLions AgainsL Lho Translor ol Hunan Tissuo lor IroliL, . 8J-
86.
K Rynning, I., Tho Iso ol Hunan Biolanls - Iullic Lav AsocLs, . 8-9J.

Hansson, M.G. & Lovin, M (ods.}, _~ ~ o e~. Isala
InivorsiLy, 200J, ISBN 91-506-1659-6, including:
~K Hansson, M.G., & Lovin, M., Biolanls as rosourcos lor holLh, 9-20
K Lindlorg, B., Clinical daLa a nocossary roquirononL lor roalising Lho oLonLial ol
liolanls, . 21-J2
K Kaijsor, M., Ixanlos lron Svodish Biolanl Rosoarch, . JJ-50
K Laago-Hollnan, J., Clinical Gononics Conanios and Biolanls Tho uso ol
liosanlos in connorcial rosoarch on Lho gonoLics ol connon disoasos
K Rynning, I., Iullic lav asocLs ol Lho uso ol liolanl sanlos Irivacy vorsus
inLorosLs ol rosoarch, . 51-90
K von Isson, I., Iocusing on orsonal inLogriLy violaLion logal guidolinos lor
oLhical racLico, . 129-148
K Holgosson, G., A Svodish SLandard lor InlornaLion and ConsonL Irocoduros in
Biolanl Rosoarch, . 149-164
K Irilsson, S., Maing Lho dolaLo on inlornod consonL, . 165-192
K KoLLis Lindllad, A., Ring, L, Iullic and aLionL orcoLion ol liolanls and
inlornod consonL, . 19-206
269
_~ ~ o e~
K HollsLadius, A., \ossnan, R., \oll, S., InLollocLual roorLy and liolanls, .
20-226
K Iorsson, A. H., GilLs & donaLions, . 22-254
K Bjrlnan, I., Connorcial ongagononL and ullic rosoarch in Lho lionodical
aroa, . 255-256
K Iaulsson, I., Irisl, R., AgroononLs concorning hunan liological naLorial, .
25-268
K IullicaLions & acLiviLios, 269-26

2. Scientific publications

Ionoij, B., HunanliologislL naLorial och vinningslrlud, Juridisl TidslrilL, Argng
12, 2000-01, Nr. 4, . J-89.
von Isson, I., ILilrvning av liolanls- och rogisLorlorslning, IrvalLningsraLLslig
LidslrilL 2002, nr 5-6, . J51-J80
Hansson, M.G., 2000, InLornaLional AsocLs: NaLional Irolilos, Scandinavia, in:
Murray, T.J., & Molhan, M.J., (ods.}, Incycloodia ol ILhical, Logal and Iolicy
Issuos in BioLochnology, John \iloy & Sons, Inc., .J1-J8.
Laago-Hollnan, J., Konnorsialisoring av svonsla liolanlor: oLL naringsoliLislL
orsolLiv, (2001}, IMIT-RaorL 2001:121, InsLiLuLo lor ManagononL ol
InnovaLion and Tochnology, SLoclholn.
Landogron I, GonLolnologior och liolanlor lrllarar sjuldonsnolanisnor.
Synosiolidrag vid lalarsLannan 2000. GonoLisl oulaLions scrooning:" IdiLor
Tho-Hung Bui T.H,. i~ 1T: 1920-1921 (2002}.

Iorsson, A.H., Cn Gva och donaLion, ISBN 91-22J-159-9, 2002.
Iorsson A.H. & \osLorlund, L., CivilraLLsliga rollolLionor anvandningon av
nanslligL liologislL naLorial, ISBN 91-22J-086-X, 2000.
Rynning, I., GonLolnilons anvandning nannisla raLLsliga asolLor nod sarslild
inrilLning Svorigo och vriga Nordon, lilaga 5 Lill BioLolnillonniLLons
sluLloLanlando ALL sranga gransor (SCI 2001:10J} . 405-468.
Rynning, I., Tho Nov Svodish AcL on Biolanls in HoalLh Caro Irivacy \orsus
Iroodon ol Rosoarch RovisiLod, Bool ol Irocoodings II, 14Lh \orld Congross on
Modical Lav, MICC MaasLrichL 10-15 AugusL 2002, . 2J0-2J5.

2.1. Forthcoming scientific publications
Bjrlnan, I., Konnorsioll vorlsanhoL inon lionodonrdoL och don ollonLliga
lorslningon, 200J.
Irilsson, S., Biolanlor och lorslning lr nyLL andanl, 200J.
Irilsson, S., Should rosoarch rosulLs lo roLurnod Lo Lho donors and Lhoir noxL-ol-lin
200J.
Irilsson, S., InlornoraL sanLyclo och liolanlor: Cn rislon lr slada, 200J.
270
m~ ~ ~
Irilsson, S., Modols ol Inlornod ConsonL and Rosoarch on Biologial MaLorial, 200J.
Hansson, M.G., ALL rosolLora nannislor son noralislL och oliLislL nyndiga
Cn inLogriLoL son oLislL logro nod Lillanning nodicinsl lorslning, ^~K
^~~ o~ p~ r~I IorLhconing 200J.
Hansson, M.G., Conlining ollicioncy and concorns alouL inLogriLy vhon using
hunan liolanls, sulniLLod.
HollsLadius, Asa, Biolanlon och innaLorialraLLon, 200J.
Laago-Hollnan, J., ConnorcialisaLion ol liolanls: a sLudy ol lioLoch conanios
dodicaLod Lo hunan gonoLics, 200J.
Iaulsson, I., AvLalsrolaLorado rollon i sanland nod lalonodolslroLags Lillgng
Lill liolanlor, 200J.
Ring, L., KoLLis Lindllad, A., Iullic and IaLionL ALLiLudos Lo Biolanls and Inlornod
ConsonL 200J.
Rynning, I., Biolanling in Lho Nordic counLrios conaraLivo logal asocLs, 200J
Rynning, I., Ion nya liolanlslagon lrLjansLor och LilllorLalonnandon, 200J
\ossnan, Richard, Biolanlon, narlnadon och raLLon, 200J.
\oll, Sanna, Biolanlor Iorslarons ollor Annans, 200J.

3. Popular science/reviews
Hansson, M.G., oL al, Cvordrivon hansyn Lill rovgivaro, IN-IolaLL, Iagons
NyhoLor 2001-09-0J.
Laago-Hollnan, J., Hunana liolanlor on uLvocllingsrosurs lr svonsl indusLri
(2001}, ManagononL ol Tochnology, Nunnor J, olLolor.
Laago-Hollnan, J., 2002, Anvandning av liolanlor lr lonnorsioll lorslning" (Iso
ol liolanls lor connorcial rosoarch}. In: Biolanlor: BoslyLLolso al hunangonoLisl
naLorialo", TolnologirdoLs raorLor 2002/14, Coonhagon, .112-11.
Rynning, I., Rogloring av liolanlorna \on angr liolanlsvorlsanhoLon In:
_~ _ ~ ~ ~~K TolnologirdoLs raorL
2002/14, Coonhagon 141-144
Rynning, I., Ion nya lagon on liolanlor inon halsooch sjulvrdon. Modlonsllad
lr Svonsl Iidoniologisl Ironing (S\II} nr 1, Aril 2002 . 2-4
\olin, S. & Rynning, I., Nya liolanllagon: rogloringon olullsLandig och dolvis ollar
Ialsla llLon on anonyniLoL. a~ No 19, -8 CcLolor 2002.

4. Conference and seminar contributions

AnvroL, M., Guldgruva ollor huvudvarl \illon nyLLa har lalonodolsindusLrin av
liolanlorna \illon loLydolso har doL aLL lagon inLo gallor rivaLa liolanlor
LocLuro on Lho courso onLiLlod Biolanlslagon", March 20-21, 200J, Isala.
KurssolroLariaLoL, Isala InivorsiLy

271
_~ ~ o e~
Irilsson, S., ILisla roglor lr liloanlor. LocLuro on Lho courso onLiLlod
Biolanlslagon", March 20-21, 200J, Isala. KurssolroLariaLoL, Isala
InivorsiLy.

Irilsson, S., Tho Iso ol Hunan Biolanls, LocLuro aL SSI-lundod rosoarch school lor
IhI sLudonLs in collular counnunicaLion, AugusL 19, 2002.

Irilsson, S., IovolononL ol and chairnan lor Lho onLiLlod Biolanlslagon",
March 20-21, 200J, Isala. KurssolroLariaLoL, Isala InivorsiLy.

von Isson, I., Ion nya liolanlslagon., lagons innohll och anvandning. LocLuro on
Lho courso onLiLlod Biolanlslagon", March 20-21, 200J, Isala. KurssolroLariaLoL,
Isala InivorsiLy.

Hansson, M.G., Annual nooLing ol Lho Svodish Cncology AssociaLion, in Jnling
March 24, 2000.

Hansson, MG., Soninar lor Grou loadors aL Anorshan Iharnacia BioLoch,
Isala, Juno 8, 2000.

Hansson, M.G., LocLuro on liolanls and oLhics aL Lho Scandinavian HoalLhcaro
AuLhoriLios Congross, Royljavil, Icoland, AugusL J1 SoLonlor 1, 2000.

Hansson, M.G., Soninar aL Linling InivorsiLy, CcLolor 4, 2000.

Hansson, M.G., LocLuro on gonoLic rosoarch and liolanls, BioLochnology Trado
Shov and IharnacouLical Congross, SLoclholn InLornaLional Iairs, Alvsj, CcLolor
9, 2000.

Hansson, M.G., LocLuro on Lho oLhics ol liolanl rosoarch, InivorsiLy ol NovcasLlo,
IK, Novonlor 22, 2000.

Hansson, M.G., LocLuro on Lho gonoLics ol INA-LosLing and liolanls, Anic Inc.,
Isala, January 1, 2001.

Hansson, M.G., Soninar on gono Lochnology and liolanling, \idondus AB,
SLoclholn, January 26, 2001.

Hansson, M.G., LocLuro on oLhical asocLs ol liolanling, Linling InivorsiLy,
Aril 2J, 2001.

Hansson, M.G., Soninar viLh scionLisLs on Lho uso ol liolanls, Isala InivorsiLy,
May 16, 2001.

Hansson, M.G., LocLuro on Lho oLhics ol liorLochnology, Tho IoundaLion lor
Tochnology Translor, SLoclholn, Juno 12, 2001.

272
m~ ~ ~
Hansson, M.G., LocLuro on Iharnacogononics, liolanls and oLhics, Svodish
IharnacouLical SocioLy, SLoclholn, AugusL 22, 2001.

Hansson, M.G., LocLuro on oLhical and logal asocLs ol liolanling, MooLing viLh all
scionLisLs aL Lho IoL. ol Modicino, Isala InivorsiLy, SlollosLor, AugusL J0,
2001.

Hansson, M.G., LocLuro on Lho oLhics ol sLon coll rosoarch, Huddingo InivorsiLy
HosiLal, SoLonlor 19, 2001.

Hansson, M.G., LocLuro on oLhical and logal asocLs ol liolanling, Tho IodoraLion
ol CounLy Councils, SLoclholn, SoLonlor 28, 2001.

Hansson, M.G., Soninar rogarding oLhical roviov ol liolanl rosoarch, Isala
Rosoarch ILhics ConniLLoo, CcLolor 1, 2001.

Hansson, M.G., Soninar on liolanling, \allonlorg ConsorLiun NorLh, Isala,
Novonlor 9, 2001.

Hansson, M.G., Soninar on oLhical and logal asocLs ol liolanling, IxocuLivo
IirocLors, Isala InivorsiLy HosiLal, January 10, 2002.

Hansson, M.G., Soninar lor Lho IarlianonLary SLanding ConniLLoo on Social
Allairs concorning Lho GovornnonL`s Biolanls Bill, Lho Rilsdag (Svodish
IarlianonL}, January 29, 2002.

Hansson, M.G., LocLuro on Gon-ILhics and liolanls, SLudonLs in nolocular liology,
BMC, Isala InivorsiLy, Iolruary 2, 2002.

Hansson, M.G., LocLuro on inLogriLy, Lho Royal Acadony ol ArLs and Scioncos ol
Isala, March 6, 2002.

Hansson, M.G., Soninar on liolanling, SvoGono & \allonlorg ConsorLiun NorLh,
SigLuna, May 29, 2001.

Hansson, M.G., Conloronco viLh a sossion on liolanling arrangod ly Lho \ollcono
TrusL, Yorl, IK, July J1 AugusL J, 2002.

Hansson, M.G., InLornaLional vorlsho on liolanling aL Isala InivorsiLy,
SoLonlor 12-1J, 2002.

Hansson, M.G., Soninar lor Clinic SuorinLondonLs aL Isala InivorsiLy HosiLal,
SoLonlor, 25, 2002.

Hansson, M.G., Soninar on liolanling, SvoGono & \allonlorg ConsorLiun NorLh,
SsLaholn, CcLolor 1, 2002.

273
_~ ~ o e~
Hansson, M.G., Soninar on Lho oLhical and logal issuos ol liolanling, SLoclholn
CounLy Council, CcLolor 8, 2002.

Hansson, M.G., SLig \ahlqvisL Synosiun, SalLsjladon, Novonlor 4-5, 2002.

Hansson, M.G., LocLuro on Lho oLhics ol liolanl rosoarch, BiooLhics Soninar aL
Iudan InivorsiLy, Shanghai, Novonlor 15, 2002.

Hansson, M.G., LocLuro on Lho oLhics ol liolanl rosoarch lor nodical sLudonLs,
Ioling Inion Modical Collogo, Boijing, Novonlor 19, 2002.

Hansson, M.G., Soninar on oLhical and logal issuos rolaLod Lo liolanl rosoarch,
AsLraZonoca, SdorLaljo, January 1, 200J.

Hansson, M.G., Soninar on liolanling, Tho IodoraLion ol CounLy Councils,
SLoclholn, January J1, 200J.

HollsLadius, A., \ossnan, R., \oll, S., In lr alla alla lr on Cn lorslaron,
lroLagoL, sjulhusoL och liolanlon. Irgor on lonlurrons, uhovs- och arloLsraLL.
LocLuro on Lho courso onLiLlod Biolanlslagon", March 20-21, 200J, Isala.
KurssolroLariaLoL, Isala InivorsiLy.

HollsLadius, A, LocLuro on coyrighL roLocLion ol liolanls. \JS conloronco
IhovsraLL, varunarlo, aLonL 2002. 1 Ioconlor 2002, Norra LaLin, SLoclholn.

Laago-Hollnan, J., Hring on liolanlor (Hoaring on Biolanls} organisod ly
TolnologirdoL in associaLion viLh IoL ILislo Rd lor IolloLingoLs Sundhodsudvalg,
IorslingsuLvalg og IdvalgoL vodr. doL oLislo Rd, Coonhagon 2/10 2002

Laago-Hollnan, J. & Hansson, M.G., Tho uso ol liolanls in rosoarch, Chalnors
Bioscionco \orlsho May 10, 2001.

Laago-Hollnan, Jons, Modicon \alloy Bio-Conloronco 19 SoLonlor 2001. Sossion
on ILhics and Modical BioLochnology: TiLlo: ConnorcialisaLion ol liolanls Lhrough
dodicaLod gononics conanios.

Lindlorg, B., LocLuro, IonsionarsunivorsiLoLoL, Biolanlor son Halsorosurs, Isala
11 Iolruary 200J.

Iaulsson, I., Tillgng Lill rovorna. Cn avLal lr indusLrin. LocLuro on Lho courso
onLiLlod Biolanlslagon", March 20-21, 200J, Isala. KurssolroLariaLoL, Isala
InivorsiLy.

Iorsson, A. H., \on agor rovoL on agandoraLLon Lill rovorna. LocLuro on Lho
courso onLiLlod Biolanlslagon", March 20-21, 200J, Isala. KurssolroLariaLoL,
Isala InivorsiLy.

274
m~ ~ ~
Ring L. &KoLLis Lindllad A., Inirical rosoarch on inlornod consonL and liolanls.
IASST 2002 (Iurooan AssociaLion lor Lho sLudy ol scionco and Lochnology}. Yorl,
J1sL July-Jrd Aug. 2002.

Rynning, I., Hoaring on liolanls, arrangod ly Lho Svodish Rosoarch Council, Lho
MinisLry ol IducaLion and Lho MinisLry ol HoalLh and Social Allairs, SLoclholn,
Aril 20, 2001.

Rynning, I., LocLuro on lorLhconing logislaLion on liolanling and rosoarch oLhics
roviov, Logal IoarLnonL ol Lho InivorsiLy AdninisLraLion, Isala InivorsiLy,
Novonlor 29, 2001.

Rynning, I., Synosiun on liolanls and hoalLh daLa rosoarch, LalarsLannan,
SLoclholn, Novonlor J0, 2001.

Rynning, I., LocLuro on Lho nov Svodish Biolanls AcL, BioLoch Iorun, SLoclholn,
Novonlor J0, 2001.

Rynning, I., LocLuro on lorLhconing logislaLion on liolanling and rosoarch oLhics
roviov, Rosoarch oLhics conniLLoo ol Lho IaculLy ol Modicino, Isala InivorsiLy,
Ioconlor 12, 2001.

Rynning, I., LocLuro on Lho Nov Svodish Biolanls (HoalLh Caro} AcL Irivacy
\orsus Iroodon ol Rosoarch RovisiLod, 14
Lh
\orld Congross on Modical Lav,
MaasLrichL, AugusL 14, 2002.

Rynning, I., LocLuro on lorLhconing logislaLion on liolanling and oLhor logal
asocLs ol rosoarch oLhics roviov, Rosoarch ILhics ConniLLoo ol Lho IaculLy ol
Modicino, Isala InivorsiLy, SoLonlor 9, 2002.

Rynning, I., LocLuro concorning logal issuos on liolanling rivacy vorsus lroodon
ol rosoarch and roorLy righLs, InLornaLional vorlsho on liolanling, Isala
InivorsiLy, SoLonlor 1J, 2002.

Rynning, I., Soninar on sLon coll rosoarch, arrangod ly Lho Svodish Rosoarch
Council, Lho Bool and Lilrary Iair (_J ~}, GoLhonlurg,
SoLonlor 20, 2002.

Rynning, I., LocLuro on Svodish logislaLion lor sLon coll rosoarch, InLornaLional
conloronco on Lho connorcializaLion ol sLon coll rosoarch, London, SoLonlor 24,
2002.

Rynning, I., Hoaring on liolanls, Lho Ianish IarlianonL (q ~~
a b o c p~I c~ r~ K

o}, Coonhagon, CcLolor 2, 2002.

275
_~ ~ o e~
Rynning, I., LocLuro on Lho roLocLion ol inLogriLy and Lho inLorosLs ol rosoarch
viLh rogard Lo Lho nov liolanl logislaLion, Synosiun on liolanls, Ino
InivorsiLy, Ioconlor 1, 2002.

SundsLrn, C., Biolanlor i don llinisla vardagon. Hur anvands liolanlor i llinisl
vorlsanhoL \illa svrighoLor sLallor don nya lagon llinilorn inlr LocLuro on Lho
courso onLiLlod Biolanlslagon", March 20-21, 200J, Isala. KurssolroLariaLoL,
Isala InivorsiLy.

\osLornarl, K., IrlaronhLor lrn llinisla rvningar. LocLuro on Lho courso onLiLlod
Biolanlslagon", March 20-21, 200J, Isala. KurssolroLariaLoL, Isala
InivorsiLy.

5. Project activities

Hoaring ol rorosonLaLivos ol indusLry, Svodish auLhoriLios and rorosonLaLivos lron
Icoland, Isala, SoLonlor 16, 1999.

Iullic Hoaring in GLolorg on Biolanls, oLhics and lav, May 11, 2000.

Iullic Hoaring in GLolorg on Biolanls, oLhics and lav, March 12, 2001.

IxhiliLion aL BioLoch Iorun, Annual BioLochnology lair, SLoclholnsnassan,
Novonlor 28-J0, 2001.

IxhiliLion aL Lho BioLoch Iorun, Annual BioLochnology lair, Malnnassan,
CcLolor 8-10, 2002.

16 naj 2001, \on agor nina collor Iullic Hoaring on oLhical and logal asocLs ol
liolanl rosoarch. Isala InivorsiLy.

10-11 nars 200J, Biolanlor son halsorosurs ILisla, juridisla och olononisla
lruLsaLLningar lr on ollolLiv och inLogriLoLssalor anvandning av liolanlor
(Biolanls as HoalLh Rosourcos ILhical, logal and ocononic roroquisiLos lor
ollicioncy and inLogriLy}, Isala SloLL, Isala.

276
The potential benets of biomedicine and biotechnology are
considerable, but this is also an area of science and medicine that
is sometimes found controversial. Decisions made by scientists,
by health care professionals and by policymakers must be well
informed and based on knowledge and sound research. Legal
experts concerned with public law and intellectual property
rights, philosophers and social pharmacists have been collaborat-
ing with geneticists, pathologists and doctors in several research
projects in order to seek the kind of biobank management that
would satisfy the interests of both the research community and
the general public as regards new medicines and forms of treat-
ment, whilst protecting the integrity of the individual. A sum-
mary of that research is presented in this book.
The research was funded by the Swedish Foundation for
Strategic Research (through the ELSA programme), the
Swedish Agency for Innovation Systems (VINNOVA), the
Federation of County Councils, the National Board of Health
and Welfare and the Knut and Alice Wallenberg Foundation
(through the Biobank Programme of SweGene and Wallenberg
Consortium North). The research programme Ethics in
Biomedicine at Uppsala University initiates and coordinates
multi-disciplinary research networks at universities in Sweden
and abroad. Information about the research programme can be
accessed through www.bioethics.uu.se.
Research Program Ethics in Biomedicine
Uppsala University
ISBN 91-506-1659-6
Univesitetstryckeriet 2003

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as resources for health

vas narloLod in Lho

. In lacL, jusL ono doso Lalon oarly in rognancy sovoroly allocLod

InsLoad, Lhoy havo choson Lo

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Lag (199J.84) om medicinsltelnisla produlter.

viLh varying Laxonony and sLrucLuro.

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TrauLh oL al., 2000

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