Stem Cell Research Guidelines

You might also like

Download as doc, pdf, or txt
Download as doc, pdf, or txt
You are on page 1of 5

APPLICATION FOR STEM CELL OVERSIGHT COMMITTEE REVIEW

INFORMATION SHEET (do not submit this pa! "ith #omp$!t!d app$i#ation %o&m'
Researchers should consult the Guidelines for Human Pluripotent Stem Cell Research (the Guidelines) and Frequently Asked
Questions posted on the CIHR wesite http!""www#cihr$irsc#%c#ca"e"&'(''#ht)l to deter)ine whether or not the research requires
re*iew y the +te) Cell ,*ersi%ht Co))ittee (+C,C)# Any questions can e directed to wi)#wol-s.kidney#ca#
IF (O)R APPLICATION*
COMPLETE
SECTIONS
/ill use e0istin% +C,C$appro*ed hu)an e)ryonic ste) cells A+,
Includes e0peri)ents in*ol*in% the en%ra-t)ent o- induced hu)an pluripotent ste) cells into hu)an and"or
non$hu)an ani)als
A+,
Is to deri*e hu)an pluripotent ste) cells -ro) hu)an e)ryos1 -etal tissue1 or a)niotic -luid A+C+,
/ill use e0istin% hu)an pluripotent ste) cells that ha*e een deri*ed -ro) hu)an e)ryos1 -etal tissue1 or
a)niotic -luid1 and ha*e not yet een appro*ed y +C,C
A+C+,
Additional in-or)ation )ay e requested -ro) the researcher i- +C,C has concerns that are not addressed in the docu)entation
pro*ided#
2roposals e0istin% +C,C$appro*ed hu)an e)ryonic ste) cell (h3+C) lines and"or hu)an induced pluripotent ste) (i2+) cells1
deri*ation o- h3+C -ro) hu)an e)ryos1 the use o- h3+C lines not yet appro*ed y +C,C1 and"or the en%ra-t)ent o- hu)an
pluripotent ste) cells into hu)an ein%s need to include the -or) Application for Stem Cells Oversight Committee Review with their
application#
P$!as! in#$ud! #omp$!t!d %o&m "ith app$i#ation and s!nd to*
4he 5idney Foundation o- Canada
C"o 6ational 7irector o- Research
6ational ,--ice
899:'&;' +herrooke +t# /est
<ontreal1 Queec H=A &4;
Application -or +te) Cell ,*ersi%ht Co))ittee Re*iew1 In-or)ation +heet (5F,C(9&8$9>)
APPLICATION FOR STEM CELL OVERSIGHT COMMITTEE REVIEW
A. GENERAL INFORMATION
APPLICATION ,ETAILS*
Nominat!d P&in#ipa$ App$i#ant*

Mai$in add&!ss o% P&in#ipa$ App$i#ant*

E-mai$ add&!ss o% P&in#ipa$ App$i#ant*

A$$ Oth!& App$i#ants*

Tit$! o% app$i#ation %o& %undin*

Fundin A!n#.*

Fundin #omp!tition*

App$i#ation Numb!&*

App$i#ation status*
2eer re*iewed! ?es1 y institution ?es1 y -undin% or%ani@ation
Appro*ed -or -undin%!
?es1 date o- appro*al! (dd"))"yyyy)
+u)itted to -undin% opportunity1 awaitin% decision
2ilot proAect usin% e0istin% %rant -undin%
,ther (please descrie)!
OVERVIEW*
/0 ,o!s this &!s!a&#h p&opos! th! us! o% human indu#!d p$u&ipot!nt st!m #!$$s1
?es
6o
I% 2(!s3*
and the answers to 41 5 and 6 are all B6oC1 then the research does not require +C,C re*iew
and the answers to 4 and 6 are B6oC and the answer to 5 is B?esC1 ut li)ited to terato)a -or)ation1 then the research
does not require +C,C re*iew# 7o not su)it this -or)# Howe*er1 you )ust in-or) +C,C in writin% (at address
ao*e) that hu)an pluripotent ste) cells will e used -or terato)a -or)ation only and include a state)ent that the
ani)als will not e used -or reproducti*e purposes#
40 ,o!s this &!s!a&#h p&opos! th! us! o% human !mb&.oni# st!m #!$$s1
?es (see elow)
6o
I% 2(!s3*
P$!as! $ist a$$ $in!s that "i$$ b! us!d*

I% an. o% th!s! $in!s ha7! not b!!n app&o7!d b. SCOC+ p$!as! #omp$!t! s!#tion C
50 Wi$$ an. non-human anima$s b! !n&a%t!d "ith human p$u&ipot!nt st!m #!$$s o& #!$$s d!&i7!d %&om human p$u&ipot!nt
st!m #!$$s in this p&o8!#t1
?es (see elow)
6o
I% 2(!s3*
I% th! !n&a%tm!nt !9p!&im!nts a&! not d!s#&ib!d in d!tai$ in th! app$i#ation %o& %undin+ p$!as! p&o7id! a
d!s#&iption o% th!s! !9p!&im!nts0
Wi$$ an. non-human anima$s !n&a%t!d "ith human p$u&ipot!nt st!m #!$$s o& #!$$s d!&i7!d %&om human
p$u&ipot!nt st!m #!$$s in th! #ou&s! o% this &!s!a&#h b! us!d %o& &!p&odu#ti7! pu&pos!s1
?es
6o
60 ,o!s th! &!s!a&#h in7o$7! &a%tin human p$u&ipot!nt st!m #!$$ $in!s into human sub8!#ts1
?es (see elow)
6o
I% 2(!s3*
App!nd #opi!s o% #ons!nt and in%o&mation %o&ms to b! us!d
Ensu&! that th! p&oposa$ d!s#&ib!s !7id!n#! %&om p&!#$ini#a$ mod!$s %o& sa%!t. and !%%i#a#.+ and that th!
&!s!a&#h is #a&&i!d out in "!$$-d!sin!d #$ini#a$ t&ia$s0 (ou ma. app!nd additiona$ in%o&mation i% n!!d!d to
p&o7id! mo&! d!tai$s than #ontain!d in th! app$i#ation0
Application -or +te) Cell ,*ersi%ht Co))ittee Re*iew1 In-or)ation +heet1 2a%e ( (5F,C(9&8$9>)
Application -or +te) Cell ,*ersi%ht Co))ittee Re*iew1 In-or)ation +heet1 2a%e 8 (5F,C(9&8$9>)
OVERVIEW*
:0 ,!s#&ib! th! pot!ntia$ b!n!%its o% this &!s!a&#h*

APPEN,ICES*
,!s#&iption o% ho" !a#h o% th! human p$u&ipot!nt st!m #!$$ $in!s "i$$ b! us!d0 2lease list each e0peri)ent that in*ol*es
the use o- hu)an pluripotent ste) cells and rie-ly ('$&9 lines) descrie how the cells will e used in each# 4his will ensure that
+C,C has a clear understandin% o- which e0peri)ents proposed in the application -or -undin% in*ol*e the use o- hu)an
pluripotent ste) cells#
On! #op. o% th! o&iina$ app$i#ation %o& %undin0 P$!as! in#$ud! th! bud!t th! $ist o% pat!nts h!$d b. th! p&in#ipa$
app$i#ant+ and th! $ist o% th! %unds &!;u!st!d and th! %unds h!$d b. a$$ app$i#ants0
Copi!s o% an. #ont&a#ts &!$!7ant to this app$i#ation+ and an. &!$!7ant bud!ta&. in%o&mation0 Fai$u&! to app!nd
&!$!7ant #ont&a#ts ma. d!$a. &ant app&o7a$ (p$!as! s!! S!#tion <0604 o% th! Guid!$in!s'* Copies o- contracts etween
researchers1 institutions and industry sponsors and any rele*ant ud%etary in-or)ation )ust e pro*ided to the +te) Cell
,*ersi%ht Co))ittee and the local R3D1 to e0a)ine and e*aluate any potential or actual con-lict o- interest and to ensure the
ri%ht to pulish -reely a-ter a )odest inter*al# +hould any potential con-licts o- interest arise -ollowin% appro*al o- an application1
the +te) Cell ,*ersi%ht Co))ittee )ust e ad*ised#
P$!as! $ist a$$ #ont&a#ts that a&! app!nd!d*

Th!&! a&! no &!$!7ant #ont&a#ts
,!s#&iption o% an. %inan#ia$ int!&!st .ou ma. ha7! in th! out#om! o% th! &!s!a&#h d!s#&ib!d in this app$i#ation (p$!as!
s!! S!#tion <060/ o% th! Guid!$in!s'* In so)e instances1 disclosure )ay not e a su--icient response to concerns aout
actual1 percei*ed or potential con-licts o- interest and researchers and"or their institutions )ay e asked y +C,C to re)edy
any possile distortion o- proper procedures attriutale to such con-licts# +hould any potential con-licts o- interest arise
-ollowin% appro*al o- an application1 the +te) Cell ,*ersi%ht Co))ittee should e ad*ised#
P$!as! !9p$ain th! #omm!&#ia$ p$an in a %!" sho&t s!nt!n#!s*

I ha7! no %inan#ia$ int!&!st in th! out#om! o% th! &!s!a&#h d!s#&ib!d in this app$i#ation
ATTESTATIONS*
i' An am!nd!d app$i#ation "i$$ b! submitt!d to SCOC %o& &!7i!" and app&o7a$ i%*
a0 an. #han!s in di&!#tion o% th! &!s!a&#h in7o$7in human p$u&ipot!nt st!m #!$$s a&! p$ann!d+ b!%o&! su#h "o&=
#omm!n#!s
b0 a T&ain!! &!#!i7!s s!pa&at! %undin %o& &!$at!d &!s!a&#h0
?es
6o
ii' SCOC "i$$ b! p&o7id!d "ith "&itt!n noti%i#ation shou$d th! us! o% additiona$ SCOC-app&o7!d st!m #!$$ $in!s not
d!s#&ib!d in th! o&iina$ &!s!a&#h app$i#ation b! p$ann!d (this noti%i#ation "ou$d in#$ud! th! tit$! o% th! o&iina$
app$i#ation+ th! nam! o% th! PI and indi#at! "hi#h #!$$ $in!s "ou$d b! us!d'0
?es
6o
iii' I und!&stand m. &!s!a&#h institution3s #on%$i#t o% int!&!st po$i#. and "i$$ #omp$. "ith that po$i#.0
?es
6o
Application -or +te) Cell ,*ersi%ht Co))ittee Re*iew1 In-or)ation +heet1 2a%e = (5F,C(9&8$9>)
B. APPLICATIONS FOR TRAINEE OR STUDENT
RESEACH S)PPORTE, >( TRAINEE OR ST),ENT F)N,ING*
Is this application -or 4rainee or student -undin% wholly susidiary to a +C,C$appro*ed proAectE
?es (see Attestations elow)
6o
ATTESTATIONS*
?es1 th! T&ain!! o& stud!nt p&oposa$ is "ho$$. subsidia&. to th! SCOC-app&o7!d p&o8!#t*
Tit$!*
L!d >.*
Fund!d >.*
,at! app&o7!d b. SCOC*
Sup!&7iso&3s sinatu&!*
C. APPLICATIONS TO:
DERIVE HUMAN PLURIPOTENT STEM CELLS FROM HUMAN EMBRYOS, FETAL TISSUE, OR AMNIOTIC FLUID;
AND/OR
USE EXISTING HUMAN PLURIPOTENT STEM CELLS THAT HAVE BEEN DERIVED FROM HUMAN EMBRYOS, FETAL
TISSUE, OR AMNIOTIC FLUID, WHICH HAVE NOT YET BEEN APPROVED BY SCOC.
,ESCRIPTIONS*
I% this app$i#ation is b!in submitt!d to us! human !mb&.os to d!&i7! human !mb&.oni# st!m #!$$s+ p$!as! d!s#&ib! th!
n!!d %o& human !mb&.os*

4his is not an application to deri*e hu)an e)ryonic ste) cells
APPEN,ICES*
Copi!s o% #ons!nt and in%o&mation %o&ms us!d
a) unsi%ned research consent (see section F#8#( o- the Guidelines)G and"or
) unsi%ned e)ryo donor or research suAect consentG and
c) in-or)ation -or)s
+C,C will re*iew these docu)ents to ensure that the consent pro*isions o- the Guidelines (see F#&1 F#8) and the Final Report o- the
ad hoc /orkin% Group on +te) Cell Research ha*e een )et#
Att!station(s' that th! !mb&.os ha7! b!!n #&!at!d %o& &!p&odu#ti7! pu&pos!s and a&! no $on!& &!;ui&!d %o& su#h
pu&pos!s
Att!station(s' that n!ith!& th! o7a no& th! sp!&m %&om "hi#h th! !mb&.os "!&! #&!at!d+ no& th! !mb&.os th!ms!$7!s+
ha7! b!!n obtain!d th&ouh #omm!&#ia$ t&ansa#tions
Att!station(s' that th! &!s!a&#h!&s did not?"i$$ not as=+ !n#ou&a!+ indu#! o& #o!&#! m!mb!&s o% th! %!&ti$it. t&!atm!nt
t!am to !n!&at! mo&! !mb&.os than n!#!ssa&. %o& th! optimum #han#! o% &!p&odu#ti7! su##!ss
Att!station(s' that th! !mb&.os ha7! not?"i$$ not b! &o"n in 7it&o %o& mo&! than /6 da.s
D: SIGNATURES
I #!&ti%. that a$$ in%o&mation p&o7id!d abo7! is #o&&!#t to th! b!st o% m. =no"$!d!*

Nam! Sinatu&! ,at!

Nam! Sinatu&! ,at!

Nam! Sinatu&! ,at!

Nam! Sinatu&! ,at!
Application -or +te) Cell ,*ersi%ht Co))ittee Re*iew1 In-or)ation +heet1 2a%e ' (5F,C(9&8$9>)

You might also like