Research Involving Prisoners: Consensus and Controversies in International and European Regulations

Bioethics ISSN 0269-9702 (print); 1467-8519 (online) doi:10.1111/j.1467-8519.2008.00634.
x
Volume 22 Number 4 2008 pp 224–238
RESEARCH INVOLVING PRISONERS: CONSENSUS AND CONTROVERSIES

IN INTERNATIONAL AND EUROPEAN REGULATIONS
BERNICE S. ELGER
Keywords
research, ABSTRACT
prisoners, This article examines international and European regulations on research
ethics, involving prisoners for consensus, differences, and their consequences,
international and offers a critical evaluation of the various approaches. Agreement exists
that prisoners are at risk of coercion, which might interfere with their ability
to provide voluntary informed consent to research. Controversy exists
about the magnitude of this risk and the consequences that should follow
from this risk. Two strategies are proposed for a method of protecting
prisoners that does not lead to discrimination: first, more caution to assure
non-coerced consent and second, restrictions on the type of research. Most
regulations stress the importance of the principle of equivalence of health-
care in places of detention as part of an efficient protection against research
risks and discrimination.
All the presented approaches have shortcomings. While ‘over-use’ of
prisoners for research as compared to the general population is ethically
unjustified, not granting prisoners access to studies beneficial to their own
health because of over-strict regulations is equally unjustified. A middle
solution should be preferred, one that grants a minimum of protection
together with the lowest possible barriers. Research that does not entail a
direct benefit for the individual detainee should be restricted to types of
research that have a benefit for detainees as a group and that are of low
risk. What will ultimately protect prisoners best, while producing the great-
est benefit for them, is access to the same healthcare available to members
of the community including research as a true option.
1. INTRODUCTION person involved should have legal capacity to give

consent but also that he or she ‘should be so situated as to
Large agreement exists in human research ethics that the be able to exercise free power of choice, without the inter-
‘voluntary consent of the human subject is absolutely vention of any element of force, fraud, deceit, duress,
essential’.1 Voluntary consent implies not only that the over-reaching, or other ulterior form of constraint or
1
The Nuremberg Code. Trials of War Criminals before the Nuremberg
Military Tribunals under Control Council. 1949. Law No. 10, Vol. 2, IRB/Guidelines/Code_of_Nuremberg.doc [accessed April 30, 2007];
pp. 181–182. Washington, D.C.: U.S. Government Printing Office. G.J. Annas et al. 1977. Informed consent to human experimentation.
Available at: http://www1.va.gov/visns/visn02/Research/forms/alb/ Cambridge, MA: Ballinger.
Address for correspondence: Centre universitaire romand de médecine légale, University of Geneva, 9, av. de Champel, 1211 Geneva 4, Switzerland.
Tel.: 0041/22/379 55 89 or 0041/22/379 56 00, Fax: 0041/22/789 24 17, Email Bernice.Elger@hcuge.ch
© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd., 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA.
Research Involving Prisoners 225
coercion.’2 In line with this fundamental requirement of national legislation. This paper focuses on interna-
expressed in the Code of Nuremberg, the US federal tional regulations, especially from the Council of Europe
regulations (45 CFR 46 subpart C)3 point out that ‘pris- and the UN, because, unlike the US regulations, they
oners may be under constraints because of their incar- have not received sufficient attention so far, although the
ceration which could affect their ability to make a truly Additional Protocol to the Convention on Human Rights
voluntary and uncoerced decision whether or not to par- and Biomedicine concerning Biomedical Research from
ticipate as subjects in research.’ As a consequence of these the Council of Europe has recently come into force and
considerations and of past abuses,4 several States in the deals with the issue of research involving prisoners. Other
USA prohibit research involving prisoners altogether5 recommendations from the Council of Europe specific to
and the recommendations published in the USA6 as well the prison context, as well as UN regulations on this
as the US federal regulations contain particularly restric- issue, are also hardly known.
tive and detailed procedures, specifically addressing On an international level, it is rarely contested that
research with prisoners that have been repeatedly criti- prisoners and other vulnerable groups are at risk for
cized in the past and have been recently evaluated by a coercion which might interfere with their ability to
commission convened by the US Institute of Medicine provide voluntary informed consent to research.8 Con-
(report published: July 12, 2006). troversy exists as regards the magnitude of this risk and
The US national regulations are internationally unique the consequences that should follow from this risk.
and linked to the particular history of medical research Whereas ‘over-use’ of prisoners for research as compared
with prisoners in this country, research which continued to the general population is ethically unjustified, not
many years after the Nuremberg trial. Since they have granting prisoners access to studies that are beneficial to
been recently challenged a number of publications their own health because of over strict regulations is
describe the US regulations.7 In Europe, most countries equally unjustified.9
do not have special regulations for prisoners. Instead, the As a matter of fact, contemporary medicine relies on
Council Europe has put forward a number of regulations evidence obtained from medical research.10 The goal of
concerning research with prisoners The very idea of the evidence-based medicine is the improvement of patient
efforts of the Council of Europe is to encourage Europe- care.11 In order to improve healthcare delivered to pris-
wide frameworks based on the strict respect of human oners, recommendations must be formulated based on
rights, offering guidance in the present situation of lack evidence obtained through different methods.12 It is not
only in the best interest of prisoners to receive treatment
2
Ibid. (The Nuremberg Code). that is efficient in their specific context and population,
3
Department of Health and Human Services. Code of Federal Regula- efficient treatment will also help to avoid unnecessary
tions Title 45 Part 46 Subpart C. Additional DHHS Protections Pertain- healthcare costs for unproven or even harmful measures.
ing to Biomedical and Behavioural Research Involving Prisoners
8
as Subject. Available at: http://www.hhs.gov/ohrp/humansubjects/ C. Regehr, M. Edwardh & J. Bradford. Research ethics and forensic
guidance/45cfr46.htm#subpartc [accessed June 30, 2007]. patients. Can J Psychiatry 2000; 45: 892–898; J. Sheather. Research
4
A.M. Hornblum AM. They were cheap and available: prisoners as involving members of the prison population: World Medical Association.
research subjects in twentieth century America. BMJ 1997; 315: 1437– Doctors working in prisons: human rights and ethical dilemmas. A
1441; A.M. Hornblum. 1998. Acres of skin. Human experiments at web-based course for healthcare personnel working in prison. Available
Holmesburg prison: a true story of abuse and expoitation in the name of at: http://www.wma.net/e/webcourse_2004.htm [Accessed April 30,
medical science. London: Routledge; US Department of Energy. Advi- 2007].
9
sory Committee on Human Radiation Experiments Report. Chapter 9: U. Schüklenk. Protecting the vulnerable: testing times for clinical
The Oregon and Washington Experiments. Available at: http:// research ethics. Soc Sci Med 2000 Sep:51(6):969–977; K. Schroeder. A
www.eh.doe.gov/ohre/roadmap/achre/chap9_2.html. [accessed April recommendation to the FDA concerning drug research on prisoners.
30, 2007]. Southern California Law Review 1983; 56: 969–1000; S. Hoffman. Ben-
5
E. Kelly. Expanding prisoners’ access to AIDS-related clinical trials: eficial and unusual punishment: an argument in support of prisoner
an ethical and clinical imperative. The Prison Journal 1995; 75: 48–68. participation in clinical trials. Ind L Review 1999–2000; 33: 475–515; L.
6
K. Schroeder. A recommendation to the FDA concerning drug Bond Sutton et al. Recruiting vulnerable populations for research:
research on prisoners. Southern California Law Review 1983; 56: 969– revisiting the ethical issues. J Prof Nurs 2003; 19: 106–112.
10
1000. Evidence based medicine. Catalogue et Index des Sites Médicaux
7
J. Mitford. 1973. Kind and Usual Punishment: The Prison Business. Francophones. Available at: http://www.chu-rouen.fr/ssf/profes/
New York: Alfred A. Knopf.; L.O. Gostin. Biomedical research involv- evidencebasedmedicine.html [Accessed June 20, 2007]; EBM. Com-
ing prisoners: ethical values and legal regulation. JAMA 2007; 297: prendre l’Evidence-Based Medicine. Available at: http://www.ebm-
737–740; S. Loewenberg. US advisory panel revisits prison research journal.presse.fr/ebm/accueil.htm [Accessed June 20, 2007].
11
rules. Lancet 2006; 368: 1143–1144; D.B. Resnik. Eliminating the daily Ibid. EBM (preceding note).
12
life risks standard from the definition of minimal risk. J Med Ethics P. Gill et al. Evidence-Based general practice: a retrospective study of
2005; 31: 35–38. interventions in one training practice. BMJ 1996; 312: 819–821.
© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

226 Bernice S. Elger
International and European documents stress the Table 1. The recommendations of the United Nations
importance of the principle of equivalence of healthcare
Text referring or relevant to
in places of detention: healthcare available to detainees research involving prisoners as
should be the same as it is available to the general popu- Title of UN document subjects
lation.13 The implementation of this principle has impor-
Body of Principles for the Principle 22: ‘No detained or
tant consequences for the recommendations concerning Protection of All Persons under imprisoned person shall, even
research involving prisoners. Any Form of Detention or with his consent, be subjected to
In the following, we will describe the international per- Imprisonment 1988.15 any medical or scientific
experimentation which may be
spective and legislation regarding this issue, with a special detrimental to his health.’
focus on Europe where the international framework has Standard Minimum Rules for Art. 3.8 ‘Non-custodial measures
not only been interpreted in a specific way but also Non-custodial Measures (The shall not involve medical or
become legally enforced. The aim of this article is to Tokyo Rules). 1990.16 psychological experimentation on,
or undue risk of physical or
provide readers with a comprehensive overview of the mental injury to, the offender.’
existing documents and their wording.
We will then examine the extent to which the interna-
tional documents reach a consensus on the appropriate
liberty should not be used as research subjects even with
regulations concerning research involving prisoners,
their consent if these experiments could be detrimental to
where possible differences lie and what the consequences
their health.
of these differences could be, not only for prisoners them-
selves but also for the role and functioning of research
ethics committees in different countries. Finally, we will The European legal framework
provide a critical evaluation of the existing approaches
suggesting arguments in favour of an ethically sound The Council of Europe, founded in 1949, is the conti-
global framework. nent’s oldest political organization. Among its members
at present are 47 countries, almost half of them from
Central and Eastern Europe. The Council of Europe
2. RECOMMENDATIONS AND should not be confused with the 27-nation European
Union. It should be noted, however, that no country has
LEGISLATIONS
ever joined the Union without first belonging to the
The recommendations from Council of Europe. Among the main component parts of
the Council of Europe is the Committee of Ministers,
the United Nations
composed of the 47 Foreign ministers or their
Among the many documents from the United Nations Strasbourg-based deputies (ambassadors/permanent rep-
(UN) regulating the rights of prisoners,14 only one men- resentatives), which is the Organization’s decision-
tions, and only in a brief way, standards that should making body. The Council of Europe has produced 198
govern research involving individuals deprived of their legally binding European treaties or conventions, many
liberty. In addition, one other UN document refers to of which are open to non-member states.
research with regard to non custodial measures (see The European Committee for the Prevention of
Table 1). Torture (CPT) is a body of independent experts that is
According to these documents from 1988 and 1990, mandated by European law created as part of the activi-
medical or psychological experiments should not be part ties of the Council of Europe. Its mandate is based on the
of non custodial measures. Individuals deprived of their European Convention for the Prevention of Torture and
13 15
United Nations. Basic Principles for the Treatment of Prisoners. United Nations. Body of Principles for the Protection of All Persons
Adopted and proclaimed by General Assembly resolution 45/111 of 14 under Any Form of Detention or Imprisonment. Adopted by General
December 1990. Available at: http://www.hri.ca/uninfo/treaties/ Assembly resolution 43/173 of 9 December 1988. UN Document
35.shtml [Accessed June 30, 2007]; United Nations. Principles of Series Symbol: ST/HR/. UN Issuing Body: Secretariat Centre for
Medical Ethics relevant to the Role of Health Personnel. Adopted by Human Rights. Available at: http://www.hri.ca/uninfo/treaties/36.shtml
General Assembly resolution 37/194of 18 December 1982. Available at: [Accessed April 2007].
16
http://www.unhchr.ch/html/menu3/b/h_comp40.htm [Accessed June United Nations. Standard Minimum Rules for Non-custodial Mea-
30, 2007]. sures (The Tokyo Rules). Adopted by General Assembly resolution
14
King’s College London. International Centre for Prison Studies. 45/110 of 14 December 1990. UN Document Series Symbol: ST/HR/
Available at: http://www.kcl.ac.uk/depsta/rel/icps/links-resources.html UN Issuing Body: Secretariat Centre for Human Rights. Available at:
and http://www.hri.ca/uninfo/treaties/ [Accessed June 20, 2007]. http://www.hri.ca/uninfo/treaties/46.shtml [Accessed January 2007].

Inhuman or Degrading Treatment or Punishment that attitude. It reminds the reader that it is sometimes desir-
has been ratified by 45 States. According to Art. 1 of this able to conduct research in the interest of improving
Convention, ‘[t]he Committee shall, by means of visits, medical treatment for prisoners. Therefore, an appropri-
examine the treatment of persons deprived of their liberty ate authority should sanction and monitor research and
with a view to strengthening, if necessary, the protection make sure that the fundamental protection of prisoners is
of such persons from torture and from inhuman or maintained. As key elements of an appropriate protection
degrading treatment or punishment.’17 As part of their are mentioned, first, the entirely voluntary consent of the
activity, the CPT has published standards that should prisoner in writing and the possibility to opt out at any
govern healthcare in places of detention. With regard to time later. This includes that no undue influence should
medical research, the CPT18 recommends to apply to exist on the prisoners’ decision to participate, such as
research involving prisoners the same rules that govern ‘adverse criticism or the loss of some privilege or favour’
research in the community in particular the approval of in case of a refusal to take part in the experiment. Second,
the research project by a ‘board of ethics’. ‘A very cau- research that can be done outside places of detention
tious approach must be followed’, however, and safe- should not involve prisoners for reasons related to ‘the
guards put in place to avoid any undue influence and to convenience of their situation’. The explanatory memo-
‘ensure that any prisoner concerned has given his free and randum does not provide any further information on
informed consent.’ The CPT directly encourages certain acceptable risk thresholds or on the definition of physical
types of research especially ‘concerning custodial pathol- or moral ‘injury’.
ogy or epidemiology or other aspects specific to the con- Six years later, in 1993, four new elements appear in the
dition of prisoners.’ (CPT p. 33). A positive consequence recommendations ‘concerning prison and criminological
of research is also noted with regard to psychiatric estab- aspects of the control of transmissible diseases including
lishments in which many individuals deprived of liberty AIDS and related health problems in prison.’ Explicitly,
live. According to the CPT, the presence of independent the criterion that research is expected to produce a direct
researchers should be encouraged to prevent the isolation health benefit for prisoners is used to distinguish between
of the staff (see Table 2). acceptable and unacceptable research projects. Notewor-
The Council of Europe Committee of Ministers has thy is the indication of the explanatory report that the
agreed to a number of recommendations which are rel- expected benefit of the experimental treatment should
evant for research involving prisoners. If one looks at exist ‘in principal’ (French translation: ‘en principe’).
these texts chronologically (see Table 2), the position of Second, in the context of the preoccupying threat of
the Council of Europe becomes more and more elabo- transmissible diseases such as AIDS in the prison context,
rated and, progresses towards the encouragement of these recommendations contain an encouragement for
certain types of research as it is found in a similar form in certain types of research related to the prevention and
the CPT standards. In line with the European Conven- treatment of these diseases, especially if this knowledge
tion on Human Rights and the already mentioned UN cannot be efficiently obtained by research outside places
documents, the principal aim of the European Prison of detention. Third, similar to the CPT standards, the
Rules from 1987 is the protection of individuals deprived principle of equivalence of healthcare now becomes
of liberty. In view of past abuses these Rules prohibit the central in the context of research. Since the AIDS epi-
participation of prisoners in any form of research ‘which demic has shown that access to experimental treatment of
may result in physical or moral injury.’ Taken verbally infectious diseases can be life-saving, the Council of
this could mean a complete prohibition of research, since Europe underlines that prisoners have the same right to
virtually no research activity is without risks although access these treatments as non-detained persons in the
some can be classified as ‘minimal’ and their possible community. Third, the attention of the Council of
consequences might not fulfil the criteria of an ‘injury’. In Europe has been captured particularly by the risks to
the explanatory memorandum, the Council of Europe which prisoners (and the community via the risk of cre-
proposes a more detailed interpretation of this protective ating resistant virus subclasses) are exposed if ongoing
trials are interrupted because of imprisonment. Prohibit-
ing prisoners from continuing to participate in such trials
17
European Committee for the Prevention of Torture and Inhuman or during their prison stay is deemed unethical. Finally, the
Degrading Treatment or Punishment (CPT) The CPT standards ‘Sub-
principle of equivalence is also used to distinguish
stantive’ sections of the CPT’s General Reports (2004). Available at:
http://www.cpt.coe.int/en/documents/eng-standards-scr.pdf [Accessed between acceptable practices with regard to epidemio-
June 30, 2007]. logical research in prison. Methods are only permitted if
18
Ibid. they are equally used in the community and only after

Table 2. European recommendations and laws (Council of Europe)

Council of Europe Text referring or relevant to research involving prisoners as subjects
European Committee for the Extract from the 7th General Report [CPT/Inf (97) 10]
Prevention of Torture and 48. As regards the issue of medical research with prisoners, it is clear that a very cautious approach
Inhuman or Degrading Treatment must be followed, given the risk of prisoners’ agreement to participate being influenced by their penal
or Punishment (CPT) The CPT situation. Safeguards should exist to ensure that any prisoner concerned has given his free and informed
standards ‘Substantive’ sections of consent.
the CPT’s General Reports
(2004).19 The rules applied should be those prevailing in the community, with the intervention of a board of
ethics. The CPT would add that it favours research concerning custodial pathology or epidemiology or
other aspects specific to the condition of prisoners. (p. 33)
Extract from the 8th General Report [CPT/Inf (98) 12]
46. External stimulation and support are also necessary to ensure that the staff of psychiatric
establishments do not become too isolated [. . .] the presence in psychiatric establishments of
independent persons (e.g. students and researchers) and external bodies (cf paragraph 55) should be
encouraged. (p. 57)
Council of Europe. Art. 27. ‘Prisoners may not be submitted to any experiments which may result in physical or moral
Committee of Ministers injury.’
European Prison Rules.
Recommendation No. R(87)3.
1987.20
Council of Europe. 48.1 Prisoners shall not be subjected to any experiments without their consent.
Recommendation Rec(2006)2 of 48.2 Experiments involving prisoners that may result in physical injury, mental distress or other damage
the Committee of Ministers to to health shall be prohibited.
member states on the European Research and evaluation
Prison Rules21 91. The prison authorities shall support a programme of research and evaluation about the purpose of
the prison, its role in a democratic society and the extent to which it is fulfilling its purpose.
Council of Europe. Committee of Art. 27. ‘In its general purport, this rule, which is clearly underpinned by the rules of general principle
Ministers Explanatory and, ultimately, by the provisions of the European Convention on Human Rights, presents no difficulty.
memorandum relating to the Indeed, the prohibition of experiments will also be reinforced by the provisions of domestic law. It is
European Prison Rules. Revised in the application that problems may arise. Obviously, in the interests of research that will lead to
European version of the Standard improvements in the effectiveness of treatment, it may sometimes be desirable to conduct experiments.
Minimum Rules for the Treatment However, the fundamental protection afforded by this rule may not be infringed. The experiments
of Prisoners. 1987.22 should be duly sanctioned by an appropriate authority. Prisoners involved in the experiments should be
allowed to be so on an entirely voluntary basis, to give their consent in writing and be permitted to opt
out of the experiments at any stage if they so wish. Prisoners should never be chosen as the vehicle for
experimentation simply as a consequence of the convenience of their situation. Nor should they ever be
put in the position where a refusal to conform with proposals for experiments would result in adverse
criticism or the loss of some privilege or favour. Furthermore, the experiments should be regularly
monitored and assessed by the administering authorities so as to ensure that the position safeguarded by
this rule is maintained.’
Council of Europe. Committee of Art. 16. ‘Persons deprived of their liberty may not undergo medical research unless it is expected to
Ministers. Recommendation No. produce a direct and significant benefit to their health.
R (93) 6 of the Committee of Ethical principles concerning research on human subjects must be strictly applied, particularly in
Ministers to member states relation to informed consent and confidentiality. All research studies carried out in prisons should be
concerning prison and subject to approval by an ethical review committee or to an alternative procedure guaranteeing these
criminological aspects of the principles.
control of transmissible diseases
including AIDS and related health Research on the prevention, treatment and management of transmissible diseases in prison populations
problems in prison. 1993.23 should be encouraged provided that such research yields information not available from studies in the
community.
19
European Committee for the Prevention of Torture and Inhuman or European Prison Rules (Adopted by the Committee of Ministers on 11
Degrading Treatment or Punishment (CPT) The CPT standards ‘Sub- January 2006 at the 952nd meeting of the Ministers’ Deputies). Avail-
stantive’ sections of the CPT’s General Reports (2004). Available at: able at: https://wcd.coe.int/ViewDoc.jsp?id=955747, accessed Septem-
http://www.cpt.coe.int/en/documents/eng-standards-scr.pdf [Accessed ber 2007.
22
June 30, 2007]. Council of Europe. Explanatory memorandum relating to the Euro-
20
Council of Europe. Committee of Ministers. European prison rules. pean Prison Rules. Revised European version of the Standard Minimum
Recommendation No. R(87)3. Adopted by the Committee of Ministers Rules for the Treatment of Prisoners. Strasbourg 1987. Available at:
of the Council of Europe on 12 February 1987. Available at: http:// http://www.uncjin.org/Laws/prisrul.htm [Accessed June 30, 2007].
23
www.uncjin.org/Laws/prisrul.htm [Accessed June 30, 2007]. Council of Europe. Committee of Ministers. Recommendation No. R
21
The revised version from 2006: Council of Europe. Recommendation (93) 6 of the Committee of Ministers to member states concerning prison
Rec(2006)2 of the Committee of Ministers to member states on the and criminological aspects of the control of transmissible diseases

Table 2. Continued
Council of Europe Prisoners should have the same access to clinical trials of treatments for all HIV/AIDS-related diseases
Recommendation No. R (93) 6 as persons living in the community.
(continued) Epidemiological HIV/AIDS monitoring including anonymous, non-correlated screening could be
considered only if such methods are used in the general population and if their application to prison
populations appears likely to yield results useful to prisoners themselves.
Prisoners should be informed in due time about the existence of any epidemiological studies carried out
in the prison where they are detained.
Publication and communication of results of research studies must ensure absolute confidentiality about
the identity of prisoners who have participated in such studies.’
Council of Europe. Committee of Art. 16. ‘Rule 27 of the European Prison Rules states:
Ministers. Explanatory ‘Prisoners may not be submitted to any experiments which may result in physical or moral injury’.
Memorandum to
Recommendation No. R (93) 6 on Although it is clearly unthinkable that prisoners should be subjected, without their consent or
Prison and criminological aspects knowledge, to experimental procedures which may damage their physical or mental health, the principle
of the control of transmissible of equal treatment with outside patients suggests that excluding them totally from such treatment may
diseases including AIDS and be unethical. This mostly applies to persons who had been undergoing clinical trials before
related health problems in prison. imprisonment and for whom it seems indispensable to continue the trials during detention.
1993.24 It is therefore recommended that prisoners should be given the benefit of clinical trials if the following
conditions are satisfied: the prisoner must give his informed and written consent and must be able to
withdraw at any time; the expected effect of the treatment should be, in principal, beneficial; the
procedures must be approved by an ethical committee independent of both the doctor carrying them out
and the prison authorities, in conformity with national legislation. This ethical committee should include
such diverse people as medical practitioners, academics, theologians, lawyers, etc. Its task would be to
decide whether the guarantees that ethical rules would be respected were sufficient for it to authorise the
projected research or therapeutic procedures in a prison context.
Another essential recommendation is to establish conditions for epidemiological monitoring of prisons
in order to assess the prevalence of transmissible diseases and to adjust health policies accordingly.
Co-operation with the national health monitoring services is necessary. In the HIV/Aids field,
co-operation with the EU/WHO Collaborating Centre, based in Paris, would be useful.’
Council of Europe. 74. Medical research on prisoners should be carried out in accordance with the principles set out in
Recommendation No. R (98) 7 of Recommendations No. R (87) 3 on the European Prison Rules, No. R (90) 3 on medical research in
the Committee of Ministers to human beings and No. R (93) 6 on prison and criminological aspects of the control of transmissible
member states concerning the diseases including Aids and related health problems in prison.
ethical and organizational aspects
of healthcare in prison.25
Council of Europe. Committee of 74. This paragraph recalls basic principles for medical research as expressed in Recommendations No. R
Ministers. Explanatory (87) 3 on the European Prison Rules (Rule 27), No. R (90) 3 on medical research on human beings
Memorandum to (principle 7) and No. R (93) 6 on prison and criminological aspects of the control of transmissible
Recommendation No. R (98) 7 on diseases including Aids and related health problems in prison (paragraph 16).
the ethical and organizational In order to properly implement these principles, the following safeguards should apply: informed and
aspects of healthcare in prison. written consent by the prisoner should be obtained, which should imply that the prisoner is not induced
1998.26 to participate by prospect of any privileges; the possibility to withdraw this consent at any time; and the
approval of the procedures by an appropriate ethical committee independent of both the doctor
carrying them out and the prison authorities, in conformity with national legislation.
25
Council of Europe. Recommendation No. R (98) 7 of the Committee
including AIDS and related health problems in prison (adopted by the of Ministers to member states concerning the ethical and organizational
Committee of Ministers on 18 October 1993, at the 500th meeting of the aspects of healthcare in prison. (Adopted by the Committee of Ministers
Ministers’ Deputies). Available at: http://www.prison.eu.org/article. on 8 April 1998, at the 627th meeting of the Ministers’ Deputies).
php3?id_article=2946 [Accessed January 30, 2007]. Available at: http://www.prison.eu.org/article.php3?id_article=2963
24
Council of Europe. Committee of Ministers. Explanatory Memoran- [Accessed July 15, 2007].
26
dum to Recommendation No. R (93) 6 on Prison and criminological Council of Europe. Committee of Ministers. Explanatory Memoran-
aspects of the control of transmissible diseases including AIDS and dum to Recommendation No. R (98) 7 on the ethical and organizational
related health problems in prison. (Adopted by the Committee of Min- aspects of healthcare in prison. (Adopted by the Committee of Ministers
isters on 18 October 1993, at the 500th meeting of the Ministers’ Depu- on 8 April 1998, at the 627th meeting of the Ministers’ Deputies).
ties). Available at: http://www.prison.eu.org/article.php3?id_article= Available at: http://www.prison.eu.org/article.php3?id_article=2964
2946 [Accessed January 30, 2007]. [Accessed July 15, 2007].

Table 2. Continued
Confidentiality: ‘C. Patient’s consent and confidentiality

Council of Europe. 13. Medical confidentiality should be guaranteed and respected with the same rigour as in the
Recommendation No. R (98) 7 of population as a whole.’
the Committee of Ministers to
member states concerning the
ethical and organizational aspects
of healthcare in prison.27
Council of Europe. Committee of ‘C. Patient’s consent and confidentiality
Ministers. Explanatory 13. This section deals with an essential aspect of medical ethics, as both consent to medical treatment
Memorandum to and confidentiality are concepts and values now almost unanimously accepted in professional and
Recommendation No. R (98) 7 on general ethics and in law. Freedom of consent to medical treatment and confidentiality are not only
the ethical and organizational fundamental rights of the individual, but also the ‘cement’ of the necessary relationship of trust between
aspects of healthcare in prison. doctor and patient, especially in prisons, where prisoners are not usually able to choose their doctor
1998.28 freely. Not only should the doctor and nursing staff carry out consultations on a confidential basis, but
they should also see that sick prisoners’ medical records are kept in a place where protection of the
confidentiality of medical documents can be guaranteed. For example, medical records may be kept in a
place to which only the medical and nursing staff have access, or they may be placed in a locked
cupboard used only by the healthcare staff.
Independence ‘D. Professional independence
Council of Europe. 19. Doctors who work in prison should provide the individual inmate with the same standards of
Recommendation No. R (98) 7 of healthcare as are being delivered to patients in the community. The health needs of the inmate should
the Committee of Ministers to always be the primary concern of the doctor.
member states concerning the
ethical and organizational aspects 20. Clinical decisions and any other assessments regarding the health of detained persons should be
of healthcare in prison.29 governed only by medical criteria. Healthcare personnel should operate with complete independence
within the bounds of their qualifications and competence.’
Independence ‘D. Professional independence
Right to outside treatment if not 19. Doctors who work in prison should endeavour to provide healthcare and preventive treatment to
available inside the prison prisoners along community lines and be guided in their clinical decisions primarily by the state of health
Council of Europe. Committee of of their patients. The health needs of a detained patient may require special treatment, only available in
Ministers. Explanatory an outside hospital with the necessary transfer out of the prison. In these circumstances the prison
Memorandum to administration must not endeavour to influence the doctor’s decision in any way. However, the full
Recommendation No. R (98) 7 on responsibility for conducting the patient to the outside hospital rests entirely with the prison authority
the ethical and organizational who must organize the appropriate security arrangements.
aspects of healthcare in prison.
1998.30 20. Medical and nursing staff should be in a position to carry out their professional activity in prison
on the sole basis of medical criteria, despite the fact that they also need to take into account the security
requirements proper to any prison. The independence of healthcare staff working in prisons may be
guaranteed, for example, by their attachment to the healthcare services for the general public or
supervision by an independent, recognized health authority (professional association, university body,
etc.).’
Council of Europe. Additional Art. 20 – Research on persons deprived of liberty
protocol to the Convention on Where the law allows research on persons deprived of liberty, such persons may participate in a research
Human Rights and Biomedicine project in which the results do not have the potential to produce direct benefit to their health only if the
concerning biomedical research. following additional conditions are met:
2005.31 i. research of comparable effectiveness cannot be carried out without the participation of persons
deprived of liberty;
ii. the research has the aim of contributing to the ultimate attainment of results capable of conferring
benefit to persons deprived of liberty;
iii. the research entails only minimal risk and minimal burden.
Article 17 – Research with minimal risk and minimal burden
1. For the purpose of this protocol, it is deemed that the research bears a minimal risk if, having regard
to the nature and scale of the intervention, it is to be expected that it will result, at the most, in a
very slight and temporary negative impact on the health of the person concerned.
2. It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the
most, temporary and very slight for the person concerned. In assessing the burden for an individual,
a person enjoying the special confidence of the person concerned shall assess the burden where
appropriate.
27
Ibid. note 26.
28 30
Ibid note 27. Ibid. note 27.
29 31
Ibid. note 26. Ibid. note 19.

persons deprived of liberty have been informed of the ducts, the UNAIDS guidelines and the Council for Inter-
ongoing anonymous screening. national Organizations of Medical Sciences (CIOMS)
The Council of Europe Recommendation of the Com- International Ethical Guidelines for Biomedical Research
mittee of Ministers concerning the ethical and organiza- Involving Human Subjects share several aspects of their
tional aspects of healthcare in prison published in 1998 approach concerning research involving prisoners (see
basically repeats the existing rules of the aforementioned Table 3). Common to all three of them is the fact that
European documents concerning research involving pris- prisoners are mentioned together with other vulnerable
oners. Additionally, this Recommendation focuses exten- groups for which similar measures of protection apply.
sively on the importance of respect for ethical corner- None of the mentioned three guidelines contains regula-
stones, such as confidentiality and consent, in all kinds of tions that apply only to prisoners (a similar common
medical activities in places of detention, not only research. approach for all types of vulnerable groups is also found in
The last and from a legal standpoint very important the Canadian Tri-Council Policy Statement).33
text relevant in the European context is the ‘Additional A second common feature of the WHO, UNAIDS and
protocol to the Convention on Human Rights and Bio- CIOMS guidelines has already been found to be part of
medicine concerning biomedical research’ in its final the recommendations of the CPT and the Council of
version from January 2005.32 It came into force on Sep- Europe. All three guidelines are concerned about pres-
tember 1, 2007 after it had been ratified by at least five sures that might interfere with prisoners’ ability to give
member States and is now legally binding for all coun- uncoerced consent. CIOMS uses the strongest expression
tries that ratified it. The protocol contains a paragraph stating that prisoners’ ‘autonomy is diminished’. Interest-
on ‘Research on persons deprived of liberty’. Interest- ingly, these guidelines list prisoners in the same para-
ingly, this paragraph only addresses research without graph together with persons unable to consent. The
direct benefit to the participating prisoners, apparently restrictions the three guidelines impose based on this fact
assuming that the right of prisoners to participate in vary in intensity. WHO concludes only that consent
research involving direct benefit does not need to be needs to be considered carefully by ethics committees.
mentioned since it is self-evident. The text provides UNAIDS not only adds that appropriate steps should be
three criteria that need to be fulfilled to permit research taken to ensure meaningful and independent ongoing
without direct benefit in places of detention. Firstly, no informed consent, to respect the rights of vulnerable
alternative exists to carry out similarly efficient research groups, to foster their well being, and to protect them
outside the prison context. Secondly, although no direct from harm, these guidelines mention in the first place that
benefit exists for individual prisoners, a benefit exists for it might be necessary ‘to exclude prisoners or other
persons deprived of liberty as a group following from groups, if their vulnerability cannot be addressed.’ It does
the research. Finally, for the first time now reference is not surprise that CIOMS which is most critical concern-
made to a risk and burden threshold: both need to be ing prisoners’ capacity to consent, imposes the most
minimal. Minimal risk and burden are both defined in elaborate restrictions. Prisoners whose capacity to
an absolute way as very slight and transitory health consent is limited are allowed to participate only in
impacts or discomfort. This definition of minimal risk is research that either is of direct benefit to them or entails
the same throughout the protocol and applies not only low risks, defined as risks not greater than the risks of
to research with persons deprived of liberty, but also to routine medical or psychological interventions to which
research on persons not able to consent, research during the person would be exposed to if he or she did not
pregnancy and research in emergency clinical situations. participate in any research. A slightly greater risk is
acceptable if three conditions are fulfilled: the research
responds to diseases to which prisoners are particularly
Other international recommendations in
susceptible, the objective of the research is ‘sufficiently
comparison with the European approach important’ to justify the risks, and the research interven-
The World Health Organization (WHO) Guidelines for tions are ‘commensurate’ with clinical interventions sub-
Good Clinical Practice for Trials on Pharmaceutical Pro- jects suffering from the disease are expected to undergo.
Compared to the regulations of the Council of Europe’s
32
Council of Europe. Additional protocol to the Convention on
33
Human Rights and Biomedicine concerning biomedical research. Stras- Medical Research Council of Canada, Natural Sciences and Engi-
bourg 15.1.05. Available at: www.coe.int/T/E/Legal_Affairs/Legal_co- neering Research Council of Canada and Social Sciences and
operation/Bioethics/Activities/Biomedical_research/ Humanities Research Council of Canada. 1998. Tri-Council Policy
195%20Protocole%20recherche%20biomedicale%20e.pdf [Accessed Statement. Available at: http://www.pre.ethics.gc.ca/english/pdf/
June 20, 2007]. TCPS%20October%202005_E.pdf [Accessed October 2007].

Table 3. Other international recommendations relevant for research involving prisoners

Title of document Text referring or relevant for to research involving prisoners as subjects
World Health Organization, ‘3.3 Informed consent

Guidelines for Good Clinical (e) Careful consideration should be given to ensuring the freedom of consent obtained from members of
Practice for Trials on a group with a hierarchical structure - such as medical, pharmacy and nursing students, hospital and
Pharmaceutical Products. 1995.34 laboratory personnel, employees of the pharmaceutical industry, and members of the armed forces. In
such cases the willingness to volunteer may be unduly influenced by the expectation, whether justified or
not, of benefits associated with participation or of a retaliatory response from senior members of the
hierarchy in case of refusal to participate. Other vulnerable groups whose consent also needs special
consideration include patients with incurable diseases, people in nursing homes, prisoners or detainees,
the unemployed or people on a very low income, patients in emergency departments, some ethnic and
racial minority groups, the homeless, nomads and refugees. If such categories are part of the population
to be enrolled in a clinical trial, the ethics committee should consider carefully the appropriateness of
the informed-consent process.’
UNAIDS35 ‘Guidance Point 13: Special measures should be taken to protect persons who are, or may be, limited in
their ability to provide informed consent due to their social or legal status.
There are several categories of persons who are legally competent to consent to participate in a trial,
and who have sufficient cognitive capacity to consent, but who may have limitations in their freedom to
make independent choices. Those who plan, review, and conduct vaccine trials should be alert to the
problems presented by the involvement of such persons, and either exclude such persons, if their
vulnerability cannot be addressed, or take appropriate steps to ensure meaningful and independent
ongoing informed consent, respect their rights, foster their well being, and protect them from harm. The
following are individuals or groups who should be given extra consideration with regard to their ability
to provide informed consent in HIV preventive vaccine trials:
Persons who are junior or subordinate members of hierarchical structures may be vulnerable to undue
influence or coercion in that they may fear retaliation if they refuse cooperation with authorities. Such
persons include members of the armed forces, students, government employees, prisoners, and refugees.
Persons who engage in illegal or socially stigmatized activities are vulnerable to undue influence and
threats presented by possible breaches of confidentiality and action by legal forces. Such persons include
sex workers, intravenous drug users, and men who have sex with men.
Persons who are impoverished or dependent on welfare programmes are vulnerable to being unduly
influenced by offers of what others may consider modest material or health inducements.
Women living in cultures where their autonomy as individuals is not sufficiently recognized are
vulnerable to influence and coercion from male partners, family, or community members.
Steps that might be taken to assure that ongoing free and informed consent is given by participants
from these groups include:
appointment of an independent ombudsperson and/or group to monitor these issues
expansion of the responsibilities of the clinical trial monitor to include adherence to the informed
consent and counselling process, or appointment of an independent counselling monitor
training of the counsellors on these issues, and
group counselling and/or interaction with local NGOs representing the groups from which such
participants are drawn.’
Council for International Guideline 9: Special limitations on risk when research involves individuals who are not capable of giving
Organizations of Medical Sciences informed consent
(CIOMS) International Ethical When there is ethical and scientific justification to conduct research with individuals incapable of giving
Guidelines for Biomedical informed consent, the risk from research interventions that do not hold out the prospect of direct
Research Involving Human benefit for the individual subject should be no more likely and not greater than the risk attached to
Subjects, 2002.36 routine medical or psychological examination of such persons. Slight or minor increases above such risk
may be permitted when there is an overriding scientific or medical rationale for such increases and when
an ethical review committee has approved them.
Commentary on Guideline 9
The low-risk standard: Certain individuals or groups may have limited capacity to give informed consent
[. . .] because, as in the case of prisoners, their autonomy is limited [. . .]. For research involving persons
[. . .] whose capacity to make an informed choice may not fully meet the standard of informed consent,
ethical review committees must distinguish between intervention risks that do not exceed those
associated with routine medical or psychological examination of such persons and risks in excess of
those.
34
World Health Organization. 1995. Guidelines for Good Clinical Prac-
tice for Trials on Pharmaceutical Products. Geneva: World Health at: http://www.bioethics.nih.gov/international/declarat/unaidsguid.
Organization. doc and http://www.unaids.org/html/pub/publications/irc-pub01/jc072-
35
UNAIDS guidance document. Ethical considerations in HIV preven- ethicalcons_en_pdf.pdf [Accessed January 30, 2007].
36
tive vaccine research. Prepublication version February 2000. Available Ibid., see note above.

Table 3. Continued
When the risks of such interventions do not exceed those associated with routine medical or
psychological examination of such persons, there is no requirement for special substantive or procedural
protective measures apart from those generally required for all research involving members of the
particular class of persons. When the risks are in excess of those, the ethical review committee must find:
1) that the research is designed to be responsive to the disease affecting the prospective subjects or to
conditions to which they are particularly susceptible; 2) that the risks of the research interventions are
only slightly greater than those associated with routine medical or psychological examination of such
persons for the condition or set of clinical circumstances under investigation; 3) that the objective of the
research is sufficiently important to justify exposure of the subjects to the increased risk; and 4) that the
interventions are reasonably commensurate with the clinical interventions that the subjects have
experienced or may be expected to experience in relation to the condition under investigation.
Guideline 12: Equitable distribution of burdens and benefits in the selection of groups of subjects in research
Groups or communities to be invited to be subjects of research should be selected in such a way that the
burdens and benefits of the research will be equitably distributed. The exclusion of groups or
communities that might benefit from study participation must be justified.
General considerations: Equity requires that no group or class of persons should bear more than its fair
share of the burdens of participation in research. Similarly, no group should be deprived of its fair share
of the benefits of research, short-term or long-term; such benefits include the direct benefits of
participation as well as the benefits of the new knowledge that the research is designed to yield. [. . .]
Subjects should be drawn from the qualifying population in the general geographic area of the trial
without regard to race, ethnicity, economic status or gender unless there is a sound scientific reason to
do otherwise.
In the past, groups of persons were excluded from participation in research for what were then
considered good reasons. As a consequence of such exclusions, information about the diagnosis,
prevention and treatment of diseases in such groups of persons is limited. This has resulted in a serious
class injustice. If information about the management of diseases is considered a benefit that is
distributed within a society, it is unjust to deprive groups of persons of that benefit. Such documents as
the Declaration of Helsinki and the UNAIDS Guidance Document Ethical Considerations in HIV
Preventive Vaccine Research, and the policies of many national governments and professional societies,
recognize the need to redress these injustices by encouraging the participation of previously excluded
groups in basic and applied biomedical research.
Members of vulnerable groups also have the same entitlement to access to the benefits of investigational
interventions that show promise of therapeutic benefit as persons not considered vulnerable, particularly
when no superior or equivalent approaches to therapy are available.
[. . .] although the burdens of research should not fall disproportionately on socio-economically
disadvantaged groups, neither should such groups be categorically excluded from research protocols. It
would not be unjust to selectively recruit poor people to serve as subjects in research designed to
address problems that are prevalent in their group – malnutrition, for example. Similar considerations
apply to institutionalized groups or those whose availability to the investigators is for other reasons
administratively convenient.
Guideline 13: Research involving vulnerable persons
Special justification is required for inviting vulnerable individuals to serve as research subjects and, if
they are selected, the means of protecting their rights and welfare must be strictly applied.
Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own
interests. More formally, they may have insufficient power, intelligence, education, resources, strength,
or other needed attributes to protect their own interests.
General considerations. The central problem presented by plans to involve vulnerable persons as research
subjects is that such plans may entail an inequitable distribution of the burdens and benefits of research
participation. Classes of individuals conventionally considered vulnerable are those with limited capacity
or freedom to consent or to decline to consent. [. . .] Ethical justification of their involvement usually
requires that investigators satisfy ethical review committees that:
the research could not be carried out equally well with less vulnerable subjects;
the research is intended to obtain knowledge that will lead to improved diagnosis, prevention or
treatment of diseases or other health problems characteristic of, or unique to, the vulnerable class –
either the actual subjects or other similarly situated members of the vulnerable class;
research subjects and other members of the vulnerable class from which subjects are recruited will
ordinarily be assured reasonable access to any diagnostic, preventive or therapeutic products that will
become available as a consequence of the research;

Table 3. Continued
the risks attached to interventions or procedures that do not hold out the prospect of direct
health-related benefit will not exceed those associated with routine medical or psychological examination
of such persons unless an ethical review committee authorizes a slight increase over this level of risk
(Guideline 9); and,
when the prospective subjects are either incompetent or otherwise substantially unable to give
informed consent, their agreement will be supplemented by the permission of their legal guardians or
other appropriate representatives.
Other vulnerable groups.
[. . .] Other groups or classes may also be considered vulnerable. They include residents of nursing
homes, people receiving welfare benefits or social assistance and other poor people and the unemployed,
patients in emergency rooms, some ethnic and racial minority groups, homeless persons, nomads,
refugees or displaced persons, prisoners, patients with incurable disease, individuals who are politically
powerless, and members of communities unfamiliar with modern medical concepts. To the extent that
these and other classes of people have attributes resembling those of classes identified as vulnerable, the
need for special protection of their rights and welfare should be reviewed and applied, where relevant.
additional protocol concerning research on persons DISCUSSION

deprived of liberty, that permit only research involving
minimal risk defined in an absolute way as very slight or In the following we will discuss areas of consent and
transitory health impact, the CIOMS guidelines are controversy found across the international guidelines and
under certain circumstances more permissive. Clinical regulations presented above. Each point of the discussion
interventions in the case of certain diseases might be asso- will be accompanied by a critical appraisal of the argu-
ciated with risks that might clearly result in more than a ments for or against different approaches, followed by a
slight and temporary health impact or discomfort. In the suggestion as to which of the approaches are preferable
case that the research subjects are only particularly sus- with regard to a global framework because they are best
ceptible to a disease, but do not suffer from it, this means supported by the arguments. A central part of the argu-
that such possibly high risks could be considered accept- ments will focus on the consequences and practical real-
able by an ethics committee following the CIOMS guide- ization of the different approaches.
lines. Another difference between the CIOMS guidelines
and the additional protocol of the Council of Europe is
that the former base their evaluation only on risks and
not on risks and burdens as is the case in the latter.
Protecting prisoners from harm: access to
Among the WHO, UNAIDS and CIOMS guidelines, research with direct benefit to prisoners
only the last contain a reference to the principle of justice Consensus exists among all international regulations
and equality that is comparable with the principle of that prisoners should have access to directly beneficial
equivalence, so central for European regulations concern- research. In particular it is mentioned explicitly by more
ing prisoners. CIOMS diagnose what they call ‘a serious and more guidelines and has recently also been recog-
class injustice’ that took place in the past with regard to nized by the US American Office for Human Research
vulnerable groups. For ‘what were then considered good Protection (OHRP)38 that stopping ongoing beneficial
reasons’, vulnerable populations were excluded from research because a person is imprisoned can be harmful.
research, the consequence being that they were in fact This position is supported by several arguments: first,
disadvantaged because no data were obtained to help informed consent has been given before the individual
address their health problems and manage more efficiently was in a situation of vulnerability. Second, for reasons
in particular diseases from which they suffer predomi- related to his or her legal status as a detainee, a research
nantly and that might be influenced by their particular life subject should not be deprived of potential benefits of
circumstances. Access to the benefits of research becomes
therefore for CIOMS as for the Council of Europe an Involving Human Subjects 2002. Available at: http://www.cioms.ch/
important issue to be assured for prisoners.37 frame_guidelines_nov_2002.htm [Accessed February 28, 2007].
38
OHRP Guidance on the Involvement of Prisoners in Research. May
37
Council for International Organizations of Medical Sciences 23, 2003. Available at: http://www.hhs.gov/ohrp/policy/index.
(CIOMS). International Ethical Guidelines for Biomedical Research html#prisoners [Accessed April 30, 2005].

ongoing research or suffer harm from the interruption institutions in the USA and has been tackled by the
of a treatment that might, as in the case of the experi- IOM commission, as reported by Gostin.39
mental treatment of an infectious disease, give rise to
resistant infectious agents which might threaten not
only the subject but others as well. These arguments Protecting prisoners against abuse: true
might only be outweighed if the place of detention, con- informed consent and caution
trary to ethical requirements worldwide and legal
requirements in Europe, does not offer adequate Consensus exists that for all studies that enrol partici-
medical care, including conditions of detention that pants during any form of detention, prisoners are in a
grant medical confidentiality and access of the research vulnerable position that might interfere with true
subject to the same supervision of the research study informed consent and that they need therefore to be pro-
(s)he has received before the imprisonment. The last tected from any exploitation and harm caused by
detail does not only depend on the prison context, but research. There is some controversy about how best to
also on the collaboration of the researcher. A number of achieve this goal. Principally, two strategies are pro-
solutions exist to overcome possible difficulties: if the posed: first, more caution to assure non coerced consent
prison facility is located too far away from the research and second restrictions of the type of research. All guide-
centre, the detainee should be transferred to an inpa- lines and regulations agree that particular attention
tient unit to which the researchers have easy access. This should be paid to the conditions that interfere with truly
requires the acceptance of higher costs for detention on voluntary consent. It is not an issue of controversy that
the side of the prison system and ultimately society, as the strategy to apply more caution is important: ethics
well as a minimum of flexibility of the researchers to committees have to pay particular attention to ensure (1)
accept more complicated conditions of supervision and that confidentiality is granted, (2) that consent given by
follow up. This solution would need to be chosen in prisoners is non coerced, and (3) that consent is truly
prison medicine in Europe because the principle of informed. To apply this caution in practice is not simple,
equivalence grants detainees the right to continue poten- however: detailed knowledge about a correctional facility
tially beneficial medical treatment during incarceration. is necessary to judge the degree of confidentiality. Evalu-
If the conditions for continuing research in a hospital ating the standard of consent is not an easy task, either.
prison unit are not fulfilled, however, the detainee might Some rules for the prevention of coercion are widely
be at greater risk of harm if (s)he continues certain types agreed: no financial incentives should exist and this
of research as compared to an interruption of the means, in most cases ,that no compensation in the form
research participation. The evaluation of how a detainee of money or advantages should be proposed, simply
in this case is best protected from harm, through because many detainees, especially those on remand,
ongoing participation or interruption of the research, is don’t have the opportunity to work, and if they do work,
best made by the local prison physician in collaboration their wages are very low. Participation in research should
with the investigator. Both might then communicate also not influence the length of the sentence nor the time
their evaluation to the research ethics committee (REC) of parole and non-participation in research should not
in charge, which then has the opportunity to approve or have any adverse consequences. Even in the absence of
contest the decision. Since a need for interruption in this any measurable pressure, however, a prisoner could feel
case is caused by unethical conditions of imprisonment, coerced because of false expectations. (S)he might believe
one could legitimately ask whether the involved actors that from the participation in research advantages will
from the medical system, physicians, investigators and follow concerning parole, or that not participating in
REC members have an obligation to report the incident research might give a bad impression to healthcare pro-
to a competent authority with the idea of promoting viders and influence her/his care, in spite of written and
necessary changes. Apart from exceptional cases, it does oral statements by the investigators that this will not
not seem convincing that no solution could be found to happen. These difficulties show the importance of an effi-
enable adequate continuation of the research, if neces- cient information process. Again, some rules are not con-
sary through hospitalization of the detainee and police troversial: the high percentage of foreigners and of people
surveillance of the entrances of the hospital room. The with low socio-educative levels requires particular efforts
problem of evaluating whether research is acceptable in and the help of translators to make information under-
prison environments that do not offer equivalent non- standable. This might not be sufficient, however, if there
research healthcare cannot be discussed here in more
detail. This is a major problem in many correctional 39
Ibid., see note 7.

is not in addition some mechanism of control to ensure European regulations and guidelines included in
that a detainee has truly understood his/her situation, the this analysis, both types of definitions of minimal
risks and benefits of the research and the degree of con- risk apply not only for research involving pris-
fidentiality in the facility. oners but also for research outside places of
detention.
b. Benefits and risks are balanced: significant ben-
Erring rather on the side of protecting: efits for prisoners as a group might justify a slight
restriction of research increase of risks above what is defined as low or
minimal.
As shown, applying caution and assuring true informed
consent is important, but whether this caution leads to
More caution to ensure informed consent versus more
efficient protection is not easy to control. As a conse-
restrictions: which is the appropriate approach?
quence, differences exist with regard to the optimism that
As part of a critical evaluation of the areas of contro-
voluntary consent will ever be possible in a place of deten-
versy found among different regulations it has first to
tion. Although it seems evident that conditions can vary
be recognized that both strategies proposed, (i.e. more
enormously from one place of detention to the other, most
caution to ensure non-coerced consent and restrictions of
guideline makers stay principally pessimistic and rely
the type of research) can become two-edged swords. To
mainly on additional restrictions to ensure protections,
some extent, a conflict exists between maximizing protec-
while others are inclined to give more freedom to ethics
tion and avoiding unjust barriers that diminish prisoners’
committees to decide for individual places and cases
access to beneficial research. This is the case because
whether the standards of consent are acceptable or not. To
increased caution and protection means, in general, more
err rather on the side of protection can be ethically pref-
complicated approval procedures, a more cumbersome
erable for several reasons: compared to the value to
consent process, and more careful supervision of the par-
protect, i.e. the health and physical integrity of prisoners,
ticular research study. All these measures might discour-
the limitations on prisoners’ choices to participate in all
age researchers from including prisoners because their
kinds of research might seem negligible. The consequences
workload doubles or triples as compared to research
of negative health impacts are judged to be of much
involving non prisoners.
greater importance than the consequences of the fact that
Concerning the different forms of increased caution
a prisoner won’t have the opportunity to participate in
and restriction for various types of research involving
non beneficial research for purely altruistic reasons.
prisoners, we will use the following questions as criteria
How should the restrictions be defined, however? Con-
for our evaluation: what are the consequences of each
troversy exists with regard to the definition of restrictions
type of measure with regard to the (1) efficiency and
and their range. The alternatives proposed by different
amount of protection, (2) the possibility of abuse of
regulations belong to the following main categories:
research due to a failure of the measure, (3) barriers to
1. Absolute limitation of risk for all research: no physi- beneficial research for prisoners?
cal or moral injury should follow from any type of Using the caution approach has the advantage that
research. ethics committees are given the opportunity to react to
2. Restriction of research that does not entail a direct the individual conditions in a place of detention and to
benefit for the individual detainee to those types the specific research project. For all restriction
that have a benefit for detainees as a group, accom- approaches, the consequences might vary substantially
panied by the following variations of risk-benefit according to the conditions of imprisonment and
considerations: judging them generally might be inadequate. Disadvan-
a. The magnitude of expected benefits is never a tages of the caution approach is the work load and
criterion; the acceptation of the type of research responsibility for the evaluating body, a local ethics
depends only on the type of associated risks. committee or more distanced central authority. The risk
These risks need to be low or minimal as defined of creating barriers through administrative and time-
by some in an absolute manner (only transitory consuming procedures is high. In addition, since the
and with very slight health impact or burden) evaluation is difficult, the risk of failure of the measures
and by others in a relative manner proportional because of inadequate evaluation is elevated. So is the
to the health risks to which research participants risk of abuse since local ethics committees might be
are exposed because of their medical condition. subject to pressures and it is difficult to control the
It should be noted that in the international and adequacy of their evaluation.

Table 4. Comparison of the consequences of the different approaches according to three evaluation criteria: (1)
efficiency and amount of protection, (2) the possibility of preventing abuse of research due to afailure of the
measure, (3) barriers to beneficial research for prisoners
Approach (1) protection (2) risk of abuse (3) barriers
Caution approach through control by research Good Intermediate High due to complicated
ethics committee: approval procedures
Approaches based on restriction:
1. ‘no physical or moral injury’ Good for research harms, Intermediate High barriers
but exposure to other harms
2. If either direct or group benefit exists and, in
case of group benefit, the research cannot be
done outside the prison setting and minimal risk
only
2a. absolute definition of minimal risk Good Low Intermediate
2a. relative definition of minimal risk Intermediate Intermediate Low barriers
2b. balancing of risks and benefits might allow Intermediate High Particularly low barriers
for slightly greater than minimal risk
What are the consequences of the different types of constitutes an ‘injury’, as compared to minor health
restriction (see Table 4)? The historically first proposed impacts, is set too high. In conclusion, this approach
solution (see above, approach 1) found in the European appears inadequate if interpreted in the most direct and
Prison rules from 1987 and the United Nations’ Body of simple form.
Principles for the Protection of All Persons under Any Approach 2a or 2b (see table 4) requires the presence of
Form of Detention or Imprisonment from 1988 is an either direct or group benefit and uses the magnitude of
absolute limitation of risk for all research: no physical the risk as a criterion of discrimination between accept-
or moral injury should follow from any type of able and non-acceptable types of research. This is defined
research. Although this type of restriction appears con- in two ways: risks have to be low or minimal according to
vincing, its application has proven to be unclear, since either an absolute (2a) or relative (2b) definition. The
most research is associated with a balance between risks latter is understood to be proportional to health interven-
and benefits. Not considering any balance in which ben- tion risks to which the subjects are routinely exposed, and
efits for individual prisoners or the entire group are not to all kinds of other general or health risks that exist
taken into account will result in an unjustified overpro- for detainees. The absolute definition of minimal risk has
tection that has a great potential for harm. It is not sur- the advantage of providing a greater protection and being
prising therefore that this general form of restriction has associated with a lower risk of abuse than the relative
after 1988 been subject to more sophisticated interpre- definition: more than slight and transitory health impacts
tation, in particular in the light of the AIDS and hepa- are never acceptable risks. On the other hand, the relative
titis epidemics diagnosed in places of detention in the definition of minimal risk scores better on the barrier
1990s and the deadly consequence that lack of access to criterion, because detainees might be deprived of access
experimental treatment could and can still have for to beneficial research for which an overwhelming major-
detainees suffering from these diseases. Clearly, if ity of experts and research subjects would agree that the
judged by the consequences, this restriction approach risks are acceptable, given the fact that routine treatment
fails with regard to at least one of the three criteria: the of the research subjects outside any research context
barriers to beneficial research for prisoners are too high. entails similar risks.
Concerning the criterion efficiency and amount of pro- Approach 2c receives an evaluation similar to the
tection, one could say that this method protects detain- approach in which minimal risk is defined in a relative
ees efficiently from research harms, but makes them too way: the barriers to beneficial research are particularly
vulnerable to other substantial harm. This approach low because detainees are not deprived of access to ben-
might score reasonably well on the third criterion: the eficial research about which an overwhelming majority of
possibility of abuse of research due to a failure of the experts and research subjects would agree that the ben-
measure does not seem to be particularly high, although efits outweigh the risks. The weak points of this
the definition of physical and moral injury might give approach, however, are limited protection and, espe-
some room for abuse if the threshold for what cially, its the risk of abuse.

CONCLUSIONS lations concerning research involving prisoners: the work

load for research ethics committees and the associated
As this evaluation shown, all approaches have shortcom- barriers for investigators related to the complicated
ings. If the aim is to defend the best balance between approval procedures could be brought down to a
protection and avoidance of barriers to beneficial minimum in a country if healthcare and living conditions
research, a middle solution should be preferred that for prisoners are efficiently controlled by the responsible
grants a minimum of protection together with the lowest authorities and places of detention can be trusted to
possible barriers. This is the case for solutions 2a and 2b. present an environment that offers to detainees the same
Whether an absolute definition of minimal risk or a rela- healthcare available to members of the community
tive definition is more adequate40 depends on the way in including research as a true option.
which ethics committees function. Since in most countries
training of these committees as well as their logistic (time
and resources) support is marginal, an absolute definition Behavioural and social science research
of risk might be necessary to prevent harm and abuse of This paper examines in detail only the issue of biomedical
prisoners as research subjects, especially since, compared research involving prisoners, since most international re-
for example with children or certain types of vulnerable commendations address only this type of research. The
patients, prisoners in general don’t have ‘natural’ advo- question remains whether behavioural and social science
cates such as parents or independent treating physicians. research in correctional institutions (including the use of
This fact suggests the following conclusion: in order to surveys, interviews, reviews of records, and field observa-
assure for prisoners the greatest protection from research tion) should be assessed by correctional authorities and
harms while at the same time the lowest barriers to ben- university (or other) research protection committees
eficial research, the influence of regulations concerning according to the same criteria as medical research. As
research is of limited importance. All of these regulations these other forms of research also involve risk and benefit
have shortcomings and present certain disadvantages for to prisoners who participate, the approval criteria dis-
prisoners. What will ultimately protect prisoners best cussed above do generally apply. It should still be noted,
while producing the greatest benefit for them will not however, that the evaluation of types of research other
depend on these regulations, but on the context in which than biomedical would benefit from further discussion
these regulations are applied. It is not accidental that for which we do not have sufficient space in this paper.
international and European documents dealing with the
healthcare of prisoners contain relatively brief parts on
research, compared with the space that is used to describe Acknowledgements
the principle of equivalence of care. The obvious condi-
This article is a longer version of a presentation to the US Institute of
tion for carrying out ethical research on prisoners is that
Medicine Committee on Ethical Considerations for Revisions to DHHS
there are no constraints or pressures. Prisoners might Regulations on Protection of Prisoners Involved in Research, held at
accept entry into a research protocol in order to receive the committee meeting in Washington DC, May 4, 2005. I thank L.
good overall care (investigations, therapeutic interven- Gostin, chair, and the Committee for the invitation. I thank D. Wendler
tions, monitoring and follow up) if healthcare provision (NIH) for helpful comments.
for prisoners is inadequate or for other benefits if the Bernice Elger is Professor of Ethics and Humanitarian medicine in
prison regime implies substandard life conditions. If the places of detention at the University of Geneva. She has been working
principle of equivalence of care is applied efficiently, pris- as an internist in the prison medicine department of the University
Hospital of Geneva for the past twelve years (50%) while teaching
oners have the possibility to consult a ‘trusted and inde-
bioethics and health law at the University of Geneva (50%). In 2005, a
pendent’ physician before consenting to research. The research grant brought her to the US, where she participated at two
issue of quality of heath care available to prisoners as a conferences organized by the US National Commission on Correctional
prerequisite for any research activities will have a greater Health Care (NCCHC), visited a large jail, and presented as a panellist
impact on protection of prisoners than any type of regu- to the IOM commission about European guidelines concerning research
involving prisoners. She has been doing research and publishing widely
lation. The realization of equivalence of care in fact
on issues in prison medicine and medical ethics.
resolves most of the problems associated with the regu-
Financial disclosure:
40
L.M. Kopelman. Minimal risk as an international ethical standard in Funding was provided by a research fund of the Swiss Research
research. J Med Philosophy 2004; 29: 351–378. Foundation.

Research Involving Prisoners: Consensus and Controversies in International and European Regulations

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Research Involving Prisoners: Consensus and Controversies in International and European Regulations

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Bioethics ISSN 0269-9702 (print); 1467-8519 (online) doi:10.1111/j.1467-8519.2008.00634.

RESEARCH INVOLVING PRISONERS: CONSENSUS AND CONTROVERSIES

1. INTRODUCTION person involved should have legal capacity to give

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

Table 2. European recommendations and laws (Council of Europe)

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

Confidentiality: ‘C. Patient’s consent and confidentiality

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

Table 3. Other international recommendations relevant for research involving prisoners

World Health Organization, ‘3.3 Informed consent

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

additional protocol concerning research on persons DISCUSSION

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

CONCLUSIONS lations concerning research involving prisoners: the work

© 2008 The Author. Journal compilation © 2008 Blackwell Publishing Ltd.

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