79C3C34C52B45572883A05D425EB0F82
Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000003:
p.000003:
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p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
...
p.000008: individual inmate due to his/her health problems
p.000008: Inmates already included in an investigation before their detention can, in principle, continue participating during
p.000008: their incarceration, provided that this remains practically feasible. In this case, there are no problems
p.000008: concerning free and informed consent, given that the test subject had already consented at a time when he/she
p.000008: was not deprived of his/her freedom.
p.000008:
p.000008:
p.000008:
p.000008: 14 Additional protocol of the Convention on Human Rights and Biomedicine, on biomedical research, Strasbourg,
p.000008: 25.01.2005:
p.000008: Art. 20 – Research on persons deprived of liberty: “Where the law allows research on persons deprived of liberty, such
p.000008: persons may participate in a research project in which the results do not have the potential to produce direct
p.000008: benefit to their health only if the following additional conditions are met: i. research of comparable
p.000008: effectiveness cannot be carried out without the participation of persons deprived of liberty; ii the research has the
p.000008: aim of contributing to the ultimate attainment of results capable of conferring benefit to persons
p.000008: deprived of liberty; iii the research entails only minimal risk and minimal burden.”
p.000008: 15 Recommendation Rec (2006)2 on European prison rules: “48.1 Prisoners shall not be subjected to any
p.000008: experiments without their consent. 48.2 Experiments involving prisoners that may result in physical
p.000008: injury, mental distress or other damage to health shall be prohibited.”
p.000008: 16 Resolution 37-194 of the United Nations, adopted by the General Assembly of 18 December 1982, Principles of Medical
p.000008: Ethics relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees
p.000008: against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment: “It is a contravention of
p.000008: medical ethics for health personnel, particularly physicians, to be involved in any professional relationship with
p.000008: prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
p.000008: ethical and scientific justification to conduct research with individuals incapable of giving informed
p.000008: consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
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Political / Illegal Activity
Searching for indicator illegal:
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p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
p.000010: With regard to free and informed consent, a number of practical obstacles need to be taken into account when conducting
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Political / vulnerable
Searching for indicator vulnerable:
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p.000002:
p.000002: Contents
p.000002: Request for an opinion Introduction
p.000002: Nature of the scientific research
p.000002: 1. Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000002: individual inmate due to his/her health problems
p.000002: 2. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, with the
p.000002: aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights necessary
p.000002: for this purpose
p.000002: 3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, without
p.000002: the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights
p.000002: necessary for this purpose
p.000002: Juridical considerations Ethical considerations
p.000002: 1. Nature of the scientific research
p.000002: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000002: individual inmate due to his/her health problems
p.000002: 1.2. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, with the
p.000002: aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights necessary
p.000002: for this purpose
p.000002: 1.3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, without
p.000002: the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights
p.000002: necessary for this purpose
p.000002: 2. Vulnerable subjects
p.000002: 3. Free and informed consent
p.000002: 4. Reimbursement of expenses in connection with participation in research
p.000002: 5. Respect for the privacy of the inmates
p.000002: 6. Evaluation by a(n) (medical) ethics committee
p.000002: Recommendations
p.000002:
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p.000002:
p.000002:
p.000002:
p.000002: Opinion no. 69 of 13 February 2017 – Final version
p.000002: 2
p.000002:
p.000002: Request for an opinion
p.000002:
p.000002: On 24 June 2013 Prof. Dr. D. Matthys, in his capacity as chairperson of the medical ethics committee of the University
p.000002: Hospital Gent (UZ Gent), asked the following question (in Dutch):
p.000002: “The ethics committee of the University Hospital Gent (UZ Gent) recently received a question about the
p.000002: possibility of research involving inmates in Belgian prisons.
p.000002: We are aware of the restraint involving studies in prisons and the many opinions and guidelines which
p.000002: prohibit this, both national and international. Up until the present time, this ethics committee has shared this
p.000002: opinion and delivered an unfavourable opinion on any research involving inmates.
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p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
p.000004: free consent to participation in scientific research. However, despite the fact that this objection cannot be made in
p.000004: general, it must be checked that each inmate is capable of granting free and informed consent. Furthermore, a
p.000004: number of specific ethical, juridical and practical issues need to be taken into account when conducting
p.000004: scientific research with this vulnerable population. These additional issues will be dealt with in this opinion.
p.000004:
p.000004: This opinion restricts itself to scientific research involving inmates, and will not address the very different issue
p.000004: of scientific research involving those who are interned. Internment falls under the domain of care, and is very
p.000004: different from conventional detention, even if
p.000004:
p.000004: 4 “[T]he following principles [can be] derived under which, besides the principles for medical
p.000004: experiments
p.000004: involving non-inmates, extra emphasis should be placed for experiments involving inmates in Belgium:
p.000004: - the experiment cannot be conducted anywhere else, i.e. outside a prison. The scientific importance of the prison
p.000004: population should be clear as justification to participate in the experiment;
p.000004: - the results contribute indisputably to an improvement of the medical care in detention circumstances;
p.000004: - the problem of consent is to be approached with the necessary caution, in order to avoid any form
p.000004: of coercion;
p.000004: - all relevant information regarding the aims and the course of the experiment is to be shared with
p.000004: the
p.000004: inmates.”
p.000004: (identifying mark of the letter: 102579/BD/TG/fd/CNR 082 13)
p.000004: 5 Shirkey H. Therapeutic orphans. J Pediatr 1968;72(1):119-120.
p.000004:
p.000004:
p.000004: Opinion no. 69 of 13 February 2017 – Final version
p.000005: 5
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p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
p.000007: research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the
p.000007: knowledge, practices or interventions that results from the research.”10
p.000007:
p.000007: The relevant legislation on the prison system and the legal status of inmates does not include specific
p.000007: rules on the participation of inmates in scientific research either.11 It does provide for the establishment of
p.000007: a Penitentiary Health Council, composed of doctors, dentists and nurses attached to the prison, who advise the
p.000007: Minister in order to promote the quality of healthcare in the best interests of the inmate patient (Art. 98). Under
p.000007: Article 3 of the Royal Decree of 12 December 2005, this Council also provides advice on requests for medical
p.000007: scientific research with due regard for ethical principles and for the possibilities inside prisons (Art. 3,
p.000007: §2, 6°).12
p.000007:
p.000007: In addition to the Human Subjects Experiments Law, there exist a number of international law rules which are not
p.000007: legally binding. The already mentioned Code of Nuremberg13 is an authoritative source of inspiration for the
p.000007: legislation in many countries. This is also the case for the Oviedo Convention which has not been signed by Belgium,
p.000007: which in Article 20 of its additional protocol on biomedical research includes a specific provision for
p.000007: research on
p.000007:
p.000007: 9 Article 10, as introduced by Article 1 of the Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004
p.000007: setting out implementation measures for the Human Persons Experiments Law, BS 26 May 2006, 26727. The principles and
...
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
p.000009: general population. In this case, however (particularly for non-therapeutic experiments), special attention should be
p.000009: paid to the voluntary nature of the consent. In this respect, it is for example important to emphasise
p.000009: during the informed consent procedure that possible participation (or non-participation) in the research will have no
p.000009: effect on the evaluation of the inmate concerned. The Committee also recommends that the (medical) ethics committee
p.000009: responsible for issuing an opinion on the study protocol be informed of the inclusion of an inmate in the study.
p.000009: Another important condition concerns the practical feasibility of making the necessary practical arrangements (such as
p.000009: additional trips to the hospital). On the basis of the testimony given by the experts heard by the
p.000009: Advisory Committee on Bioethics, it appears that there is a strong commitment on the part of the prison system to
...
p.000009: insights necessary for this purpose
p.000009: Some problems, including medical, psycho(patho)logical, social or criminological, which are possibly related to
p.000009: incarceration or which are clearly more common in inmates than in the general population, are relevant for the
p.000009: population of inmates.
p.000009:
p.000009: As a consequence, there exists sufficient legitimation for such research, which can then receive the
p.000009: approval of an ethics committee provided that the relevant ethical issues are adequately identified and
p.000009: addressed in the submitted research protocol. It goes without saying that written, free and informed consent
p.000009: from each individual participant is essential.
p.000009:
p.000009:
p.000009: 1.3. Scientific research which explicitly aims to recruit (partly) from the subject population of
p.000009: inmates, without the aim of improving the health of, care for and/or detention conditions of inmates or
p.000009: of acquiring the insights necessary for this purpose
p.000009: The Committee is of the opinion that in the absence of a link between the research and (1) the individual care problem
p.000009: of the inmate (cf. point 1) or (2) an intended improvement of the health of, care for and/or detention conditions of
p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
...
p.000011: have a far greater value within prison walls.
p.000011:
p.000011:
p.000011: 5. Respect for the privacy of the inmates
p.000011: The restriction of freedom imposed on inmates has obvious implications for participation in scientific research. The
p.000011: cooperation of third parties will be required to enable participation in research, with a consequent risk of a loss of
p.000011: privacy.
p.000011:
p.000011: This risk of a loss of privacy can however be restricted to a minimum. In the first place, recruitment
p.000011: of test subjects occurs under the supervision of the prison doctor, with respect for professional secrecy. The
p.000011: inmate's consent is required so that, in the context of the recruitment for a research investigation, the
p.000011: prison doctor may consult the inmate's medical file. The Committee recommends that the relevant (medical)
p.000011: ethics committee closely monitors possible conflicts of interest regarding the prison doctor.
p.000011:
p.000011:
p.000011: 6. Evaluation by a(n) (medical) ethics committee
p.000011: Experiments and other scientific (medical) research in vulnerable populations, in this case inmates, demand a
p.000011: careful evaluation of the particular research protocol by the relevant (medical) ethics committee(s).
p.000011: However, in order to thoroughly evaluate the ethical issues related to the scientific (medical) research,
p.000011: knowledge of the specific context is required. It cannot be assumed that this knowledge will be present in
p.000011: the evaluating (medical) ethics committee(s).
p.000011:
p.000011: In order to establish whether (1) the study or investigation is relevant for the population of inmates and (2) the
p.000011: ethical issues – taking into account the specific context of research inside prison – are adequately defined
p.000011: and addressed, the Committee recommends calling upon the expertise of the prison system. After all, it must
p.000011: be ascertained whether the researchers, in striving to conduct successful and safe research, sufficiently
p.000011: take into
p.000011:
p.000011: Opinion no. 69 of 13 February 2017 – Final version
p.000012: 12
p.000012:
p.000012: account the circumstances which can differ inside prison compared to outside. For example, sometimes the continuity
p.000012: of participation should be taken into account: not all inmates reside for a sufficiently long period in (the
p.000012: same) prison, which can have an impact on the practical organisation of the experiment or investigation. This
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
p.000008: ethical and scientific justification to conduct research with individuals incapable of giving informed
p.000008: consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
p.000009: general population. In this case, however (particularly for non-therapeutic experiments), special attention should be
p.000009: paid to the voluntary nature of the consent. In this respect, it is for example important to emphasise
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
p.000010: With regard to free and informed consent, a number of practical obstacles need to be taken into account when conducting
p.000010: scientific research with inmates. For example, the population of inmates is very heterogeneous, and the
...
Searching for indicator influence:
(return to top)
p.000006: fraud, deception or any other form of restriction or coercion. This means that the inmates must know
p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
p.000007: research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the
p.000007: knowledge, practices or interventions that results from the research.”10
p.000007:
...
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
p.000010: With regard to free and informed consent, a number of practical obstacles need to be taken into account when conducting
p.000010: scientific research with inmates. For example, the population of inmates is very heterogeneous, and the
p.000010: knowledge of Dutch, French and/or English cannot be generally assumed.
p.000010:
p.000010: When inmates are involved in research, particular attention should be paid to informing the test subjects. It is
p.000010: advisable to explicitly mention the fact that participation in the experiment has no influence whatsoever on the
p.000010: assessment of the behaviour of the inmate and his/her sentence, and the protection of privacy deserves special
p.000010: attention (cf. point 5).
p.000010:
p.000010:
p.000010: 4. Reimbursement of expenses in connection with participation in research
p.000010: The purpose of this reimbursement is to compensate the expenses incurred or the loss of income suffered by the test
p.000010: subject as a result of his/her participation in an experiment or
p.000010:
p.000010: Opinion no. 69 of 13 February 2017 – Final version
p.000011: 11
p.000011:
p.000011: research study. (Medical) ethics committees are to ensure that this reimbursement of expenses covers
p.000011: realistic expenses, without becoming a reward. This is done in order to prevent financial and/or material
p.000011: incentives corrupting the free consent to participate in an investigation.
p.000011:
p.000011: As noted by the experts heard by the Advisory Committee on Bioethics, the granting of financial or
p.000011: material compensation or any sort of advantage to inmates is particularly delicate. Firstly, in general
p.000011: inmates do not have to incur any expenses as a result of their participation in an experiment or research study:
p.000011: for example, they do not have to travel anywhere or interrupt paid work in order to participate. Moreover,
p.000011: material and/or financial compensation for inmates is likely to weigh more quickly on the voluntary nature of consent.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000008: experiments without their consent. 48.2 Experiments involving prisoners that may result in physical
p.000008: injury, mental distress or other damage to health shall be prohibited.”
p.000008: 16 Resolution 37-194 of the United Nations, adopted by the General Assembly of 18 December 1982, Principles of Medical
p.000008: Ethics relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees
p.000008: against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment: “It is a contravention of
p.000008: medical ethics for health personnel, particularly physicians, to be involved in any professional relationship with
p.000008: prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
p.000008: ethical and scientific justification to conduct research with individuals incapable of giving informed
p.000008: consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000005: juridical considerations are first presented, followed by a clarification of the various ethical issues.
p.000005:
p.000005:
p.000005: Nature of the scientific research
p.000005:
p.000005: The desirability and acceptability of scientific research involving inmates depends to a large extent on the nature
p.000005: and purpose of the research. Depending on the recruiting strategy6 used, such research can concern: (1)
p.000005: studies which do not explicitly aim to recruit inmates as subjects, but which are relevant for an individual inmate due
p.000005: to his/her health problems; (2) studies which explicitly aim to (partly) recruit from the subject population of
p.000005: inmates, with the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000005: insights necessary for this purpose; or (3) studies which explicitly aim to (partly) recruit from the
p.000005: subject population of inmates, without the aim of improving the health of, care for and/or detention
p.000005: conditions of inmates or of acquiring the insights necessary for this purpose.
p.000005:
p.000005: 1. Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000005: individual inmate due to his/her health problems
p.000005: This includes investigations which are not set up with the intention of including inmates, but for which inmates can
p.000005: be included – before or during their detention – due to a concrete syndrome or care issue. An example is an
p.000005: oncological study in which an inmate as cancer patient wishes to (continue to) participate because of his/her illness.
p.000005: Neither the request to participate nor the research design are in this case related to the detention, but are related
p.000005: to the health problem for which they receive (medical) attention.
p.000005:
p.000005: 2. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, with
p.000005: the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000005: insights necessary for this purpose
p.000005: Some problems – medical, psycho(patho)logical, social or criminological – can be related to detention or manifest
p.000005: themselves more frequently amongst inmates than the general population. Research on such problems, with as
p.000005: ultimate goal the improvement of the health of, care for and/or detention circumstances of inmates, is evidently in the
p.000005: best interests of the population in which the research will be conducted. There is also no possibility of
p.000005:
p.000005: 6 This division in three categories is based on the intentions and recruiting strategy of the
p.000005: researchers. This division should therefore be considered from the perspective of the researcher and not that of the
p.000005: participant. Whether the recruitment of inmates as test subjects is ethically permissible for each of the three
p.000005: categories, is discussed in more detail in the ethical considerations (below).
p.000005:
p.000005:
p.000005: Opinion no. 69 of 13 February 2017 – Final version
p.000006: 6
p.000006:
p.000006: obtaining the same results in another population.
p.000006:
p.000006: 3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates,
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
p.000004: free consent to participation in scientific research. However, despite the fact that this objection cannot be made in
p.000004: general, it must be checked that each inmate is capable of granting free and informed consent. Furthermore, a
p.000004: number of specific ethical, juridical and practical issues need to be taken into account when conducting
p.000004: scientific research with this vulnerable population. These additional issues will be dealt with in this opinion.
p.000004:
p.000004: This opinion restricts itself to scientific research involving inmates, and will not address the very different issue
p.000004: of scientific research involving those who are interned. Internment falls under the domain of care, and is very
p.000004: different from conventional detention, even if
p.000004:
p.000004: 4 “[T]he following principles [can be] derived under which, besides the principles for medical
p.000004: experiments
p.000004: involving non-inmates, extra emphasis should be placed for experiments involving inmates in Belgium:
...
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
p.000009: general population. In this case, however (particularly for non-therapeutic experiments), special attention should be
p.000009: paid to the voluntary nature of the consent. In this respect, it is for example important to emphasise
p.000009: during the informed consent procedure that possible participation (or non-participation) in the research will have no
p.000009: effect on the evaluation of the inmate concerned. The Committee also recommends that the (medical) ethics committee
p.000009: responsible for issuing an opinion on the study protocol be informed of the inclusion of an inmate in the study.
p.000009: Another important condition concerns the practical feasibility of making the necessary practical arrangements (such as
p.000009: additional trips to the hospital). On the basis of the testimony given by the experts heard by the
...
p.000009: of the inmate (cf. point 1) or (2) an intended improvement of the health of, care for and/or detention conditions of
p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
...
Social / Child
Searching for indicator children:
(return to top)
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
p.000004: free consent to participation in scientific research. However, despite the fact that this objection cannot be made in
p.000004: general, it must be checked that each inmate is capable of granting free and informed consent. Furthermore, a
p.000004: number of specific ethical, juridical and practical issues need to be taken into account when conducting
p.000004: scientific research with this vulnerable population. These additional issues will be dealt with in this opinion.
p.000004:
p.000004: This opinion restricts itself to scientific research involving inmates, and will not address the very different issue
p.000004: of scientific research involving those who are interned. Internment falls under the domain of care, and is very
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
p.000004: free consent to participation in scientific research. However, despite the fact that this objection cannot be made in
p.000004: general, it must be checked that each inmate is capable of granting free and informed consent. Furthermore, a
p.000004: number of specific ethical, juridical and practical issues need to be taken into account when conducting
p.000004: scientific research with this vulnerable population. These additional issues will be dealt with in this opinion.
p.000004:
p.000004: This opinion restricts itself to scientific research involving inmates, and will not address the very different issue
p.000004: of scientific research involving those who are interned. Internment falls under the domain of care, and is very
p.000004: different from conventional detention, even if
p.000004:
p.000004: 4 “[T]he following principles [can be] derived under which, besides the principles for medical
p.000004: experiments
p.000004: involving non-inmates, extra emphasis should be placed for experiments involving inmates in Belgium:
p.000004: - the experiment cannot be conducted anywhere else, i.e. outside a prison. The scientific importance of the prison
p.000004: population should be clear as justification to participate in the experiment;
...
p.000007: detailed guidance on good clinical practices were established in Guideline 2005/28/EU which was implemented in Belgium
p.000007: in the Royal Decree of 18 May 2006.
p.000007: 10 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000007: Human Subjects (20), see also
p.000007: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
p.000007: 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
p.000007:
p.000007:
p.000007: Opinion no. 69 of 13 February 2017 – Final version
p.000008: 8
p.000008:
p.000008: people who have been deprived of their liberty.14 Other international texts which pay particular
p.000008: attention to the involvement of inmates in research are the recommendation of the Council of Europe on European prison
p.000008: rules from 200615, resolution 37-194 from the United Nations adopted by the General Assembly of 18 December
p.000008: 198216 and the Council for International Organisations of Medical Sciences (CIOMS) international ethical
p.000008: guidelines for biomedical research involving human subjects from 200317. In addition to the importance of special
p.000008: protection, this last text also highlights explicitly the risk that certain groups be systematically
p.000008: excluded from participation in research.18
p.000008:
p.000008:
p.000008: Ethical considerations
p.000008: 1. Nature of the scientific research
p.000008:
p.000008: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000008: individual inmate due to his/her health problems
p.000008: Inmates already included in an investigation before their detention can, in principle, continue participating during
p.000008: their incarceration, provided that this remains practically feasible. In this case, there are no problems
p.000008: concerning free and informed consent, given that the test subject had already consented at a time when he/she
p.000008: was not deprived of his/her freedom.
p.000008:
p.000008:
p.000008:
p.000008: 14 Additional protocol of the Convention on Human Rights and Biomedicine, on biomedical research, Strasbourg,
p.000008: 25.01.2005:
p.000008: Art. 20 – Research on persons deprived of liberty: “Where the law allows research on persons deprived of liberty, such
p.000008: persons may participate in a research project in which the results do not have the potential to produce direct
p.000008: benefit to their health only if the following additional conditions are met: i. research of comparable
p.000008: effectiveness cannot be carried out without the participation of persons deprived of liberty; ii the research has the
p.000008: aim of contributing to the ultimate attainment of results capable of conferring benefit to persons
p.000008: deprived of liberty; iii the research entails only minimal risk and minimal burden.”
p.000008: 15 Recommendation Rec (2006)2 on European prison rules: “48.1 Prisoners shall not be subjected to any
p.000008: experiments without their consent. 48.2 Experiments involving prisoners that may result in physical
p.000008: injury, mental distress or other damage to health shall be prohibited.”
p.000008: 16 Resolution 37-194 of the United Nations, adopted by the General Assembly of 18 December 1982, Principles of Medical
p.000008: Ethics relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees
p.000008: against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment: “It is a contravention of
p.000008: medical ethics for health personnel, particularly physicians, to be involved in any professional relationship with
p.000008: prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
...
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p.000002:
p.000002:
p.000002: Opinion no. 69 of 13 February 2017 – Final version
p.000002: 2
p.000002:
p.000002: Request for an opinion
p.000002:
p.000002: On 24 June 2013 Prof. Dr. D. Matthys, in his capacity as chairperson of the medical ethics committee of the University
p.000002: Hospital Gent (UZ Gent), asked the following question (in Dutch):
p.000002: “The ethics committee of the University Hospital Gent (UZ Gent) recently received a question about the
p.000002: possibility of research involving inmates in Belgian prisons.
p.000002: We are aware of the restraint involving studies in prisons and the many opinions and guidelines which
p.000002: prohibit this, both national and international. Up until the present time, this ethics committee has shared this
p.000002: opinion and delivered an unfavourable opinion on any research involving inmates.
p.000002: However, given repeated requests to conduct research with inmates and the recent approval by the Flemish government of
p.000002: the decree of 8 March 2013 regarding the organisation of assistance and services to inmates (published in the official
p.000002: state journal of 11 April 2013), the ethics committee wondered how it should best deal with this question.
p.000002: Which position should be taken with respect to research relating to healthcare in prison which
p.000002: therefore cannot be conducted elsewhere and which can contribute to an improvement of the medical care
p.000002: in detention conditions? Are there regulations on which research involving inmates is allowed, and which is
p.000002: not?
p.000002: A forensic psychiatric centre will soon be opened in our region. With the approval of the new decree of 8
p.000002: March 2013, our ethics committee expects an increase in the number of requests for research involving inmates.
p.000002: (…)”
p.000002:
p.000002: On 29 October 2013, Mrs. Laurette Onkelinx, then Minister of Social Affairs and Public Health, made the
p.000002: following similar request for an opinion on “experiments on human subjects involving the specific target
p.000002: population of detainees and those interned” to the Advisory Committee on Bioethics (in Dutch):
p.000002: “Research within the framework of the Law of 7 May 2004 on experiments on human subjects poses a fundamental
p.000002: problem for the specific target population of detainees and those interned.
p.000002: Ethical committees1 are regularly confronted with this question. Of course, it is obvious that in the case of
p.000002: participation in research, the subjects must be thoroughly informed and free and informed written consent is necessary,
p.000002: but the subjects in question find themselves, given their conviction and/or forced confinement, in
p.000002: circumstances in which they cannot completely autonomously and freely consent.
p.000002: Nevertheless, it is extremely desirable, in the interests of this target group, that scientific research be made
p.000002: possible; such research can […] have medical […] and also psychological or sociological research aims.
p.000002:
p.000002: 1 The Committee favours the term 'medical ethics committee' over 'ethics committee'.
p.000002:
p.000002: Opinion no. 69 of 13 February 2017 – Final version
p.000003: 3
p.000003:
p.000003: Since the Second World War, with the Nuremberg Code, and also on the deontological advice of the Order
p.000003: of Physicians (Orde der Geneesheren)2, such research has been the subject of much reservation, and to this day no
p.000003: special guidelines exist.
p.000003: I would like to ask you for advice on the opportunity for guidelines on this matter and concrete recommendations. It
p.000003: appears to me to be desirable that a framework be formed for scientific research that can be beneficial to these target
p.000003: groups, that can improve the health and detention circumstances, and that can have favourable implications for
p.000003: the development of care and guidance programmes leading to a possible release.
p.000003: In particular, I wish to ask you for recommendations on the question of consent, pointing out the
p.000003: possible role of prison staff in a research study and the information given. I also refer to the caution that
p.000003: must be advised if researchers wish to offer a form of reimbursement.
p.000003: (…)”
p.000003:
p.000003: The above requests were declared to be admissible at the plenary meetings of the Committee of 8 July and
p.000003: 16 December 2013.3 At the start of the Committee's fifth mandate on 8 September 2014, the requests were
p.000003: assigned to the select committee 2014-2 ‘Experiments on human subjects’, which prepared this opinion.
p.000003:
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p.000003:
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p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
...
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
p.000004: free consent to participation in scientific research. However, despite the fact that this objection cannot be made in
p.000004: general, it must be checked that each inmate is capable of granting free and informed consent. Furthermore, a
p.000004: number of specific ethical, juridical and practical issues need to be taken into account when conducting
p.000004: scientific research with this vulnerable population. These additional issues will be dealt with in this opinion.
p.000004:
p.000004: This opinion restricts itself to scientific research involving inmates, and will not address the very different issue
p.000004: of scientific research involving those who are interned. Internment falls under the domain of care, and is very
p.000004: different from conventional detention, even if
p.000004:
p.000004: 4 “[T]he following principles [can be] derived under which, besides the principles for medical
p.000004: experiments
p.000004: involving non-inmates, extra emphasis should be placed for experiments involving inmates in Belgium:
p.000004: - the experiment cannot be conducted anywhere else, i.e. outside a prison. The scientific importance of the prison
p.000004: population should be clear as justification to participate in the experiment;
p.000004: - the results contribute indisputably to an improvement of the medical care in detention circumstances;
p.000004: - the problem of consent is to be approached with the necessary caution, in order to avoid any form
p.000004: of coercion;
p.000004: - all relevant information regarding the aims and the course of the experiment is to be shared with
p.000004: the
p.000004: inmates.”
p.000004: (identifying mark of the letter: 102579/BD/TG/fd/CNR 082 13)
p.000004: 5 Shirkey H. Therapeutic orphans. J Pediatr 1968;72(1):119-120.
p.000004:
p.000004:
p.000004: Opinion no. 69 of 13 February 2017 – Final version
p.000005: 5
p.000005:
p.000005: internees also reside inside prison walls. The rules for scientific research also strongly differ between the two
p.000005: groups. The Committee emphasises that the findings of this opinion do not apply to those who are interned.
p.000005:
p.000005: This opinion distinguishes between three categories of scientific research. For each of these categories, various
p.000005: juridical considerations are first presented, followed by a clarification of the various ethical issues.
p.000005:
p.000005:
p.000005: Nature of the scientific research
p.000005:
p.000005: The desirability and acceptability of scientific research involving inmates depends to a large extent on the nature
p.000005: and purpose of the research. Depending on the recruiting strategy6 used, such research can concern: (1)
p.000005: studies which do not explicitly aim to recruit inmates as subjects, but which are relevant for an individual inmate due
p.000005: to his/her health problems; (2) studies which explicitly aim to (partly) recruit from the subject population of
p.000005: inmates, with the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000005: insights necessary for this purpose; or (3) studies which explicitly aim to (partly) recruit from the
p.000005: subject population of inmates, without the aim of improving the health of, care for and/or detention
p.000005: conditions of inmates or of acquiring the insights necessary for this purpose.
p.000005:
p.000005: 1. Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000005: individual inmate due to his/her health problems
p.000005: This includes investigations which are not set up with the intention of including inmates, but for which inmates can
...
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
p.000007: research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the
p.000007: knowledge, practices or interventions that results from the research.”10
p.000007:
p.000007: The relevant legislation on the prison system and the legal status of inmates does not include specific
p.000007: rules on the participation of inmates in scientific research either.11 It does provide for the establishment of
p.000007: a Penitentiary Health Council, composed of doctors, dentists and nurses attached to the prison, who advise the
p.000007: Minister in order to promote the quality of healthcare in the best interests of the inmate patient (Art. 98). Under
p.000007: Article 3 of the Royal Decree of 12 December 2005, this Council also provides advice on requests for medical
p.000007: scientific research with due regard for ethical principles and for the possibilities inside prisons (Art. 3,
p.000007: §2, 6°).12
p.000007:
p.000007: In addition to the Human Subjects Experiments Law, there exist a number of international law rules which are not
p.000007: legally binding. The already mentioned Code of Nuremberg13 is an authoritative source of inspiration for the
p.000007: legislation in many countries. This is also the case for the Oviedo Convention which has not been signed by Belgium,
p.000007: which in Article 20 of its additional protocol on biomedical research includes a specific provision for
p.000007: research on
p.000007:
p.000007: 9 Article 10, as introduced by Article 1 of the Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004
p.000007: setting out implementation measures for the Human Persons Experiments Law, BS 26 May 2006, 26727. The principles and
p.000007: detailed guidance on good clinical practices were established in Guideline 2005/28/EU which was implemented in Belgium
p.000007: in the Royal Decree of 18 May 2006.
p.000007: 10 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000007: Human Subjects (20), see also
p.000007: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
p.000007: 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
p.000007:
p.000007:
p.000007: Opinion no. 69 of 13 February 2017 – Final version
p.000008: 8
p.000008:
p.000008: people who have been deprived of their liberty.14 Other international texts which pay particular
p.000008: attention to the involvement of inmates in research are the recommendation of the Council of Europe on European prison
p.000008: rules from 200615, resolution 37-194 from the United Nations adopted by the General Assembly of 18 December
p.000008: 198216 and the Council for International Organisations of Medical Sciences (CIOMS) international ethical
p.000008: guidelines for biomedical research involving human subjects from 200317. In addition to the importance of special
p.000008: protection, this last text also highlights explicitly the risk that certain groups be systematically
p.000008: excluded from participation in research.18
p.000008:
p.000008:
p.000008: Ethical considerations
p.000008: 1. Nature of the scientific research
p.000008:
p.000008: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000008: individual inmate due to his/her health problems
p.000008: Inmates already included in an investigation before their detention can, in principle, continue participating during
p.000008: their incarceration, provided that this remains practically feasible. In this case, there are no problems
p.000008: concerning free and informed consent, given that the test subject had already consented at a time when he/she
p.000008: was not deprived of his/her freedom.
p.000008:
p.000008:
p.000008:
p.000008: 14 Additional protocol of the Convention on Human Rights and Biomedicine, on biomedical research, Strasbourg,
p.000008: 25.01.2005:
p.000008: Art. 20 – Research on persons deprived of liberty: “Where the law allows research on persons deprived of liberty, such
p.000008: persons may participate in a research project in which the results do not have the potential to produce direct
p.000008: benefit to their health only if the following additional conditions are met: i. research of comparable
p.000008: effectiveness cannot be carried out without the participation of persons deprived of liberty; ii the research has the
p.000008: aim of contributing to the ultimate attainment of results capable of conferring benefit to persons
p.000008: deprived of liberty; iii the research entails only minimal risk and minimal burden.”
p.000008: 15 Recommendation Rec (2006)2 on European prison rules: “48.1 Prisoners shall not be subjected to any
p.000008: experiments without their consent. 48.2 Experiments involving prisoners that may result in physical
p.000008: injury, mental distress or other damage to health shall be prohibited.”
p.000008: 16 Resolution 37-194 of the United Nations, adopted by the General Assembly of 18 December 1982, Principles of Medical
p.000008: Ethics relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees
p.000008: against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment: “It is a contravention of
p.000008: medical ethics for health personnel, particularly physicians, to be involved in any professional relationship with
p.000008: prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
...
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
p.000009: general population. In this case, however (particularly for non-therapeutic experiments), special attention should be
p.000009: paid to the voluntary nature of the consent. In this respect, it is for example important to emphasise
p.000009: during the informed consent procedure that possible participation (or non-participation) in the research will have no
p.000009: effect on the evaluation of the inmate concerned. The Committee also recommends that the (medical) ethics committee
p.000009: responsible for issuing an opinion on the study protocol be informed of the inclusion of an inmate in the study.
p.000009: Another important condition concerns the practical feasibility of making the necessary practical arrangements (such as
p.000009: additional trips to the hospital). On the basis of the testimony given by the experts heard by the
p.000009: Advisory Committee on Bioethics, it appears that there is a strong commitment on the part of the prison system to
p.000009: facilitate participation (or the continuation of participation) in scientific research, where possible.
p.000009:
p.000009:
p.000009: 1.2. Scientific research which explicitly aims to recruit (partly) from the subject population of
p.000009: inmates, with the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000009: insights necessary for this purpose
p.000009: Some problems, including medical, psycho(patho)logical, social or criminological, which are possibly related to
p.000009: incarceration or which are clearly more common in inmates than in the general population, are relevant for the
p.000009: population of inmates.
p.000009:
p.000009: As a consequence, there exists sufficient legitimation for such research, which can then receive the
p.000009: approval of an ethics committee provided that the relevant ethical issues are adequately identified and
p.000009: addressed in the submitted research protocol. It goes without saying that written, free and informed consent
p.000009: from each individual participant is essential.
p.000009:
p.000009:
p.000009: 1.3. Scientific research which explicitly aims to recruit (partly) from the subject population of
p.000009: inmates, without the aim of improving the health of, care for and/or detention conditions of inmates or
p.000009: of acquiring the insights necessary for this purpose
p.000009: The Committee is of the opinion that in the absence of a link between the research and (1) the individual care problem
p.000009: of the inmate (cf. point 1) or (2) an intended improvement of the health of, care for and/or detention conditions of
...
p.000010: attention (cf. point 5).
p.000010:
p.000010:
p.000010: 4. Reimbursement of expenses in connection with participation in research
p.000010: The purpose of this reimbursement is to compensate the expenses incurred or the loss of income suffered by the test
p.000010: subject as a result of his/her participation in an experiment or
p.000010:
p.000010: Opinion no. 69 of 13 February 2017 – Final version
p.000011: 11
p.000011:
p.000011: research study. (Medical) ethics committees are to ensure that this reimbursement of expenses covers
p.000011: realistic expenses, without becoming a reward. This is done in order to prevent financial and/or material
p.000011: incentives corrupting the free consent to participate in an investigation.
p.000011:
p.000011: As noted by the experts heard by the Advisory Committee on Bioethics, the granting of financial or
p.000011: material compensation or any sort of advantage to inmates is particularly delicate. Firstly, in general
p.000011: inmates do not have to incur any expenses as a result of their participation in an experiment or research study:
p.000011: for example, they do not have to travel anywhere or interrupt paid work in order to participate. Moreover,
p.000011: material and/or financial compensation for inmates is likely to weigh more quickly on the voluntary nature of consent.
p.000011: This is because, on the one hand, inmates have less opportunity to obtain similar advantages and, on the other hand,
p.000011: informal means of payment such as phone cards, cigarettes etc. are used within prison walls. Material rewards
p.000011: that would count as a modest form of compensation outside prison (such as a phone card) can de facto
p.000011: have a far greater value within prison walls.
p.000011:
p.000011:
p.000011: 5. Respect for the privacy of the inmates
p.000011: The restriction of freedom imposed on inmates has obvious implications for participation in scientific research. The
p.000011: cooperation of third parties will be required to enable participation in research, with a consequent risk of a loss of
p.000011: privacy.
p.000011:
p.000011: This risk of a loss of privacy can however be restricted to a minimum. In the first place, recruitment
p.000011: of test subjects occurs under the supervision of the prison doctor, with respect for professional secrecy. The
p.000011: inmate's consent is required so that, in the context of the recruitment for a research investigation, the
p.000011: prison doctor may consult the inmate's medical file. The Committee recommends that the relevant (medical)
p.000011: ethics committee closely monitors possible conflicts of interest regarding the prison doctor.
p.000011:
p.000011:
p.000011: 6. Evaluation by a(n) (medical) ethics committee
p.000011: Experiments and other scientific (medical) research in vulnerable populations, in this case inmates, demand a
p.000011: careful evaluation of the particular research protocol by the relevant (medical) ethics committee(s).
p.000011: However, in order to thoroughly evaluate the ethical issues related to the scientific (medical) research,
p.000011: knowledge of the specific context is required. It cannot be assumed that this knowledge will be present in
p.000011: the evaluating (medical) ethics committee(s).
p.000011:
p.000011: In order to establish whether (1) the study or investigation is relevant for the population of inmates and (2) the
p.000011: ethical issues – taking into account the specific context of research inside prison – are adequately defined
p.000011: and addressed, the Committee recommends calling upon the expertise of the prison system. After all, it must
p.000011: be ascertained whether the researchers, in striving to conduct successful and safe research, sufficiently
p.000011: take into
p.000011:
p.000011: Opinion no. 69 of 13 February 2017 – Final version
p.000012: 12
p.000012:
p.000012: account the circumstances which can differ inside prison compared to outside. For example, sometimes the continuity
p.000012: of participation should be taken into account: not all inmates reside for a sufficiently long period in (the
p.000012: same) prison, which can have an impact on the practical organisation of the experiment or investigation. This
p.000012: problem can be avoided by including a minimum detention term as inclusion criterion in the protocol.
p.000012:
p.000012: Based on the consultation of experts conducted by the Advisory Committee on Bioethics, the Penitentiary Health Council
p.000012: appears to be currently the most appropriate contact point for a (medical) ethics committee to seek the abovementioned
p.000012: external expertise. This Council is composed of doctors, psychiatrists, (psychiatric) nurses and
p.000012: representatives from administration.
p.000012:
p.000012: Such a central advisory body would have the additional advantage that an inventory would be made of all experiments and
p.000012: other scientific research involving prisons. Centrally storing this data would guarantee a uniform approach and
p.000012: prevent the unnecessary organisation of similar experiments.
p.000012:
p.000012: Finally, the Committee notes the possibility that (medical) ethics committees will have to evaluate
p.000012: research with a particular societal sensitivity, such as genetic research and research involving neuro-imaging.
p.000012:
p.000012:
p.000012: Recommendations
p.000012: The Committee unanimously makes the following recommendations. These recommendations only concern inmates, not those
p.000012: interned.
p.000012:
p.000012: 1 Participation of an inmate in scientific research should be possible for:
p.000012:
p.000012: 11 scientific research that does not explicitly aim to recruit inmates as test subjects, but which is
p.000012: relevant to an individual inmate due to his/her health problems:
...
p.000013: times. The Committee also recommends that the relevant (medical) ethics committee closely monitors possible
p.000013: conflicts of interest on the part of the third parties involved.
p.000013:
p.000013: 4 The Committee requests particular attention for correctly obtaining the free and informed consent of
p.000013: the inmate who is test subject, with special precautions when it comes to non-therapeutic research, i.e. research that
p.000013: does not aim at the direct improvement of the health of and/or the care for the individual inmate. It should also be
p.000013: made clear to the inmate that whether or not he/she participates in a scientific investigation will have
p.000013: neither a favourable nor an unfavourable effect on his/her evaluation or sentence.
p.000013:
p.000013: 5 The greatest precaution is recommended when considering granting compensation or reimbursement to inmates.
p.000013:
p.000013: 6 It is recommended that an inventory be made of the research data involving inmates in a
p.000013: centralised way, in order to strive for a uniform approach and to prevent the unnecessary duplication of
p.000013: similar research.
p.000013:
p.000013: 7 (Medical) ethics committees should ensure that they have sought the necessary expertise when
p.000013: evaluating studies involving inmates. If this expertise is not available amongst the members of the (medical)
p.000013: ethics committee, it is advisable to seek external advice from within the prison system. Support from a new
p.000013: central advisory body, as yet to be set up, for example within the Penitentiary Health Council, is
p.000013: desirable.
p.000013: ***
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Opinion no. 69 of 13 February 2017 – Final version
p.000014: 14
p.000014:
p.000014: This opinion was prepared in the select committee 2014/2, consisting of:
p.000014:
p.000014: Joint chairpersons
p.000014: Evelyne Langenaken Robert Rubens
p.000014: Joint reporters
p.000014: Wim Pinxten Steven Lierman
p.000014: Members
p.000014: André Herchuelz Julien Libbrecht Robert Nailis Stany Wens
p.000014: Member of the Bureau
p.000014: Paul Schotsmans
p.000014:
p.000014: Member of the secretariat
p.000014:
p.000014: Veerle Weltens
p.000014: Experts consulted
p.000014:
p.000014: Dr. Francis Van Mol, Honorary Chief Physician-Director of the Prison Healthcare Service
p.000014: Dr. Luc Proot, former Chairperson of the Penitentiary Health Council
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: The working documents of the select committee 2014/2 – request for opinion, personal contributions of the members,
p.000014: minutes of the meetings, documents consulted – are stored as annexes 2014/2 at the Committee's Documentation Centre,
p.000014: where they may be consulted and copied.
p.000014:
p.000014: * * *
p.000014:
p.000014: This opinion is available on the website www.health.belgium.be/bioeth, under the
p.000014: “Opinions” section.
p.000014:
p.000014: * * *
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Opinion no. 69 of 13 February 2017 – Final version
...
Searching for indicator restricted:
(return to top)
p.000009: inmates, without the aim of improving the health of, care for and/or detention conditions of inmates or
p.000009: of acquiring the insights necessary for this purpose
p.000009: The Committee is of the opinion that in the absence of a link between the research and (1) the individual care problem
p.000009: of the inmate (cf. point 1) or (2) an intended improvement of the health of, care for and/or detention conditions of
p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
p.000010: With regard to free and informed consent, a number of practical obstacles need to be taken into account when conducting
p.000010: scientific research with inmates. For example, the population of inmates is very heterogeneous, and the
p.000010: knowledge of Dutch, French and/or English cannot be generally assumed.
p.000010:
p.000010: When inmates are involved in research, particular attention should be paid to informing the test subjects. It is
p.000010: advisable to explicitly mention the fact that participation in the experiment has no influence whatsoever on the
p.000010: assessment of the behaviour of the inmate and his/her sentence, and the protection of privacy deserves special
p.000010: attention (cf. point 5).
p.000010:
p.000010:
...
p.000011: material compensation or any sort of advantage to inmates is particularly delicate. Firstly, in general
p.000011: inmates do not have to incur any expenses as a result of their participation in an experiment or research study:
p.000011: for example, they do not have to travel anywhere or interrupt paid work in order to participate. Moreover,
p.000011: material and/or financial compensation for inmates is likely to weigh more quickly on the voluntary nature of consent.
p.000011: This is because, on the one hand, inmates have less opportunity to obtain similar advantages and, on the other hand,
p.000011: informal means of payment such as phone cards, cigarettes etc. are used within prison walls. Material rewards
p.000011: that would count as a modest form of compensation outside prison (such as a phone card) can de facto
p.000011: have a far greater value within prison walls.
p.000011:
p.000011:
p.000011: 5. Respect for the privacy of the inmates
p.000011: The restriction of freedom imposed on inmates has obvious implications for participation in scientific research. The
p.000011: cooperation of third parties will be required to enable participation in research, with a consequent risk of a loss of
p.000011: privacy.
p.000011:
p.000011: This risk of a loss of privacy can however be restricted to a minimum. In the first place, recruitment
p.000011: of test subjects occurs under the supervision of the prison doctor, with respect for professional secrecy. The
p.000011: inmate's consent is required so that, in the context of the recruitment for a research investigation, the
p.000011: prison doctor may consult the inmate's medical file. The Committee recommends that the relevant (medical)
p.000011: ethics committee closely monitors possible conflicts of interest regarding the prison doctor.
p.000011:
p.000011:
p.000011: 6. Evaluation by a(n) (medical) ethics committee
p.000011: Experiments and other scientific (medical) research in vulnerable populations, in this case inmates, demand a
p.000011: careful evaluation of the particular research protocol by the relevant (medical) ethics committee(s).
p.000011: However, in order to thoroughly evaluate the ethical issues related to the scientific (medical) research,
p.000011: knowledge of the specific context is required. It cannot be assumed that this knowledge will be present in
p.000011: the evaluating (medical) ethics committee(s).
p.000011:
...
Social / Religion
Searching for indicator conviction:
(return to top)
p.000002: Which position should be taken with respect to research relating to healthcare in prison which
p.000002: therefore cannot be conducted elsewhere and which can contribute to an improvement of the medical care
p.000002: in detention conditions? Are there regulations on which research involving inmates is allowed, and which is
p.000002: not?
p.000002: A forensic psychiatric centre will soon be opened in our region. With the approval of the new decree of 8
p.000002: March 2013, our ethics committee expects an increase in the number of requests for research involving inmates.
p.000002: (…)”
p.000002:
p.000002: On 29 October 2013, Mrs. Laurette Onkelinx, then Minister of Social Affairs and Public Health, made the
p.000002: following similar request for an opinion on “experiments on human subjects involving the specific target
p.000002: population of detainees and those interned” to the Advisory Committee on Bioethics (in Dutch):
p.000002: “Research within the framework of the Law of 7 May 2004 on experiments on human subjects poses a fundamental
p.000002: problem for the specific target population of detainees and those interned.
p.000002: Ethical committees1 are regularly confronted with this question. Of course, it is obvious that in the case of
p.000002: participation in research, the subjects must be thoroughly informed and free and informed written consent is necessary,
p.000002: but the subjects in question find themselves, given their conviction and/or forced confinement, in
p.000002: circumstances in which they cannot completely autonomously and freely consent.
p.000002: Nevertheless, it is extremely desirable, in the interests of this target group, that scientific research be made
p.000002: possible; such research can […] have medical […] and also psychological or sociological research aims.
p.000002:
p.000002: 1 The Committee favours the term 'medical ethics committee' over 'ethics committee'.
p.000002:
p.000002: Opinion no. 69 of 13 February 2017 – Final version
p.000003: 3
p.000003:
p.000003: Since the Second World War, with the Nuremberg Code, and also on the deontological advice of the Order
p.000003: of Physicians (Orde der Geneesheren)2, such research has been the subject of much reservation, and to this day no
p.000003: special guidelines exist.
p.000003: I would like to ask you for advice on the opportunity for guidelines on this matter and concrete recommendations. It
p.000003: appears to me to be desirable that a framework be formed for scientific research that can be beneficial to these target
p.000003: groups, that can improve the health and detention circumstances, and that can have favourable implications for
p.000003: the development of care and guidance programmes leading to a possible release.
p.000003: In particular, I wish to ask you for recommendations on the question of consent, pointing out the
p.000003: possible role of prison staff in a research study and the information given. I also refer to the caution that
...
p.000006: Law) does not provide specific conditions for experiments involving inmates. The new European Regulation
p.000006: 536/2014 on clinical trials on medicinal products for human use, which will become applicable in the near
p.000006: future, does not change this in any way.7
p.000006:
p.000006: As a consequence, the general conditions under which an experiment can be undertaken or continued according to Article
p.000006: 5 of the Human Subjects Experiments Law are applicable for this category of people (inmates), as well as the
p.000006: requirement of free and informed consent as intended in Article 5 of the same Law. For inmates, particular attention
p.000006: should be given to the voluntary character of the consent to participate in the experiment. This voluntary nature is
p.000006: threatened if the inmate experiences a certain pressure to participate in an experiment. Under Article 1 of the Code of
p.000006: Nuremberg, the test subject must be capable of making a free choice without the intervention of any violence,
p.000006: fraud, deception or any other form of restriction or coercion. This means that the inmates must know
p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000007: which in Article 20 of its additional protocol on biomedical research includes a specific provision for
p.000007: research on
p.000007:
p.000007: 9 Article 10, as introduced by Article 1 of the Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004
p.000007: setting out implementation measures for the Human Persons Experiments Law, BS 26 May 2006, 26727. The principles and
p.000007: detailed guidance on good clinical practices were established in Guideline 2005/28/EU which was implemented in Belgium
p.000007: in the Royal Decree of 18 May 2006.
p.000007: 10 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000007: Human Subjects (20), see also
p.000007: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
p.000007: 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
p.000007:
p.000007:
p.000007: Opinion no. 69 of 13 February 2017 – Final version
p.000008: 8
p.000008:
p.000008: people who have been deprived of their liberty.14 Other international texts which pay particular
p.000008: attention to the involvement of inmates in research are the recommendation of the Council of Europe on European prison
p.000008: rules from 200615, resolution 37-194 from the United Nations adopted by the General Assembly of 18 December
p.000008: 198216 and the Council for International Organisations of Medical Sciences (CIOMS) international ethical
p.000008: guidelines for biomedical research involving human subjects from 200317. In addition to the importance of special
p.000008: protection, this last text also highlights explicitly the risk that certain groups be systematically
p.000008: excluded from participation in research.18
p.000008:
p.000008:
p.000008: Ethical considerations
p.000008: 1. Nature of the scientific research
p.000008:
p.000008: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000008: individual inmate due to his/her health problems
p.000008: Inmates already included in an investigation before their detention can, in principle, continue participating during
p.000008: their incarceration, provided that this remains practically feasible. In this case, there are no problems
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.000006: carried out in the population of inmates, these studies belong to a third category: experiments or other
p.000006: scientific investigations which specifically focus on the target group of inmates, without the aim of improving the
p.000006: health of, care for and/or detention conditions of inmates or of acquiring the insights necessary for
p.000006: this purpose. In these studies, the recruitment of inmates is explicitly mentioned in the research protocol.
p.000006:
p.000006:
p.000006: Juridical considerations
p.000006:
p.000006: The Law of 7 May 2004 on experiments involving human subjects (henceforth: Human Subjects Experiments
p.000006: Law) does not provide specific conditions for experiments involving inmates. The new European Regulation
p.000006: 536/2014 on clinical trials on medicinal products for human use, which will become applicable in the near
p.000006: future, does not change this in any way.7
p.000006:
p.000006: As a consequence, the general conditions under which an experiment can be undertaken or continued according to Article
p.000006: 5 of the Human Subjects Experiments Law are applicable for this category of people (inmates), as well as the
p.000006: requirement of free and informed consent as intended in Article 5 of the same Law. For inmates, particular attention
p.000006: should be given to the voluntary character of the consent to participate in the experiment. This voluntary nature is
p.000006: threatened if the inmate experiences a certain pressure to participate in an experiment. Under Article 1 of the Code of
p.000006: Nuremberg, the test subject must be capable of making a free choice without the intervention of any violence,
p.000006: fraud, deception or any other form of restriction or coercion. This means that the inmates must know
p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000006: should be given to the voluntary character of the consent to participate in the experiment. This voluntary nature is
p.000006: threatened if the inmate experiences a certain pressure to participate in an experiment. Under Article 1 of the Code of
p.000006: Nuremberg, the test subject must be capable of making a free choice without the intervention of any violence,
p.000006: fraud, deception or any other form of restriction or coercion. This means that the inmates must know
p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000008: against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment: “It is a contravention of
p.000008: medical ethics for health personnel, particularly physicians, to be involved in any professional relationship with
p.000008: prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
p.000008: ethical and scientific justification to conduct research with individuals incapable of giving informed
p.000008: consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
...
Social / orphan
Searching for indicator orphaned:
(return to top)
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Opinion no. 69 of 13 February 2017 on experiments and other scientific research involving inmates
p.000002:
p.000002: Contents
p.000002: Request for an opinion Introduction
p.000002: Nature of the scientific research
p.000002: 1. Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000002: individual inmate due to his/her health problems
p.000002: 2. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, with the
p.000002: aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights necessary
p.000002: for this purpose
p.000002: 3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, without
p.000002: the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights
p.000002: necessary for this purpose
p.000002: Juridical considerations Ethical considerations
p.000002: 1. Nature of the scientific research
p.000002: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000002: individual inmate due to his/her health problems
p.000002: 1.2. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, with the
p.000002: aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights necessary
p.000002: for this purpose
p.000002: 1.3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, without
p.000002: the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the insights
p.000002: necessary for this purpose
p.000002: 2. Vulnerable subjects
p.000002: 3. Free and informed consent
p.000002: 4. Reimbursement of expenses in connection with participation in research
p.000002: 5. Respect for the privacy of the inmates
p.000002: 6. Evaluation by a(n) (medical) ethics committee
p.000002: Recommendations
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
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p.000002:
p.000002: Request for an opinion
p.000002:
p.000002: On 24 June 2013 Prof. Dr. D. Matthys, in his capacity as chairperson of the medical ethics committee of the University
p.000002: Hospital Gent (UZ Gent), asked the following question (in Dutch):
p.000002: “The ethics committee of the University Hospital Gent (UZ Gent) recently received a question about the
p.000002: possibility of research involving inmates in Belgian prisons.
p.000002: We are aware of the restraint involving studies in prisons and the many opinions and guidelines which
p.000002: prohibit this, both national and international. Up until the present time, this ethics committee has shared this
p.000002: opinion and delivered an unfavourable opinion on any research involving inmates.
p.000002: However, given repeated requests to conduct research with inmates and the recent approval by the Flemish government of
p.000002: the decree of 8 March 2013 regarding the organisation of assistance and services to inmates (published in the official
p.000002: state journal of 11 April 2013), the ethics committee wondered how it should best deal with this question.
p.000002: Which position should be taken with respect to research relating to healthcare in prison which
p.000002: therefore cannot be conducted elsewhere and which can contribute to an improvement of the medical care
p.000002: in detention conditions? Are there regulations on which research involving inmates is allowed, and which is
p.000002: not?
p.000002: A forensic psychiatric centre will soon be opened in our region. With the approval of the new decree of 8
p.000002: March 2013, our ethics committee expects an increase in the number of requests for research involving inmates.
p.000002: (…)”
p.000002:
p.000002: On 29 October 2013, Mrs. Laurette Onkelinx, then Minister of Social Affairs and Public Health, made the
p.000002: following similar request for an opinion on “experiments on human subjects involving the specific target
p.000002: population of detainees and those interned” to the Advisory Committee on Bioethics (in Dutch):
p.000002: “Research within the framework of the Law of 7 May 2004 on experiments on human subjects poses a fundamental
p.000002: problem for the specific target population of detainees and those interned.
p.000002: Ethical committees1 are regularly confronted with this question. Of course, it is obvious that in the case of
p.000002: participation in research, the subjects must be thoroughly informed and free and informed written consent is necessary,
p.000002: but the subjects in question find themselves, given their conviction and/or forced confinement, in
p.000002: circumstances in which they cannot completely autonomously and freely consent.
p.000002: Nevertheless, it is extremely desirable, in the interests of this target group, that scientific research be made
p.000002: possible; such research can […] have medical […] and also psychological or sociological research aims.
p.000002:
p.000002: 1 The Committee favours the term 'medical ethics committee' over 'ethics committee'.
p.000002:
p.000002: Opinion no. 69 of 13 February 2017 – Final version
p.000003: 3
p.000003:
p.000003: Since the Second World War, with the Nuremberg Code, and also on the deontological advice of the Order
p.000003: of Physicians (Orde der Geneesheren)2, such research has been the subject of much reservation, and to this day no
p.000003: special guidelines exist.
p.000003: I would like to ask you for advice on the opportunity for guidelines on this matter and concrete recommendations. It
p.000003: appears to me to be desirable that a framework be formed for scientific research that can be beneficial to these target
p.000003: groups, that can improve the health and detention circumstances, and that can have favourable implications for
p.000003: the development of care and guidance programmes leading to a possible release.
p.000003: In particular, I wish to ask you for recommendations on the question of consent, pointing out the
p.000003: possible role of prison staff in a research study and the information given. I also refer to the caution that
p.000003: must be advised if researchers wish to offer a form of reimbursement.
p.000003: (…)”
p.000003:
p.000003: The above requests were declared to be admissible at the plenary meetings of the Committee of 8 July and
p.000003: 16 December 2013.3 At the start of the Committee's fifth mandate on 8 September 2014, the requests were
p.000003: assigned to the select committee 2014-2 ‘Experiments on human subjects’, which prepared this opinion.
p.000003:
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p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
p.000004: certainly when this research deals with problems specific to detention. Moreover, there is no fundamental reason
p.000004: to deny them access to the possible fruits of scientific research, and it must be recognised that
p.000004: inmates are in principle competent to grant or refuse free and informed consent. The deprivation of liberty to
p.000004: which inmates are subjected in our democratic society, does not in principle exclude the possibility of
p.000004: free consent to participation in scientific research. However, despite the fact that this objection cannot be made in
p.000004: general, it must be checked that each inmate is capable of granting free and informed consent. Furthermore, a
p.000004: number of specific ethical, juridical and practical issues need to be taken into account when conducting
p.000004: scientific research with this vulnerable population. These additional issues will be dealt with in this opinion.
p.000004:
p.000004: This opinion restricts itself to scientific research involving inmates, and will not address the very different issue
p.000004: of scientific research involving those who are interned. Internment falls under the domain of care, and is very
p.000004: different from conventional detention, even if
p.000004:
p.000004: 4 “[T]he following principles [can be] derived under which, besides the principles for medical
p.000004: experiments
p.000004: involving non-inmates, extra emphasis should be placed for experiments involving inmates in Belgium:
p.000004: - the experiment cannot be conducted anywhere else, i.e. outside a prison. The scientific importance of the prison
p.000004: population should be clear as justification to participate in the experiment;
p.000004: - the results contribute indisputably to an improvement of the medical care in detention circumstances;
p.000004: - the problem of consent is to be approached with the necessary caution, in order to avoid any form
p.000004: of coercion;
p.000004: - all relevant information regarding the aims and the course of the experiment is to be shared with
p.000004: the
p.000004: inmates.”
p.000004: (identifying mark of the letter: 102579/BD/TG/fd/CNR 082 13)
p.000004: 5 Shirkey H. Therapeutic orphans. J Pediatr 1968;72(1):119-120.
p.000004:
p.000004:
p.000004: Opinion no. 69 of 13 February 2017 – Final version
p.000005: 5
p.000005:
p.000005: internees also reside inside prison walls. The rules for scientific research also strongly differ between the two
p.000005: groups. The Committee emphasises that the findings of this opinion do not apply to those who are interned.
p.000005:
p.000005: This opinion distinguishes between three categories of scientific research. For each of these categories, various
p.000005: juridical considerations are first presented, followed by a clarification of the various ethical issues.
p.000005:
p.000005:
p.000005: Nature of the scientific research
p.000005:
p.000005: The desirability and acceptability of scientific research involving inmates depends to a large extent on the nature
p.000005: and purpose of the research. Depending on the recruiting strategy6 used, such research can concern: (1)
p.000005: studies which do not explicitly aim to recruit inmates as subjects, but which are relevant for an individual inmate due
p.000005: to his/her health problems; (2) studies which explicitly aim to (partly) recruit from the subject population of
p.000005: inmates, with the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000005: insights necessary for this purpose; or (3) studies which explicitly aim to (partly) recruit from the
p.000005: subject population of inmates, without the aim of improving the health of, care for and/or detention
p.000005: conditions of inmates or of acquiring the insights necessary for this purpose.
p.000005:
p.000005: 1. Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000005: individual inmate due to his/her health problems
p.000005: This includes investigations which are not set up with the intention of including inmates, but for which inmates can
p.000005: be included – before or during their detention – due to a concrete syndrome or care issue. An example is an
p.000005: oncological study in which an inmate as cancer patient wishes to (continue to) participate because of his/her illness.
p.000005: Neither the request to participate nor the research design are in this case related to the detention, but are related
p.000005: to the health problem for which they receive (medical) attention.
p.000005:
p.000005: 2. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates, with
p.000005: the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000005: insights necessary for this purpose
p.000005: Some problems – medical, psycho(patho)logical, social or criminological – can be related to detention or manifest
p.000005: themselves more frequently amongst inmates than the general population. Research on such problems, with as
p.000005: ultimate goal the improvement of the health of, care for and/or detention circumstances of inmates, is evidently in the
p.000005: best interests of the population in which the research will be conducted. There is also no possibility of
p.000005:
p.000005: 6 This division in three categories is based on the intentions and recruiting strategy of the
p.000005: researchers. This division should therefore be considered from the perspective of the researcher and not that of the
p.000005: participant. Whether the recruitment of inmates as test subjects is ethically permissible for each of the three
p.000005: categories, is discussed in more detail in the ethical considerations (below).
p.000005:
p.000005:
p.000005: Opinion no. 69 of 13 February 2017 – Final version
p.000006: 6
p.000006:
p.000006: obtaining the same results in another population.
p.000006:
p.000006: 3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates,
p.000006: without the aim of improving the health of, care for and/or detention conditions of inmates or of
p.000006: acquiring the insights necessary for this purpose
p.000006: It is possible that some researchers might see practical and methodological advantages (e.g. less variables, more
p.000006: accurate follow-up) in the inclusion of inmates, simply because of the restricted liberty imposed on inmates. If such
p.000006: studies do not focus on the improvement of the health, care or welfare of inmates, and do not have to be exclusively
p.000006: carried out in the population of inmates, these studies belong to a third category: experiments or other
p.000006: scientific investigations which specifically focus on the target group of inmates, without the aim of improving the
p.000006: health of, care for and/or detention conditions of inmates or of acquiring the insights necessary for
p.000006: this purpose. In these studies, the recruitment of inmates is explicitly mentioned in the research protocol.
p.000006:
p.000006:
p.000006: Juridical considerations
p.000006:
p.000006: The Law of 7 May 2004 on experiments involving human subjects (henceforth: Human Subjects Experiments
p.000006: Law) does not provide specific conditions for experiments involving inmates. The new European Regulation
p.000006: 536/2014 on clinical trials on medicinal products for human use, which will become applicable in the near
p.000006: future, does not change this in any way.7
...
p.000006: should be given to the voluntary character of the consent to participate in the experiment. This voluntary nature is
p.000006: threatened if the inmate experiences a certain pressure to participate in an experiment. Under Article 1 of the Code of
p.000006: Nuremberg, the test subject must be capable of making a free choice without the intervention of any violence,
p.000006: fraud, deception or any other form of restriction or coercion. This means that the inmates must know
p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
...
p.000007: research on
p.000007:
p.000007: 9 Article 10, as introduced by Article 1 of the Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004
p.000007: setting out implementation measures for the Human Persons Experiments Law, BS 26 May 2006, 26727. The principles and
p.000007: detailed guidance on good clinical practices were established in Guideline 2005/28/EU which was implemented in Belgium
p.000007: in the Royal Decree of 18 May 2006.
p.000007: 10 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000007: Human Subjects (20), see also
p.000007: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
p.000007: 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
p.000007:
p.000007:
p.000007: Opinion no. 69 of 13 February 2017 – Final version
p.000008: 8
p.000008:
p.000008: people who have been deprived of their liberty.14 Other international texts which pay particular
p.000008: attention to the involvement of inmates in research are the recommendation of the Council of Europe on European prison
p.000008: rules from 200615, resolution 37-194 from the United Nations adopted by the General Assembly of 18 December
p.000008: 198216 and the Council for International Organisations of Medical Sciences (CIOMS) international ethical
p.000008: guidelines for biomedical research involving human subjects from 200317. In addition to the importance of special
p.000008: protection, this last text also highlights explicitly the risk that certain groups be systematically
p.000008: excluded from participation in research.18
p.000008:
p.000008:
p.000008: Ethical considerations
p.000008: 1. Nature of the scientific research
p.000008:
p.000008: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000008: individual inmate due to his/her health problems
p.000008: Inmates already included in an investigation before their detention can, in principle, continue participating during
p.000008: their incarceration, provided that this remains practically feasible. In this case, there are no problems
p.000008: concerning free and informed consent, given that the test subject had already consented at a time when he/she
p.000008: was not deprived of his/her freedom.
p.000008:
p.000008:
...
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
p.000009: general population. In this case, however (particularly for non-therapeutic experiments), special attention should be
p.000009: paid to the voluntary nature of the consent. In this respect, it is for example important to emphasise
p.000009: during the informed consent procedure that possible participation (or non-participation) in the research will have no
p.000009: effect on the evaluation of the inmate concerned. The Committee also recommends that the (medical) ethics committee
p.000009: responsible for issuing an opinion on the study protocol be informed of the inclusion of an inmate in the study.
p.000009: Another important condition concerns the practical feasibility of making the necessary practical arrangements (such as
p.000009: additional trips to the hospital). On the basis of the testimony given by the experts heard by the
p.000009: Advisory Committee on Bioethics, it appears that there is a strong commitment on the part of the prison system to
p.000009: facilitate participation (or the continuation of participation) in scientific research, where possible.
p.000009:
p.000009:
p.000009: 1.2. Scientific research which explicitly aims to recruit (partly) from the subject population of
p.000009: inmates, with the aim of improving the health of, care for and/or detention conditions of inmates or of acquiring the
p.000009: insights necessary for this purpose
p.000009: Some problems, including medical, psycho(patho)logical, social or criminological, which are possibly related to
p.000009: incarceration or which are clearly more common in inmates than in the general population, are relevant for the
p.000009: population of inmates.
p.000009:
p.000009: As a consequence, there exists sufficient legitimation for such research, which can then receive the
p.000009: approval of an ethics committee provided that the relevant ethical issues are adequately identified and
p.000009: addressed in the submitted research protocol. It goes without saying that written, free and informed consent
p.000009: from each individual participant is essential.
p.000009:
p.000009:
p.000009: 1.3. Scientific research which explicitly aims to recruit (partly) from the subject population of
p.000009: inmates, without the aim of improving the health of, care for and/or detention conditions of inmates or
p.000009: of acquiring the insights necessary for this purpose
p.000009: The Committee is of the opinion that in the absence of a link between the research and (1) the individual care problem
p.000009: of the inmate (cf. point 1) or (2) an intended improvement of the health of, care for and/or detention conditions of
p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
...
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
p.000010: With regard to free and informed consent, a number of practical obstacles need to be taken into account when conducting
p.000010: scientific research with inmates. For example, the population of inmates is very heterogeneous, and the
p.000010: knowledge of Dutch, French and/or English cannot be generally assumed.
p.000010:
p.000010: When inmates are involved in research, particular attention should be paid to informing the test subjects. It is
p.000010: advisable to explicitly mention the fact that participation in the experiment has no influence whatsoever on the
p.000010: assessment of the behaviour of the inmate and his/her sentence, and the protection of privacy deserves special
p.000010: attention (cf. point 5).
p.000010:
p.000010:
p.000010: 4. Reimbursement of expenses in connection with participation in research
p.000010: The purpose of this reimbursement is to compensate the expenses incurred or the loss of income suffered by the test
p.000010: subject as a result of his/her participation in an experiment or
p.000010:
p.000010: Opinion no. 69 of 13 February 2017 – Final version
p.000011: 11
p.000011:
p.000011: research study. (Medical) ethics committees are to ensure that this reimbursement of expenses covers
p.000011: realistic expenses, without becoming a reward. This is done in order to prevent financial and/or material
p.000011: incentives corrupting the free consent to participate in an investigation.
p.000011:
p.000011: As noted by the experts heard by the Advisory Committee on Bioethics, the granting of financial or
p.000011: material compensation or any sort of advantage to inmates is particularly delicate. Firstly, in general
p.000011: inmates do not have to incur any expenses as a result of their participation in an experiment or research study:
p.000011: for example, they do not have to travel anywhere or interrupt paid work in order to participate. Moreover,
p.000011: material and/or financial compensation for inmates is likely to weigh more quickly on the voluntary nature of consent.
p.000011: This is because, on the one hand, inmates have less opportunity to obtain similar advantages and, on the other hand,
p.000011: informal means of payment such as phone cards, cigarettes etc. are used within prison walls. Material rewards
p.000011: that would count as a modest form of compensation outside prison (such as a phone card) can de facto
p.000011: have a far greater value within prison walls.
p.000011:
p.000011:
p.000011: 5. Respect for the privacy of the inmates
...
p.000011: ethics committee closely monitors possible conflicts of interest regarding the prison doctor.
p.000011:
p.000011:
p.000011: 6. Evaluation by a(n) (medical) ethics committee
p.000011: Experiments and other scientific (medical) research in vulnerable populations, in this case inmates, demand a
p.000011: careful evaluation of the particular research protocol by the relevant (medical) ethics committee(s).
p.000011: However, in order to thoroughly evaluate the ethical issues related to the scientific (medical) research,
p.000011: knowledge of the specific context is required. It cannot be assumed that this knowledge will be present in
p.000011: the evaluating (medical) ethics committee(s).
p.000011:
p.000011: In order to establish whether (1) the study or investigation is relevant for the population of inmates and (2) the
p.000011: ethical issues – taking into account the specific context of research inside prison – are adequately defined
p.000011: and addressed, the Committee recommends calling upon the expertise of the prison system. After all, it must
p.000011: be ascertained whether the researchers, in striving to conduct successful and safe research, sufficiently
p.000011: take into
p.000011:
p.000011: Opinion no. 69 of 13 February 2017 – Final version
p.000012: 12
p.000012:
p.000012: account the circumstances which can differ inside prison compared to outside. For example, sometimes the continuity
p.000012: of participation should be taken into account: not all inmates reside for a sufficiently long period in (the
p.000012: same) prison, which can have an impact on the practical organisation of the experiment or investigation. This
p.000012: problem can be avoided by including a minimum detention term as inclusion criterion in the protocol.
p.000012:
p.000012: Based on the consultation of experts conducted by the Advisory Committee on Bioethics, the Penitentiary Health Council
p.000012: appears to be currently the most appropriate contact point for a (medical) ethics committee to seek the abovementioned
p.000012: external expertise. This Council is composed of doctors, psychiatrists, (psychiatric) nurses and
p.000012: representatives from administration.
p.000012:
p.000012: Such a central advisory body would have the additional advantage that an inventory would be made of all experiments and
p.000012: other scientific research involving prisons. Centrally storing this data would guarantee a uniform approach and
p.000012: prevent the unnecessary organisation of similar experiments.
p.000012:
p.000012: Finally, the Committee notes the possibility that (medical) ethics committees will have to evaluate
p.000012: research with a particular societal sensitivity, such as genetic research and research involving neuro-imaging.
p.000012:
p.000012:
p.000012: Recommendations
p.000012: The Committee unanimously makes the following recommendations. These recommendations only concern inmates, not those
p.000012: interned.
p.000012:
p.000012: 1 Participation of an inmate in scientific research should be possible for:
p.000012:
p.000012: 11 scientific research that does not explicitly aim to recruit inmates as test subjects, but which is
p.000012: relevant to an individual inmate due to his/her health problems:
p.000012: • for inmates who were already included in an experiment or other scientific investigation prior to
p.000012: their detention, there is no problem in the area of free and informed consent, given that consent was given
p.000012: before the inmate was deprived of his/her freedom;
p.000012: • for inmates who wish to participate in an experiment or other scientific investigation during
p.000012: their detention and who are capable of giving free and informed consent, the Committee recommends
p.000012: that the (medical) ethics committee responsible for evaluating the research protocol, be informed of the
p.000012: inclusion of an inmate;
p.000012:
p.000012: 12 scientific research which explicitly aims to recruit (partly) from the population of inmates, with the aim of
p.000012: improving the health of, care for and/or detention circumstances of inmates or of acquiring the insights
p.000012: necessary for this
p.000012:
p.000012:
p.000012: Opinion no. 69 of 13 February 2017 – Final version
p.000013: 13
p.000013:
p.000013: purpose.
p.000013:
p.000013: 2 The Committee considers scientific research which explicitly aims to recruit test subjects (partly)
p.000013: from the population of inmates without the aim of improving the health of, care for and/or detention circumstances of
p.000013: inmates or of acquiring the insights necessary for this purpose, as unethical.
p.000013:
p.000013: 3 In the context of scientific research in which inmates participate, attention should be paid to the practical
p.000013: arrangements necessary, and it may be that third parties should be informed of the participation of an inmate
p.000013: in an experiment or investigation. In this case, the privacy of the inmate should be maximally respected at all
p.000013: times. The Committee also recommends that the relevant (medical) ethics committee closely monitors possible
p.000013: conflicts of interest on the part of the third parties involved.
p.000013:
p.000013: 4 The Committee requests particular attention for correctly obtaining the free and informed consent of
p.000013: the inmate who is test subject, with special precautions when it comes to non-therapeutic research, i.e. research that
p.000013: does not aim at the direct improvement of the health of and/or the care for the individual inmate. It should also be
p.000013: made clear to the inmate that whether or not he/she participates in a scientific investigation will have
p.000013: neither a favourable nor an unfavourable effect on his/her evaluation or sentence.
p.000013:
p.000013: 5 The greatest precaution is recommended when considering granting compensation or reimbursement to inmates.
p.000013:
p.000013: 6 It is recommended that an inventory be made of the research data involving inmates in a
p.000013: centralised way, in order to strive for a uniform approach and to prevent the unnecessary duplication of
p.000013: similar research.
p.000013:
...
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000009: The Committee is of the opinion that in the absence of a link between the research and (1) the individual care problem
p.000009: of the inmate (cf. point 1) or (2) an intended improvement of the health of, care for and/or detention conditions of
p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
...
Searching for indicator poverty:
(return to top)
p.000009: the inmate population or the acquisition of the insights necessary for this purpose (cf. point 2), there are
p.000009: insufficient grounds to justify conducting this research with inmates.
p.000009:
p.000009: If similar research results can be obtained in a population of less vulnerable test subjects than inmates and if the
p.000009: research aims at no specific or relevant benefit for inmates, research protocols which specifically focus on the
p.000009: inclusion of inmates lack ethical legitimacy.
p.000009:
p.000009:
p.000009:
p.000009: Opinion no. 69 of 13 February 2017 – Final version
p.000010: 10
p.000010:
p.000010: This does not preclude however, as earlier mentioned, the participation of individual inmates in a trial in the context
p.000010: of care for a health problem, provided that they are able to give free and informed consent and that the necessary
p.000010: practical arrangements can be made.
p.000010:
p.000010:
p.000010: 2. Vulnerable subjects
p.000010: Inmates are vulnerable test subjects. Not only is their freedom restricted, this population also has a higher
p.000010: concentration of people with serious psychological problems, given the often poor access to (psychiatric) healthcare,
p.000010: the high level of poverty (or disadvantage), social stigmatisation, the problem of illegal residence in Belgium, drug
p.000010: problems and narcotic use, etc.
p.000010:
p.000010: Given that the behaviour of inmates can have an impact on the length of their sentence (e.g. in the case of
p.000010: conditional release), it must be ensured that inmates do not associate participation in experiments with
p.000010: behaviour that can lead to more favourable evaluations.
p.000010:
p.000010: It must also be ensured that researchers do not prefer inmates as test subjects because of the simple assumption that
p.000010: this population, due to their restricted freedom, will be better able to comply with the protocol conditions.
p.000010:
p.000010:
p.000010: 3. Free and informed consent
p.000010: The mere fact of detention does not constitute a principle impediment to the granting of valid free and
p.000010: informed consent, and, consequently, inmates are, in principal, just as capable of giving their free and informed
p.000010: consent as citizens from the general population. Just as in the general population some people are unable to give their
p.000010: consent, so will some inmates, due to their personal situation, not be capable of giving free and informed consent, and
p.000010: will be unable to express their will.
p.000010:
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
p.000007: research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the
p.000007: knowledge, practices or interventions that results from the research.”10
p.000007:
p.000007: The relevant legislation on the prison system and the legal status of inmates does not include specific
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
p.000008: ethical and scientific justification to conduct research with individuals incapable of giving informed
p.000008: consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
p.000008: cognitive capacity. For research involving persons who are unable to consent, or whose capacity to make an informed
p.000008: choice may not fully meet the standard of informed consent, ethical review committees must distinguish between
p.000008: intervention risks that do not exceed those associated with routing medical or psychological
p.000008: examination of such persons and risks in excess of those.”
p.000008: 18 Commentary on Guideline 12: “Members of vulnerable groups also have the same entitlement to access to the benefits
p.000008: of investigational interventions that show promise of therapeutic benefit as persons not considered
p.000008: vulnerable, particularly when no superior or equivalent approaches to therapy are available.”
p.000008:
p.000008:
p.000008: Opinion no. 69 of 13 February 2017 – Final version
p.000009: 9
p.000009:
p.000009: Inmates who wish to participate in scientific research during their incarceration and who are capable of giving free
p.000009: and informed consent can, in principle, participate in the scientific study, just like citizens from the
p.000009: general population. In this case, however (particularly for non-therapeutic experiments), special attention should be
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.000003: 16 December 2013.3 At the start of the Committee's fifth mandate on 8 September 2014, the requests were
p.000003: assigned to the select committee 2014-2 ‘Experiments on human subjects’, which prepared this opinion.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
p.000007: 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
p.000007:
p.000007:
p.000007: Opinion no. 69 of 13 February 2017 – Final version
p.000008: 8
p.000008:
p.000008: people who have been deprived of their liberty.14 Other international texts which pay particular
p.000008: attention to the involvement of inmates in research are the recommendation of the Council of Europe on European prison
p.000008: rules from 200615, resolution 37-194 from the United Nations adopted by the General Assembly of 18 December
p.000008: 198216 and the Council for International Organisations of Medical Sciences (CIOMS) international ethical
p.000008: guidelines for biomedical research involving human subjects from 200317. In addition to the importance of special
p.000008: protection, this last text also highlights explicitly the risk that certain groups be systematically
p.000008: excluded from participation in research.18
p.000008:
p.000008:
p.000008: Ethical considerations
p.000008: 1. Nature of the scientific research
p.000008:
p.000008: 1.1 Scientific research which does not explicitly aim to recruit inmates as subjects, but which is relevant for an
p.000008: individual inmate due to his/her health problems
p.000008: Inmates already included in an investigation before their detention can, in principle, continue participating during
p.000008: their incarceration, provided that this remains practically feasible. In this case, there are no problems
p.000008: concerning free and informed consent, given that the test subject had already consented at a time when he/she
p.000008: was not deprived of his/her freedom.
p.000008:
p.000008:
p.000008:
p.000008: 14 Additional protocol of the Convention on Human Rights and Biomedicine, on biomedical research, Strasbourg,
p.000008: 25.01.2005:
p.000008: Art. 20 – Research on persons deprived of liberty: “Where the law allows research on persons deprived of liberty, such
p.000008: persons may participate in a research project in which the results do not have the potential to produce direct
p.000008: benefit to their health only if the following additional conditions are met: i. research of comparable
...
p.000008: deprived of liberty; iii the research entails only minimal risk and minimal burden.”
p.000008: 15 Recommendation Rec (2006)2 on European prison rules: “48.1 Prisoners shall not be subjected to any
p.000008: experiments without their consent. 48.2 Experiments involving prisoners that may result in physical
p.000008: injury, mental distress or other damage to health shall be prohibited.”
p.000008: 16 Resolution 37-194 of the United Nations, adopted by the General Assembly of 18 December 1982, Principles of Medical
p.000008: Ethics relevant to the Role of Health Personnel, particularly Physicians, in the Protection of Prisoners and Detainees
p.000008: against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment: “It is a contravention of
p.000008: medical ethics for health personnel, particularly physicians, to be involved in any professional relationship with
p.000008: prisoners or detainees the purpose of which is not solely to evaluate, protect or improve their physical and mental
p.000008: health.” (Principle 3)
p.000008: 17 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. Guideline 9: Special
p.000008: limitations on risk when research involves individuals who are not capable of giving informed consent. “When there is
p.000008: ethical and scientific justification to conduct research with individuals incapable of giving informed
p.000008: consent, the risk from research interventions that do not hold out the prospect of direct benefit for
p.000008: the individual subject should be no more likely and not greater than the risk attached to routine
p.000008: medical or psychological examination of such persons. Slight or minor increases above such risk may be permitted when
p.000008: there is an overriding scientific or medical rationale for such increases and when an ethical review committee has
p.000008: approved them.”
p.000008: Commentary on Guideline 9: “The low-risk standard: Certain individuals or groups may have limited capacity to give
p.000008: informed consent either because, as in the case of prisoners, their autonomy is limited, or because they have limited
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000003: (…)”
p.000003:
p.000003: The above requests were declared to be admissible at the plenary meetings of the Committee of 8 July and
p.000003: 16 December 2013.3 At the start of the Committee's fifth mandate on 8 September 2014, the requests were
p.000003: assigned to the select committee 2014-2 ‘Experiments on human subjects’, which prepared this opinion.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 2 Their new title is the “Orde der Artsen” (Order of Doctors).
p.000003: 3 The treatment of this request underwent delay as a consequence of the treatment of a previous request for an opinion
p.000003: (cf. Opinion no. 62) and the transition from the fourth to the fifth mandate (2014-18).
p.000003:
p.000003:
p.000003: Opinion no. 69 of 13 February 2017 – Final version
p.000004: 4
p.000004:
p.000004: Introduction
p.000004:
p.000004: As a result of various reports of unethical experiments on human subjects during the Second World War and in the
p.000004: decades since, attention to the ethical quality of medical-scientific research increased greatly and
p.000004: various guidelines for medical-scientific research involving human subjects were drafted, including the
p.000004: Nuremberg Code (1947), the Declaration of Helsinki (1964) and the Belmont Report (1979). Forced or
p.000004: unknowing participation in experiments has been historically strongly condemned, thus raising a great
p.000004: reserve with respect to scientific and medical-scientific research in populations of vulnerable subjects,
p.000004: such as (orphaned) children and inmates. Numerous guidelines, including the Code of Medical Duties (Art.
p.000004: 90), formally prohibit experiments on prisoners. The National Council of the Order of Doctors expressed in a
p.000004: letter from 19 September 2013 its opinion on the conditions4 under which medical-scientific research involving
p.000004: inmates is admissible.
p.000004:
p.000004: In the meantime, it has become clear that the lack of scientific research involving vulnerable populations can have
p.000004: important negative consequences for those who belong to these populations. When the specific problems
p.000004: facing these populations are insufficiently researched, these groups are deprived to a great extent of the
p.000004: fruits of scientific progress. As such, these groups can become 'therapeutic orphans', by analogy with the terminology
p.000004: that Shirkey5 used for the underrepresentation of children in clinical research.
p.000004:
p.000004: Inmates as a group, and possibly also as individuals, can therefore benefit from participation in scientific research,
...
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
p.000007: trials must be conducted in accordance with the Declaration of Helsinki concerning the ethical principles for medical
p.000007: research involving human subjects, adopted by the general meeting of the World Medical Association, in its last
p.000007: available edition.9 This Declaration includes general rules for the protection of vulnerable people, without
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
p.000007: research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the
p.000007: knowledge, practices or interventions that results from the research.”10
p.000007:
p.000007: The relevant legislation on the prison system and the legal status of inmates does not include specific
p.000007: rules on the participation of inmates in scientific research either.11 It does provide for the establishment of
p.000007: a Penitentiary Health Council, composed of doctors, dentists and nurses attached to the prison, who advise the
p.000007: Minister in order to promote the quality of healthcare in the best interests of the inmate patient (Art. 98). Under
p.000007: Article 3 of the Royal Decree of 12 December 2005, this Council also provides advice on requests for medical
p.000007: scientific research with due regard for ethical principles and for the possibilities inside prisons (Art. 3,
p.000007: §2, 6°).12
p.000007:
p.000007: In addition to the Human Subjects Experiments Law, there exist a number of international law rules which are not
p.000007: legally binding. The already mentioned Code of Nuremberg13 is an authoritative source of inspiration for the
p.000007: legislation in many countries. This is also the case for the Oviedo Convention which has not been signed by Belgium,
p.000007: which in Article 20 of its additional protocol on biomedical research includes a specific provision for
p.000007: research on
p.000007:
p.000007: 9 Article 10, as introduced by Article 1 of the Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004
p.000007: setting out implementation measures for the Human Persons Experiments Law, BS 26 May 2006, 26727. The principles and
p.000007: detailed guidance on good clinical practices were established in Guideline 2005/28/EU which was implemented in Belgium
p.000007: in the Royal Decree of 18 May 2006.
p.000007: 10 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000007: Human Subjects (20), see also
p.000007: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
p.000007: 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.
p.000007:
p.000007:
p.000007: Opinion no. 69 of 13 February 2017 – Final version
p.000008: 8
p.000008:
p.000008: people who have been deprived of their liberty.14 Other international texts which pay particular
p.000008: attention to the involvement of inmates in research are the recommendation of the Council of Europe on European prison
p.000008: rules from 200615, resolution 37-194 from the United Nations adopted by the General Assembly of 18 December
p.000008: 198216 and the Council for International Organisations of Medical Sciences (CIOMS) international ethical
...
General/Other / oviedo
Searching for indicator oviedo:
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p.000006: 536/2014 on clinical trials on medicinal products for human use, which will become applicable in the near
p.000006: future, does not change this in any way.7
p.000006:
p.000006: As a consequence, the general conditions under which an experiment can be undertaken or continued according to Article
p.000006: 5 of the Human Subjects Experiments Law are applicable for this category of people (inmates), as well as the
p.000006: requirement of free and informed consent as intended in Article 5 of the same Law. For inmates, particular attention
p.000006: should be given to the voluntary character of the consent to participate in the experiment. This voluntary nature is
p.000006: threatened if the inmate experiences a certain pressure to participate in an experiment. Under Article 1 of the Code of
p.000006: Nuremberg, the test subject must be capable of making a free choice without the intervention of any violence,
p.000006: fraud, deception or any other form of restriction or coercion. This means that the inmates must know
p.000006: before and during their participation that they remain free to cooperate or not, without a refusal on their part
p.000006: having any negative consequences of any sort.8 It is therefore necessary that the decision to
p.000006: participate or to withdraw from participation be completely independent from the circumstances of
p.000006: the inmate's detention, conviction or sentence. The Convention on Human Rights and Biomedicine from the Council
p.000006: of Europe (henceforth the Oviedo Convention),
p.000006:
p.000006: 7 Regulation (EU) no. 536/2014 from 16 April 2014 concerning clinical trials on medicinal products for human use and
p.000006: repealing Directive 2001/20/EC. This regulation will become applicable under Article 99 when the EU Portal and the EU
p.000006: Database have become fully functional and in particular six months after the European Commission has published a notice
p.000006: in the official Journal of the European Union.
p.000006: 8 Cf. Opinion no. 36, see chapter 3: Current ethical reflection in the human sciences, point d.
p.000006: Situation in Belgium.
p.000006:
p.000006:
p.000006: Opinion no. 69 of 13 February 2017 – Final version
p.000007: 7
p.000007:
p.000007: which has not been signed or ratified by Belgium, also emphasises the importance of the absence of any pressure or
p.000007: influence, including financial incentive, especially when dealing with those who find themselves in a vulnerable or
p.000007: dependent position such as inmates.
p.000007:
p.000007: In addition, under Article 4 of the Human Persons Experiments Law, all experiments must be designed, implemented and
p.000007: published according to the ethical and scientific quality requirements that are internationally recognised
p.000007: and that must be respected during the planning, implementation, registration and publication of the experiments,
p.000007: more specifically trials. The Royal Decree of 30 June 2004 in implementing this Law of 7 May 2004 states that clinical
...
p.000007: however specifically mentioning inmates. The Declaration considers medical research involving a vulnerable
p.000007: group to be justified only if “the research is responsive to the health needs or priorities of this group and the
p.000007: research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the
p.000007: knowledge, practices or interventions that results from the research.”10
p.000007:
p.000007: The relevant legislation on the prison system and the legal status of inmates does not include specific
p.000007: rules on the participation of inmates in scientific research either.11 It does provide for the establishment of
p.000007: a Penitentiary Health Council, composed of doctors, dentists and nurses attached to the prison, who advise the
p.000007: Minister in order to promote the quality of healthcare in the best interests of the inmate patient (Art. 98). Under
p.000007: Article 3 of the Royal Decree of 12 December 2005, this Council also provides advice on requests for medical
p.000007: scientific research with due regard for ethical principles and for the possibilities inside prisons (Art. 3,
p.000007: §2, 6°).12
p.000007:
p.000007: In addition to the Human Subjects Experiments Law, there exist a number of international law rules which are not
p.000007: legally binding. The already mentioned Code of Nuremberg13 is an authoritative source of inspiration for the
p.000007: legislation in many countries. This is also the case for the Oviedo Convention which has not been signed by Belgium,
p.000007: which in Article 20 of its additional protocol on biomedical research includes a specific provision for
p.000007: research on
p.000007:
p.000007: 9 Article 10, as introduced by Article 1 of the Royal Decree of 18 May 2006 amending the Royal Decree of 30 June 2004
p.000007: setting out implementation measures for the Human Persons Experiments Law, BS 26 May 2006, 26727. The principles and
p.000007: detailed guidance on good clinical practices were established in Guideline 2005/28/EU which was implemented in Belgium
p.000007: in the Royal Decree of 18 May 2006.
p.000007: 10 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving
p.000007: Human Subjects (20), see also
p.000007: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
p.000007: medical-research-involving-human-subjects/
p.000007: 11 See in particular the Law of 12 January 2005 on the prison system and the legal status of inmates, including a
p.000007: chapter on healthcare and health protection (chapter VII).
p.000007: 12 Royal Decree of 12 December 2005 which determines the date that Article 98 of the fundamental Law of 12 January 2005
p.000007: on the prison system and the legal status of inmates and regulating the composition, powers and functioning of the
p.000007: Penitentiary Health Council, will take effect. (BS 29 September 2005)
p.000007: 13 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp.
...
General/Other / restricted liberty
Searching for indicator restricted liberty:
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p.000005: insights necessary for this purpose
p.000005: Some problems – medical, psycho(patho)logical, social or criminological – can be related to detention or manifest
p.000005: themselves more frequently amongst inmates than the general population. Research on such problems, with as
p.000005: ultimate goal the improvement of the health of, care for and/or detention circumstances of inmates, is evidently in the
p.000005: best interests of the population in which the research will be conducted. There is also no possibility of
p.000005:
p.000005: 6 This division in three categories is based on the intentions and recruiting strategy of the
p.000005: researchers. This division should therefore be considered from the perspective of the researcher and not that of the
p.000005: participant. Whether the recruitment of inmates as test subjects is ethically permissible for each of the three
p.000005: categories, is discussed in more detail in the ethical considerations (below).
p.000005:
p.000005:
p.000005: Opinion no. 69 of 13 February 2017 – Final version
p.000006: 6
p.000006:
p.000006: obtaining the same results in another population.
p.000006:
p.000006: 3. Scientific research which explicitly aims to recruit (partly) from the subject population of inmates,
p.000006: without the aim of improving the health of, care for and/or detention conditions of inmates or of
p.000006: acquiring the insights necessary for this purpose
p.000006: It is possible that some researchers might see practical and methodological advantages (e.g. less variables, more
p.000006: accurate follow-up) in the inclusion of inmates, simply because of the restricted liberty imposed on inmates. If such
p.000006: studies do not focus on the improvement of the health, care or welfare of inmates, and do not have to be exclusively
p.000006: carried out in the population of inmates, these studies belong to a third category: experiments or other
p.000006: scientific investigations which specifically focus on the target group of inmates, without the aim of improving the
p.000006: health of, care for and/or detention conditions of inmates or of acquiring the insights necessary for
p.000006: this purpose. In these studies, the recruitment of inmates is explicitly mentioned in the research protocol.
p.000006:
p.000006:
p.000006: Juridical considerations
p.000006:
p.000006: The Law of 7 May 2004 on experiments involving human subjects (henceforth: Human Subjects Experiments
p.000006: Law) does not provide specific conditions for experiments involving inmates. The new European Regulation
p.000006: 536/2014 on clinical trials on medicinal products for human use, which will become applicable in the near
p.000006: future, does not change this in any way.7
p.000006:
p.000006: As a consequence, the general conditions under which an experiment can be undertaken or continued according to Article
p.000006: 5 of the Human Subjects Experiments Law are applicable for this category of people (inmates), as well as the
p.000006: requirement of free and informed consent as intended in Article 5 of the same Law. For inmates, particular attention
p.000006: should be given to the voluntary character of the consent to participate in the experiment. This voluntary nature is
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| children | Child |
| cioms | cioms guidelines |
| cognitive | Cognitive Impairment |
| conviction | Religion |
| dependent | Dependent |
| drug | Drug Usage |
| helsinki | declaration of helsinki |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| influence | Drug Usage |
| liberty | Incarcerated |
| military | Soldier |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| orphaned | orphan |
| oviedo | oviedo |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| restricted | Incarcerated |
| restricted liberty | restricted liberty |
| union | Trade Union Membership |
| violence | Threat of Violence |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['influence'] |
| influence | ['drug'] |
| liberty | ['prison', 'restricted'] |
| poor | ['poverty'] |
| poverty | ['poor'] |
| prison | ['liberty', 'restricted'] |
| restricted | ['liberty', 'prison'] |
Trigger Words
capacity
coercion
consent
ethics
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input