Non-discriminatory research ethics. Law reform and implementation challenges in the light of the UN Convention on the Rights of Persons with Disabilities.
The main purpose of ethics regulation of human subjects research has always been to provide protection. Certain groups, such as persons with impaired capacity to provide free and informed consent, have been viewed as vulnerable to exploitation and harm, and therefore in need of particular safeguards. Recently, these safeguards have been criticised for being over-protective, hindering important research from being conducted and violating human rights law, such as the UN Convention on the Rights of Persons with Disabilities (CRPD) – a convention which grants persons with disabilities wide-ranging rights to autonomy and participation in society.
The project aims to explore how current regulations could be revised to comply with the CRPD and still provide vulnerable research participants with appropriate protection. To assist researchers, universities and others who will apply such revised rules, key implementation challenges will be identified and analysed. These concern, among other things, how "supported decision-making", a new paradigm called for by the CRPD, can be operationalised in the research context. The project is relevant to all research where informed consent is the default requirement. Its findings will be applicable to many codes of research ethics, although its focus will be on Swedish law. The project is located at the intersection of ethics and human rights law, and will combine standard methods of analysis in applied ethics with legal doctrinal method.
Final report
AIM AND DEVELOPMENT
Individuals with impaired capacity to provide free and informed consent to participation in research—have been considered vulnerable to exploitation and harm, and therefore in need of special protection. The aim of this project has been to examine whether current research ethics regulations protecting such individuals comply with the human rights guaranteed by the UN Convention on the Rights of Persons with Disabilities (CRPD)—a convention that grants persons with disabilities extensive rights to self-determination and participation in society. The project has also aimed to investigate how current regulations could be revised to better align with the CRPD while still ensuring adequate protection for vulnerable research participants. The Convention obliges ratifying states to ensure that persons with disabilities have access to the support they may need to provide consent to research participation. Accordingly, an additional objective of the project has been to identify and analyze key implementation challenges of this “support paradigm.”
The project has been interdisciplinary, involving both legal and ethical analyses. In the initial phase, we focused on the extent to which current Swedish research ethics regulation aligns with the CRPD, while the later phase concentrated on questions of potential regulatory reform and on effective decision-making support. However, many of the project’s questions were addressed in parallel throughout.
RESULTS
What have we learned? First, the project has confirmed that the Swedish Ethical Review Act, the Declaration of Helsinki, and most international research ethics regulations and codes concerning research involving human participants, in certain respects conflict with the CRPD. These conflicts relate to various aspects of research ethics protections for individuals with impaired decision-making capacity, and to different provisions of the CRPD. In simplified terms, the Convention affirms that individuals with cognitive and intellectual disabilities have the same right as others to decide for themselves whether to participate in research studies (Article 12, on equal recognition before the law), as well as the same right to be considered eligible for participation at all (Article 5, on equality and non-discrimination). Research ethics frameworks, on the other hand, generally assume that some adults lack the capacity to consent; they grant next-of-kin a problematic degree of influence; and, through their protective provisions, limit opportunities for inclusion of this group in research.
Nevertheless, it has proven difficult to determine exactly how serious these conflicts are, and precisely what reforms to the research ethics regulations would be required to achieve normative alignment. The primary reason for this ongoing uncertainty is that the CRPD is, in some key respects, difficult to interpret, and there is still considerable disagreement about its implications for the obligations of ratifying states. This means that Sweden, like other States Parties, is practically obliged to interpret the convention not only through narrowly legal interpretive methods, but also with consideration to other perspectives, particularly ethical ones.
Second, related to this interpretive space, the project has identified ways to enable greater participation and self-determination for individuals with impaired decision-making capacity without seriously compromising essential protections against harm. In some areas, this could likely be achieved through what is known as treaty-conforming interpretation—i.e., interpreting existing research ethics rules in light of the CRPD. For example, the Swedish Ethical Review Act and its preparatory works do not specify in detail what a person must be able to understand for their consent to be considered valid. Some basic information is mandated for researchers to provide to prospective participants, and the Ethical Review Authority specifies what other information is expected to be conveyed, but the legislation does not clarify what constitutes sufficiently informed consent. It would therefore be possible, without legislative amendments, to clarify—based on Sweden’s obligations under the CRPD—that research participants need only understand a subset of the information researchers are required to provide.
Among the project’s conclusions is that, in many situations, it should be sufficient for valid consent that the individual understands, roughly, that they are being asked to contribute to society’s knowledge production and that the study is not being conducted for their personal benefit; that participation is voluntary; and whatever else is necessary to assess whether there is a serious risk of harm. Full understanding of other study aspects—which researchers should likely still be obliged to disclose—may be desirable but not decisive.
Thus, in some respects, the Ethical Review Act could be reinterpreted in light of Sweden’s international commitments. In other respects, increased participation by persons with cognitive and intellectual disabilities would require actual revision of the research ethics framework—specifically, replacing unjustifiably restrictive protective rules with ones that better balance the individual’s right to protection with their right to participation. One example is the rule stating that persons with impaired decision-making capacity may only be included in research if the study cannot be conducted with individuals capable of consenting; i.e., that they may only be recruited when absolutely necessary. The project’s analysis of this provision suggests that it is, in short, overly protective and could be replaced with a rule allowing inclusion of individuals with impaired capacity even when others could have been included instead, provided that the risks and burdens involved do not exceed a certain (specified) level.
A third significant finding is that providing support to prospective research participants with decision-making disabilities involves certain specific challenges. As noted, the CRPD obliges states parties to ensure the availability of decision-making support for individuals unable to decide independently on research participation. Such support – likely to be provided by trusted individuals with a broader support mandate, rather than by persons assuming a supportive role solely in the context of research – must of course be of high quality. Particularly challenging, however, is providing adequate support in relation to aspects of research that are often misunderstood, and which individuals with cognitive and intellectual disabilities may find especially difficult to grasp correctly. The project has particularly highlighted the so-called therapeutic misconception – that research participants in clinical studies often do not fully understand that the interventions are not designed for their personal benefit but for the production of generalizable knowledge—and has examined how decision-making support must be structured to minimize the risk that persons with disabilities fall victim to this misconception. Also essential to quality assurance is ensuring that the support provided does not in practice constitute undue influence over the person with a disability. The project has therefore also analyzed how undue influence may be understood in the context of Article 12 of the CRPD, and in light of general ethical considerations.
As expected, the project has not been able to offer detailed guidance on precisely how the relevant regulations should be reformed, or exactly how new policies should be implemented. However, it has clearly pointed out that both lawmakers and research institutions have significant responsibilities in this area, and has suggested the general direction that reform efforts ought to take.
DISSEMINATION AND PUBLIC OUTREACH
The project and its findings have been presented at seminars in various academic disciplines (medical ethics, law, human rights), and at national and international conferences (Lund University Medical Ethics Conference; the IALMH (International Academy of Law and Mental Health) congress in Lyon; the IASSIDD (International Association for the Scientific Study of Intellectual and Developmental Disabilities) mini-conference “Ethics is everyone’s business”). The project was also presented to Lund University’s Council for Ethics and Academic Freedom.
During the course of the project, we have also been consulted by researchers engaged in more practice-oriented disability studies, in dialogue about the project’s questions and results.
The Ministry of Education has been informed of the need to revise the Ethical Review Act, particularly those sections that do not currently align with the CRPD, and of the importance of addressing these issues in the continued preparation of the proposed new research ethics legislation (Government Report Ds 24:21), which has recently been circulated for consultation.
Individuals with impaired capacity to provide free and informed consent to participation in research—have been considered vulnerable to exploitation and harm, and therefore in need of special protection. The aim of this project has been to examine whether current research ethics regulations protecting such individuals comply with the human rights guaranteed by the UN Convention on the Rights of Persons with Disabilities (CRPD)—a convention that grants persons with disabilities extensive rights to self-determination and participation in society. The project has also aimed to investigate how current regulations could be revised to better align with the CRPD while still ensuring adequate protection for vulnerable research participants. The Convention obliges ratifying states to ensure that persons with disabilities have access to the support they may need to provide consent to research participation. Accordingly, an additional objective of the project has been to identify and analyze key implementation challenges of this “support paradigm.”
The project has been interdisciplinary, involving both legal and ethical analyses. In the initial phase, we focused on the extent to which current Swedish research ethics regulation aligns with the CRPD, while the later phase concentrated on questions of potential regulatory reform and on effective decision-making support. However, many of the project’s questions were addressed in parallel throughout.
RESULTS
What have we learned? First, the project has confirmed that the Swedish Ethical Review Act, the Declaration of Helsinki, and most international research ethics regulations and codes concerning research involving human participants, in certain respects conflict with the CRPD. These conflicts relate to various aspects of research ethics protections for individuals with impaired decision-making capacity, and to different provisions of the CRPD. In simplified terms, the Convention affirms that individuals with cognitive and intellectual disabilities have the same right as others to decide for themselves whether to participate in research studies (Article 12, on equal recognition before the law), as well as the same right to be considered eligible for participation at all (Article 5, on equality and non-discrimination). Research ethics frameworks, on the other hand, generally assume that some adults lack the capacity to consent; they grant next-of-kin a problematic degree of influence; and, through their protective provisions, limit opportunities for inclusion of this group in research.
Nevertheless, it has proven difficult to determine exactly how serious these conflicts are, and precisely what reforms to the research ethics regulations would be required to achieve normative alignment. The primary reason for this ongoing uncertainty is that the CRPD is, in some key respects, difficult to interpret, and there is still considerable disagreement about its implications for the obligations of ratifying states. This means that Sweden, like other States Parties, is practically obliged to interpret the convention not only through narrowly legal interpretive methods, but also with consideration to other perspectives, particularly ethical ones.
Second, related to this interpretive space, the project has identified ways to enable greater participation and self-determination for individuals with impaired decision-making capacity without seriously compromising essential protections against harm. In some areas, this could likely be achieved through what is known as treaty-conforming interpretation—i.e., interpreting existing research ethics rules in light of the CRPD. For example, the Swedish Ethical Review Act and its preparatory works do not specify in detail what a person must be able to understand for their consent to be considered valid. Some basic information is mandated for researchers to provide to prospective participants, and the Ethical Review Authority specifies what other information is expected to be conveyed, but the legislation does not clarify what constitutes sufficiently informed consent. It would therefore be possible, without legislative amendments, to clarify—based on Sweden’s obligations under the CRPD—that research participants need only understand a subset of the information researchers are required to provide.
Among the project’s conclusions is that, in many situations, it should be sufficient for valid consent that the individual understands, roughly, that they are being asked to contribute to society’s knowledge production and that the study is not being conducted for their personal benefit; that participation is voluntary; and whatever else is necessary to assess whether there is a serious risk of harm. Full understanding of other study aspects—which researchers should likely still be obliged to disclose—may be desirable but not decisive.
Thus, in some respects, the Ethical Review Act could be reinterpreted in light of Sweden’s international commitments. In other respects, increased participation by persons with cognitive and intellectual disabilities would require actual revision of the research ethics framework—specifically, replacing unjustifiably restrictive protective rules with ones that better balance the individual’s right to protection with their right to participation. One example is the rule stating that persons with impaired decision-making capacity may only be included in research if the study cannot be conducted with individuals capable of consenting; i.e., that they may only be recruited when absolutely necessary. The project’s analysis of this provision suggests that it is, in short, overly protective and could be replaced with a rule allowing inclusion of individuals with impaired capacity even when others could have been included instead, provided that the risks and burdens involved do not exceed a certain (specified) level.
A third significant finding is that providing support to prospective research participants with decision-making disabilities involves certain specific challenges. As noted, the CRPD obliges states parties to ensure the availability of decision-making support for individuals unable to decide independently on research participation. Such support – likely to be provided by trusted individuals with a broader support mandate, rather than by persons assuming a supportive role solely in the context of research – must of course be of high quality. Particularly challenging, however, is providing adequate support in relation to aspects of research that are often misunderstood, and which individuals with cognitive and intellectual disabilities may find especially difficult to grasp correctly. The project has particularly highlighted the so-called therapeutic misconception – that research participants in clinical studies often do not fully understand that the interventions are not designed for their personal benefit but for the production of generalizable knowledge—and has examined how decision-making support must be structured to minimize the risk that persons with disabilities fall victim to this misconception. Also essential to quality assurance is ensuring that the support provided does not in practice constitute undue influence over the person with a disability. The project has therefore also analyzed how undue influence may be understood in the context of Article 12 of the CRPD, and in light of general ethical considerations.
As expected, the project has not been able to offer detailed guidance on precisely how the relevant regulations should be reformed, or exactly how new policies should be implemented. However, it has clearly pointed out that both lawmakers and research institutions have significant responsibilities in this area, and has suggested the general direction that reform efforts ought to take.
DISSEMINATION AND PUBLIC OUTREACH
The project and its findings have been presented at seminars in various academic disciplines (medical ethics, law, human rights), and at national and international conferences (Lund University Medical Ethics Conference; the IALMH (International Academy of Law and Mental Health) congress in Lyon; the IASSIDD (International Association for the Scientific Study of Intellectual and Developmental Disabilities) mini-conference “Ethics is everyone’s business”). The project was also presented to Lund University’s Council for Ethics and Academic Freedom.
During the course of the project, we have also been consulted by researchers engaged in more practice-oriented disability studies, in dialogue about the project’s questions and results.
The Ministry of Education has been informed of the need to revise the Ethical Review Act, particularly those sections that do not currently align with the CRPD, and of the importance of addressing these issues in the continued preparation of the proposed new research ethics legislation (Government Report Ds 24:21), which has recently been circulated for consultation.