Scientific discoveries and precision medicine research, especially efforts to identify individually tailored approaches to healthcare considering individual variability in genetics, environmental, and lifestyle factors, have the potential to transform health. This goal is especially critical for those who experience social injustices and substantial health disparities. Yet the inclusion of adults with intellectual disability in precision medicine research, a growing field in clinical and translational genomic research, raises ethical, social, and legal concerns about their ability to make informed decisions to participate, and subsequently whether this population should be excluded altogether or enrolled only via proxy consent. Both practices demand scrutiny and are sometimes without legal or ethical justification. Supported decision-making, a reasonable accommodation and relatively recent legal and ethical construct, can facilitate first-person consent and maintain the prospective participant’s position as the decision-maker. As such, supported decision-making is a promising development with critical implications for consent to precision medicine research. Using findings from our national survey with adults with intellectual disability and a legal analysis, our academic-community research partnership developed recommendations and a tool for using supported decision-making for enrollment in precision medicine research. We conclude with persistent challenges that need resolving to ensure the responsible inclusion of adults with intellectual disability in precision medicine research, and clinical research more generally.

This exploratory study aimed to empower people with serious mental illness to create and implement supported decision-making plans and study the impact on their decision-making process. We found that study participants were able to: (1) use supported decision-making once empowered to do so; (2) decide when and how to use supported decision-making; and (3) develop individualized decision-making strategies based upon their unique characteristics and situations. The adoption of supported decision-making in clinical practice, research, and policy is essential to ensure the rights and well-being of adults with decisional incapacity. In particular, integrating supported decision-making into clinical research protocols can enhance informed consent processes and promote meaningful participation of individuals with serious mental illness, balancing respect for their autonomy with appropriate protections.

This paper argues that research ethics for individuals with intellectual and developmental disabilities must attend to the value of non-domination. First, we highlight the role of domination in the history of abusive research practices against individuals with intellectual and developmental disabilities, practices which directly led to existing protections for this vulnerable population. Second, we argue that existing protections do not adequately safeguard potential participants from domination in decision-making about whether to participate. This is a distinct concern from the well-established criticisms that existing protections may wrongfully exclude potential participants. Finally, we outline and defend an account of supported decision-making grounded in the value of non-domination in order to safeguard potential participants from domination. Our account nonetheless preserves supported decision-making’s possibilities for greater inclusion of individuals with intellectual and developmental disabilities in research participation.

People with intellectual and other cognitive disabilities often face barriers to participating in clinical research, particularly related to the informed consent process. Recent federal policy and legal efforts have advanced strategies to address these challenges, including using supported decision-making. This article discusses this recent progress and the risks and potential opportunities to continuing it in a shifting federal landscape.

In recent decades, theorists of disability rights have made the moral and legal case for supported decision-making. Whereas surrogate decision-making, the long upheld legal standard, looks to a third party to make a decision for a person deemed to lack the capacity to make that decision for themselves, support in decision-making empowers that person to make their own decisions. In this article, we argue for a significant shift in the norms governing enrollment in clinical trials. Rather than assume that support is only appropriate for individuals who cannot independently make sufficiently informed enrollment decisions, we propose “support in decision-making for all” when research protocols are beyond a certain risk threshold. Drawing inspiration from the universal design movement and feminist insights about autonomy, we argue that making support in decision-making the presumption has substantial expressive and practical benefits, and better empowers all potential research participants to make more informed, autonomous decisions.

While supported decision-making for persons with dynamic cognitive impairment has been considered in the context of medical treatment, there has been little attention to its application in the context of enrolling cognitively impaired subjects in clinical research. The Common Rule allows enrollment permission from a Legally Authorized Representative, one empowered under institutional policy to provide consent for subjects lacking decision-making capacity, but many Legally Authorized Representatives lack knowledge of the person’s values and preferences adequate to an ethically valid judgement about research enrollment. Supported decision-making and surrogate decision-making can be complementary as subjects transition between impairment stages, providing an opportunity to address ethical problems with the current practice of reliance on uninformed surrogates. Through designation of a supporter who is willing to serve through the progression of impairment, dementia patients choose their supporter and ultimate surrogate, engage with them on the issues that later give rise to requests to enroll the subject in research, and ensure that the surrogate will have knowledge of the values and preferences of the subject necessary to an ethically defensible substituted judgement. Legal frameworks can be adapted to provide recognition of research enrollment as an area of valid decision by supporters on behalf of beneficiaries.

Federal disability anti-discrimination laws expect clinical trials to render study processes and sites accessible to potential participants, including through the provision of reasonable accommodations. Nonetheless, people with disabilities, and particularly people with mental illness, are often excluded from clinical trials. Supported decision-making, a strategy that allows people to select trusted others to help them understand and communicate decisions, is an important accommodation to further inclusion. However, because mental illness can be dynamic and vary widely in nature (e.g., diagnosis, symptom severity, functional impairment) and duration (e.g., short-term, intermittent, progressive, permanent), supported decision-making is neither a one-size-fits-all strategy nor one that can serve as a reasonable accommodation in every situation. While prior work on supported decision-making has focused predominantly on adults with intellectual and developmental disabilities or dementias, people with mental illness may also benefit from supported decision-making, although the variability in decision-making capacity in mental illness presents nuanced challenges. Here, we explore supported decision-making in the case of people with intermittent or episodic mental illness that may impact decision-making capacity to varying degrees at different times.

Supported decision-making is rapidly gaining attention as an alternative to guardianship and other forms of surrogate decision-making for people with cognitive disabilities. This article provides an overview of the legal status of supported decision-making in the United States, with particular attention to how states are recognizing supported decision-making in different legal contexts. It then explores how the law of supported decision-making applies to clinical research. It explains that although federal research regulations and guidance do not explicitly address formal supported decision-making, individuals may use supported decision-making to make decisions about participating in clinical research and researchers may be required to allow such use under federal laws that protect against disability discrimination. It then concludes by considering legal barriers to greater use of supported decision-making and how these barriers might be overcome.

Co-decision-making is the middle of the three new tiers of support for those whose capacity is in question or lacking under the Assisted Decision-Making (Capacity) Act 2015. In co-decision-making, decision-making authority is shared jointly between the person and their chosen co-decision-maker. Co-decision-making is a new and challenging concept and the capacity test to be applied by healthcare professional assessors is complex. I suggest that thinking about the minimum requirements for joint decision-making and about the idea of ‘partial capacity’ are helpful in determining where co-decision-making fits on a capacity spectrum. Whatever the difficulties, co-decision-making is a core support arrangement in the new law, and there is a responsibility on all seeking to support a relevant person to work to ensure it is a viable and useful option.

This paper describes the perspectives of a service user academic and a psychiatric trainee in response to their engagement in service user supervision, now offered as part of our psychological medicine education, as a feature of an innovative service user-led, recovery and human rights focused, contact-based education programme. The supervision, being deliberately focused on exploring and addressing responsiveness to the traditionally underprivileged service user’s perspective, and hence vastly different to clinical supervision, was acknowledged by the trainee as being of distinct value, translating into changes in practice, particularly in terms of addressing power imbalances, enhancing communication with patients, supporting recovery and enabling supported decision-making. The main barrier to implementation of such changes was identified as being the lack of support of senior clinicians. The active support and enablement of trainees who want to share and apply new perspectives, models and approaches being advocated, including through current training, would likely be of benefit to all.