1. Introduction
Increasing representation in clinical research is critical to addressing health disparities.Reference Krofah 1 Exclusion from research limits access to new treatments and clinical care provided through trials, compounding existing disparities. Efforts to increase representation in clinical research have historically focused on race and ethnicity, with more recent efforts focused on gender and age. 2 People with disabilities 3 have not generally been included. 4
The COVID-19 pandemic brought visibility to the impact of longstanding health disparities, with higher rates of severe disease and death experienced by people of color, Native Americans,Reference Hill and Artiga 5 and people with disabilities.Reference Weaver 6 This created momentum to address these disparities, including through an increased focus on representation in clinical research. 7 For the first time, disability has become part of the conversation. The inclusion of disabled people in clinical research, however, will require an intentional focus on addressing the unique barriers they face, including policies and protocols on informed consent that may unjustifiably exclude people with intellectual and other cognitive disabilities who have the capacity to consent or could with modifications. This article focuses on federal policy and legal efforts that began during the Biden administration to address these barriers, including through the use of supported decision-making in clinical research, and discusses the serious threats to, and potential opportunities for, continued progress during the Trump administration.
2. Exclusion of People with Intellectual and Cognitive Disabilities from Clinical Research
People with disabilities experience significant health disparities, including higher rates of chronic health conditions and preventable disease and shorter life expectancies.Reference Mitra 8 Yet disabled people — particularly people with intellectual and other cognitive disabilities — have been disproportionately excluded from clinical research by eligibility criteria that directly or indirectly prevent their participation. Researchers evaluating a sample of protocols found 42 percent excluded people with intellectual and cognitive disabilities, with the primary justification being concerns about capacity to consent. They also found that the vast majority of protocols (82 percent) did not explicitly allow people to use supports or modifications that would allow them to participate.Reference Plosky 9 In another study, researchers found that nearly 75 percent of clinical trials funded by the National Institutes of Health (NIH) had criteria that excluded people with intellectual disabilities for similar reasons.Reference McDonald, Schwartz and Sabatello 10
People want to participate in clinical research. One study found adults with intellectual disabilities are interested in participating in clinical research and believe their inclusion is important. They believe they can and should be able to make their own decisions about participating, including with assistance through supported decision-making.Reference McDonald 11
Exclusion from clinical research can have significant impacts. For example, people with intellectual disabilities have largely been excluded from Alzheimer’s disease research, despite the fact that 50 percent of people with Down syndrome will develop Alzheimer’s disease after age 30 and over 70 percent by age 60.Reference Norins 12 In 2021, the Centers for Medicare and Medicaid Services (CMS) proposed a national coverage policy for a new Alzheimer’s treatment that would have completely excluded people with intellectual disabilities because they had not been included in trials. CMS received over 1,800 public comments opposing the exclusion and stating that people with intellectual disabilities should have equal access to the treatment. 13 One commenter explained the long-term impacts of the exclusion:
[I]f people with Down syndrome are denied access to [the drug], there will be no evidence of its effects, no baseline data upon which to make coverage or treatment decision going forwards (sic)…. If people with Down syndrome are excluded today, there will be no way to determine whether this treatment or any of its progeny will benefit — or harm — them tomorrow. 14
In response to the comments, CMS’ final determination removed the exclusion, allowed for coverage when participating in clinical research, and required that future studies include participants representative of people with Alzheimer’s disease, including those with Down syndrome. 15
3. Frameworks for Informed Consent and Supported Decision-Making
3.1 Informed Consent
The US Department of Health and Human Services (HHS) has regulations governing the protection of people participating in research conducted, funded, or regulated by any federal agency, 16 referred to as the Common Rule. Researchers must get participants’ informed consent by providing them sufficient information, facilitating their understanding, and ensuring their decision to participate is voluntary. 17
These regulations created an ethical and legal framework in response to highly publicized abuses in research, including of people with intellectual and other cognitive disabilities. 18 In light of their history, the regulations address situations involving people who “are vulnerable to coercion or undue influence,” including “individuals with impaired decision-making capacity” for whom researchers must include “additional safeguards” to protect their “rights and welfare.” 19 The one example in the regulations of such a safeguard is the use of legally authorized representatives when individuals cannot themselves consent. 20 As scholars have recognized, these regulations may inadvertently be contributing to the exclusion of people with intellectual and other cognitive disabilities in the name of protectionism.Reference John 21
3.2 Supported Decision-Making
Supported decision-making can help people with disabilities have the legal capacity to make their own decisions with assistance, as needed, from a trusted individual(s) of their choosing who helps them understand information, consider options, and communicate their decisions. 22 It is an alternative to guardianship and other forms of substituted decision-making; in supported decision-making, the individual retains their right to make decisions. Over the last decade, the concept of supported decision-making has gained recognition by courts and in state laws and policies, with at least 39 states and the District of Columbia since 2015 passing a range of laws and policies related to the use of supported decision-making. 23 Depending on state laws and policies, it can be documented in a written agreement or used informallyReference Kohn 24 and can be used in a variety of contexts, including for healthcare decisions that require informed consent.Reference Appelbaum and Trachsel 25
To further participation of people with intellectual or other cognitive disabilities, researchers are beginning to examine how supported decision-making can be integrated into the clinical research process. One researcher discusses how it can increase the participation of people whose disabilities impact their consent capacity but who can, with supported decision-making, give informed consent.Reference Bierer 26 Another provides recommendations for implementing it in clinical research, including by educating researchers and Institutional Review Boards (IRBs) about supported decision-making laws and practices and incorporating it into clinical research protocols.Reference Silverman 27
4. Federal Policies to Increase Inclusion of Disabled People in Clinical Research
Galvanized by the health disparities and disability discrimination that became visible during the COVID-19 pandemic, the disability community advocated for federal action. The Biden administration responded with a number of policies to begin to address the health disparities experienced by disabled people, including through a focus on increasing their participation in clinical research.
4.1 Policies to Include People with Disabilities in Health Equity Initiatives, Including Clinical Research
On January 20, 2021, the first day of the Biden administration, President Biden issued Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, which identified people with disabilities as an underserved population. 28 For many federal agencies, this meant considering disability for the first time in their health equity efforts. HHS developed an Equity Action Plan to implement the Executive Order, which included increasing diversity in clinical research as a goal. 29 The plan explicitly listed disabled people as underrepresented in clinical research and identified actions to increase participation by underrepresented populations. 30
The momentum and legitimacy of the need to research and address health disparities experienced by disabled people was cemented when, driven by input and active engagement from the disability community, 31 NIH designated people with disabilities as a health disparities population in September 2023. 32 The designation means that NIH funding to address health disparities is available to disability researchers, and it encourages the inclusion of disabled people in research.
Following the designation, NIH launched an effort to develop an NIH-wide Disability Research Strategic Plan. 33 NIH held community roundtables and repeatedly heard about barriers disabled people face in participating in research. 34 In December 2024, NIH released and invited comment on a framework for the strategic plan. It includes a specific goal to “promote engagement and inclusion of people with disabilities in the … research ecosystem.” 35
To further HHS’ Equity Action Plan and comply with new requirements from Congress, the Food and Drug Administration (FDA) in June 2024 issued for comment a draft guidance regarding Diversity Action Plans, which would require research sponsors to set enrollment goals based on age, sex, race, and ethnicity, in research funded or overseen by FDA. 36 While the plans are not required by statute to include enrollment goals based on disability, FDA’s guidance noted that other factors — including disability — can create health disparities and impact access to clinical research and “encourages sponsors to consider such additional factors … when developing Diversity Action Plan goals.” 37 The FDA specifically sought comment on ways sponsors could broaden the populations covered in their plans.
4.2 Policy Efforts to Address Informed Consent for People with Intellectual and Other Cognitive Disabilities in Clinical Research
Other federal policy actions specific to informed consent aimed to help increase the participation of people with intellectual and other cognitive disabilities in clinical research. In August 2023, the FDA issued updated guidance on informed consent to IRBs, clinical investigators, and research sponsors. 38 Consistent with the Common Rule, the guidance requires “additional safeguards” in research involving people “who are likely to be vulnerable to coercion or undue influence” such as people whose intellectual or cognitive disabilities may impact their consent capacity. 39 It recommends that IRBs that regularly review protocols involving these populations include people knowledgeable about strategies for obtaining their informed consent.
The guidance makes clear that the consent capacity required to participate depends on the complexity of the study design and the level of risks and benefits. It also states that allowing people to consent on their own behalf may require modifications to the consent form and process, including strategies to “enhance consent capacity,” such as simplifying or repeating information and “involv[ing] a subject advocate or trusted family member/friend to assist when sharing information about the clinical investigation….” 40 While the guidance does not specifically use the term supported decision-making, this latter strategy can encompass it. The guidance also makes clear that when an individual, even with modifications, cannot give informed consent, a legally authorized representative may do so, with the individual remaining actively involved in decision-making to the extent they desire and are able. 41
The FDA held a public workshop on diversity in clinical trials in November 2023, which included a focus on barriers to enrollment of disabled people and considerations regarding informed consent for people with intellectual disabilities, as directed by Congress. 42 Workshop panelists discussed moving away from the current default of exclusion of people with intellectual disabilities to a presumption of inclusion, where exclusions must be justified on scientific or ethical grounds. Panelists presented research on how criteria have prevented the participation of people with intellectual disabilities and how reasonable modifications, such as plain language documents, accessible technology, and modified formats, can enable their participation. 43
Panelists also addressed strategies on informed consent for people with intellectual disabilities. They highlighted the importance of presuming competence; many people with intellectual disabilities are capable of making their own decisions, and it is a stereotype that all lack the capacity to consent. They discussed supported decision-making as both a best practice and a legal requirement. 44
NIH has similarly explored policies and best practices related to informed consent for clinical research by people with intellectual and other cognitive disabilities. In February 2024, NIH held an “ethics grand rounds” to discuss supported decision-making in researchReference Wendler and Kohn 45 and then held a two-day convening of experts in April 2024 to further explore the topic.
Finally, the National Council on Disability (NCD), an independent federal agency, issued a report in August 2024 entitled The Implicit and Explicit Exclusion of People with Disabilities in Clinical Trials. 46 It found that disability is often not included in clinical research diversity initiatives and that disabled people — particularly those with intellectual disabilities — are often inappropriately excluded by criteria that are not scientifically justified. 47 The report highlights recent federal actions, including the FDA’s informed consent guidance and workshops discussed above, and the role that federal civil rights laws can play in addressing barriers to participation, discussed below. 48
Regarding informed consent, the report found that consent documents are often unnecessarily complex and that the process often does not allow a person to receive help from caregivers in making their own decisions (a description of supported decision-making without specifically using the term) or to have a legally authorized representative provide consent. 49 The report recommends that NIH and FDA issue updated informed consent regulations and guidance encouraging researchers to include statements about available reasonable modifications, including caregiver support, in clinical trial documents. 50
5. Legal Framework to Increase Disability Participation in Clinical Research
It is not only Biden-era federal policy actions that created momentum to address the health disparities experienced by disabled people, including through inclusion in clinical research. Recent updates to civil rights regulations have also solidified a legal framework for preventing the unjustifiable exclusion of people with disabilities from clinical research.
5.1 Updated Regulations Implementing Section 504 of the Rehabilitation Act
In response to the discrimination faced by disabled people during the COVID-19 pandemic, advocates urged HHS to update its regulations implementing Section 504 of the Rehabilitation Act for the first time in nearly fifty years. Section 504 prohibits discrimination on the basis of disability for recipients of federal financial assistance. 51
In May 2024, HHS issued updated Section 504 regulations, which include provisions prohibiting discrimination in medical treatment. 52 The regulations generally prohibit discrimination in medical treatment decisions and specifically prohibit: (1) the denial of medical treatment based on bias or stereotypes, a judgment that disabled people are a burden, or a belief that disabled lives are worth less than those of people without disabilities; (2) denial of clinically appropriate treatment for a separate symptom or condition that would be provided to a similarly situated non-disabled person without an underlying disability; and (3) the provision of medical treatment that would not be provided to a non-disabled person unless it is clinically justified. 53 The definition of medical treatment is “broad and inclusive” and includes clinical research. 54
The regulations also include requirements that apply to all federally funded programs and activities, including clinical research. One such requirement is to provide “reasonable modifications in policies, practices or procedures” unless “the modification would fundamentally alter the nature of the program or activity.” 55 Covered entities also cannot use eligibility criteria that screen out disabled people, unless they can prove the criteria are necessary. 56
The preamble includes a discussion of the regulations’ application to clinical research. 57 It notes the benefits of participating in clinical research, including access to treatments that would not otherwise be available, and the harms exclusion causes, such as limiting the reach of medical innovations. It describes how exclusion of disabled people from research can violate Section 504, such as using “overly narrow eligibility criteria rooted in stereotypes, bias or misunderstanding of the capacities of people with specific disabilities” or criteria that “unnecessarily screen out people with disabilities …,” 58 making clear researchers cannot exclude people with intellectual or other cognitive disabilities based on stereotypes that they cannot provide informed consent. It states that to comply with the law, researchers must evaluate study participants on an individualized basis. 59
The regulations also discuss the requirement to provide reasonable modifications in the clinical research context. The preamble explains that supported decision-making is a type of reasonable modification. 60 With respect to clinical research, “concerns around informed consent could be addressed through a reasonable modification permitting the prospective study participant with an intellectual disability to use supported decision-making by bringing a friend or family member to help study staff explain the study risks and benefits to them.” 61
5.2 Updated Regulations Implementing Section 1557 of the Affordable Care Act
Section 1557 of the Affordable Care Act prohibits discrimination on the basis of race, color, national origin, sex, age, and disability in any health program or activity that receives federal financial assistance. 62 In April 2024, HHS released updated Section 1557 regulations, which explicitly include clinical research as a covered health program or activity. 63 The regulations prohibit research protocols that target or exclude the populations covered by the statute (including people with disabilities), unless there is a non-discriminatory justification for the criteria, 64 similar to Section 504. The Section 1557 regulations also include a requirement to make reasonable modifications, identical to Section 504. 65 While supported decision-making is not specifically mentioned in the preamble to the Section 1557 regulation, the regulations require their reasonable modification provisions to be interpreted consistent with other disability laws. 66
6. Threats and Opportunities for Advancing Inclusion of Disabled People in Clinical Research, Including Through Supported Decision-Making
Progress has been made in addressing the health disparities and discrimination faced by disabled people — including the unjustified exclusion of people with intellectual and other cognitive disabilities from clinical research — through federal policy and legal efforts during the Biden administration. With the change in administration, the question is whether progress will continue or if these recent advances will be rolled back.
6.1 Threats to Progress
The signs from the first ten months of the Trump administration signal retreat from previous efforts to increase diverse representation in clinical research. On his first day in office, President Trump rescinded Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, discussed earlier in this article for its inclusion of disability as an underserved population. 67 President Trump also issued a far-reaching Executive Order entitled Ending Radical and Wasteful Government DEI Programs and Preferencing (hereinafter DEI Executive Order). 68 The DEI Executive Order characterizes Executive Order 13985 and agencies’ Equity Plans and initiatives to implement it as “illegal” and orders the termination of all DEI programs, initiatives, and efforts across the federal government. 69
The broad reach of the DEI Executive Order became clear as federal agencies’ webpages began to be removed. Within days of the DEI Executive Order, materials related to diversity in clinical trials had been removed from the FDA’s website, including its draft guidance on Diversity Action plans.Reference Herper and Lawrence 70 In response, researchers have highlighted the scientific importance of ensuring that drugs and devices are tested on the populations who might use them, noting that they may “work differently for people of different backgrounds.” 71 A major research advocacy group stated ending efforts related to representation would “impe[de] clinical research, undermin[e] FDA’s scientific integrity and threat[en] the quality of care for all patients” and urged new FDA leadership to “stay the course in improving clinical research and patient care.”Reference Steenhuysen 72 Based on the administration’s efforts to eliminate DEI efforts over its first ten months, and its guidance to federal grantees about what constitutes unlawful discrimination, 73 it is almost certain that the FDA will not finalize its Diversity Action Plan guidance or otherwise require sponsors to ensure diverse representation in clinical research.
While the Section 504 regulations remain in force as of this writing, they too face threats. Seventeen states’ attorneys general filed a lawsuit challenging the updated Section 504 regulations. 74 While the lawsuit’s claims focus on other issues — such as the definition of disability (and whether gender dysphoria can be considered a disability) and public entities’ obligation to provide services in the most integrated setting, the plaintiffs seek to enjoin the entirety of the regulations. 75 However, even if a court were to rule in favor of the states, a court might narrow relief, leaving intact the many provisions (like those related to medical treatment and reasonable modifications) that are not directly challenged. The litigation has been on hold since the start of the Trump administration and continues to be as of this writing, with the court approving the parties’ request to pause all briefing while the administration reviews its position on the regulations. 76
The updated Section 1557 regulations are also being challenged in several lawsuits. The claims in those cases focus solely on issues related to protections on the basis of sex, not disability, and courts’ relief to date has been similarly limited to sex-related provisions. 77 As of this writing, the Trump administration has not yet taken any positions related to Section 1557’s disability provisions.
Separate from litigation, the Section 504 and 1557 regulations could be swept into the Trump administration’s deregulatory efforts. President Trump has issued several executive actions directing agencies to review all existing regulations and rescind any that are deemed burdensome, unnecessary, or unlawful. 78 In implementing this initiative, HHS issued a Request for Information (RFI) in spring 2025 seeking input on which regulations to consider rescinding, which received more than 13,000 comments. 79 As of this writing, HHS has not yet taken action rescinding regulations in response to the RFI but likely will in the coming months.
6.2 Opportunities
Despite these serious threats, there may be opportunities to continue progress. Most significant is that NIH is moving forward on developing an agency-wide Disability Research Strategic Plan. NIH continued to seek feedback after the change in administration on its Framework for Disability Health Research, which includes a focus on increasing disability participation in clinical trials and research, as discussed above. 80 NIH also continues to update a website dedicated to NIH’s Disability Health Research Program, and according to the website, NIH has established a Disability Health Research Coordinating Committee and will be launching a Disability Health Research Working Group. 81 Implementation of the Framework could provide opportunities for NIH to fund research to identify best practices and develop technical assistance resources for clinical researchers and IRBs, including around the use of supported decision-making.
NIH is engaged in several research initiatives where it could pilot the use of supported decision-making protocols to increase the participation of people with intellectual and other cognitive disabilities. For example, NIH has the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project, a cross-institute initiative focused on the health of people with Down syndrome. 82 One of the goals of the project is to increase the number of people with Down syndrome participating in clinical research. 83 Its research plan mentions the need for strategies, such as templates, “for addressing issues of consent and assent in individuals with reduced decisional capacity.” 84 Supported decision-making should be included as a strategy.
Similarly, NIH has included a focus on recruiting people with disabilities in its All of Us Research Program, an effort to build a health research database representative of the country’s population. 85 NIH has partnered with disability organizations to recruit disabled people into the program. 86 Despite a focus on disability inclusion, its current protocol excludes many people with intellectual and cognitive disabilities by requiring decisional capacity to consent to participate, without any reference to reasonable modifications like supported decision-making. 87 Despite the protocol describing the project as “minimal risk,” it explicitly excludes adults without decisional capacity as a “vulnerable population” without reference to strategies to enhance consent capacity like supported decision-making or even the use of legally authorized representatives for people who do not have capacity to consent even with reasonable modifications. 88
The current protocol includes a reference to “supported consent,” but it is defined as assistance from research staff — not a supporter chosen by the individual — and only for “individuals intellectually capable of providing informed consent [who] may require or prefer assistance with the consent process, due to physical, social, educational or other limitations.” 89 The protocol does not mention supported decision-making and notes that the program will later develop a procedure for “consent by proxy for adults without the decisional capacity to consent.” 90 With some early efforts underway, NIH should prioritize updating the All of Us protocol to allow supported decision-making and pilot its use in the initiative.
Finally, HHS’ recent guidances and initiatives related to addressing barriers to informed consent have not been withdrawn as of this writing. To advance their implementation, researchers and IRBs need technical assistance related to participation of disabled people in clinical research, including how and when to use supported decision-making. HHS’ Administration for Community Living (ACL) 91 has expertise and funds several initiatives related to supported decision-making. 92 HHS’ Office for Human Research Protections, NIH, and FDA could partner with ACL to develop best practices and provide technical assistance to the field for using supported decision-making in clinical research. Technical assistance could leverage existing resources like the Accessibility by Design toolkit, which includes a checklist for implementing supported decision-making in clinical research. 93
7. Conclusion
There has been unprecedented momentum and federal action to begin to address the health disparities experienced by people with disabilities over the last several years. Ensuring that people with all types of disabilities can participate in clinical research is critical to these efforts. Federal policy and legal efforts during the Biden administration helped make major strides to address the barriers preventing their participation, including advancing the use of supported decision-making for people whose disabilities impact their consent capacity. Incorporating supported decision-making into the clinical research process is one important step to addressing barriers for people with intellectual and other cognitive disabilities; it is a step that is not just consistent with federal policy but also required by federal law.
We are at a crossroads with the change in administrations. Progress is threatened by the Trump administration’s broader efforts to eliminate DEI initiatives and to deregulate. Yet opportunities still exist for the federal government to advance implementation of supported decision-making in clinical research through guidance, technical assistance, and best practices for the clinical research field, building off the efforts related to informed consent and disability rights laws that remain in place.
Disclosures
The author has nothing to disclose.
Open access
