Query into the Absence of People with Disabilities in Clinical Trials | NCD 23 02

Opportunity Information: Apply for NCD 23 02

The National Council on Disability (NCD) grant opportunity titled "Query into the Absence of People with Disabilities in Clinical Trials" funds a short, focused research-and-reporting project that examines why people with disabilities (PWDs) are routinely left out of clinical research and what can be done to fix it. The core problem the opportunity highlights is that PWDs often face higher risks for many health conditions, yet clinical trials frequently do not include them in meaningful numbers. The announcement points to a striking example: Alzheimer’s trials commonly exclude people with Down syndrome, even though a very large share of people with Down syndrome are expected to develop Alzheimer’s disease or dementia by midlife. Beyond higher risk, the opportunity stresses that disability can change how diseases present, how they are managed, and how patients respond to interventions, meaning exclusion produces evidence that may not translate well to real-world clinical care for disabled patients.

A major emphasis of the opportunity is how exclusions happen in practice. The background notes that disability-related exclusions are well-documented across research and are especially common for psychiatric disabilities, substance use disorders, and intellectual disabilities. It cites patterns in eligibility criteria that screen out people based on a wide range of disability-related domains, including psychiatric history, substance use, HIV or hepatitis status, cognitive or intellectual disability, sensory disabilities (vision and hearing), mobility limitations, residence in long-term care, and speech or communication disabilities. One of the most pointed findings included in the description is that researchers often provide clear, documented justification for only a minority of these exclusions. The opportunity also calls out a common mechanism driving ongoing exclusion: vague, subjective, and reusable exclusion language that gets copied from study to study, such as exclusions based on an investigator’s opinion of whether someone is “well-motivated,” “capable,” “frail,” or otherwise “inappropriate,” as well as broad statements about any condition that could “confound” data interpretation. In other words, the opportunity is not only about explicit disability bans, but also about the gray areas that allow bias to operate unchecked.

The project is framed as both a scientific and civil rights issue. The opportunity argues that stigma and bias, paired with the broad discretion investigators have to exclude participants, predictably leads to underrepresentation of PWDs. It also describes specific examples of barriers that disproportionately impact people with intellectual disabilities, such as requiring participants to pass cognitive assessments unrelated to the study’s true requirements or requiring reading and writing when accommodations could make participation feasible. The description notes that few studies offer reasonable accommodations, even though universal design approaches for medical research have been available for years. Importantly, the announcement links exclusion to legal obligations: federally funded researchers must avoid disability discrimination under Section 504 of the Rehabilitation Act, and exclusion may also implicate Section 1557 of the Affordable Care Act, which prohibits discrimination in covered health programs and activities that receive federal financial assistance.

The main deliverable is a final public-facing report that diagnoses the problem and recommends solutions. NCD wants the contractor or recipient to address both explicit and implicit exclusion, explain the repercussions of exclusion for the disability community, clarify what legal requirements apply to clinical trial investigators and institutions, and describe consequences for failing to meet those requirements. The final report is expected to go beyond critique and lay out recommendations and “promising practices” that increase acceptance and participation of PWDs in trials. The research questions are practical and systems-oriented: how researchers, administrators, and universities can ensure meaningful participation; what practices reduce conscious and unconscious bias in trial recruitment and eligibility decisions; what federal agencies should do to ensure inclusion; why inclusion of PWDs improves the value and quality of clinical evidence; and what harms result when disabled people are not represented.

The timeline is short and structured around iterative drafts with NCD input. The total project period is six months, and the work is broken into staged deliverables: a detailed preliminary framing paper, a revised framing paper after NCD Council and staff feedback, a first draft report presenting early findings and recommendations, and then a final report capped at 100 pages (excluding endnotes and appendices). The final report must include an executive summary with key findings and recommendations, and it must contain clear sections describing methodology, all findings, and all recommendations, with recommendations organized by the entity they are directed to (for example, federal agencies versus universities or trial sponsors). In addition, the recipient must produce a brief “Report Highlights” companion document written in plain language that summarizes the scope, major findings, and recommendations and links back to the full report.

From an administrative standpoint, this is a discretionary funding opportunity from the National Council on Disability using a cooperative agreement, meaning the agency expects to be involved during the project as drafts are developed and refined. The funding opportunity number is NCD 23 02 (Assistance Listing/CFDA 92.002). Eligibility is listed as unrestricted, open to any type of entity, subject to any clarifications in the full notice. The opportunity anticipates a single award with a maximum budget of $30,000. The posting lists a creation date of February 24, 2023, and an original closing date of March 22, 2023.

Overall, the grant is designed to produce a policy-relevant, legally grounded, evidence-informed report that explains why people with disabilities are missing from clinical trials, identifies the mechanisms that allow exclusion to persist (including bias and vague eligibility criteria), and provides concrete, entity-specific recommendations to improve inclusion through accommodations, universal design, institutional practices, and federal oversight.

• The National Council on Disability in the other (see text field entitled explanation of other category of funding activity for clarification) sector is offering a public funding opportunity titled "Query into the Absence of People with Disabilities in Clinical Trials" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 92.002.
• This funding opportunity was created on Feb 24, 2023.
• Applicants must submit their applications by Mar 22, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $30,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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