Advancing the Inclusion of People with Disabilities in Clinical Research Challenge

Advancing the Inclusion of People with Disabilities in Clinical Research Challenge

Recognizing practices that strengthen research by preventing unnecessary exclusion.

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NIH logo from 2012

 This challenge will build collective knowledge of effective, practical strategies for including people with disabilities in clinical research and support implementation of the NIH Strategic Plan for Disability Health Research FY26-FY30. 

Submissions close 1/15/2027 5:00 pm ET

Total prizes: $1,000,000

Overview 

The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) within the National Institutes of Health (NIH) Office of the Director (OD) announces the Advancing the Inclusion of People with Disabilities in Clinical Research Challenge. Through its Disability Health Research Program (DHRP), DPCPSI leads the strategic coordination of disability health research across NIH. In partnership with the National Cancer Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute on Deafness and Other Communication Disorders, National Institute on Minority Health and Health Disparities, National Institute of Nursing Research, and NIH Office of Disease Prevention, DPCPSI seeks to identify, recognize, and disseminate exemplary approaches to promoting the inclusion of people with disabilities in clinical research. The total prize purse from NIH for this Challenge is $1,000,000. 

Subject of the Challenge 

More than one in four people in the United States has a disability,1 and nearly all Americans will experience disability at some point in their lives. Despite constituting a large portion of the American population, people with disabilities are often implicitly or explicitly excluded from being participants in clinical research without adequate scientific justification. This occurs explicitly due to unnecessarily restrictive eligibility criteria and implicitly due to factors like inaccessible study procedures and incorrect assumptions about disabled people’s capacity to consent or participate in research. Excluding people with disabilities from clinical research without adequate scientific justification violates federal regulations and ethical research principles, undermines the generalizability of research findings, and prevents people with disabilities from receiving the benefits of participating in clinical research (e.g., access to cutting-edge diagnostics and interventions).2,3 

When people with disabilities are appropriately included, clinical research is strengthened. People with disabilities experience many of the conditions under study, often at higher rates than people without disabilities,4 and their participation produces evidence that better reflects the populations that new interventions are intended to serve. Studies that enroll people with disabilities also capture safety and efficacy data across real-world variation in function, comorbidity, and concurrent medication use before interventions reach clinical practice rather than after. The accessibility practices that support the participation of people with disabilities, such as plain language consent materials and flexible study procedures, tend to improve comprehension, participation, and data quality for all participants.5-7 

In 2026, NIH released the inaugural NIH Strategic Plan for Disability Health Research, FY26-FY30, which identifies the inclusion of people with disabilities in research as a crosscutting theme and commits NIH to developing programs, policies, and resources that maximize the participation of people with disabilities in clinical research.8 This includes ensuring that disabled people can use reasonable accommodations, such as alternative consent formats and supported decision-making, during the informed consent process. The plan also recognizes that inclusion involves more than enrollment. Exemplary approaches account for the needs, experiences, and perspectives of disabled people at every stage of a study, from planning and design through the conduct of research and the communication of results, and they are developed in partnership with people with disabilities, their families, and their care partners. 

As the goal of the Challenge is broad adoption of exemplary approaches, submissions should include documents suitable for public dissemination, such as best practice resources, study protocols, standard operating procedures, toolkits, and training materials. In addition to receiving cash prizes, winners will have their materials publicly disseminated by NIH as models for investigators, institutions, sponsors, and institutional review boards across the clinical research enterprise. The Challenge will build collective knowledge of effective, practical strategies for including people with disabilities in clinical research and support implementation of the NIH Strategic Plan for Disability Health Research FY26-FY30. 

Statutory Authority to Conduct the Challenge 

DPCPSI is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. The mission of DPCPSI, as established by the NIH Reform Act of 2006 (P.L. 109-482), is to advance biomedical and behavioral science through crosscutting, innovative strategies that foster collaboration and synergies across NIH. This Challenge is consistent with and promotes that mission by identifying, recognizing, and disseminating exemplary approaches to promoting the inclusion of people with disabilities in clinical research across NIH’s portfolio. 

References 

  1. CDC data shows over 70 million US adults reported having a disability. News release. Centers for Disease Control and Prevention. July 16, 2024. Accessed June 1, 2026. https://www.cdc.gov/media/releases/2024/s0716-Adult-disability.html 
  2. DeCormier Plosky W, Ne’eman A, Silverman BC, Strauss DH, Francis LP, Stein MA, Bierer BE. Excluding people with disabilities from clinical research: eligibility criteria lack clarity and justification. Health Aff (Millwood). 2022;41(10):1423–1432. doi:10.1377/hlthaff.2022.00520. 
  3. National Council on Disability. The Implicit and Explicit Exclusion of People with Disabilities in Clinical Trials. Washington, DC: NCD; August 14, 2024. 
  4. Krahn GL, Walker DK, Correa-De-Araujo R. Persons with disabilities as an unrecognized health disparity population. Am J Public Health. 2015;105(Suppl 2):S198–S206. doi:10.2105/AJPH.2014.302182. 
  5. Williams AS, Moore SM. Universal design of research: inclusion of persons with disabilities in mainstream biomedical studies. Sci Transl Med. 2011;3(82):82cm12. doi:10.1126/scitranslmed.3002133. 
  6. Rios D, Magasi S, Novak C, Harniss M. Conducting accessible research: including people with disabilities in public health, epidemiological, and outcomes studies. Am J Public Health. 2016;106(12):2137–2144. doi:10.2105/AJPH.2016.303448. 
  7. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14:28. doi:10.1186/1472-6939-14-28. 
  8. National Institutes of Health. NIH Strategic Plan for Disability Health Research, FY26-FY30. Bethesda, MD: NIH; 2026. 

Dates

Challenge Launch: September 28, 2026 

Submission Start/End: September 28, 2026 – January 15, 2027 

Judging Start/End: January 20, 2027 – February 26, 2027 

Winner Announced: March 25, 2027 

Prizes

The total prize purse for the Challenge is $1,000,000. NIH anticipates awarding cash prizes of $50,000 for up to twenty winners. 

In addition to cash awards, prize-winning resources will be publicly amplified and disseminated by NIH for use by researchers and research institutions. 

Award Approving Official: 

The Award Approving Official will be the Director, DPCPSI, or as otherwise delegated, within the NIH Office of the Director. 

Payment of the Prize: 

Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. 

Entities participating in this Challenge are encouraged, but not required, to request and obtain a free Unique Entity ID (UEI), if they have not already done so, via SAM.gov as this will expedite prize payment. Additional information can be found at https://sam.gov/content/entity-registration. 

If participating as a Team, in the event of winning a cash prize, the Team Leader shall be paid the prize in full and is solely responsible for allocating any prize amount among the members of the Team. If participating as an Entity, in the event of winning a cash prize, the prize will be paid directly to the Entity, not the Entity Point of Contact. NIH will not arbitrate, intervene, advise on, or resolve any matters between team members. 

NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, or any part of it, for any reason, and/or (b) not award any prizes if no submissions are deemed worthy. 

Rules

Eligibility Rules: 

To be eligible to win a prize under this Challenge, a Participant (whether an individual, team, or entity) —  

  1. Shall have registered to participate in the Challenge under the rules promulgated by the National Institutes of Health (NIH) as published in this announcement;  
  2. Shall have complied with all the requirements set forth in this announcement;  
  3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced. 
  4. Shall not be a federal entity or federal employee acting within the scope of their employment;  
  5. Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity;  
  6. Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge; 
  7. Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).  
  8.  Shall be 18 years of age or older at the time of submission. 

Participation Rules: 

  1. Participants (whether individuals, team or entities) may not use federal funds from a grant award or cooperative agreement to develop their Challenge submissions or to fund efforts in support of their Challenge submissions. 
  2. Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.  
  3. By participating in this Challenge, each Participant (whether an individual, team, or entity) agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise. 
  4. Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no Participant (whether an individual, team or entity) participating in the Challenge is required to obtain liability insurance, or demonstrate financial responsibility, or agree to indemnify the federal government against third party claims for damages arising from or related to Challenge activities in order to participate in this Challenge. 
  5. A Participant (whether an individual, team, or entity) shall not be deemed ineligible because the Participant used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Participants participating in the Challenge on an equitable basis. 
  6. By participating in this Challenge, each Participant (whether an individual, team, or entity) warrants that they are sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the Participant (or is an improved version of an existing work that the Participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the Participant is aware. 
  7. By participating in this Challenge, each Participant (whether an individual, team, or entity) grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the submission on the web or elsewhere, and a nonexclusive, nontransferable, irrevocable, paid-up license to practice, or have practiced for or on its behalf, the solution throughout the world. Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Participant’s rights to the federal government. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH, but Participants must grant to the federal government the nonexclusive licenses recited herein. 
  8. Each Participant (whether an individual, team, or entity) agrees to follow all applicable federal, state, and local laws, regulations, and policies. 
  9. Each Participant (whether an individual, team, or entity) participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein. 
  10. As a condition for winning a cash prize in this Challenge, each Participant (whether an individual, team, or entity) that has been selected as a winner must complete and submit all requested winner verification and payment documents to NIH within 10 business days of formal notification. Failure to return all required verification documents by the date specified in the notification may be a basis for disqualification of a cash prize winning submission. 

Judging Criteria

Submissions will be evaluated by a Review Panel composed of individuals with subject matter expertise in disability health research using the Review Criteria listed below. The Review Panel will individually evaluate each submission, with each criterion being rated on a five-point scale from “not at all” to “completely.” Ratings across criteria will be combined to produce a score for each submission that is provided to the Judging Panel. The Judging Panel, composed of federal employees from NIH and potentially other agencies, will select the winners pending final award decision approval by the Award Approving Official. 

Review Criteria 

  • Completeness and Clarity of the Submission. The extent to which the submission clearly and fully describes the approach, including its goals, the specific barriers to inclusion it addresses, the strategies and methods used, and the clinical research context and population(s) reached. 

  • Relevance to Disability Inclusion in Clinical Research. The extent to which the approach directly and substantively addresses recognized barriers to including people with disabilities in clinical research, such as restrictive eligibility criteria, inaccessible study sites or materials, informed consent, reasonable accommodations, or communication access. 

  • Meaningful Engagement of People with Disabilities. The extent to which people with lived experience of disability were meaningfully involved in designing, implementing, or governing the approach, and the degree to which the approach reflects the diversity of disability types and intersecting identities. 

  • Demonstrated Effectiveness and Impact. The extent to which the submission provides evidence that the approach has been implemented and has improved the recruitment, accommodation, participation, experience, or retention of people with disabilities in clinical research. 

  • Potential for Dissemination, Adaptation, and Sustainability. The extent to which the approach can be adopted, adapted, scaled, and sustained by other investigators, institutions, or research settings, including evidence of transferability, supporting resources or tools, and demonstrated interest or need in the research community. 

How to Enter

Registration and Submission Process 

The registration and submission portal for the Advancing the Inclusion of People with Disabilities in Clinical Research Challenge is available at https://disabilityinresearch.org.

During the registration process, participants will be required to identify whether they are registering to compete in this Challenge as one of the following: as an Individual (i.e., on behalf of yourself), a Team (i.e., registering as a group of individuals competing together but not on behalf of an established organization, institution, or corporation), or as an Entity (i.e., registering as a group of individuals competing together on behalf of a legally established organization, institution, or corporation). Participants will need to provide the name, affiliation, and contact information of all individuals competing in this Challenge as part of a Team or on behalf of an Entity. All Participants must certify they have read, understand, and agree to abide by the official eligibility rules, participation rules, and requirements for the Challenge as stated in this announcement. 

  • For Individuals: To be eligible to receive a cash prize, each Individual must be a citizen or permanent resident of the United States. In the event of winning a cash prize, the Individual will be paid the prize in full. 

  • For Teams: Each participating Team is required to identify a Team Leader who will register and submit on behalf of the Team members. The Team Leader is responsible for all communications with the Challenge sponsors and, in the event of winning a cash prize, will be paid the prize in full. To be eligible to receive a cash prize, the Team Leader must be a citizen or permanent resident of the United States. In the event that a dispute regarding the identity of the Team Leader who actually submitted the entry cannot be resolved to DPCPSI’s satisfaction, the affected submission will be deemed ineligible. 

  • For Entities: Each participating Entity is required to identify a Point of Contact who will register and submit on behalf of the Entity. The Point of Contact is responsible for all communications with the Challenge sponsors. In the event of winning a cash prize, the prize will be paid directly to the Entity, not to the Point of Contact. To be eligible to receive a cash prize, the Entity must be incorporated in and maintain a primary place of business in the United States. In the event that a dispute regarding the identity of the Point of Contact who actually submitted the entry cannot be resolved to DPCPSI’s satisfaction, the affected submission will be deemed ineligible. 

We invite submissions from the broad range of sectors and stakeholders engaged in disability health research, including from academia, industry, not-for-profit, professional societies, patient advocacy groups, community organizations, and others. 

Submission Requirements: 

Completed submissions must be received by 5:00 PM ET on January 15, 2027. 

Once Participants have completed the registration step in the online submission portal at the link above, they must provide the following as their formal submission: 

  1. Title and Executive Summary (1 page) 

  1. Description of the approach for advancing the inclusion of people with disabilities in clinical research, including how it addresses the Review Criteria (2-3 pages) 

  1. Documents that educate or implement the approach that are suitable for public dissemination, such as best practice resources, study protocols, standard operating procedures, toolkits, and training materials (no page limit) 

Participants must submit all of the above to be considered for a prize. 

All submissions must be in English and Section 508 conformant. Participants must not use the HHS logo, official seal, or the logo of NIH in their submissions and must not claim federal government endorsement. 

Submissions are reviewed on a rolling basis as they are received during the open submission period. This review is administrative only: we confirm that your entry meets the eligibility requirements, that all required fields and materials are complete, and that your uploaded materials meet Section 508 accessibility standards. It does not assess the quality or merit of your submission and does not affect scoring. All merit evaluation is performed separately by the Review Panel after the submission period closes, and only complete, eligible submissions advance to the Review Panel. 

To be guaranteed time to make corrections, submit your entry by 5:00 PM ET on January 5, 2027. For entries received by that date, we will notify you of any missing item, eligibility question, or accessibility issue within 5 business days so you can make corrections before the deadline. Entries received after January 5 are still accepted through the final deadline but will be reviewed as submitted, and we may not be able to notify you in time to make changes. You may edit and resubmit your entry as many times as you wish until the deadline of 5:00 PM ET on January 15, 2027; the most recent version is the one that will be considered. If you need any accommodation or assistance to complete or correct your submission, please contact [email protected] for support. 

Additional Information 

For Further Information Contact: 

NIH Disability Health Research Program Team 
Division of Program Coordination, Planning, and Strategic Initiatives 
Office of the Director 
National Institutes of Health
[email protected]

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