INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed)

The National Institutes of Health, an agency within the U.S. Department of Health and Human Services, is forecasting a funding opportunity under the INCLUDE Project, which stands for INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE. This initiative seeks to improve health outcomes and quality of life for individuals with Down syndrome by supporting transformative research efforts. The funding opportunity, titled "INCLUDE Project: Transformative Research Awards for Down syndrome (R01 Clinical Trial Not Allowed)," is identified under the opportunity number RFA-OD-25-020. The forecast was issued on September 25, 2025, and applications are anticipated to open on December 19, 2025. The purpose of this program is to solicit Transformative Research Award applications from scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, or unconventional research. Proposals should demonstrate potential to generate new scientific paradigms, establish new and improved clinical approaches, or develop transformative technologies related to Down syndrome. Applications are invited in all topics relevant to Down syndrome research or its co-occurring conditions, and importantly, no preliminary data are required. Success will depend on the strength of the logic and the compelling potential of the proposed research to make a major impact. The funding instrument for this opportunity is a grant, with a total estimated program funding amount of $3,000,000. Up to four awards are expected to be made, with individual awards ranging between $250,000 and $500,000. Cost sharing or matching is not required for applicants. Projects funded under this program are anticipated to begin on September 1, 2026, with award notifications scheduled for the same date. Eligibility for this program is broad, encompassing state governments, county governments, city or township governments, special district governments, independent school districts, public and private institutions of higher education, public housing authorities, Indian housing authorities, nonprofits with or without 501(c)(3) status (other than institutions of higher education), small businesses, for-profit organizations other than small businesses, Native American tribal governments (federally recognized), Native American tribal organizations other than federally recognized tribal governments, U.S. territories and possessions, faith-based or community-based organizations, regional organizations, eligible agencies of the federal government, and foreign institutions. This wide eligibility scope underscores the intent to attract a diverse pool of applicants capable of advancing research on Down syndrome. The application timeline is clearly defined in the forecast. The estimated posting date is December 19, 2025, with applications due by February 19, 2026. The forecast specifies that this is a non-clinical trial R01 mechanism and highlights the importance of timely submission through Grants.gov. Since this is a forecasted opportunity, applicants are encouraged to monitor for updates and the official Notice of Funding Opportunity when published. There are no pre-application requirements such as letters of intent mentioned in the forecast notice. Applicants seeking more information are advised to contact Charlene Schramm, Ph.D., who is listed as the grantor point of contact. Dr. Schramm can be reached by telephone at 301-402-3793 or via email at schrammc@nih.gov. Her role is to provide clarification and guidance for potential applicants navigating the submission process. In summary, this forecasted opportunity represents a significant investment by NIH in supporting transformative and innovative research with potential to substantially impact the field of Down syndrome. By funding projects that challenge existing paradigms and introduce novel scientific approaches, the INCLUDE Project aims to accelerate discoveries that will improve clinical outcomes, treatment options, and overall quality of life for individuals living with Down syndrome.