INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed)

The INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed) is a federal funding opportunity issued by the National Institutes of Health under the U.S. Department of Health and Human Services. The funding opportunity is part of the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project, which was established to advance scientific understanding of Down syndrome and improve health outcomes and quality of life for individuals with Down syndrome throughout the lifespan. The opportunity supports exploratory and developmental research intended to generate innovative scientific insights, pilot approaches, and new methodologies that can contribute to the broader INCLUDE Project objectives. The program is administered through NIH and includes participation from multiple NIH institutes and centers associated with a wide range of biomedical, behavioral, and clinical research areas. The purpose of this funding opportunity is to encourage investigators to pursue high-risk, high-reward exploratory projects that address important scientific questions related to Down syndrome. NIH specifically notes that supported projects may assess the feasibility of novel areas of investigation, test innovative methodologies, establish new experimental systems, or apply existing techniques in unique ways to emerging scientific problems. The funding opportunity is designed for projects that may involve substantial scientific risk but also possess the potential for major breakthroughs or transformative advances in biomedical and behavioral research. Areas of interest include research connected to co-occurring conditions across the lifespan among individuals with Down syndrome, translational science, and methodologies capable of advancing understanding of Down syndrome-related health conditions. The funding mechanism for this opportunity is an R21 exploratory/developmental research award. NIH estimates a total program funding amount of approximately $1,000,000 and anticipates making approximately five awards under this notice of funding opportunity. The published award ceiling is $200,000, while no explicit award floor is identified in the synopsis. The funding opportunity does not require cost sharing or matching funds, making participation accessible to a broad range of eligible applicants. Allowable project activities generally include exploratory biomedical, behavioral, or clinical research activities consistent with NIH policy and the stated objectives of the INCLUDE Project. Because the funding opportunity specifically states that clinical trials are not allowed, applicants must ensure that proposed activities remain within the non-clinical trial parameters established by NIH. Eligibility for the funding opportunity is intentionally broad and inclusive. Eligible applicants include public and state controlled institutions of higher education, private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit organizations other than small businesses, small businesses, county governments, city or township governments, state governments, special district governments, independent school districts, Native American tribal governments, Native American tribal organizations, public housing authorities, and other entities identified within the NOFO. The announcement also explicitly permits foreign organizations, foreign components of U.S. organizations, and international collaborations to participate. Applicants are instructed to review Section III of the full NOFO for additional eligibility guidance and institutional requirements. Because the opportunity is federal in nature and does not impose state-based geographic limitations, the program is considered nationwide in scope and also permits international participation. The application process requires applicants to submit proposals through NIH submission systems in accordance with standard NIH application procedures. The funding opportunity was posted on May 12, 2026, and applications are accepted through June 15, 2028. The opportunity is currently open for submissions. The synopsis does not identify a mandatory pre-application phase such as a letter of intent, concept paper, or pre-proposal requirement. Applicants should prepare all required NIH application materials, including research plans, institutional information, budget documentation, and compliance-related materials typically required for NIH research submissions. Because the funding mechanism supports exploratory and developmental studies, applicants should clearly articulate innovation, feasibility, scientific rationale, and anticipated impact in their submissions. NIH indicates that funded projects are expected to align with the goals and objectives of the INCLUDE Project and demonstrate the potential to significantly advance understanding of Down syndrome and associated conditions. Applications are likely to be evaluated using standard NIH peer review criteria emphasizing significance, investigator qualifications, innovation, approach, and research environment, along with alignment to INCLUDE priorities. The funding opportunity is recurring in nature because NIH research programs are commonly reissued and because the current opportunity remains open through mid-2028. Applicants with technical difficulties accessing the full announcement electronically are instructed to contact The INCLUDE Project at DownSyndromeINCLUDE@mail.nih.gov for assistance. The opportunity is categorized within the Health funding activity area and is associated with multiple federal assistance listings connected to biomedical research disciplines.

Focus on innovative exploratory research approaches that align with INCLUDE Project objectives and demonstrate potential for significant scientific impact in Down syndrome research.