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

The INCLUDE Project: Transformative Research Awards for Down syndrome is a federal funding opportunity issued by the National Institutes of Health under the U.S. Department of Health and Human Services. The program is part of the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE initiative, commonly referred to as the INCLUDE Project. The initiative was established to advance scientific understanding of Down syndrome and improve the health and quality of life of individuals with Down syndrome across the lifespan. This funding opportunity seeks to support transformative and exceptionally innovative research projects that can create new scientific paradigms, generate unconventional approaches, or develop groundbreaking technologies related to Down syndrome and its co-occurring conditions. The purpose of this Notice of Funding Opportunity is to encourage individual investigators or collaborative groups of scientists to propose highly innovative and potentially high-impact research projects. The opportunity specifically welcomes applications that challenge existing assumptions or introduce entirely new approaches to research related to Down syndrome. NIH emphasizes that no preliminary data are required for submission, which lowers barriers for unconventional or early-stage scientific concepts that may otherwise struggle to compete in traditional research programs. Applications may address any area relevant to Down syndrome or associated co-occurring conditions, including biomedical, translational, behavioral, technological, or clinical relevance, provided the project demonstrates a compelling rationale and strong potential for transformative impact. The funding mechanism for this opportunity is the R01 grant mechanism, and clinical trials are not allowed under this announcement. The estimated total program funding is $3,000,000 with approximately four awards anticipated. Individual awards may request up to $500,000. The funding announcement does not identify a matching requirement or cost-sharing obligation, meaning applicants are not expected to provide non-federal matching funds. The notice also does not specify a mandatory minimum award amount. Funding decisions are expected to prioritize scientific innovation, originality, transformative potential, and the strength of the proposed scientific logic. NIH intends for this opportunity to support research capable of fundamentally improving scientific understanding or care approaches associated with Down syndrome. Eligibility for the opportunity is broad and inclusive. Eligible applicants include nonprofit organizations, public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, independent school districts, public housing authorities, small businesses, and for-profit organizations other than small businesses. The announcement also permits foreign organizations, foreign components of U.S. organizations, and international collaborations. Because the opportunity is federally administered through NIH and contains no geographic limitations within the United States, the opportunity should be considered nationwide in scope. Applicants are instructed to review Section III of the Notice of Funding Opportunity for additional details regarding eligibility requirements and allowable participation structures. Applications are submitted through standard NIH grant submission systems and procedures. The announcement does not identify a required letter of intent, concept paper, or other mandatory pre-application phase. The funding opportunity was posted on May 12, 2026, and applications are currently accepted through June 15, 2028. The notice does not indicate that the funding opportunity is rolling or recurring. Applicants are expected to prepare a full research application package in accordance with NIH R01 submission requirements, including scientific narratives, budgets, institutional information, and supporting documentation. Because the opportunity emphasizes transformative and unconventional science, applicants should focus on demonstrating originality, significance, and the potential for major impact in Down syndrome research. NIH states that projects should clearly demonstrate a compelling potential to create substantial advances in Down syndrome-related research. Applications that establish new scientific paradigms, introduce transformative technologies, or produce major improvements in clinical or translational approaches are likely to align strongly with the goals of the initiative. The funding opportunity specifically highlights the importance of innovation and scientific impact rather than extensive prior data. Applicants with questions regarding the opportunity may contact the INCLUDE Project through the official NIH program email address at DownSyndromeINCLUDE@mail.nih.gov. The opportunity remains open until June 15, 2028, after which the announcement is expected to archive on August 14, 2028.

Emphasize transformative and highly innovative approaches with strong potential to create major impact in Down syndrome research. Focus on originality and scientific significance rather than extensive preliminary data.