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

The National Institutes of Health, under the U.S. Department of Health and Human Services, has released a forecasted funding opportunity for the INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed). This program is part of NIH’s broader commitment to improve the health and quality of life for individuals with Down syndrome by supporting innovative research that addresses critical scientific gaps identified in the INCLUDE Project objectives. The opportunity is designated under assistance listing 93.310 for Trans-NIH Research Support and is currently presented as Forecast 1. The purpose of this funding announcement is to invite applications for exploratory and developmental projects that advance the scientific understanding of Down syndrome. Research supported under this initiative is expected to assess the feasibility of new areas of investigation, develop innovative methodologies, or test novel experimental systems. These studies are intended to generate preliminary findings that may ultimately lead to breakthroughs in biomedical, behavioral, or clinical research. Projects may carry significant risk but should also demonstrate potential for high reward, including the development of new techniques, models, or applications that could transform the field. The estimated total program funding available for this round is $1,000,000, with approximately five awards expected to be made. Individual awards will range from a minimum of $50,000 to a maximum of $200,000. As this opportunity is structured as an R21 mechanism, the emphasis is on short-term, early-stage, and high-risk/high-reward research rather than large-scale projects. Applicants should design budgets that align with the scale and scope of exploratory and developmental work. Eligibility for this program is broad, encompassing a wide range of applicant types including state, county, city, township, and special district governments, public housing authorities, independent school districts, public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations including small businesses, and Native American tribal governments and organizations. Additionally, regional organizations, faith-based and community-based organizations, U.S. territories and possessions, eligible federal agencies, and non-U.S. entities are eligible to apply. This inclusive approach reflects NIH’s goal of encouraging participation from diverse institutions and communities. The funding timeline indicates an estimated posting date of December 19, 2025, with applications due by February 19, 2026. Awards are expected to be issued on September 1, 2026, with funded projects starting on the same date. As of now, no pre-application requirements such as letters of intent or concept papers are specified in the notice, though applicants should monitor the official posting for any updates. The opportunity is expected to recur, given NIH’s continued emphasis on the INCLUDE Project, but applicants are advised to prepare submissions based on the current forecast cycle. Applications must be submitted through Grants.gov in accordance with NIH’s standard grant submission requirements. Evaluation will focus on the potential of the proposed research to advance the INCLUDE Project’s objectives, the degree of innovation, and the applicant’s capacity to carry out exploratory research. Given that clinical trials are not allowed under this announcement, projects should instead focus on pre-clinical, behavioral, methodological, or data-driven research approaches. For further information, applicants may contact Dr. Melissa Parisi, MD, PhD, who is listed as the grantor contact. She can be reached by phone at 301-728-1861 or by email at parisima@mail.nih.gov. Interested applicants are encouraged to reach out early in the application development process to clarify programmatic questions and ensure alignment with NIH priorities.