INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)

The INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required) is a federal funding opportunity administered by the National Institutes of Health within the U.S. Department of Health and Human Services. This initiative is part of the broader INCLUDE Project, which seeks to advance scientific understanding of co-occurring conditions across the lifespan in individuals with Down syndrome. The program is designed to improve health outcomes and quality of life by supporting innovative, milestone-driven clinical research efforts that address critical health conditions affecting this population. The primary purpose of this funding opportunity is to support exploratory and developmental clinical trials through a phased R61/R33 mechanism. The R61 phase focuses on preliminary work, including feasibility studies, protocol development, and early-stage testing, while the R33 phase supports the implementation of full clinical trials contingent upon successful completion of defined milestones in the R61 phase. The program emphasizes rigorous milestone planning, requiring applicants to define measurable benchmarks that determine progression between phases. This structure ensures that only projects demonstrating sufficient promise advance to later-stage funding. Funding is provided as a discretionary grant, with an estimated total program funding of 3000000 dollars and an anticipated four awards. Although specific award ceilings and floors are not defined in the available summary, the total project period for any awarded proposal may not exceed five years. Within this timeframe, applicants may request up to two years of support for the R61 phase and up to three additional years for the R33 phase. The funding is intended to cover costs associated with clinical trial development and execution, including personnel, study design, data collection, and related research expenses. No cost sharing or matching requirement is specified, indicating that applicants are not required to contribute additional funds. Eligibility for this opportunity is broad and inclusive, encompassing a wide range of entity types. Eligible applicants include nonprofit organizations with or without 501(c)(3) status, institutions of higher education (both public and private), small businesses, for-profit organizations, state and local governments, tribal governments and organizations, and special district entities. Importantly, the program also allows foreign organizations and international collaborations to apply, as well as foreign components of U.S.-based organizations. This expansive eligibility framework reflects the NIH’s intent to foster diverse participation and encourage global collaboration in Down syndrome research. The application process requires submission through standard NIH mechanisms, typically involving electronic submission via Grants.gov. While specific application components are not detailed in the synopsis, NIH clinical trial applications generally require comprehensive research plans, milestone descriptions, budgets, biosketches, and compliance documentation. The program mandates the inclusion of clearly defined R61 milestones, which are critical for evaluation and transition to the R33 phase. Applicants are encouraged to consult the full Notice of Funding Opportunity for detailed submission instructions and requirements. Applications are currently being accepted, with a posted date of May 13, 2026, and a final application deadline of June 15, 2028. There is no indication of a rolling or recurring cycle, suggesting a fixed submission window. The extended application period provides ample time for applicants to develop high-quality proposals and meet all requirements. Contact for program-related inquiries is available via the INCLUDE Project email address at DownSyndromeINCLUDE@mail.nih.gov, which serves as the primary point of communication for applicants needing assistance or clarification. Overall, this funding opportunity represents a significant investment in advancing clinical research for individuals with Down syndrome. By supporting phased clinical trials with clearly defined milestones, the NIH aims to accelerate the development of effective treatments for co-occurring conditions. The program’s flexible eligibility criteria, structured funding mechanism, and emphasis on measurable outcomes make it a valuable opportunity for researchers and institutions committed to improving health outcomes in this underserved population.

Ensure milestones are clearly defined measurable and feasible to enable transition from R61 to R33 phase