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

The National Institutes of Health (NIH), an agency within the U.S. Department of Health and Human Services, has announced a forecasted funding opportunity under the INCLUDE Project, formally known as the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE. This program aims to support clinical research that advances the understanding of health issues faced by individuals with Down syndrome. The opportunity is issued as a phased award using the R61/R33 grant mechanism, which requires a clinical trial. The funding notice emphasizes that the proposed studies should be designed with clear, measurable milestones to ensure progression through each stage. The purpose of this program is to encourage innovative clinical trial applications that address both critical health conditions and co-occurring issues experienced by people with Down syndrome. The NIH seeks to improve overall health and quality of life by funding research that is both exploratory and developmentally focused. Successful applicants will be expected to provide strong evidence for the feasibility of their proposed clinical trials during the R61 phase, which may then transition into the R33 phase for expanded trial support if milestones are achieved. The total project period cannot exceed five years, with up to two years allowed for the R61 phase and up to three years for the R33 phase. The scope of funding is centered on milestone-driven clinical trials designed to identify, treat, or manage health conditions in individuals with Down syndrome. NIH underscores that only proposals with measurable R61 milestones will be eligible to transition into the R33 phase. Spending under this opportunity will be limited to activities that directly support the planning, development, and conduct of clinical trials, including preparatory work during the R61 phase and expanded intervention studies during the R33 phase. Awarded projects must adhere to NIH grant rules and federal regulations governing the use of federal research funds. Eligibility for this opportunity is broad and includes state governments, county governments, city or township governments, special district governments, independent school districts, public housing authorities, tribal governments, nonprofit organizations (both with and without IRS 501(c)(3) status), public and private institutions of higher education, small businesses, for-profit entities other than small businesses, and federally recognized as well as non-federally recognized Native American tribal organizations. Additional eligible applicants include federal agencies, U.S. territories, faith-based and community-based organizations, regional organizations, and non-U.S. (foreign) institutions. The wide eligibility criteria reflect NIH’s commitment to engaging diverse research institutions and organizations in addressing health challenges faced by the Down syndrome community. The estimated total program funding for this opportunity is three million dollars. Awards are expected to range from a minimum of $100,000, with a ceiling not yet specified in the announcement. Approximately four awards are anticipated under this program. No cost sharing or matching requirement is associated with this opportunity. The award start date is projected for September 1, 2026, with projects beginning on that same date. Funding is contingent upon the availability of appropriations and the submission of meritorious applications. The forecasted timeline indicates that the notice will be officially posted on December 19, 2025, with applications due by February 19, 2026. The estimated award date and project start date are both September 1, 2026. At present, there are no pre-application requirements such as letters of intent or concept papers identified in the notice. Applicants are advised to prepare full applications by the due date. The opportunity is classified as forecasted, meaning it is not yet open for applications but will become active after the posting date. Applicants seeking more information may contact Laurie Ryan, PhD, at the National Institutes of Health. She can be reached by phone at 301-496-9350 or by email at ryanl@nih.gov. Interested organizations should monitor Grants.gov for updates and ensure all registrations are completed in advance of the application due date. Since this is a forecast, final details including award ceiling and application instructions may be refined when the notice of funding opportunity is formally published.