INCLUDE Project: Omics Phenotypes Related to Down Syndrome (X01 Clinical Trial Not Allowed)

The National Institutes of Health, within the U.S. Department of Health and Human Services, administers the INCLUDE Project, an initiative focused on improving the health and quality of life for individuals with Down syndrome. This funding opportunity is part of a broader federal effort to better understand co occurring conditions across the lifespan in individuals with Down syndrome through advanced scientific research. The INCLUDE Project supports collaborative, data driven research and emphasizes the integration of genomic and multi omics data to accelerate scientific discovery. This specific opportunity is structured as a forecasted notice and is expected to be formally released in April 2027. The purpose of this opportunity is to solicit applications for the submission of biospecimens to NIH supported resources, where extensive genomic and multi omics analyses will be conducted. The emphasis is on generating large scale, integrated datasets that can be used to uncover molecular mechanisms underlying health conditions associated with Down syndrome. The resulting data will be incorporated into the INCLUDE Data Hub, which serves as a centralized repository accessible to the broader research community. This aligns with NIH priorities to promote open science, data sharing, and collaborative discovery. Unlike traditional grant mechanisms, this opportunity does not provide direct funding to applicants. Instead, selected applicants will benefit from access to NIH supported resources that will perform omics assays on submitted samples. Applicants are encouraged to propose studies using existing biospecimens collected from individuals with Down syndrome and appropriate control groups. Because there is no direct funding provided, there are no award ceilings, floors, or total funding allocations specified, and no cost sharing or matching requirements apply. Eligibility for this opportunity is broad and inclusive, reflecting NIH priorities to support a wide range of research institutions and organizations. Eligible applicants include institutions of higher education, nonprofits with or without 501 c 3 status, small businesses, for profit organizations, tribal governments, state and local governments, and certain international entities. Federal agencies, faith based organizations, and regional organizations are also eligible. This inclusive eligibility framework supports interdisciplinary collaboration and ensures that diverse research entities can contribute to advancing knowledge in this field. The application process is expected to follow standard NIH submission procedures, typically requiring submission through Grants.gov and adherence to NIH application guidelines. Applicants will need to prepare detailed proposals describing the biospecimens, associated clinical or phenotypic data, and proposed omics analyses. While specific application components are not yet fully detailed due to the forecasted status, applicants should anticipate requirements such as project descriptions, data sharing plans, and documentation of sample availability and consent. The estimated application due date is June 15, 2027, with an anticipated award date of April 1, 2028, and project start date also on April 1, 2028. As this is a forecasted opportunity, applicants are encouraged to begin early engagement and preparation. The opportunity is not described as recurring, and no pre application requirements such as letters of intent are specified at this stage. For further information or inquiries, applicants may contact the INCLUDE Project team via email at DownSyndromeINCLUDE at mail dot nih dot gov.