The Omics Phenotypes Related to Down Syndrome for the INCLUDE Project (X01 Clinical Trial Not Allowed) funding opportunity is offered through the National Institutes of Health (NIH), coordinated by the Office of the Director and several NIH institutes. This resource access award is intended to facilitate the generation of genomic and multi-omics data by providing applicants with access to NIH-supported sequencing centers and data sharing resources. No direct funding is provided to the applicants. Instead, selected investigators will submit biospecimens for omics analysis, with the resulting data incorporated into the INCLUDE Data Hub. The goal is to uncover molecular mechanisms underlying health conditions related to Down syndrome.

The purpose of this initiative is to enhance understanding of Down syndrome and co-occurring health conditions by leveraging omics technologies, including whole genome and exome sequencing, transcriptomics, epigenomics, proteomics, metabolomics, and single-cell RNA and ATAC sequencing. The project prioritizes biospecimens from individuals with Down syndrome and matched controls, particularly from underrepresented racial and ethnic populations. Samples must already be extracted and ready to ship, and participants must have provided broad consent for data sharing. The data generated will be openly shared to facilitate cross-disease research and increase inclusivity within the Down syndrome research community.

Although no financial awards are made, this opportunity grants access to advanced sequencing and data infrastructure. Applicants must detail their sample readiness, consent for data use, demographic and clinical data availability, and the scientific rationale for sequencing. Cohorts with rich phenotypic and clinical data are prioritized, particularly those able to support cross-disease analysis. Applications proposing new omics assays or enhanced diversity are also encouraged.

Eligible applicants include a wide range of organizations, such as higher education institutions, nonprofits, for-profit businesses, governments at all levels, tribal organizations, and foreign institutions. Required registrations include SAM, eRA Commons, Grants.gov, and others. Applications may be submitted through the NIH ASSIST system, institutional systems, or Grants.gov Workspace. All applications must comply with NIH application guidelines and must include Institutional Certifications for genomic data sharing.

Submissions must include a detailed description of the study population, data analysis plans, data sharing agreements, and sample readiness. Required attachments also include clinical, phenotypic, and demographic data, with templates available via NIH resources. Applications will be peer-reviewed based on scientific merit, feasibility, value to the Down syndrome research community, and compliance with NIH data sharing policies.

The application process includes an optional letter of intent due 30 days prior to the application deadline, with annual due dates on March 13 through 2026. The expiration date for this opportunity is March 14, 2026. Investigators selected will be expected to collaborate with NIH sequencing centers and contribute data to the INCLUDE Data Hub. No financial reporting or traditional Notice of Award is issued; instead, successful applicants will receive access instructions for sequencing services.