Down Syndrome Cohort Research Sites (DS-CRS) for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project (U01 Clinical Trial Not Allowed) | RFA OD 24 003

Opportunity Information: Apply for RFA OD 24 003

This NIH funding opportunity (RFA-OD-24-003) supports the INCLUDE Project's effort to improve health and quality of life for people with Down syndrome by building a large, well-characterized cohort that spans the full lifespan. The award mechanism is a U01 cooperative agreement (clinical trial not allowed), which means awardees will not just run independent projects; they will work closely with NIH and partner sites under a shared governance structure, common expectations, and coordinated milestones. The central idea is to stand up multiple Down Syndrome Cohort Research Sites (DS-CRS) that can recruit and follow participants with Down syndrome, collect standardized clinical and research information, and contribute biospecimens and high-value datasets that can be broadly shared with the scientific community for future discovery.

The program these sites will join is called the Down Syndrome Cohort Development Program (DS-CDP). DS-CRS awardees are expected to recruit individuals with Down syndrome across different ages and life stages, with the goal of capturing the wide range of co-occurring conditions and outcomes that can appear from infancy through older adulthood. Sites will collect biospecimens and assemble a rich set of phenotypic data, imaging, and omics information to enable deep phenotyping. In practice, that means the cohort is meant to go beyond basic demographics or routine clinical measures and move toward harmonized, research-grade characterization that can support many downstream studies, including work on comorbidities, trajectories of health, and biological mechanisms relevant to Down syndrome.

A defining feature of this NOFO is that research sites must participate in all aspects of developing and executing a common protocol. Rather than each site designing its own separate study, the DS-CRS network will collaboratively plan how participants are enrolled, what data elements are captured, how biospecimens are collected and handled, what imaging or omics approaches are used, and how quality control and standardization are maintained. Sites are also expected to contribute to interpretation of results and to help translate findings into outputs that can be useful for the broader Down syndrome community, clinicians, and researchers. A major deliverable is making data and associated resources readily available to the scientific community, consistent with NIH data sharing expectations and the infrastructure established for this program.

This DS-CRS solicitation is part of a coordinated set of INCLUDE Project funding announcements that divide responsibilities across complementary components. It runs in parallel with a companion NOFO (RFA-OD-24-005) that will fund the Clinical Cohort Coordinating Center (DS-4C), which will provide overall coordination for the DS-CDP, such as network management, harmonization, and cross-site operations. In addition, a related NOFO (RFA-OD-24-004) will support a Federated Biobanking Resource that will store and distribute biospecimens collected by the cohort research sites. In other words, the DS-CRS sites are the on-the-ground recruitment and data/specimen collection hubs, while the coordinating center and federated biobank provide the backbone for consistent operations and broad access to high-quality samples and data.

A required and non-negotiable application element is the Plan for Enhancing Diverse Perspectives (PEDP). NIH will evaluate the PEDP as part of scientific and technical peer review, and applications that do not include a PEDP will be considered incomplete and withdrawn. The emphasis on diverse perspectives signals that the program expects intentional strategies to broaden representation in the research enterprise and in the cohort itself, which can include (depending on the applicant's approach) plans around participant diversity, community partnerships, recruitment and retention practices, workforce and leadership diversity, and inclusion of different institutional or regional perspectives. Applicants are explicitly encouraged to follow the NOFO's PEDP instructions and use NIH guidance materials when preparing this plan.

The funding instrument is a cooperative agreement and the activity code is U01, with a stated award ceiling of $300,000. As a discretionary NIH opportunity under multiple CFDA listings, it is positioned within the broad federal health research portfolio. The listing indicates this was posted with an original closing date of December 15, 2023, and it is administered by the National Institutes of Health.

Eligibility is broad and includes many types of U.S.-based organizations and governmental units. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) and small businesses; and federally recognized Native American tribal governments as well as other tribal organizations. The NOFO also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, eligible federal agencies, faith-based or community-based organizations, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations are allowed, and foreign components as defined by NIH policy are permitted, which can matter for collaborations, specialized analyses, or certain data generation activities that involve international partners under a U.S. applicant institution.

Overall, this opportunity is best understood as NIH building a shared national research resource: a coordinated network of cohort sites that can enroll people with Down syndrome across the lifespan, generate standardized and deeply informative datasets and biospecimens, and feed those resources into a federated infrastructure designed for broad scientific use. The long-term value is not just what any single site discovers, but the scale, consistency, and accessibility of the combined cohort resource that can accelerate many lines of Down syndrome research under the INCLUDE Project umbrella.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Down Syndrome Cohort Research Sites (DS-CRS) for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.865, 93.866.
• This funding opportunity was created on 2023-10-19.
• Applicants must submit their applications by 2023-12-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $300,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA OD 24 003

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