INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Exploratory/Developmental Research Grant Award (R21 Clinical Trial Not Allowed) | RFA OD 21 007

Opportunity Information: Apply for RFA OD 21 007

The NIH funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Exploratory/Developmental Research Grant Award (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-OD-21-007) supports early-stage, high-impact research ideas aimed at advancing the goals of the INCLUDE Project. The core purpose is to seed new exploratory or developmental studies that respond to critical needs in Down syndrome research, especially research that helps explain, prevent, or better manage health conditions that commonly co-occur with Down syndrome across the lifespan. The R21 mechanism is designed for projects that are still at a formative stage, where preliminary data may be limited, but the scientific premise is strong and the potential payoff is significant.

This FOA is oriented toward innovative, sometimes higher-risk concepts that could open new directions rather than simply extending established work. Examples of the kinds of projects envisioned include feasibility studies that test whether a novel research question or emerging experimental system can work in practice, or projects that apply an existing method in a unique way to answer a new scientific question relevant to Down syndrome and its associated conditions. The emphasis is on ideas that could lead to breakthroughs, or that could produce new tools and resources for the field, such as novel models, agents, methods, technologies, or analytical approaches with broad usefulness for biomedical, behavioral, or clinical research related to Down syndrome.

A key boundary condition is that this is an "R21 Clinical Trial Not Allowed" announcement, meaning applicants cannot propose a clinical trial as defined by NIH policy under this FOA. In practical terms, the projects can still be clinically relevant and may involve human data or clinical populations when appropriate, but the work must not be structured as an interventional clinical trial intended to prospectively assign participants to an intervention to study health-related outcomes. Applicants typically use this type of FOA to build foundational knowledge, develop or validate methods, generate preliminary evidence, or establish feasibility that could later support larger-scale studies through other mechanisms.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments. Higher education institutions are eligible, including public/state controlled and private institutions of higher education. The FOA also allows applications from nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations other than small businesses, and small businesses. In addition, the announcement highlights several categories of "other eligible applicants" such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and Indian/Native American Tribal Governments that are not federally recognized.

There are important limits on foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant can include certain elements of the project that involve international collaboration or performance sites when scientifically justified and appropriately documented, even though a foreign institution cannot be the direct applicant.

Administrative details provided in the source data indicate this is a discretionary grant opportunity offered by the National Institutes of Health. The opportunity was created on 2021-09-24, and the original closing date listed is 2022-11-03. Multiple CFDA (now often referenced as Assistance Listing) numbers are associated with the opportunity, reflecting the multi-institute, cross-cutting nature of the INCLUDE initiative and the wide set of NIH programs that may be involved in supporting Down syndrome research aligned with INCLUDE objectives. Overall, the FOA is best read as an entry point for creative, development-focused projects that can quickly test promising ideas and generate momentum toward larger future studies that meaningfully improve understanding of Down syndrome and co-occurring conditions across life stages.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Exploratory/Developmental Research Grant Award (R21 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): 93.121, 93.173, 93.213, 93.233, 93.310, 93.351, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.855, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2021-09-24.
• Applicants must submit their applications by 2022-11-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 21 007

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