INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed) | RFA OD 27 003

Opportunity Information: Apply for RFA OD 27 003

The National Institutes of Health (NIH) is offering an INCLUDE Project funding opportunity titled "INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (R21 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-OD-27-003. This is a discretionary grant mechanism in the health category that uses the NIH R21 exploratory/developmental research format, meaning it is designed to support early-stage, high-impact ideas that may still be preliminary but show strong potential to move the field forward. A key limitation is built into the title and requirements: clinical trials are not allowed under this NOFO, so applicants need to design studies that do not meet NIH's definition of a clinical trial (for example, not prospectively assigning human participants to an intervention to evaluate health-related outcomes).

The overall purpose of the NIH INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project is to improve health and quality of life for people with Down syndrome. This specific NOFO focuses on new exploratory and developmental research projects that directly respond to critical needs and priorities aligned with the INCLUDE Project objectives. In practice, this means the NIH is looking for research that helps close major gaps in knowledge about Down syndrome across the lifespan, including co-occurring conditions and factors that shape health outcomes, with an emphasis on innovation and the potential to create new directions for future research.

Projects supported by this opportunity are expected to be bold and experimental. The NOFO highlights examples such as feasibility assessments for a novel area of investigation, testing a new experimental system that could strengthen health-related research, or applying an existing method in a unique and innovative way to open up a new scientific area. The NIH is explicitly signaling that higher-risk ideas are welcome when the upside is compelling, such as the possibility of a breakthrough or the creation of broadly useful tools. Outputs could include new techniques, agents, methodologies, models, datasets, analytic approaches, or applications that materially change how biomedical, behavioral, or clinical research related to Down syndrome is conducted, even if the proposed work is not yet ready for large-scale validation.

The award parameters provided indicate an award ceiling of $200,000 and an expectation of about 5 awards. The original closing date listed is June 15, 2028, which suggests a longer application window than many opportunities, although applicants should still verify the current cycle dates, submission windows, and any updates directly in the NOFO and on NIH systems because NIH opportunities can have multiple receipt dates or policy changes over time.

Eligibility is broad and includes a wide range of U.S. entities: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible applicants as defined in the NOFO. Importantly, the opportunity explicitly allows foreign involvement: non-U.S. entities (foreign organizations) may apply; non-U.S. components of U.S. organizations are eligible; and foreign components, as defined by the NIH Grants Policy Statement, are allowed. That means international collaborations and projects led by non-U.S. institutions can be responsive, as long as they meet all NIH policy and application requirements.

In short, this funding opportunity is meant for researchers who want to test promising, potentially transformative ideas in Down syndrome research without running a clinical trial, particularly ideas that can establish feasibility, create new models or methods, or open new scientific directions aligned with the INCLUDE Project mission to improve lifelong health outcomes for individuals with Down syndrome.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "INCLUDE Project: Exploratory/Developmental Research Awards for Down syndrome (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, 93.233, 93.310, 93.351, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.855, 93.865, 93.866, 93.867, 93.879.
• This funding opportunity was created on 2026-05-12.
• Applicants must submit their applications by 2028-06-15.
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• The number of recipients for this funding is limited to 5 candidate(s).
• 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 27 003

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