Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional) | RFA NR 25 003

Opportunity Information: Apply for RFA NR 25 003

The National Institutes of Health (NIH) is offering a cooperative agreement opportunity titled "Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional)" under Funding Opportunity Number RFA-NR-25-003. This initiative is designed to fund unusually innovative intervention research that directly addresses social determinants of health (SDOH). The central goal is to support bold, high-impact projects that, if successful, could materially prevent, reduce, or eliminate health disparities and move the needle on health equity in a meaningful way. The emphasis is on transformative ideas with a strong, clearly articulated rationale showing why the approach should lead to major improvements, rather than incremental advances.

A defining feature of this opportunity is its focus on intervention research targeting SDOH, meaning applicants are expected to propose strategies that act on upstream conditions shaping health outcomes, such as social, economic, environmental, educational, and community-level factors. NIH is looking for proposals where the logic is compelling and the intervention is truly innovative, with a credible pathway to significant population-level or systems-level impact. Importantly, preliminary data are not required, which signals that NIH is intentionally creating room for newer, riskier, or less conventional approaches that may not yet have extensive pilot evidence but are well-justified and potentially game-changing.

The award mechanism is a U01 cooperative agreement, which typically indicates substantial scientific or programmatic involvement by NIH staff during the project compared to standard grants. In practice, that often means the project team should be prepared to collaborate closely with NIH on aspects such as study design refinement, implementation considerations, monitoring, and dissemination planning. The listing also notes "Clinical Trial Optional," meaning an application may include a clinical trial if it fits the project, but a clinical trial is not mandatory. Applicants can propose intervention studies that are not clinical trials as long as they align with the FOA requirements and are appropriate for addressing SDOH-driven disparities.

The opportunity sits within activity areas spanning education, environment, and health, reflecting the cross-cutting nature of SDOH work and reinforcing that proposed interventions can reasonably operate across sectors and settings. The CFDA (Assistance Listing) numbers associated with the announcement are 93.113, 93.273, 93.361, and 93.846, indicating that multiple NIH-related assistance listings may be relevant depending on the participating institute or program alignment.

Eligibility is broad and includes a wide range of domestic organizations and governmental entities. Eligible applicants include state, county, and 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized governments; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible organizations. The announcement also explicitly highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible agencies of the federal government, regional organizations, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions.

At the same time, the announcement is explicit about foreign involvement: non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. In other words, applicants must be U.S.-based eligible entities and cannot propose foreign subcomponents as part of the applying organization.

Key logistics included in the source data are that the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. The original closing date is February 28, 2025. The stated award ceiling is $500,000, which generally implies a cap on requested direct costs per year or total costs depending on the FOA specifics, but applicants would need to confirm within the full announcement how NIH defines and applies that ceiling for budgeting. The opportunity record shows a creation date of December 11, 2024. The number of expected awards is not clearly provided in the excerpt, so applicants should consult the full FOA for anticipated award counts, project period expectations, and institute participation.

Overall, this grant is aimed at applicants with high-upside intervention concepts that confront the structural and social drivers of unequal health outcomes. NIH is signaling interest in projects that do more than describe disparities, instead testing creative, actionable solutions with the potential for large, durable improvements in equity. The lack of a preliminary data requirement makes it especially suitable for teams proposing novel cross-sector interventions, community-engaged approaches, policy or systems changes, or new implementation models that are logically strong and designed for real-world impact.

• The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.273, 93.361, 93.846.
• This funding opportunity was created on 2024-12-11.
• Applicants must submit their applications by 2025-02-28. (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 $500,000.00 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 NR 25 003

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