Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Allowed) | RFA RM 21 021

Opportunity Information: Apply for RFA RM 21 021

The NIH funding opportunity "Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Allowed)" (RFA-RM-21-021; CFDA 93.310) supports unusually innovative, high-impact research aimed at preventing, reducing, or eliminating health disparities and advancing health equity. It is designed for projects that are potentially game-changing in how interventions are developed, implemented, or disseminated, with an emphasis on bold ideas that could shift practice or understanding in meaningful ways if they work. A key feature is that preliminary data are not required, which signals that NIH is intentionally making room for earlier-stage but well-reasoned concepts that are not yet extensively tested. Even without preliminary results, proposals are expected to be strongly justified, with a clear, logical argument for why the approach is likely to produce a major impact on inequities in health outcomes or access to effective care.

The award mechanism is a U01 cooperative agreement, meaning NIH anticipates substantial scientific or programmatic involvement during the project period compared to a standard research grant. Applicants should expect a more collaborative relationship with the funding institute or center, which often includes ongoing input on milestones, coordination, or other elements meant to help the project achieve its intended impact. Clinical trials are explicitly allowed under this opportunity, so projects may include testing interventions in real-world or clinical settings when that is appropriate for the proposed strategy to address disparities and equity gaps.

The initiative is open to a wide range of applicant organizations across the public, private, nonprofit, and academic sectors. Eligible applicants include state, county, city, township, and special district governments; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The announcement also highlights additional eligible applicant types that often play central roles in equity-focused work, such as faith-based or community-based organizations, Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with regional organizations and U.S. territories or possessions.

There are important limitations related to foreign involvement. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the primary applicant, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed, which means a U.S.-based applicant may include certain foreign elements of the research as part of the project when justified and compliant with NIH policy.

Administratively, the opportunity is categorized as discretionary funding and falls under the health activity category, with the National Institutes of Health as the sponsoring agency. The original closing date listed for this specific announcement was May 28, 2021, and the posting indicates an expected award ceiling was not specified in the provided summary. Overall, the program is best suited to applicants proposing ambitious, carefully reasoned intervention research that directly targets mechanisms and conditions driving health disparities, and that has a credible pathway to real-world impact through development, implementation, or dissemination at scale.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2021-03-25.
• Applicants must submit their applications by 2021-05-28. (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 RM 21 021

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