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

FAQs: Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Allowed)

1) What is this NIH funding opportunity?

This opportunity is the NIH funding announcement titled "Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Allowed)" (RFA-RM-21-021; CFDA 93.310). It supports unusually innovative, high-impact research intended to prevent, reduce, or eliminate health disparities and advance health equity.

2) What kind of research is NIH looking for under this program?

NIH is looking for projects that are bold, potentially game-changing, and unusually innovative in how they develop, implement, or disseminate interventions. The emphasis is on ideas that could meaningfully shift practice or understanding related to health disparities and health equity if they work.

3) What does "transformative" mean in the context of this opportunity?

"Transformative" refers to research that could be high-impact and practice-shifting, not incremental. The program is designed to create space for approaches that may change how interventions are created or delivered, or how evidence is moved into real-world use, in ways that could substantially affect inequities in outcomes or access to effective care.

4) Are preliminary data required to apply?

No. A key feature of this opportunity is that preliminary data are not required. That said, proposals still need to be strongly justified and present a clear, logical rationale for why the approach is likely to have major impact on health inequities.

5) If preliminary data are not required, what does NIH expect instead?

Even without preliminary results, NIH expects applications to be carefully reasoned and well-supported conceptually. The proposal should make a strong case for why the strategy is likely to work and why it could lead to a meaningful reduction in disparities or an advance in health equity.

6) What award mechanism is used for this funding opportunity?

The mechanism is a U01 cooperative agreement. This is different from a standard research project grant because NIH anticipates substantial scientific or programmatic involvement during the project period.

7) What does a U01 cooperative agreement mean for the relationship with NIH?

A U01 typically involves a more collaborative relationship with the funding institute or center. Applicants should expect ongoing NIH involvement that may include input on milestones, coordination activities, or other elements intended to help the project reach its intended impact.

8) Are clinical trials allowed under this opportunity?

Yes. Clinical trials are explicitly allowed. Projects may include testing interventions in clinical or real-world settings when that aligns with the proposed approach to address disparities and equity gaps.

9) What is the primary purpose of the funded projects?

The primary purpose is to support research aimed at preventing, reducing, or eliminating health disparities and advancing health equity, especially through ambitious intervention research with a credible pathway to real-world impact.

10) What types of organizations are eligible to apply?

The initiative is open to a wide range of applicant organizations across public, private, nonprofit, and academic sectors, including:

• 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
• Other entities

11) Are community-based and faith-based organizations eligible?

Yes. The announcement specifically highlights eligibility for applicant types that often play central roles in equity-focused work, including faith-based and community-based organizations.

12) Are minority-serving institutions specifically included as eligible applicants?

Yes. The opportunity highlights several categories of institutions commonly involved in equity-related efforts, including:

• Historically Black Colleges and Universities (HBCUs)
• Hispanic-serving Institutions
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

13) Are U.S. territories or possessions eligible?

Yes. The announcement indicates eligibility includes U.S. territories or possessions, and it also mentions regional organizations.

14) Can a foreign (non-U.S.) organization apply as the primary applicant?

No. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply as the primary applicant under this opportunity.

15) Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are not eligible to apply as the applicant.

16) Are any foreign elements allowed in a project at all?

Yes, in a limited way. The opportunity allows foreign components (as defined by the NIH Grants Policy Statement). This means a U.S.-based applicant may include certain justified foreign elements of the research as part of the project, as long as it complies with NIH policy.

17) What federal agency sponsors this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

18) What is the funding type and activity category?

The opportunity is categorized as discretionary funding and falls under the health activity category.

19) What is the opportunity number and CFDA listing provided?

The announcement is RFA-RM-21-021 and the CFDA listing provided is 93.310.

20) What was the original closing date listed in the summary?

The original closing date listed for this specific announcement was May 28, 2021.

21) Is the award ceiling known from the provided summary?

No. The posting indicates the expected award ceiling was not specified in the provided summary.

22) What kinds of projects are likely to be a strong fit for this program?

Based on the description, the program is best suited to applicants proposing ambitious, carefully justified 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.

23) Does this opportunity focus more on developing interventions, implementing them, or disseminating them?

It can support any of these, with an emphasis on projects that could be transformative in how interventions are developed, implemented, or disseminated, particularly where the outcome is meaningful advancement of health equity.

24) Does NIH expect projects to be tested in real-world settings?

The announcement indicates that clinical trials are allowed and that projects may include testing interventions in real-world or clinical settings when appropriate for the proposed strategy to address disparities and equity gaps.