NIH Directors Transformative Research Awards (R01 Clinical Trial Optional) | RFA RM 24 004

Opportunity Information: Apply for RFA RM 24 004

The NIH Directors Transformative Research Awards (R01 Clinical Trial Optional), funding opportunity number RFA-RM-24-004, is a National Institutes of Health (NIH) grant program designed to back unusually bold, high-impact research ideas that could fundamentally change how a field thinks or operates. The program is part of the NIH Common Fund High-Risk, High-Reward Research (HRHR) portfolio and is meant for proposals that are exceptionally innovative, original, unconventional, or paradigm-shifting. NIH is explicitly looking for projects that could create entirely new scientific paradigms, open up dramatically improved clinical approaches, or produce genuinely transformative technologies, rather than incremental advances.

A key feature of this opportunity is its openness to the full breadth of NIH-relevant science. Applications can fall anywhere across NIH's broad mission, including behavioral, social, biomedical, applied, and formal sciences. Projects may be basic, translational, or clinical in nature, and clinical trials are allowed but not required (hence "clinical trial optional"). The emphasis is on the potential for major impact: applicants are expected to make a compelling, logic-driven case that the work, if successful, would meaningfully shift a broad area of science or health. Notably, the program does not require preliminary data, which aligns with its goal of enabling high-risk concepts that may not yet have the standard evidence base expected in more conventional funding mechanisms.

NIH also highlights a strong interest in attracting applicants from diverse backgrounds, including those from underrepresented groups, and encourages applications from the full range of eligible institutions and geographic locations. Eligible applicants span many organization types, including public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and various levels of government (state, county, city/township, special districts), as well as tribal governments and tribal organizations. The announcement also calls out additional eligible categories such as 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 faith-based or community-based organizations and certain regional organizations.

There are important constraints around foreign participation. Non-domestic (non-U.S.) entities are not eligible to apply as applicants, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" may be allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may be able to include certain international elements in the project if they meet NIH policy requirements.

Another distinctive aspect of this funding opportunity is the peer review process. NIH is piloting an approach intended to focus reviewers more directly on the science by withholding the identities of investigators and institutions until the final phase of review. Because of that, applicants must follow specific instructions for anonymizing parts of the application package. The goal is to strengthen fairness and ensure that review is driven as much as possible by the quality, rigor, and transformative promise of the proposed work rather than by reputation or institutional prestige.

Administratively, this is a discretionary grant opportunity in the health category (CFDA 93.310) offered by NIH. The original closing date listed for applications is September 3, 2024, and the funding instrument is an R01 mechanism, which typically supports a defined research project but, in this case, is explicitly tuned to support high-risk, high-reward transformative ideas. The opportunity description does not specify an award ceiling or the expected number of awards in the provided text, so applicants would need to consult the full notice for any budget, project period, or award volume details.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Directors Transformative Research Awards (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2024-03-18.
• Applicants must submit their applications by 2024-09-03. (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 RM 24 004

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