NIH Directors Transformative Research Awards (R01 Clinical Trial Optional) | RFA RM 21 017

Opportunity Information: Apply for RFA RM 21 017

The NIH Directors Transformative Research Awards (R01 Clinical Trial Optional), listed under Funding Opportunity Number RFA-RM-21-017 (CFDA 93.310), is a discretionary NIH grant opportunity designed to back research that is genuinely high-risk and high-reward. The program is aimed at projects that are not just incremental improvements on existing work, but proposals that are groundbreaking, exceptionally innovative, original, or unconventional in a way that could reshape a field. In practical terms, NIH is looking for ideas that could create entirely new scientific paradigms, lead to dramatically better clinical approaches, or produce truly transformative technologies, rather than projects that simply extend current methods or knowledge by small steps.

A notable feature of this opportunity is that it welcomes proposals across the full breadth of NIHs mission. That includes behavioral, social, biomedical, applied, and formal sciences, and it can span basic research, translational research, and clinical research. Clinical trials are optional under this R01 mechanism, meaning applicants can propose work that includes a clinical trial if appropriate, but they do not need to force a trial component into a project that is better suited to non-trial designs. The emphasis is on the potential for major impact, and applicants are expected to make a strong logical case for why the concept could substantially move a broad area of health-related science forward.

The program explicitly removes a common barrier for early-stage or unconventional projects by stating that no preliminary data are required. Instead, the application must clearly demonstrate compelling potential based on the strength of the underlying rationale, conceptual framework, and proposed approach. Because the goal is transformative impact, reviewers are meant to weigh the boldness and plausibility of the idea, not just how much supporting data already exists. This setup is meant to encourage investigators to propose ideas that might be difficult to fund through more traditional mechanisms that favor extensive prior evidence.

NIH also places a strong emphasis on broad participation and diversity in the research workforce. The announcement encourages applications from individuals with diverse backgrounds and from the full range of eligible institutions across all geographic regions. Along with the standard eligible applicant types (including state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses), the opportunity highlights additional eligible applicants such as 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

There are specific restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed, meaning a U.S.-based applicant may include certain foreign elements or collaborations if they meet NIHs policy requirements and are well-justified.

Finally, this award sits within the NIH Common Funds High-Risk, High-Reward Research program, which signals both the intent and the review mindset: the NIH is deliberately investing in ideas that might fail but, if they succeed, could change the landscape of science or medicine. The original closing date shown for this specific posting was September 1, 2021, and while the listing does not provide an award ceiling or expected number of awards in the provided text, the central takeaway is that the program is built to identify and support unusually ambitious research proposals with the potential for outsized, field-shaping impact.

• 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 2021-06-04.
• Applicants must submit their applications by 2021-09-01. (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 21 017

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