NIH Directors Transformative Research Awards (R01 Clinical Trial Optional)

The NIH Director’s Transformative Research Award, part of the High-Risk, High-Reward Research program, is designed by the Office of Strategic Coordination within the Common Fund of the National Institutes of Health (NIH). This program aims to catalyze exceptionally innovative and groundbreaking research projects that have the potential to revolutionize existing scientific paradigms, establish novel clinical approaches, or create transformative technologies. This opportunity is framed to encourage applications from individual scientists or collaborative teams proposing high-risk, high-impact research ideas. This grant mechanism emphasizes bold and unconventional approaches in scientific research. It supports investigators willing to explore pioneering concepts, even if those concepts challenge current standards or understanding. Importantly, the application process does not require preliminary data or detailed experimental plans, making it uniquely accessible to those with innovative ideas that are not yet fully developed. The mechanism for this opportunity is the R01 activity code, which is typically used for health-related research and development projects. The total estimated program funding is $8,000,000, with an anticipated number of seven awards. While the forecast does not specify an exact award ceiling or floor, applicants can expect substantial support relative to NIH's typical R01 grants. Cost sharing or matching is not a requirement for this program. Eligible applicants span a broad array of entities, including public and state-controlled institutions of higher education, independent school districts, nonprofits with 501(c)(3) status, small businesses, and both federally and non-federally recognized tribal organizations and governments. For-profit entities other than small businesses, public housing authorities, county and state governments, and private institutions of higher education are also eligible to apply. This broad eligibility is intended to attract a wide spectrum of researchers with transformative ideas. Although this is a forecasted opportunity, the estimated post date is June 20, 2025, allowing applicants time to prepare their submissions. The application deadline is expected to be September 3, 2025, with awards anticipated around September 18, 2026, and project starts by September 28, 2026. As applications are not being accepted at this time, the notice serves as an advance signal to allow ample preparation time for interested parties. For more information, interested applicants may contact Patricia Labosky, Ph.D., at the Office of the Director. She can be reached at 301-594-4863 or via email at Transformative_Awards@mail.nih.gov. Further details will be made available when the full Notice of Funding Opportunity is officially posted.