NIH Directors Transformative Research Awards (R01 Clinical Trial Optional)

The NIH Director’s Transformative Research Award, funded through the Common Fund initiative of the Office of the NIH Director, is a specialized funding mechanism intended to support exceptionally bold, innovative, and unconventional research projects that have the potential to transform broad areas of biomedical, behavioral, social, applied, or formal sciences. It is part of the NIH High-Risk, High-Reward Research (HRHR) Program. The funding opportunity is open to individual investigators or collaborative teams proposing new research paradigms, transformative technologies, or radically novel clinical strategies. This initiative does not require preliminary data, allowing for high-risk but potentially high-impact research to be prioritized based on conceptual strength and anticipated impact. Administered under Activity Code R01, the Transformative Research Award opportunity does not limit budgets but requires that requests be well-justified relative to the scope of the project. Approximately $8 million in funding is anticipated for FY 2026, supporting around seven awards with a maximum project period of five years. Clinical trials are optional under this funding opportunity, and applicants may propose projects with or without such trials. The award mechanism is a grant, and NIH policies governing grants apply in full. The application submission opens on August 3, 2025, and the deadline is September 3, 2025, at 5:00 PM local time. Late submissions will not be accepted. There are no requirements for a letter of intent. The peer review process will occur in three stages, culminating in an advisory council review in May 2026 and potential funding awards starting July 2026. Applications must be submitted electronically using NIH ASSIST, Grants.gov Workspace, or institutional system-to-system tools, with required registrations in systems such as SAM, eRA Commons, and Grants.gov. Eligibility for this award is broad, encompassing public and private institutions of higher education, nonprofit and for-profit organizations, local and state governments, tribal organizations, housing authorities, school districts, regional and community-based entities, and other eligible domestic applicants. Foreign organizations are not eligible to apply directly, although foreign components of U.S. organizations are permitted. All applicants must complete system registrations in advance, including SAM, NCAGE (for foreign components), UEI, and eRA Commons. Applicants must craft their proposal with an emphasis on the significance, innovation, and transformative potential of their research idea. Specific aims should not be included; instead, applicants should use sections labeled “Significance, Innovation, and Impact” and “Insight and Rationale” to describe their vision and rationale without detailed experimental plans or preliminary data. Reviewers will focus on the importance, innovation, and feasibility of the project. Emphasis will be placed on how the proposed research might shift scientific paradigms or offer substantial advances in public health or research methods. For assistance and inquiries, scientific and administrative contacts include Dr. Patricia Labosky at Transformative_Awards@mail.nih.gov. Additional contacts for submission issues are available through eRA Commons, GrantsInfo@nih.gov, and support@grants.gov. A pre-recorded informational webinar is also available to support applicants in preparing submissions.