NIH Director's Transformative Research Award (R01 Clinical Trial Optional)

The NIH Director's Transformative Research Award is a federal grant opportunity administered by the National Institutes of Health within the U.S. Department of Health and Human Services. The opportunity number is RFA-RM-28-003, and the Assistance Listing is 93.310, Trans-NIH Research Support. The opportunity is categorized as discretionary funding, uses a grant funding instrument, and falls within the Health funding activity category. The award is part of the NIH Common Fund's High-Risk, High-Reward Research Program. The source identifies this opportunity as a forecast rather than a currently posted funding opportunity, with a forecast date and last updated date of September 3, 2026. The NIH Director's Transformative Research Award supports individual scientists and research teams pursuing bold, groundbreaking, and unconventional research. Supported research is expected to have the potential to transform science, create new scientific paradigms, establish new clinical approaches, or develop transformative technologies. The opportunity title identifies the funding mechanism as an R01 and states that clinical trials are optional. The provided forecast does not specify detailed allowable cost categories, spending restrictions, indirect cost limitations, subaward restrictions, or a period of performance. Those details therefore cannot be established from the current source and may become available when the full opportunity is posted. The opportunity does not require cost sharing or matching. The forecast anticipates approximately six awards, but it does not provide an estimated total program funding amount, award ceiling, or award floor. Because those monetary values are absent, no minimum or maximum award amount can be established from the source. The estimated award date is August 30, 2028, and the estimated project start date is September 30, 2028. The opportunity is associated with fiscal year 2028. Eligibility is broad. Eligible applicants listed in the forecast include special district governments, public and state controlled institutions of higher education, county governments, nonprofit organizations with 501(c)(3) status other than institutions of higher education, Native American tribal organizations other than federally recognized tribal governments, small businesses, federally recognized Native American tribal governments, state governments, private institutions of higher education, city or township governments, public housing authorities and Indian housing authorities, independent school districts, for profit organizations other than small businesses, and nonprofits without 501(c)(3) status other than institutions of higher education. Additional eligible applicants include Indian or Native American tribal governments other than federally recognized governments, eligible agencies of the federal government, U.S. territories or possessions, faith-based or community-based organizations, regional organizations, and non-domestic entities or foreign institutions. The forecast provides an estimated post date of March 15, 2027 and an estimated application due date of September 3, 2027. Because the opportunity is still forecasted as of the September 4, 2026 analysis date, applications are not yet indicated as open. The source does not identify a letter of intent, concept paper, pre-proposal, notice of intent, initial application, or other pre-application gating requirement. It also does not provide application questions, required proposal components, required uploads, evaluation criteria, review scoring criteria, or detailed submission mechanics. These items should not be inferred from the forecast and will require review of the full funding announcement when it becomes available. The source lists the NIH Director's Transformative Research Award Program as the grantor contact and directs applicants to make contact by email at Transformative_Awards@mail.nih.gov. No individual contact person or telephone number is provided. The estimated award date is August 30, 2028, followed by an estimated project start date of September 30, 2028. No recurring or annual application cycle is stated in the source, so the opportunity is treated as non-recurring based on the information currently available. The current timeline is therefore an estimated March 15, 2027 posting, an estimated September 3, 2027 application deadline, an estimated August 30, 2028 award date, and an estimated September 30, 2028 project start date.

Emphasize how the proposed research is bold, groundbreaking, and unconventional and how it could transform science, create new scientific paradigms, establish new clinical approaches, or develop transformative technologies.