NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Not Allowed)

The NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Not Allowed), under the Funding Opportunity Number PA-25-304, is issued by the Department of Health and Human Services and administered through the National Institutes of Health (NIH). This grant is a reissue of PA-20-195 and is supported by multiple NIH Institutes and Centers including NEI, NHGRI, NIA, NIAAA, NIAID, NIBIB, NICHD, NIDCD, NIDCR, NIDA, NIEHS, NIMH, NINR, NLM, NCCIH, and NIMHD. The opportunity is also supported by the Office of Data Science Strategy (ODSS). The purpose of this funding program is to support innovative exploratory and developmental research projects at their early and conceptual stages, with the potential to lead to significant advances in biomedical, behavioral, or clinical research. Applications proposing clinical trials are not allowed under this Notice of Funding Opportunity (NOFO). The grant is designed to foster the development of novel ideas, methodologies, agents, and technologies that may not yet be backed by substantial preliminary data. The projects submitted should be distinct from traditional R01 grants and should not propose long-term or well-established lines of inquiry. This program encourages studies that take innovative approaches, apply existing methodologies in new ways, or explore untested areas with significant risk but the potential for high reward. Examples of appropriate projects include testing the feasibility of a novel research direction or applying current techniques to unstudied problems. The funding instrument is a grant, with a combined direct cost budget not exceeding $275,000 for the two-year project period, and no more than $200,000 allowed in any single year. The project period cannot exceed two years. No specific number of awards is guaranteed as funding is contingent upon NIH appropriations and the receipt of meritorious applications. Cost sharing is not required, and foreign organizations as well as components of U.S. organizations based abroad are eligible to apply. Applications must be submitted electronically via ASSIST, an institutional S2S system, or Grants.gov Workspace, and must conform to all instructions in the NIH Application Guide. Applications are due at 5:00 PM local time of the applicant organization on standard NIH due dates: February 16, June 16, and October 16 for new applications; March 16, July 16, and November 16 for renewals or resubmissions; and May 7, September 7, and January 7 for AIDS-related projects. The earliest submission date is January 16, 2025, and the expiration date is January 8, 2028. Eligibility for the grant includes a broad spectrum of organizations and individuals, such as higher education institutions (public and private), nonprofit and for-profit organizations, government entities at all levels (state, local, tribal, and territorial), school districts, housing authorities, community-based organizations, and foreign organizations. Individual principal investigators must have an eRA Commons account and demonstrate the skills and resources necessary to execute the proposed research. Review criteria include the significance and innovation of the research, scientific rigor and feasibility, and qualifications of investigators and institutional support. Additional factors such as protections for human subjects, use of vertebrate animals, and data management practices are also evaluated. Peer review and advisory council assessments form the basis for final award decisions. Questions may be directed to the NIH eRA Service Desk or specific contacts listed on the R21 IC-Specific Scientific Interests and Contact website.

Applicants are encouraged to review IC-specific scientific interests and contact program staff to ensure alignment with priorities.