NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Required)

The NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Required) is a funding opportunity issued by the National Institutes of Health (NIH), specifically designed to support early-stage, exploratory, and developmental research that includes clinical trials. The grant provides support for high-risk, high-reward studies that may not yet have substantial preliminary data but show strong potential for significant advances in biomedical, behavioral, or clinical science. It is intended to encourage innovation, creative discoveries, and novel methodologies that could have a transformative impact on public health. This funding opportunity is supported by multiple NIH Institutes and Centers (ICs), including but not limited to the National Eye Institute (NEI), the National Institute on Aging (NIA), and the National Institute of Mental Health (NIMH). Each participating IC has its own scientific priorities and applicants must ensure that their proposed research aligns with the mission and interests of at least one of these participating components. Applicants are strongly encouraged to consult the R21 IC-Specific Scientific Interests and Contact website to identify the most appropriate IC for their project and to communicate with the relevant program staff prior to submission. The total budget for an R21 grant may not exceed $275,000 in direct costs over a two-year period, with no more than $200,000 in direct costs allowed in any single year. This budget format supports brief, exploratory projects with a high potential payoff, especially those that would not qualify under traditional NIH R01 funding. The award is highly competitive and based on scientific merit as determined by NIH’s rigorous peer review process. The project must include at least one NIH-defined clinical trial, which includes studies involving human subjects assigned to an intervention for biomedical or behavioral outcome evaluation. Eligibility for this grant is broad and includes public and private institutions of higher education, nonprofit and for-profit organizations, governmental units at the state and local level, tribal entities (both federally recognized and others), and foreign institutions. Applicants must be registered in several federal systems including SAM, eRA Commons, and Grants.gov. Principal Investigators must also have an eRA Commons ID, and institutions must ensure proper registration before application submission. Applications are submitted through the NIH ASSIST platform, institutional system-to-system platforms, or Grants.gov Workspace. The grant opportunity was posted on December 18, 2024, and the earliest application submission date is January 16, 2025. NIH uses standard R21 deadlines for submissions, with key dates including February 16, June 16, and October 16 each year through 2027. Applications are reviewed in a three-cycle process, and the earliest possible award date depends on the submission cycle. The funding opportunity expires on January 8, 2028. Review criteria focus on the importance and innovation of the research, the rigor and feasibility of the proposed approach, and the expertise and resources of the investigators and institution. Additional considerations include the protection of human subjects, the handling of vertebrate animals or biohazards if applicable, and plans for data sharing. Awards are governed by the NIH Grants Policy Statement and may include additional IC-specific conditions. For assistance with submission or questions about the funding opportunity, applicants may contact the eRA Service Desk, NIH Grants Info, or the Grants.gov Customer Support. Direct programmatic contacts are provided through the IC-Specific website.