The NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) supports basic science experimental studies involving human participants that fall within the NIH definition of a clinical trial while meeting the criteria for basic research. This funding opportunity is designed for research that prospectively assigns human participants to conditions to assess biomedical or behavioral outcomes aimed at understanding fundamental aspects of phenomena without specific applications toward products or processes.

The purpose of this funding opportunity is to foster innovative, hypothesis-driven studies that advance knowledge of biological, behavioral, or psychological processes. Eligible projects must involve prospective experimental manipulation of independent variables in humans but cannot focus on product development, treatment efficacy, or clinical outcomes. Mechanistic clinical trials and applied studies should seek alternative funding opportunities under “Clinical Trials Required” or “Clinical Trials Optional” announcements. Examples include research examining fundamental biological processes, such as mechanisms underlying sensory perception or neural function, through experimental manipulations in human participants.

Eligible applicants include higher education institutions, nonprofit and for-profit organizations, governmental agencies, and foreign organizations. Foreign components of U.S. institutions are also eligible. All applicants must comply with NIH registration requirements, including System for Award Management (SAM), Grants.gov, and eRA Commons, well in advance of the submission deadline. Applications must propose projects with a maximum period of five years and budgets reflecting the actual needs of the research, as there is no predefined budget limit.

Applications will be evaluated based on significance, innovation, approach, investigator qualifications, and the adequacy of institutional resources. Proposals will be assessed for their scientific rigor, experimental design, potential for reproducibility, and feasibility of the proposed studies. The review process will emphasize the importance of the proposed work to advance understanding of fundamental biological or behavioral mechanisms and evaluate its overall impact on the research field.

Applications must be submitted through Grants.gov and tracked via eRA Commons. Standard NIH due dates apply, with the first deadline on February 5, 2025. Applicants are encouraged to contact program staff within participating Institutes and Centers to ensure alignment with programmatic priorities and confirm eligibility under this funding mechanism. Awards will be made based on scientific merit, program relevance, and funding availability, with individual project start dates contingent upon NIH review timelines.