Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

The National Institutes of Health (NIH) invites applications for the Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). This opportunity supports discrete, specified projects that involve basic science experimental studies with human participants, which meet the NIH definition of both a clinical trial and basic research. These studies prospectively assign human participants to experimental conditions to assess biomedical or behavioral outcomes with the goal of understanding fundamental phenomena rather than specific applications toward processes or products. Studies designed with specific applications in mind, such as testing mechanisms of interventions or measurable improvements in health outcomes, should apply under separate clinical trial-related funding announcements.

The purpose of this funding opportunity is to advance knowledge of basic biological, behavioral, and physiological processes through experimental research in humans. This funding mechanism supports investigations that manipulate independent variables in human participants and assess the resulting outcomes to better understand fundamental aspects of human systems or behaviors. Observational studies and those designed toward specific clinical applications are not eligible under this announcement.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, small businesses, local, state, and federal governments, tribal organizations, independent school districts, and foreign institutions. Individuals with the necessary skills, knowledge, and resources to conduct the proposed research are encouraged to apply. Eligible program directors and principal investigators (PD/PI) must have active eRA Commons accounts, and applicant organizations must complete required registrations in DUNS, SAM, eRA Commons, and Grants.gov prior to submission. Foreign institutions and components are also eligible.

Application budgets are not limited but must reflect the actual needs of the proposed project. The maximum project period is five years. Applicants requesting $500,000 or more in direct costs in any year must contact the relevant NIH Institute or Center at least six weeks before submission. Applications will be evaluated based on significance, investigator qualifications, innovation, approach, and environment. Reviewers will also assess study design, ethical considerations, and data management plans to ensure rigor and validity.

Standard NIH submission deadlines apply. Applications for non-AIDS research are due on June 5, October 5, and February 5 annually, while AIDS-related applications are due on September 7, January 7, and May 7 annually. All applications must be submitted by 5:00 PM local time of the applicant organization. Applications will undergo a two-level review process, including scientific peer review and advisory council review, to determine scientific merit, availability of funds, and alignment with program priorities.

Applicants must use the NIH ASSIST system, Grants.gov Workspace, or institutional system-to-system solutions for submission. Data Management and Sharing Plans are required for all submissions as of January 25, 2023. Successful applicants must comply with NIH policies for clinical trials, human subject protections, data monitoring, and reporting requirements. For additional guidance, applicants are encouraged to contact NIH staff listed under the IC-specific scientific interests.

This funding opportunity remains open until its expiration date of January 8, 2025. Full details, including application requirements, submission guidelines, and review criteria, are outlined in the SF424 (R&R) Application Guide and the NIH Grants Policy Statement.