The NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed), funding opportunity number PA-25-301, supports discrete, specific research projects in scientific areas aligned with the missions of the participating NIH Institutes and Centers (ICs). Applications proposing clinical trials are not accepted under this Notice of Funding Opportunity (NOFO). Researchers are encouraged to review the IC-specific research interests and consult with NIH staff prior to submission to ensure alignment with programmatic priorities.

The purpose of this NOFO is to foster fundamental scientific discoveries and innovative research strategies that advance knowledge in medical and associated sciences, improve health, and enhance the nation’s capacity to prevent diseases. The NIH aims to support research that addresses the causes, diagnosis, prevention, and treatment of diseases, human growth and development, the biological effects of environmental contaminants, and the understanding of mental, physical, and addictive disorders. The NIH also promotes the dissemination and exchange of medical and health information.

Eligible applicants include higher education institutions (public or private), nonprofits with or without 501(c)(3) status, for-profit organizations, small businesses, local governments, state governments, tribal governments (federally and non-federally recognized), foreign organizations, faith-based or community-based organizations, and U.S. territories. Foreign entities and foreign components of U.S. organizations are eligible to apply. There is no budget cap for applications, but budgets must reflect the actual needs of the project. The maximum project period is five years.

Applicants must complete necessary registrations prior to submission, including SAM.gov, eRA Commons, and Grants.gov. Applications must adhere strictly to the NIH How to Apply – Application Guide and comply with all submission requirements. Proposals requesting $500,000 or more in direct costs in any year must contact NIH program staff at least six weeks before submission. Applications are due February 5, June 5, and October 5 annually, with AIDS-specific deadlines falling approximately one month later. Late submissions will not be accepted.

The peer review process will evaluate applications based on significance, innovation, rigor, feasibility, investigator expertise, and institutional resources. Factors such as protections for human subjects, the use of vertebrate animals, biohazards, and data sharing plans will also be reviewed. NIH will prioritize funding decisions based on scientific merit, programmatic relevance, and availability of funds. Awardees are expected to comply with NIH’s Data Management and Sharing Policy and other federal regulations.

Applicants will receive a Notice of Award (NoA) upon successful review and approval, which formalizes the terms and conditions of funding. Annual Research Performance Progress Reports (RPPR), invention statements, and financial reports will be required for post-award monitoring. Specific inquiries can be directed to NIH contacts listed in the R01 IC-Specific Scientific Interests and Contact website for scientific, peer review, and grants management matters.

This NOFO remains active until January 8, 2028.