NIH Research Program Projects (Parent P01 Clinical Trial Optional)

The National Institutes of Health (NIH) is soliciting applications through Notice of Funding Opportunity PA-27-061 for investigator-initiated Program Project (P01) awards. These grants support broadly based, multidisciplinary research programs centered on a specific major scientific objective or theme aligned with the missions of participating Institutes, Centers, and Offices. The maximum project period is five years, and while application budgets are not limited, they must reflect the actual needs of the proposed research. Eligible applicants include small businesses and other for-profit organizations, all of whom must maintain active SAM.gov registration, a Unique Entity Identifier, and eRA Commons and ORCID accounts. Applications must include a required overall component, one administrative core, between two and five research projects, and up to five optional shared resource cores. Submissions are evaluated based on significance, investigator qualifications, innovation, approach, and environment. For projects involving clinical trials, additional requirements include registration on ClinicalTrials.gov, adherence to human subject protections under 45 CFR Part 46, and the implementation of cybersecurity incident reporting procedures that notify HHS within 48 hours of discovery.