NIA Program Project Applications (P01 Clinical Trial Optional)

The National Institute on Aging (NIA), part of the National Institutes of Health (NIH), invites applications for the NIA Program Project Applications (P01 Clinical Trial Optional) funding opportunity. This initiative supports investigator-initiated program project grant (P01) applications focused on scientific areas aligned with the NIA's mission, such as aging processes, age-related diseases, and conditions impacting older adults. The P01 mechanism is designed to foster collaborative, multi-project research efforts that pursue shared goals and synergistic outcomes not attainable by individual investigators operating independently. Each P01 application must include at least three interrelated research projects that share a central scientific theme and an administrative core to coordinate the overall program. Optionally, applicants may propose one or more shared resource cores utilized by multiple projects. Revision applications are also permitted, allowing for expansion or new project proposals within an existing award’s framework but must not extend the project beyond its current end date. Clinical trials may be included as part of an individual project, but the overarching theme of the P01 must not be a clinical trial in itself. Eligible applicants include higher education institutions, nonprofit and for-profit organizations, state and local governments, tribal entities, public housing authorities, and other U.S.-based institutions. Foreign institutions are ineligible, though foreign components are allowed. Applications must be submitted electronically via NIH ASSIST or other system-to-system solutions through Grants.gov. Required registrations include SAM, eRA Commons, and Grants.gov, among others. All principal investigators and key personnel must have eRA Commons IDs. Letters of intent are requested 30 days before the application due date and should be directed to Ramesh Vemuri, Ph.D., at the NIA. The funding opportunity operates on NIH standard application cycles, with submission dates in January, May, and September annually, and continues until its expiration on January 8, 2026. Awards may last up to five years, with budgets tailored to project needs. While there is no budget cap, applications requesting $500,000 or more in direct costs must contact an NIA scientific contact six weeks in advance. Historically, awards over $2 million in direct costs are rare and require additional review. Applications will undergo NIH’s two-level peer review process, assessing significance, innovation, approach, investigator qualifications, and research environment. Special attention is given to integration among projects and the effectiveness of the administrative core. Post-award expectations include compliance with data sharing, human subjects protections, and use of the Clinical Research Operations Management System (CROMS) when applicable. Contacts for scientific, peer review, and financial inquiries include Sanoj K. Suneja, Ph.D., Ramesh Vemuri, Ph.D., and Mr. E.C. Melvin, respectively.