NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed)

The National Institute of Allergy and Infectious Diseases (NIAID) within the NIH is offering the Investigator-Initiated Program Project Grant (P01) funding opportunity (PAR-22-225) to support multi-project research programs that advance understanding, prevention, and treatment of infectious and immune-mediated diseases. Eligible research areas include the biology of infectious agents, host-microbe interactions, immune system functioning, immune-related disorders (e.g., autoimmunity, asthma, transplant rejection), and translational efforts for developing vaccines, diagnostics, and treatments. Each application must include at least two synergistic research projects led by independent investigators (Project Leaders) that are united by a central theme and demonstrate collaborative potential. An administrative core is mandatory for program coordination, and applicants may include optional scientific cores that serve multiple projects. Clinical trials are not supported under this FOA, though sample analyses from external trials are permitted. Program projects should demonstrate synergy by generating knowledge that surpasses the contributions of individual projects. This involves active data sharing and resource exchange, including samples, technologies, and cohort data that enhance each project’s outcomes. Synergistic interactions are expected to yield advancements in scientific knowledge and, where relevant, to inform the development of vaccines, therapeutics, or diagnostics. Applicants may use NIAID’s online resources for further guidance on P01 applications and may submit concurrent applications under the R01 mechanism if they choose. The funding level for this opportunity is determined by project needs, without specific budgetary caps. Project periods may last up to five years, and award funding is contingent on NIH appropriations. Eligible applicants include higher education institutions, nonprofits, for-profit entities, and government agencies, but foreign institutions are not eligible. However, foreign components of U.S.-based organizations are allowed. Registration with SAM, eRA Commons, and Grants.gov is mandatory before submission, and applications requiring over $500,000 in direct annual costs must contact NIAID staff at least six weeks in advance. NIAID also encourages prospective applicants to consult with institute staff approximately 15 weeks before the application due date to confirm alignment with program priorities. Application deadlines occur biannually on January 11 and June 8 for non-AIDS applications, with a separate cycle for AIDS-related submissions. Submissions must follow the SF424 (R&R) Multi-Project Application Guide, with strict adherence to page limits: 12 pages for each research project and overall component, and six pages for each core. Detailed data management and sharing plans are required, and applicants are expected to contribute data to public repositories like ImmPort if funded. Post-submission corrections are only accepted under specific circumstances and must comply with NIH policies on late applications. Evaluation criteria include the scientific merit and innovation of each project, overall program coherence, the synergistic value of proposed cores, and the ability of the research team to collaborate effectively. Reviewers will score applications based on program significance, investigator qualifications, innovation, approach, and environment. Projects must convincingly justify the benefits of the proposed multi-project approach compared to separate research initiatives. Upon submission, applications undergo a review by NIH’s Center for Scientific Review, with high-scoring applications advancing to an NIAID advisory council. For applications selected for funding, standard NIH grant policies apply. This FOA remains open until September 8, 2025, with available resources accessible via NIH’s electronic submission and grants administration systems.