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

The NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed) funding opportunity is offered by the National Institutes of Health through the National Institute of Allergy and Infectious Diseases. The opportunity supports integrated, investigator-initiated biomedical research programs focused on infectious, immunologic, allergic, and immune-mediated diseases. The funding announcement emphasizes collaborative, synergistic multi-project research programs that align with the NIAID mission, including studies on infectious microbes such as HIV, host-microbe interactions, immune system development and dysfunction, allergy, asthma, autoimmunity, immunodeficiency, transplant rejection, and translational research related to vaccines, therapeutics, and diagnostics. The program is intended to support large-scale collaborative scientific efforts that can generate outcomes beyond what could be achieved through independently conducted projects. The funding mechanism uses the NIH P01 Research Program Project structure and requires applicants to propose a minimum of two scientifically distinct but synergistic research projects organized around a common central theme or objective. Every application must also include an Administrative Core responsible for managing the overall program and supporting coordination, communication, infrastructure, progress monitoring, and collaboration among participating projects. Optional Scientific Cores may also be proposed when shared facilities, technologies, analytical tools, or resources are necessary to support at least two of the research projects within the proposed program. The announcement specifically prohibits clinical trials, although investigators may include analyses of samples obtained from independently funded clinical trials. NIAID strongly emphasizes scientific synergy and expects applicants to demonstrate how the proposed collaborative structure will enhance scientific outcomes compared to separate standalone projects. Eligible applicants include a broad range of domestic public and private entities such as higher education institutions, nonprofit organizations, for-profit organizations, small businesses, tribal governments, local governments, state governments, public housing authorities, regional organizations, independent school districts, and faith-based or community-based organizations. Foreign organizations and non-domestic components of U.S. organizations are not eligible to apply, although foreign components and unfunded international collaborations may be permitted under NIH policy. The opportunity does not require cost sharing or matching funds. Applicant organizations may submit multiple scientifically distinct applications. Program Directors and Principal Investigators must possess active eRA Commons accounts and ORCID registration. Applications involving foreign subawards or subcontracts are prohibited unless submitted under a separate NIH funding opportunity specifically designated for international collaborations. The announcement was posted on May 7, 2026, and the earliest submission date is August 25, 2026. Standard NIH due dates apply, with recurring application deadlines scheduled three times annually through May 25, 2029. The first application deadline is September 25, 2026, followed by January 25 and May 25 cycles in subsequent years. Applications are due by 5:00 PM local time of the applicant organization. Scientific peer review, advisory council review, and earliest project start dates are scheduled according to NIH review cycles. For example, applications submitted by September 25, 2026 are expected to undergo scientific review in March 2027, advisory council review in May 2027, and may begin funding as early as July 2027. The funding opportunity expires on May 26, 2029, and the recurring submission structure indicates an ongoing multi-year program cycle. Applicants must follow the NIH Multi-Project Application Guide and submit applications electronically through Grants.gov using either the NIH ASSIST system or institutional system-to-system submission platforms. Required application components include an Overall Program component, an Administrative Core, and at least two Research Projects. Optional Scientific Cores may be added when justified. The application package contains extensive instructions for each component, including page limitations, required forms, budget information, human subjects documentation, resource sharing plans, and Data Management and Sharing Plans. The Overall component is limited to 12 pages, Administrative and Scientific Core components are limited to 6 pages each, and each Research Project component is limited to 12 pages. The announcement also strongly encourages applicants to consult with NIAID staff at least 15 weeks before submission to confirm alignment with NIAID priorities and programmatic goals. Applications will undergo NIH peer review based on standard NIH scientific merit criteria, including significance, investigators, innovation, approach, and environment. Additional review emphasis is placed on the degree of coordination, synergy, and integration among proposed projects and cores. Reviewers will evaluate whether the overall program structure provides added scientific value compared to conducting the projects independently. Administrative and Scientific Cores will receive separate evaluations related to management quality, operational effectiveness, facilities, and support capabilities. Additional review considerations include protections for human subjects, vertebrate animals, biohazards, resource sharing plans, authentication of key resources, and budget justification. Funding decisions will also consider programmatic priorities, scientific merit, and availability of appropriated funds. Award budgets are not capped and must reflect the actual needs of the proposed research program. The maximum project period is five years. NIH policies governing federal grant administration, cybersecurity, data sharing, reporting, and compliance apply to all funded awards. Award recipients are required to submit annual Research Performance Progress Reports and comply with NIH Data Management and Sharing requirements. Questions regarding scientific aspects of the opportunity may be directed to the NIAID scientific contact at NIAID_P01_NOFO@mail.nih.gov, while financial and grants management questions may be directed to NIAIDFinancial-GrantsContact@mail.nih.gov. The opportunity supports large-scale collaborative biomedical research programs intended to advance scientific understanding and public health outcomes related to infectious and immune-mediated diseases.

Demonstrate strong scientific synergy across projects and clearly explain why the proposed collaborative structure provides greater scientific value than independent projects. Emphasize coordination, shared resources, integrated research goals, and alignment with NIAID mission priorities. Consult NIAID staff at least 15 weeks before submission to confirm programmatic alignment.