NINDS Program Project Grant (P01 Clinical Trial Optional)

The National Institute of Neurological Disorders and Stroke (NINDS), a branch of the National Institutes of Health (NIH), invites applications for the Program Project Grant (P01) with an emphasis on collaborative, high-impact research in neurology. This funding opportunity is aimed at fostering interactive research that addresses significant scientific questions in line with the NINDS mission. These grants are intended to fund research that integrates multiple, interdependent projects led by experts from various scientific backgrounds, with each project contributing uniquely to a shared, overarching research goal. The program encourages diverse teams, including those from underrepresented groups, to propose studies that promise to yield greater scientific benefits when conducted collectively rather than as isolated projects. The P01 award allows applicants to propose projects with optional human mechanistic trials but prohibits clinical trials focused on intervention safety or efficacy. Applications should emphasize how the proposed projects collectively advance the field and outline why these projects are interdependent. Applicants are encouraged to discuss budget plans with NINDS program staff at least eight weeks prior to submission. The program’s director, an established researcher with demonstrated leadership capabilities, must oversee the initiative, ensuring that each project’s goals align with the central theme of the grant. The NINDS P01 grant has specific requirements for application structure and content, with a minimum of three research projects and supporting administrative and research cores. Each project within the application must be scientifically robust on its own and contribute to the synergistic goals of the program. Core components provide essential resources or services to the projects, and both projects and cores must exhibit high scientific and technical quality. The program director must outline an administrative structure to coordinate activities, oversee quality control, and facilitate collaboration, with a detailed explanation of responsibilities among all team members. Eligible applicants include higher education institutions, both public and private, nonprofits, government agencies, and other entities based in the United States, although foreign institutions cannot apply as primary applicants. Entities must be registered in the System for Award Management (SAM), eRA Commons, and Grants.gov, among other platforms. The application process includes a comprehensive review based on NIH standards and may involve a scientific merit review, advisory council review, and council-level considerations. Applicants are encouraged to ensure all registrations are completed well before the application deadline, as failure to do so could delay submission. Review criteria include the significance of the overall program, innovation, scientific approach, the collaborative capacity of the research teams, and the adequacy of the administrative and research core infrastructure. The reviewers also assess each project’s standalone scientific merit and its contribution to the overall theme, evaluating the extent to which combining projects into a single program enhances their collective value. For projects involving human or animal subjects, detailed ethical protections and inclusion criteria are mandatory. Furthermore, applicants proposing studies involving NIH-defined clinical trials are advised to use the NIH’s Research Methods Resources. Key dates include an earliest submission date of April 25, 2024, with application deadlines on May 25, 2024, and subsequent deadlines for new and renewal applications, extending through January 8, 2025. A letter of intent is due 30 days before each application deadline. Applicants should carefully adhere to NIH submission guidelines and submit applications via the ASSIST system or an institutional system-to-system solution on Grants.gov.