The National Institute of Mental Health (NIMH) Biobehavioral Research Awards for Innovative New Scientists (BRAINS) program (R01 Clinical Trial Optional) is designed to support early-stage investigators in launching high-impact research projects focused on mental health. This award aims to facilitate the careers of outstanding scientists with innovative approaches to understanding, diagnosing, treating, or preventing mental health disorders. The BRAINS award aligns with NIMH’s strategic goals to address gaps in mental health research and to foster a new generation of scientists committed to groundbreaking work in mental health. The program offers a flexible structure, allowing applicants to include clinical trials, and emphasizes projects that may lack preliminary data but demonstrate potential for transformative contributions to mental health.

Applications are due annually on June 20, with the next deadlines falling on June 20, 2024, and June 20, 2025. Letters of intent should be submitted 30 days before the due date. NIMH plans to fund 6-8 projects each year with an annual budget of up to $500,000 in direct costs over a maximum five-year project period. Awards will focus on projects that align with NIMH’s strategic plan objectives and are innovative in methodology or hypothesis, even if high-risk, provided they offer significant potential for advancing the field. NIMH especially encourages applications from scientists pursuing unconventional hypotheses or approaches that have the potential to redefine understanding in mental health research.

Eligibility is restricted to Early Stage Investigators (ESIs) in tenure-track or equivalent positions with demonstrated independence in research. Only U.S.-based institutions may apply, and non-domestic (non-U.S.) entities or components are ineligible. Institutions are encouraged to offer substantial support for the PD/PI, including research resources, protected research time, and access to facilities. Applicants must also form an external advisory committee to support career development, providing mentorship and feedback over the course of the project. This advisory committee is structured to include experts in the PD/PI’s field and at least one individual with clinical or translational expertise.

Applications must be submitted through the NIH ASSIST system, Grants.gov Workspace, or an institutional S2S system, and must adhere to the SF424 (R&R) Application Guide instructions. Key components include a Research Strategy section that addresses the significance, innovation, and approach of the proposed work, along with a detailed Data Management and Sharing Plan for NIMH's Data Archive. Specific items include a timeline for project goals, a statement of the applicant’s career objectives, and a departmental letter detailing institutional support. Budget considerations should include travel for presenting research at relevant meetings and for advisory committee gatherings.

Review criteria focus on the project’s potential to contribute to the understanding and treatment of mental illnesses, the qualifications of the applicant, and the innovativeness and feasibility of the proposed approach. Human subjects and clinical trials are permitted if applicable, and applicants must include thorough data management plans in alignment with NIMH’s open-access policies. NIMH will prioritize applications that meet its mission and strategic objectives and demonstrate a strong commitment to advancing mental health research and public impact.