BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed)

The Department of Health and Human Services, through the National Institutes of Health (NIH) and participating institutes such as the National Institute on Drug Abuse, the National Institute on Aging, and several others, has reissued a funding opportunity titled BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed). This opportunity, listed under funding opportunity number RFA-DA-27-004, is part of the NIH BRAIN Initiative, a large-scale research effort launched in 2014 to develop innovative technologies for studying brain function in unprecedented detail. The BRAIN Initiative is supported by multiple NIH institutes and centers, with the goal of accelerating the development and application of new neurotechnologies to ultimately improve prevention and treatment of brain disorders. This program specifically supports the development of theories, models, and methods that will help researchers quantitatively and predictively understand brain function across multiple scales, from cellular processes to behavior. The funding opportunity emphasizes projects that can analyze, integrate, and interpret complex, large-scale data sets produced by the BRAIN Initiative, including anatomical, connectivity, physiological, and behavioral data. Importantly, any experimental work must be limited to model parameter estimation and testing the validity of the analytical tools being developed. The final products of funded projects are expected to be widely disseminated to the neuroscience community, along with robust resource and software sharing plans. The program will support the creation of predictive and mechanistic theories of brain function, computational models linking neural activity to behavior, and advanced statistical and computational tools to handle the complexity of neuroscience datasets. Projects must leverage high-resolution data, such as cellular imaging or single-unit recordings, and are encouraged to integrate across temporal scales and data types. Tools for analyzing behavior must explicitly incorporate neural data and span multiple timescales relevant to the processes being studied. Applications not meeting these criteria, such as those relying solely on low-resolution noninvasive measures like EEG or fMRI without integration of circuit-level data, will be considered non-responsive. Applicants eligible to apply include higher education institutions, nonprofit organizations, for-profit businesses, local and state governments, tribal governments and organizations, foreign institutions, and certain other entities. However, NIH will not issue awards to applicants that include foreign subawards or subcontracts. Individuals with the necessary skills and resources are encouraged to apply, provided they work through eligible organizations. There are no cost-sharing requirements under this announcement. Applications may be submitted electronically through NIH ASSIST, Grants.gov Workspace, or institutional system-to-system platforms, and must follow all instructions in the NIH Application Guide as well as the additional requirements outlined in the NOFO. Key dates include the earliest open date of September 28, 2025, with the first application due date on October 28, 2025. Additional due dates occur in October 2026 and October 2027, with reviews occurring in the following March and earliest award start dates in July of each year. The final expiration date for this NOFO is November 9, 2027. NIH anticipates providing $6 million per year to fund up to 15 awards annually. Application budgets are not capped, but are expected to fall within $150,000 to $350,000 in direct costs per year, with a maximum project period of three years. No clinical trials are allowed under this opportunity. Applicants must include comprehensive resource sharing and data management plans, and funded investigators will be expected to collaborate and participate in BRAIN Initiative meetings and conferences. Review criteria will emphasize the significance, innovation, rigor, feasibility, investigator expertise, and the extent of collaboration across disciplines. Questions regarding scientific or research aspects of this NOFO may be directed to Dr. Jessica Mollick at the National Institute on Drug Abuse via email at BRAINTheoriesFOA@mail.nih.gov or telephone at 301-827-2949. General grants information can be obtained from GrantsInfo@nih.gov, and application process questions may be directed to Grants.gov support or the eRA Service Desk. Financial inquiries may be sent to the Chief Grants Management Officer at nidagmbemail@nida.nih.gov.