BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Basic Experimental Studies with Humans Required)

The National Institutes of Health, under the U.S. Department of Health and Human Services, is offering funding through the BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Clinical Trial Not Allowed). This opportunity is administered across multiple NIH institutes, reflecting a coordinated federal effort to advance neuroscience through innovative technologies. The BRAIN Initiative, launched in 2014, seeks to transform understanding of brain function by enabling detailed mapping, monitoring, and modulation of neural circuits, ultimately contributing to improved treatments for neurological and psychiatric conditions. This funding opportunity specifically supports exploratory, early-stage research projects that leverage invasive surgical procedures to directly record and stimulate neuronal activity in the human brain. These studies aim to uncover how neural activity across cells and networks contributes to cognition, perception, emotion, and behavior. The program emphasizes feasibility and planning work that will lay the groundwork for future large-scale research grants. Projects must be hypothesis-driven and may incorporate computational models, behavioral assays, and multimodal measurement approaches to generate new insights into human brain function. Funding is provided through the R61 exploratory/developmental grant mechanism, with budgets limited to $700,000 in direct costs per year for a maximum project period of three years. NIH anticipates committing approximately $6 million per cycle to fund around five awards. The program does not require cost sharing. Funds are intended to support research activities, including multidisciplinary collaboration, data collection, and analysis, but are not permitted for clinical trials, therapeutic development, or regulatory approval activities. Projects must focus on fundamental neuroscience rather than disease treatment or intervention efficacy. Eligibility is broad and includes higher education institutions, nonprofits, for-profit organizations, and various levels of government entities. However, foreign organizations and applications involving foreign subawards are not eligible. Applicants must ensure compliance with NIH registration requirements, including SAM, eRA Commons, and Grants.gov. Individual investigators must demonstrate the expertise and resources necessary to conduct the proposed research, and multidisciplinary teams are strongly encouraged. Collaboration across institutions is recommended due to the limited availability of suitable patient populations for invasive procedures. Applications must be submitted electronically through NIH-approved systems such as ASSIST or Grants.gov. Required components include a research strategy, data management and sharing plan, and a one-page team management plan outlining governance, collaboration, and communication structures. Proposals must address neuroethical considerations, including informed consent, risk management, and post-study patient care. Applications that fail to include required documentation or do not adhere to NIH guidelines will not be reviewed. The application timeline includes multiple submission cycles. The first due date is June 9, 2026, with subsequent deadlines on February 11, 2027. Applications are due by 5:00 PM local time of the applicant organization. Peer review occurs several months after submission, followed by advisory council review and earliest project start dates in April 2027 or December 2027 depending on the cycle. The opportunity is recurring within the specified timeframe and expires on February 12, 2027. Applications are evaluated through NIH peer review based on criteria including scientific significance, innovation, rigor, feasibility, and team expertise. Additional considerations include ethical protections for human subjects and the appropriateness of the research environment. Selected applicants will receive a Notice of Award and must comply with federal reporting and data sharing requirements. For inquiries, applicants may contact the program via email at BRAINeROH@ninds.nih.gov or consult NIH support services for submission assistance.

Ensure strong multidisciplinary collaboration; clearly justify human-based research; address neuroethical considerations thoroughly; align with BRAIN Initiative goals