BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional)

The BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional), offered by the National Institutes of Health (NIH), is designed to support empirical research exploring core ethical questions raised by the rapid development of neurotechnologies and neuroscience. This funding opportunity, a reissue of RFA-MH-24-190, aligns with NIH’s strategic goals outlined in “BRAIN 2025: A Scientific Vision” and its subsequent updates. It seeks to enhance interdisciplinary collaboration between ethicists and neuroscientists, encouraging innovative studies that integrate ethical considerations with technological advancements in brain research. The initiative is underpinned by contributions from multiple NIH institutes, including NIMH, NEI, NIA, NIAAA, NIBIB, NICHD, NIDCD, NIDA, NINDS, and NCCIH. This grant program supports research projects led by highly qualified teams that investigate ethical issues such as data privacy, informed consent, health disparities, the use of neurotechnologies in special populations, and public attitudes toward brain research. Proposed studies should address ethical challenges specific to BRAIN-supported research, rather than general bioethics or disease-specific ethics. Key areas include participant engagement, cybersecurity and data privacy, implications of neuromodulation, and ethical use of human brain data. High-risk, high-reward proposals with limited preliminary data are welcomed if a strong rationale is provided. Applicants may submit proposals under a maximum project period of four years with budgets not exceeding $300,000 in direct costs annually. The initiative anticipates awarding up to eight new grants each year from FY 2025 to FY 2027, supported by an estimated total of $3 million annually, contingent upon funding availability. Applications may be new or resubmissions and may or may not include clinical trials. All applications must comply with NIH policy guidelines and must include a detailed timeline with operational milestones, as well as data management and sharing plans. Eligible applicants span a wide range of organizational types including higher education institutions (public and private), nonprofits (with or without 501(c)(3) status), for-profit entities (including small businesses), local and state governments, tribal governments and organizations, U.S. territories, foreign organizations, and federal agencies including NIH intramural programs. All entities must complete several registrations including SAM, eRA Commons, and Grants.gov to be eligible. Applications must be submitted electronically by 5:00 PM local time on the due dates of October 11, 2024; October 10, 2025; or October 9, 2026. Letters of intent are encouraged and should be submitted 30 days prior to these due dates to assist NIH in planning the review process. Contact for scientific inquiries is Dr. James Churchill (james.churchill@nih.gov), and questions about peer review and financial aspects can be directed to Dr. Nicholas Gaiano and Heather Weiss respectively. The earliest possible start dates for awards are July 2025, July 2026, and July 2027, respectively. Evaluation criteria include significance, innovation, approach, investigator qualifications, and research environment. Applications will be reviewed for scientific merit by NIH peer review panels and selected for funding based on peer review scores, program priorities, and available funds. Compliance with human subjects protections and data safety monitoring is mandatory for funded projects involving human participants.