BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R01 Clinical Trial Not Allowed)

This NIH RFA funds transformative, mechanistic research that uses invasive intracranial recording or stimulation during neurosurgical procedures to uncover how individual neurons and networks generate perception, cognition, emotion, and behavior. Applicants must propose rigorous, hypothesis‑driven studies that leverage human brain access, optionally integrating animal models or computational work to bridge scales. The program encourages multidisciplinary teams (clinicians, neuroscientists, engineers, data scientists, ethicists) and will create a consortium to develop standards, share data, and address neuroethical issues. Up to five cooperative‑agreement awards (U01) are anticipated, with a total estimated budget of $8 M. Projects are expected to produce high‑impact findings by the end of the award period and contribute data to a shared repository. • Focus: invasive human neuroscience (recording & stimulation) – no clinical trials (R01 not allowed). • Funding mechanism: Cooperative Agreement (U01) – up to 5 awards. • Estimated total funding: $8 M; average award ≈ $1.6 M. • Eligibility: U.S. public, private, nonprofit, for‑profit, small business, tribal, and state/local entities (foreign entities not eligible). • Duration: typical NIH U01 award 5 years. • Deliverables: data management & sharing plan, annual RPPR, consortium participation, neuroethical standards.