The BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R21 Clinical Trial Optional) is a funding opportunity released by the National Institutes of Health (NIH), specifically under the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. This initiative seeks to fund exploratory and developmental research through the R21 mechanism, focusing on the ethical considerations surrounding the application of cutting-edge neurotechnologies and neuroscience advancements. Administered by several NIH Institutes and Centers including NIMH, NEI, NIA, NIAAA, NIBIB, NICHD, NIDCD, NIDA, NINDS, and NCCIH, the program aims to ensure that as scientific discovery accelerates, ethical reflection and empirical study remain tightly integrated into the research process.

The purpose of this grant opportunity is to encourage interdisciplinary teams to explore high-priority ethical questions raised by the rapid progress in brain science, particularly in research supported by the BRAIN Initiative. Proposals should integrate neuroethical research with current scientific advancements to ensure responsible development and application of neuroscience technologies. Research topics may include issues like data privacy in brain data, informed consent for neural interventions, ethical implications of predictive diagnostics, participant engagement especially within vulnerable populations, and social implications of access to neurotechnologies.

Eligible projects may include both clinical and non-clinical trials and should be novel, higher-risk, and shorter in duration compared to companion R01 funding opportunities. The research must be well-justified in its relevance to ethical concerns raised by BRAIN-supported research, with clearly defined goals, milestones, and methodological rigor. Projects are limited to a two-year period and must not exceed $275,000 in total direct costs, with no more than $200,000 requested in any single year.

Eligible applicants include a broad range of U.S. and non-U.S. institutions and organizations, including higher education institutions (both public and private), nonprofits, for-profits, tribal governments, local and state governments, and foreign entities. This includes small businesses, public housing authorities, independent school districts, and other community-based organizations. All applicant institutions must be registered with federal systems such as SAM.gov and eRA Commons prior to submission.

Applications are accepted annually, with due dates in October for each cycle through 2026. A letter of intent is encouraged 30 days before the submission deadline. The review process includes scientific merit review, advisory council review, and potential award announcements in July following each application cycle. Proposals are evaluated based on significance, innovation, investigator qualifications, research approach, environment, and ethical consideration integration.