The BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional) funding opportunity is issued by the National Institutes of Health (NIH) as part of its BRAIN Initiative. This grant seeks to support multidisciplinary teams conducting research on the ethical challenges arising from technological and scientific advances in brain science. It aims to complement and integrate with the transformative neuroscience research funded by the BRAIN Initiative, fostering exploration of key ethical issues related to human brain research.

The purpose of this funding opportunity is to encourage studies that explore the intersection of neuroscience and ethics, particularly those linked to emerging neurotechnologies and scientific developments within the BRAIN Initiative. Applicants are invited to investigate topics including, but not limited to, informed consent in special populations, public perception of brain modulation, disparities in access to technology, data privacy, cybersecurity of brain data, and ethical use of neural data and devices. Research should be data-driven and ideally incorporate ethicists into neuroscience research efforts.

Funding will support projects with a budget of up to $300,000 in direct costs per year, with a project period of up to four years. Approximately $3 million is expected to be allocated annually from 2025 to 2027, supporting up to eight new awards each year. Applications must clearly describe the novelty, potential impact, and methodological approach of the proposed research, and include measurable milestones. Preliminary data are not required, allowing space for high-risk, high-reward projects that aim to generate significant advances in ethical practices in neuroscience.

Eligible applicants include a wide array of organizations such as public and private higher education institutions, nonprofits, for-profits including small businesses, local and state governments, tribal entities, and international organizations. The funding opportunity is open to both domestic and foreign entities. Applications must be submitted through ASSIST, Grants.gov, or an institutional system-to-system solution, and require various registrations including SAM, eRA Commons, and Grants.gov.

Applications are due annually in October for three consecutive years: October 11, 2024; October 10, 2025; and October 9, 2026. Letters of intent are encouraged 30 days prior to each due date. The review process involves both scientific merit and advisory council evaluations, with awards anticipated the following July. Submissions must comply with NIH's application guide, include a detailed project timeline, and adhere to human subject protections, where applicable.

Evaluation criteria include the significance, innovation, approach, investigator qualifications, and project environment. Special emphasis is placed on how well the project addresses pressing ethical concerns tied to BRAIN Initiative research, and whether the proposed research is likely to lead to transformative understanding or policy advancements. Additional considerations include feasibility, risk management, and data sharing commitments in line with NIH policies.