PROJECT SUMMARY/ABSTRACT A central goal for the second half of the BRAIN Initiative is to develop new circuit-based treatments for brain diseases. However, improving care for neuropsychiatric illness will require not only discovering interventions, but also ensuring that research products meet patients’ needs and are accessible to underserved groups. While neuroethics to date has largely examined individualistic concerns (such as privacy, consent and identity), this application uses closed-loop neuromodulation as a circuit-based treatment paradigm for examining neuroethical challenges at a societal level such as equity/access and the democratization of research methods. To address challenging topics including socioeconomic, racial/ethnic, and geographic disparities will require special expertise in rigorous social science and in community engagement, to include perspectives missing in academic neuroethical discourse. Applying principles of community-engaged research, a Community Advisory Board will be recruited to meet quarterly with project leaders and advise on preliminary findings, research methods and the dissemination of results. Nationwide collaborations have been developed to facilitate research pursuing three specific aims: 1) Compare ethical concerns about novel neurotechnology among diverse groups; 2) Examine practice and patient factors in access to closed-loop neuromodulation in varied clinical settings; and 3) Investigate ethical and practical challenges in reducing barriers to closed-loop neuromodulation research. Aim 1 will address the views of prospective patients/users about neurotechnology in a nationally-representative sample with a focus on underserved groups. Aim 2 will examine the clinic setting via comparative ethnographic research in epilepsy centers using NeuroPace RNS treatment, which is currently the only FDA-approved and commercially available closed-loop brain implant, and therefore can be used to anticipate broader challenges in psychiatry and neurology with future applications of closed-loop approaches. Aim 3 will utilize a novel opportunity for studying ethical concerns in research through a new NIH-funded international collaboration to disseminate expertise and best practices in closed-loop neuromodulation. The approach is innovative, in the applicants’ view, addressing societal-level neuroethical concerns with advanced social scientific and community engagement methods not widely applied in neuroethics. The proposed research is significant because it addresses considerations of equity and democratization that are critical to future neurotechnology and neuroscience. Ultimately, this work will broaden the scope of normative issues addressed in neuroethics, such as distributive justice and tensions in broadening research. In neurotechnology, the work will contribute to fuller engagement with ethical challenges in the adoption of new techniques and the early integration of neuroethics in efforts to lower research barriers.

PROJECT NARRATIVE/PUBLIC HEALTH SIGNIFICANCE The proposed research is relevant to public health because new neurotechnologies in development represent the most promising pathway to much-needed new treatments for neuropsychiatric disorders, but existing disparities and research practices raise concerns about whether new advances will be developed for and disseminated to groups of greatest need. A rigorous examination of disparities and other ethical challenges in dissemination is critical to ensure that the public investment in BRAIN Initiative-funded neurotechnology achieves the broad aim of improving treatment for brain disorders.