Project Summary / Abstract This 4-year Neuroethics R01 based at the University of Minnesota (UMN) will convene a national Working Group of top neuroethics, neurolaw, and neuroscience experts to conduct empirical research and generate evidence-based consensus recommendations for the ethical conduct of population research using highly portable, cloud-enabled MRI in new and diverse populations in field settings. NIH is supporting the development of both high-field portable MRI (3U01EB025153-02S2, PI: Garwood), and ultra- low field MRI (P41EB015896, PI: Rosen). As portable MRI develops quickly, guidance is urgently needed on unresolved ethical, legal, and social issues (ELSI). This R01 project builds on two NIH Administrative Supplements that have preliminarily identified the most pressing unresolved ELSI issues: (1) informed consent; (2) data security and privacy; (3) establishing local capacity to interpret and communicate neuroimaging data; (4) extensive reliance on cloud-based artificial intelligence (AI) for data analysis; (5) potential bias of interpretive algorithms in diverse populations; (6) return of research results and incidental (or secondary) findings to research participants; and (7) responding to participant requests for access to their data. Building on this preliminary work, Aim 1 will utilize survey research to inform a systematic Working Group (WG) process described in Aim 2. In Aim 1a, we will survey the U.S. general public, including over- sampling of rural, older adult, non-Hispanic African American, Hispanic/Latino, and economically disadvantaged respondents, to probe likely research use cases, issues they raise, potential solutions, and willingness to participate in research. In Aim 1b, we will survey expert stakeholders to elicit views on current/future research use cases and how to address the ELSI challenges. Expert stakeholders will be from 5 key groups: (1) researchers utilizing brain MRI and scientists developing new MRI technology; (2) neuroethics and legal scholars; (3) industry stakeholders; (4) leaders in regulatory agencies and standard-setting organizations; and (5) leaders in patient advocacy organizations. Aim 2 builds on Aim 1 to generate evidence-based consensus guidance on the ethical conduct of research in the field using highly portable, cloud-enabled neuroimaging. In Aim 2a, we will use a modified Delphi method to elicit initial WG views on issue priorities, research use cases, and potential recommendations, and will develop an Annotated Bibliography. In Aim 2b, the WG will pursue a structured process of analysis and consensus building that is well-established in bioethics and law, in order to identify best practices and formulate recommendations informed by the Aim 1 work. In Aim 2c, we will solicit feedback on our recommendations from expert readers and through a major public conference. Project products will include: an online Annotated Bibliography, WG consensus recommendations, individual targeted articles, published empirical analyses, a webcast public conference, a symposium issue of a peer-reviewed journal, online access to our work, and wide dissemination.

Project Narrative This innovative 4-year project based at the University of Minnesota will convene a national Working Group of top neuroethics, neurolaw, and neuroscience experts to conduct empirical research and generate evidence- based consensus recommendations for the ethical conduct of research using highly portable, cloud-enabled MRI in new and diverse populations in field settings. Highly-portable MRI, a transformative technology supported by the NIH BRAIN Initiative, will allow researchers to conduct population-based neuroscience research, including racial and ethnic minorities, rural, and socioeconomically disadvantaged populations that are currently underrepresented in neuroimaging research, and will accelerate research on brain biomarkers for neurodegeneration. The project team will address fundamental challenges in field-based neuroimaging research such as informed consent, data privacy, and return of results; produce Working Group consensus recommendations and targeted individual articles; publish empirical analyses; create a symposium issue of a peer-reviewed journal presenting project publications; create a publicly accessible Annotated Bibliography; produce a webcast and videotaped public conference; build an online portal offering access to our work; and conduct wide dissemination.