Journal of Law and the Biosciences

Ethical, Legal, and Policy Challenges in Field-based Neuroimaging Research Using Emerging Portable MRI Technologies: Guidance for Investigators and for Oversight

Shen FX, Wolf SM, Lawrenz F, Comeau DS, Dzirasa K, Evans BJ, Fair D, Farah MJ, Han DS, Illes J, Jackson JD, Klein E, Rommelfanger KS, Rosen MS, Torres E, Tuite P, Vaughan JT, Garwood M.

Abstract

Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.

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Contemporary Clinical Trials

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Journal of Clinical and Translational Science