Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight.

Autor:	Shen FX; University of Minnesota, Law School, Minneapolis, MN 55455, United States; Massachusetts General Hospital, Center for Law, Brain & Behavior, Boston, MA 02114, United States; Harvard Medical School, Center for Bioethics, Boston, MA 02115, United States., Wolf SM; University of Minnesota, Law School and Medical School, Minneapolis, MN 55455, United States., Lawrenz F; University of Minnesota, Department of Educational Psychology, Minneapolis, MN 55455, United States., Comeau DS; Harvard Medical School, Department of Radiology, Boston, MA 02115, United States; Beth Israel Deaconess Medical Center, Department of Radiology, Boston MA 02115; Mass General Brigham, Human Research Office/Institutional Review Board, Boston, MA 02114, United States., Dzirasa K; Duke University, Departments of Psychiatry & Behavioral Sciences, Neurosurgery, and Neurobiology, Durham, NC 27710, United States., Evans BJ; Levin College of Law, Wertheim College of Engineering, University of Florida, Gainesville, FL 32611, United States., Fair D; University of Minnesota, Department of Pediatrics, Medical School, Masonic Institute for the Developing Brain; Institute of Child Development, College of Education & Human Development, Minneapolis, MN 55414, United States., Farah MJ; University of Pennsylvania, Department of Psychology, Philadelphia, PA 19104, United States., Han SD; University of Southern California, Departments of Psychology, Family Medicine, Neurology, and Gerontology, Los Angeles, CA 90089, United States., Illes J; University of British Columbia, Department of Medicine, Neuroethics Canada, Division of Neurology, Vancouver, BC V6T 2B5, Canada., Jackson JD; Harvard Medical School, Department of Neurology, Boston, MA 02115, United States; CRESCENT Advising, LLC, Belmont, MA 02478, United States., Klein E; Oregon Health & Science University, Department of Neurology, Portland, OR 97239, United States; University of Washington, Center for Neurotechnology & Department of Philosophy, Seattle, WA 98195, United States., Rommelfanger KS; Institute of Neuroethics (IoNx) Think and Do Tank; Ningen Neuroethics Co-Lab, Atlanta, GA 30322, United States., Rosen MS; Massachusetts General Hospital, Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA 02129, United States; Harvard Medical School, Department of Radiology, Boston, MA 02115, United States., Torres E; University of Minnesota, Department of Biomedical Engineering & Center for Magnetic Resonance Research, Minneapolis, MN 55455, United States; Adialante, Minneapolis, MN 55408, United States., Tuite P; University of Minnesota, Department of Neurology, Minneapolis, MN 55455, United States., Vaughan JT; Columbia University, Columbia Magnetic Resonance Research Center & Zuckerman Institute, New York, NY 100027, United States., Garwood M; University of Minnesota, Department of Radiology & Center for Magnetic Resonance Research, Minneapolis, MN 55455, United States.
Jazyk:	angličtina
Zdroj:	Journal of law and the biosciences [J Law Biosci] 2024 Jun 07; Vol. 11 (1), pp. lsae008. Date of Electronic Publication: 2024 Jun 07 (Print Publication: 2024).
DOI:	10.1093/jlb/lsae008
Abstrakt:	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. Competing Interests: M.S.R. is a founder and equity holder of Hyperfine, Vizma Life Sciences, Intact Data Services, and Q4ML. M.S.R. serves on the scientific advisory boards of ABQMR, Synex Medical, Nanalysis, and O2M Technologies. J.T.V. is a co-founder of MR Access, Inc. E.T. is a co-founder of Adialante. (© The Author(s) 2024. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School.)
Databáze:	MEDLINE
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