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

Author:

Shen Francis X1ORCID,Wolf Susan M2ORCID,Lawrenz Frances3ORCID,Comeau Donnella S4ORCID,Dzirasa Kafui5ORCID,Evans Barbara J6ORCID,Fair Damien7ORCID,Farah Martha J8ORCID,Han S Duke9ORCID,Illes Judy10ORCID,Jackson Jonathan D11ORCID,Klein Eran12ORCID,Rommelfanger Karen S13ORCID,Rosen Matthew S14ORCID,Torres Efraín15ORCID,Tuite Paul16ORCID,Vaughan J Thomas17ORCID,Garwood Michael18ORCID

Affiliation:

1. 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

2. University of Minnesota , Law School and Medical School, Minneapolis, MN 55455 , United States

3. University of Minnesota , Department of Educational Psychology, Minneapolis, MN 55455 , United States

4. 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

5. Duke University , Departments of Psychiatry & Behavioral Sciences, Neurosurgery, and Neurobiology, Durham, NC 27710 , United States

6. Levin College of Law , Wertheim College of Engineering, University of Florida, Gainesville, FL 32611 , United States

7. 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

8. University of Pennsylvania , Department of Psychology, Philadelphia, PA 19104 , United States

9. University of Southern California , Departments of Psychology, Family Medicine, Neurology, and Gerontology, Los Angeles, CA 90089, United States

10. University of British Columbia , Department of Medicine, Neuroethics Canada, Division of Neurology, Vancouver, BC V6T 2B5 , Canada

11. Harvard Medical School , Department of Neurology, Boston, MA 02115, United States; CRESCENT Advising, LLC, Belmont, MA 02478 , United States

12. 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

13. Institute of Neuroethics (IoNx) Think and Do Tank; Ningen Neuroethics Co-Lab , Atlanta, GA 30322 , United States

14. 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

15. University of Minnesota , Department of Biomedical Engineering & Center for Magnetic Resonance Research, Minneapolis, MN 55455, United States; Adialante, Minneapolis, MN 55408 , United States

16. University of Minnesota , Department of Neurology, Minneapolis, MN 55455 , United States

17. Columbia University , Columbia Magnetic Resonance Research Center & Zuckerman Institute, New York, NY 100027 , United States

18. University of Minnesota , Department of Radiology & Center for Magnetic Resonance Research, Minneapolis, MN 55455 , United States

Abstract

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.

Funder

NIH/NIMH

Highly Portable and Cloud-Enabled Neuroimaging Research: Confronting Ethics in Field Research with New Populations

Publisher

Oxford University Press (OUP)

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