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使用新兴便携式磁共振成像技术进行现场神经成像研究中的伦理、法律和政策挑战:给研究者及监督者的指导意见

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

作者信息

Shen Francis X, Wolf Susan M, Lawrenz Frances, Comeau Donnella S, Dzirasa Kafui, Evans Barbara J, Fair Damien, Farah Martha J, Han S Duke, Illes Judy, Jackson Jonathan D, Klein Eran, Rommelfanger Karen S, Rosen Matthew S, Torres Efraín, Tuite Paul, Vaughan J Thomas, Garwood Michael

机构信息

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.

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

出版信息

J Law Biosci. 2024 Jun 7;11(1):lsae008. doi: 10.1093/jlb/lsae008. eCollection 2024 Jan-Jun.

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.

摘要

研究人员正在迅速开发和部署高度便携的磁共振成像(MRI)技术,以开展基于实地的研究。这项新技术将扩大使用范围,把新的研究人员纳入偏远和非常规环境的研究中,并将促进农村、经济上处于不利地位以及历史上代表性不足的人群更多地参与进来。为了解决高度可及和便携的MRI所引发的伦理、法律和社会问题,一个跨学科工作组(WG)开展了为期多年的结构化分析和共识达成过程,该过程以对专家和公众观点的实证研究为依据。本文介绍了工作组的共识建议。这些建议涉及技术质量控制、研究的设计与监督,包括研究参与者以及扫描环境中其他人的安全、不同参与者的参与、治疗性误解、使用人工智能算法获取和分析MRI数据、数据隐私与安全、结果反馈及偶然发现的管理,以及研究参与者数据的获取与控制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ea5/11157461/b70bb9b1c1e3/lsae008f1.jpg

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