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注意差距:弥合植入式脑机接口人体研究中的伦理考量与监管监督之间的差距。

Mind the gap: bridging ethical considerations and regulatory oversight in implantable BCI human subjects research.

作者信息

Wilkins R Bert, Coffin Tara, Pham Michelle, Klein Eran, Marathe Megh

机构信息

WCG Clinical, Cary, NC, United States.

Center for Bioethics and Social Justice, Department of Medicine, Michigan State University, East Lansing, MI, United States.

出版信息

Front Hum Neurosci. 2025 Jul 23;19:1633627. doi: 10.3389/fnhum.2025.1633627. eCollection 2025.

Abstract

The advent of Brain-Computer Interface (BCI) technology brings groundbreaking advancements in medical science but also raises important ethical considerations. This manuscript explores the ethical dimensions of implantable BCIs (iBCIs), focusing on the central role of Institutional Review Boards (IRBs) in the United States, in safeguarding participant rights and welfare. As federally mandated bodies, IRBs ensure that informed consent is obtained ethically, emphasizing participant autonomy, preventing undue coercion, while supporting clear and practical communication of risks and benefits. As part of this discussion, this paper touches on the ethical challenges surrounding the enrollment of participants with impaired consent capacity and the long-term implications of implanted brain devices. Additionally, this work underscores the critical importance of robust cybersecurity measures to prevent data breaches and unauthorized manipulation of brain activity. By examining risk assessments, data management practices, and the need for external cybersecurity expertise, this work offers a comprehensive framework for IRB review of iBCI research. This perspective aims to guide ethical iBCI research and protect human subjects in this rapidly evolving field.

摘要

脑机接口(BCI)技术的出现给医学带来了突破性进展,但也引发了重要的伦理考量。本手稿探讨了可植入脑机接口(iBCI)的伦理层面,重点关注美国机构审查委员会(IRB)在保障参与者权利和福利方面的核心作用。作为联邦授权机构,IRB确保以符合伦理的方式获得知情同意,强调参与者的自主性,防止不当胁迫,同时支持对风险和益处进行清晰且切实可行的沟通。作为此次讨论的一部分,本文探讨了围绕同意能力受损的参与者招募以及植入式脑设备的长期影响所面临的伦理挑战。此外,这项工作强调了强大的网络安全措施对于防止数据泄露和未经授权的脑活动操纵的至关重要性。通过审查风险评估、数据管理实践以及对外部网络安全专业知识的需求,这项工作为IRB对iBCI研究的审查提供了一个全面的框架。这一观点旨在指导符合伦理的iBCI研究,并在这个快速发展的领域保护人类受试者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9deb/12325254/5eebf3035094/fnhum-19-1633627-g001.jpg

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