脑机接口临床研究伦理审查的挑战与建议

doi:10.24920/004377

Chinese Medical Sciences Journal ›› 2024, Vol. 39 ›› Issue (2): 131-139.doi: 10.24920/004377

脑机接口临床研究伦理审查的挑战与建议

王雪芹¹,孙洪强¹,司佳玥²,林子琰³,翟晓梅⁴,陆林^1,^5,^*()

¹北京大学第六医院，北京大学精神卫生研究所，NHC 精神健康重点实验室，国家精神疾病临床研究中心，中国医学科学院创新单元（No. 2018RU006）北京 100191，中国
²加州大学戴维斯分校，心理学系，戴维斯 95616，美国
³多伦多大学，心理学系，多伦多 M4S 1A1, 加拿大
⁴群医学与公共卫生学院，中国医学科学院北京协和医学院，北京 100730，中国
⁵北京大学前沿交叉科学研究院，北大-清华生命科学联合中心，北京大学IDG麦戈文脑科学研究所，北京 100871，中国

收稿日期:2024-05-15 接受日期:2024-06-03 出版日期:2024-06-30 发布日期:2024-06-12
通讯作者: * 陆林，E-mail：linlu@bjmu.edu.cn

Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces

Xue-Qin Wang¹,Hong-Qiang Sun¹,Jia-Yue Si²,Zi-Yan Lin³,Xiao-Mei Zhai⁴,Lin Lu^1,^5,^*()

¹Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Chinese Academy of Medical Sciences Research Unit (No.2018RU006), Beijing 100191, China
²Department of Psychology, University of California, Davis 95616, USA
³Department of Psychology, University of Toronto, Toronto M5S 1A1, Canada
⁴School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
⁵Academy for Advanced Interdisciplinary Studies, Peking-Tsinghua Centre for Life Sciences and Peking University-International Development Group/McGovern Institute for Brain Research, Peking University, Beijing 100871, China

Received:2024-05-15 Accepted:2024-06-03 Published:2024-06-30 Online:2024-06-12
Contact: * linlu@bjmu.edu.cn

摘要/Abstract

摘要：

脑机接口技术的医学研究和应用发展迅速。作为一种新兴的生物医学工程技术，脑机接口在脑疾病的诊断与治疗、神经康复、精神障碍与心理健康等领域的临床研究备受关注。然而，脑机接口临床研究也引发了诸多挑战和伦理学方面的关注。本文探讨了医疗健康领域脑机接口研究在国际范围的伦理治理现状，阐释了脑机接口临床研究面临的多维伦理挑战，并为脑机接口的临床研究伦理审查需要关注的内容提出若干建议。尽管医疗领域脑机接口的研究和应用展现了巨大潜力，脑机接口技术的前沿性、临床研究及脑网络的复杂性使脑机接口研究伦理成为伦理学领域新的重要内容。为保障脑机接口临床研究“负责任的创新”，我们建议建立脑机接口研究伦理治理的全球框架和评估系统，并为脑机接口的前沿临床研究制定具体指南。

关键词: 脑机接口, 临床研究, 生命伦理学, 伦理治理, 伦理审查

Abstract:

Brain-computer interface (BCI) technology is rapidly advancing in medical research and application. As an emerging biomedical engineering technology, it has garnered significant attention in the clinical research of brain disease diagnosis and treatment, neurological rehabilitation, and mental health. However, BCI also raises several challenges and ethical concerns in clinical research. In this article, the authors investigate and discuss three aspects of BCI in medicine and healthcare: the state of international ethical governance, multidimensional ethical challenges pertaining to BCI in clinical research, and suggestive concerns for ethical review. Despite the great potential of frontier BCI research and development in the field of medical care, the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI. To ensure "responsible innovation" in BCI research in healthcare and medicine, the creation of an ethical global governance framework and system, along with special guidelines for cutting-edge BCI research in medicine, is suggested.

Key words: brain-computer interface, clinical research, bioethics, ethical governance, ethical review

基金资助: 科技部脑科学与类脑研究重大项目(2021ZD0201900), 子课题5(2021ZD0201905)

Xue-Qin Wang, Hong-Qiang Sun, Jia-Yue Si, Zi-Yan Lin, Xiao-Mei Zhai, Lin Lu. Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces[J].Chinese Medical Sciences Journal, 2024, 39(2): 131-139.

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