脑机接口临床研究伦理审查的挑战与建议

王雪芹; 孙洪强; 司佳玥; 林子琰; 翟晓梅; 陆林

doi:10.24920/004377

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脑机接口临床研究伦理审查的挑战与建议

中国医学科学杂志（英文） 2024年39卷第2期页码：131-139

医学健康伦理 | Updated：2025-03-07

- 脑机接口临床研究伦理审查的挑战与建议
- Affiliations：
  
  1.Peking 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
  2.Department of Psychology, University of California, Davis 95616, USA
  3.Department of Psychology, University of Toronto, Toronto M5S 1A1, Canada
  4.School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
  5.Academy 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, ChinaBengbu 233030, Anhui, China
- Author bio：
  
  陆林，E-mail：linlu@bjmu.edu.cn
- Funds：
  
  the Ministry of Science and Technology of the People's Republic of China(2021ZD0201900);Project 5(2021ZD0201905)
- DOI：10.24920/004377
  中图分类号：
- 收稿日期：2024-05-15，
  
  录用日期：2024-06-03，
  
  网络出版日期：2024-06-12，
  
  纸质出版日期：2024-06-30
- Accepted：
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王雪芹,孙洪强,司佳玥等.脑机接口临床研究伦理审查的挑战与建议[J].中国医学科学杂志（英文）,2024,39(02):131-139.

Wang Xue-Qin,Sun Hong-Qiang,Si Jia-Yue,et al.Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces[J].Chinese Medical Sciences Journal,2024,39(02):131-139.
王雪芹,孙洪强,司佳玥等.脑机接口临床研究伦理审查的挑战与建议[J].中国医学科学杂志（英文）,2024,39(02):131-139. DOI： 10.24920/004377.

Wang Xue-Qin,Sun Hong-Qiang,Si Jia-Yue,et al.Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces[J].Chinese Medical Sciences Journal,2024,39(02):131-139. DOI： 10.24920/004377.

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重要的新内容。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。

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.

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