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脑-机接口临床研究伦理审查的挑战与建议

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

机构信息

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.

Department of Psychology, University of California, Davis 95616, USA.

出版信息

Chin Med Sci J. 2024 Jun 30;39(2):131-139. doi: 10.24920/004377.


DOI:10.24920/004377
PMID:38862406
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.

摘要

脑机接口(BCI)技术在医学研究和应用中迅速发展。作为一种新兴的生物医学工程技术,它在脑疾病诊断和治疗的临床研究、神经康复和心理健康等领域引起了广泛关注。然而,BCI 在临床研究中也带来了一些挑战和伦理问题。本文作者对医学和医疗保健领域的 BCI 进行了调查和讨论,包括国际伦理治理现状、BCI 在临床研究中的多维伦理挑战以及伦理审查的建议关注点。尽管前沿 BCI 研究和开发在医疗保健领域具有巨大的潜力,但它自身带来的伦理挑战以及临床研究和大脑功能的复杂性,为 BCI 提出了新的伦理特殊领域。为了确保医疗保健和医学领域 BCI 研究的“负责任创新”,建议建立一个伦理的全球治理框架和系统,并制定医学前沿 BCI 研究的特殊指导方针。

相似文献

[1]
Challenges and Suggestions of Ethical Review on Clinical Research Involving Brain-Computer Interfaces.

Chin Med Sci J. 2024-6-30

[2]
Ethical aspects of brain computer interfaces: a scoping review.

BMC Med Ethics. 2017-11-9

[3]
Artificial Intelligence in Healthcare and Medicine: Promises, Ethical Challenges and Governance.

Chin Med Sci J. 2019-6-30

[4]
Translational Bioethics in China: Brain-Computer Interface Research as a Case Study.

Ethics Hum Res. 2024

[5]
Ethical Considerations in Ending Exploratory Brain-Computer Interface Research Studies in Locked-in Syndrome.

Camb Q Healthc Ethics. 2018-10

[6]
Using brain-computer interfaces: a scoping review of studies employing social research methods.

BMC Med Ethics. 2019-3-7

[7]
[Ethics considerations on brain-computer interface technology].

Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2023-4-25

[8]
[An emerging discipline: brain-computer interfaces medicine].

Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2024-8-25

[9]
[The role and responsibility of clinical neuroscience in brain-computer interface clinical research].

Zhonghua Yi Xue Za Zhi. 2024-6-18

[10]
Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning.

Sci Eng Ethics. 2016-10

引用本文的文献

[1]
Brain-Computer Interfaces in Parkinson's Disease Rehabilitation.

Biomimetics (Basel). 2025-7-23

[2]
Informed consent competency assessment for brain-computer interface clinical research and application in psychiatric disorders: A systematic review.

World J Psychiatry. 2025-8-19

[3]
Exploring the intersection of brain-computer interfaces and traditional, complementary, and integrative medicine.

Integr Med Res. 2025-6

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