脑机接口临床研究多学科伦理审查指南

doi:10.3969/j.issn.1006-7795.2026.02.001

首都医科大学学报

脑机接口临床研究多学科伦理审查指南

王雪芹^1，2#,孙莹炜^1，3#,李晓玲^1，4,贾彩彩^1，3,尚爻^1，3,白彩珍^1，5,刘芳^1，3*,陆林²

1.北京医学伦理学会，北京 100069；2.北京大学第六医院，北京大学精神卫生研究所，国家卫生健康委员会精神卫生学重点实验室（北京大学），精神心理疾病国家临床医学研究中心（北京大学第六医院），北京 100191；3.首都医科大学马克思主义学院，北京 100069；4.首都医科大学宣武医院，北京 100053；5.首都医科大学附属北京天坛医院，北京 100070

收稿日期:2026-01-21 修回日期:2026-03-06 出版日期:2026-04-21 发布日期:2026-04-21
通讯作者: 刘芳 E-mail:liufangv@ccmu.edu.cn
基金资助:
北京市医学伦理管理质量提高项目（京伦2024-3）。

Multidisciplinary ethical review guidelines for clinical research on brain-computer interface

Wang Xueqin^1，2#, Sun Yingwei^1，3#, Li Xiaoling^1，4, Jia Caicai^1，3, Shang Yao^1，3, Bai Caizhen^1，5, Liu Fang1^，3*, Lu Lin²

1.Beijing Medical Ethics Association, Beijing 100069,China; 2.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), Beijing 100191, China;3. School of Marxism, Capital Medical University, Beijing 100069,China; 4.Xuanwu Hospital, Capital Medical University, Beijing 100053, China;5. Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China

Received:2026-01-21 Revised:2026-03-06 Online:2026-04-21 Published:2026-04-21
Supported by:
This study was supported by Beijing Medical Ethics Management Quality Improvement Project（Jinglun 2024-3）.

摘要/Abstract

摘要： 脑机接口作为生物智能与机器智能融合的关键性技术，为脑疾病诊疗、神经康复、心理健康等医疗服务领域提供了突破性的解决方案，但仍面临诸多风险与挑战。为指导和规范北京市医疗卫生机构开展涉及人的脑机接口临床研究伦理审查工作，提升伦理审查质量，保护研究参与者的权益，促进负责任的创新，依据相关法规和政策文件，制定了脑机接口临床研究多学科伦理审查指南。其从审查要素、特定群体保护、利益冲突声明、审查程序等方面审慎阐述。

关键词: 脑机接口, 临床研究, 多学科, 伦理审查, 审查要素, 审查程序

Abstract: As a key technology for the integration of biological intelligence and machine intelligence, brain-computer interface provide breakthrough solutions in medical service fields such as brain disease diagnosis and treatment, neural rehabilitation, and mental health. However, it still faces numerous risks and challenges. To guide and standardize the ethical review of clinical research involving brain-computer interface in medical institutions in Beijing, improve the quality of ethical review, protect the rights and interests of research participants, and promote responsible innovation, a multidisciplinary ethical review guideline for brain-computer interface clinical research has been formulated on the basis of the laws, regulations, and policy documents. It carefully elaborates on aspects such as review elements, protection of specific groups, declaration of conflicts of interest, and review procedures.

Key words: brain-computer interface, clinical research, multidisciplinary, ethical review, review elements, review process

中图分类号:

R-052

王雪芹, 孙莹炜, 李晓玲, 贾彩彩, 尚爻, 白彩珍, 刘芳, 陆林. 脑机接口临床研究多学科伦理审查指南[J]. 首都医科大学学报, doi: 10.3969/j.issn.1006-7795.2026.02.001.

Wang Xueqin, Sun Yingwei, Li Xiaoling, Jia Caicai, Shang Yao, Bai Caizhen, Liu Fang, Lu Lin. Multidisciplinary ethical review guidelines for clinical research on brain-computer interface[J]. Journal of Capital Medical University, doi: 10.3969/j.issn.1006-7795.2026.02.001.

脑机接口临床研究多学科伦理审查指南

Multidisciplinary ethical review guidelines for clinical research on brain-computer interface

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