中国医学伦理学2025，Vol.38Issue(1)：23-30,8.DOI:10.12026/j.issn.1001-8565.2025.01.04
《涉及精神障碍临床研究的伦理审查指南》解析
Analysis of the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders
王雪芹 1孙洪强 1李义庭 2陆林1
作者信息
- 1. 北京大学第六医院<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>/国家精神心理疾病临床医学研究中心<北京大学第六医院>,北京 100191
- 2. 首都医科大学医学人文学院,北京 100069
- 折叠
摘要
Abstract
The ethical review of clinical research involving mental disorders in the ethical governance of scientific and technological has obvious particularities,especially in the field of artificial intelligence and brain-computer interfaces which are reflected in the impact on mental autonomy,the impaired informed consent ability of participants with severe mental disorders in research,and other aspects.In addition,the stigma of illness,the use of placebo,and psychological assessment methods in clinical research have also drawn attention to the ethical review of psychiatry.In 2020,the Beijing Municipal Health Commission issued the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders(Guidelines).Shen Yucun's Psychiatry,compiled in 2023,revised the application of the Guidelines in the context of ethical governance.An analysis was conducted on the purpose and significance of its issuance and revision,its scope of application,the principal responsibility of ethical review in medical and health institutions,and the key content of ethical review in psychiatry,to improve the quality of ethical review in clinical research involving mental disorders and promote the standardized development of clinical research in psychiatry.关键词
精神障碍/临床研究/人工智能/脑机接口/伦理审查Key words
mental disorder/clinical research/artificial intelligence/brain-computer interface/ethical review引用本文复制引用
王雪芹,孙洪强,李义庭,陆林..《涉及精神障碍临床研究的伦理审查指南》解析[J].中国医学伦理学,2025,38(1):23-30,8.
