《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
科技伦理治理中涉及精神障碍临床研究的伦理审查具有明显的特殊性,尤其在人工智能与脑机接口领域,体现在对精神自主性的影响、严重精神障碍研究参与者参加研究的知情同意能力受损等方面;另外,临床研究中的病耻感、安慰剂应用及心理评估的方法等,也使得精神医学伦理审查备受关注.2020 年,北京市卫生健康委员会发布了《涉及精神障碍临床研究的伦理审查指南》,《沈渔邨精神病学》(第七版)对《涉及精神障碍临床研究的伦理审查指南》在伦理治理背景下的应用进行了修订,对其印发和修订的目的和意义、适用范围、医疗卫生机构伦理审查的主体责任、精神医学伦理审查的重点内容进行了分析,以提高涉及精神障碍临床研究的伦理审查质量,推动精神医学临床研究的规范发展.
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
出版年
2025
国家科技期刊平台
NSTL
万方数据