Analysis of the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders
10.12026/j.issn.1001-8565.2025.01.04
- VernacularTitle:《涉及精神障碍临床研究的伦理审查指南》解析
- Author:
Xueqin WANG
1
;
Hongqiang SUN
1
;
Yiting LI
2
;
Lin LU
1
Author Information
1. Peking University Sixth Hospital （Institute of Mental Health， Peking University）/Key Laboratory of Mental Health， National Health Commission of the People’s Republic of China （Peking University）/National Clinical Research Center for Mental Disorders （Peking University Sixth Hospital）， Beijing 100191， China
2. College of Medical Humansties， Capital Medical University， Beijing 100069， China
- Publication Type:Journal Article
- Keywords:
mental disorder;
clinical research;
artificial intelligence;
brain-computer interface;
ethical review
- From:
Chinese Medical Ethics
2025;38(1):23-30
- CountryChina
- Language:Chinese
-
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.
