Practice and reflection on informed consent exemption from ethical review in investigator-initiated retrospective clinical trials
10.3760/cma.j.cn113565-20241116-00303
- VernacularTitle:研究者发起的回顾性临床研究中豁免知情同意的伦理审查实践与思考
- Author:
Yuan CHEN
1
;
Yujia ZHOU
1
;
Yuanhai ZHANG
1
;
Xueqiong ZHU
1
Author Information
1. 温州医科大学附属第二医院 325027
- Publication Type:Journal Article
- Keywords:
Informed consent;
Exemption;
Ethical review
- From:
Chinese Journal of Medical Science Research Management
2025;38(4):353-358
- CountryChina
- Language:Chinese
-
Abstract:
Objective:In order to improve the normativity and integrity of informed consent exemption from ethical review of retrospective clinical trials initiated by investigators in hospital settings, protecting the legitimate rights and interests of research participants, and improving the efficiency of ethical review.Methods:According to the relevant ethical review regulations at all levels and combined with the practical experience of ethical management in the second affiliated hospital of Wenzhou medical university in Zhejiang province, the present research took the primary review of clinical research projects initiated by investigators at the above institution as the research objectives, analyzed the problems existing during the application and ethical review of informed consent exemption, and summarized the construction and implementation effect of the hospital's clinical research ethical management system.Results:Main problems in the application for exemption of informed consent and ethical review were poor understanding of the essence of informed consent, insufficient consideration of privacy protection, the risk of abuse of informed consent exemption and inadequate effort of ethical review. With the aim of improving the standardization of ethical review of exempt consent, it was recommended to clarify the scope of exemption review, formulate strict exemption procedures, and strengthen the ethics training of all relevant personnel.Conclusions:Standardizing the ethical review management of investigator-initiated retrospective clinical trials contributes to protecting the legal rights and interests of research participants, and promoting the high-quality development of the ethical review norms of clinical research.
