Practice and reflection on ethical review of multicentre studies in a tertiary hospital
10.12026/j.issn.1001-8565.2025.01.09
- VernacularTitle:某三级医院多中心研究伦理审查的实践与思考
- Author:
Lingling YU
1
;
Wei LIU
1
;
Pengjun ZHANG
1
Author Information
1. Scientific Research Administration Department， Beijing Hospital/National Center of Gerontology/Institute of Geriatrics， Chinese Academy of Medical Sciences， Beijing 100730， China
- Publication Type:Journal Article
- Keywords:
tertiary hospital;
multicentre study;
ethical review;
ethical mutual recognition
- From:
Chinese Medical Ethics
2025;38(1):58-62
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo analyse the implementation of mutual recognition of ethical review in a tertiary hospital， providing ideas for exploring ethical review of multicenter studies. MethodsThe ethical review of multicenter studies conducted by the hospital from 2018 to 2022 was analyzed. ResultsA total of 1，582 projects were reviewed in the hospital from 2018 to 2022， of which 773 （48.9%） were multicentre studies. In multicenter study projects， 70.4% of the studies were conducted as a participating unit. Mutual recognition of ethical review and fast review were implemented for all participating projects. After a rapid review of 24 studies， the presiding committee recommended submitting them for conference review. The reasons for the transfer to conference review included issues with the study protocol （11 projects）， informed consent （12 projects）， and other supporting documents （5 projects）. Twenty-one studies were eventually approved by the ethics committee after modification， and 3 studies were not approved by the ethics committee because the sponsor refused to modify the study protocols. ConclusionFor participating in multicentre studies， the ethics committees of participating units implement mutual recognition of ethical reviews and adopt a rapid review approach to review all study data， which can achieve both quality and efficiency.
