某三级医院多中心研究伦理审查的实践与思考
Practice and reflection on ethical review of multicentre studies in a tertiary hospital
于玲玲 1刘伟 1张鹏俊1
作者信息
- 1. 北京医院科研处/国家老年医学中心/中国医学科学院老年医学研究院,北京 100730
- 折叠
摘要
目的 分析某三级医院伦理审查互认实施情况,为探索多中心研究伦理审查提供思路.方法 对该医院 2018-2022 年参与的多中心研究伦理审查情况进行分析.结果 该医院 2018-2022 年共审查项目 1 582 项,其中多中心研究 773 项(48.9%).多中心研究项目中作为参加单位研究占 70.4%.对所有参与项目均实施伦理审查互认,进行快速审查.其中 24 项研究快速审查后,主审委员建议提交会议审查,转成会议审查的原因分别为研究方案问题(11 项)、知情同意书问题(12 项)、其他支持文件问题(5 项).21 项研究修改后最终获得伦理委员会的批准,3 项研究因申办方拒绝修改研究方案而未获得伦理委员会的批准.结论 对于参与的多中心研究,参加单位伦理委员会实施伦理审查互认,采用快速审查的方式,审查所有研究资料,可以做到质量和效率兼顾.
Abstract
Objective:To analyse the implementation of mutual recognition of ethical review in a tertiary hospital,providing ideas for exploring ethical review of multicenter studies.Methods:The ethical review of multicenter studies conducted by the hospital from 2018 to 2022 was analyzed.Results:A 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.Conclusion:For 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.
关键词
三级医院/多中心研究/伦理审查/伦理互认Key words
tertiary hospital/multicentre study/ethical review/ethical mutual recognition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