儿科人群多中心临床试验伦理协作审查模式研究  

Study on the mode of ethical collaborative review of multi-center clinical trials in pediatric population

作　　者：奚益群[1] 唐燕[1] 郭春彦[2] 梁宇光 王谦 王晓玲[2] 王天有[2] XI Yiqun;TANG Yan;GUO Chunyan;LIANG Yuguang;WANG Qian;WANG Xiaoling;WANG Tianyou(Children’s Hospital of Shanghai Jiao Tong University,Children’s Hospital of Shanghai,Shanghai,200062,PRC)

机构地区：[1]上海市儿童医院/上海交通大学附属儿童医院,上海市200062 [2]首都医科大学附属北京儿童医院,北京市100045

出　　处：《中国医院》2021年第12期81-83,共3页Chinese Hospitals

基　　金：国家科技重大专项课题(2017ZX09304029)。

摘　　要：论述了儿科人群多中心临床试验伦理协作审查模式的建立背景、适用范围、相关定义、参与协作审查的伦理委员会资格要求、协作审查的流程,以及参与协作审查的各方伦理委员会的职责。依据国家相关法规及文件的规定,以签订“互认协议”的方式构建儿科人群多中心临床试验伦理审查结论互认的协作审查模式,推进儿科人群多中心临床试验的规范、高效开展。This article mainly discussed the background,scope of application,definitions,qualification requirements of ethics committees participating in the collaborative review,process of the collaborative review,and the responsibilities of the ethics committees of the various parties involved in the collaborative review.According to the regulations and documents of the State,this article established a collaborative review model of ethical review of multi-center clinical trials in the pediatric population to promote the standardization and efficient development of multi-center clinical trials in the pediatric population by signing a mutual recognition agreement.

关 键 词：儿科人群 多中心临床试验 伦理审查 协作审查 

分 类 号：R197.3[医药卫生—卫生事业管理]