国际关注突发公共卫生事件伦理审查经验及其启示  

The Experience and Enlightenment of Ethics Committee Review of Public Health Emergency Event of International Concern

作　　者：胡蝶花 王晓敏[1,3,4] 粟志英 阳国平[1,3,4] 黄志军[1,3,4] HU Diehua;WANG Xiaomin;SU Zhiying;YANG Guoping;HUANG Zhijun(Research Center for Clinical Trial,the Third Xiangya Hospital of Central South University,Changsha 410013,China;School of Public Administration, Central South University, Changsha 410075,China;Center for Clinical Pharmacology,the Third Xiangya Hospital of Central South University,Changsha 410013,China;Research Center for Medical Ethics,Central South University,Changsha 410013,China)

机构地区：[1]中南大学湘雅三医院临床试验研究中心,湖南长沙410013 [2]中南大学公共管理学院,湖南长沙410075 [3]中南大学湘雅三医院临床药理中心,湖南长沙410013 [4]中南大学医学伦理学研究中心,湖南长沙410013

出　　处：《中国医学伦理学》2020年第10期1193-1198,共6页Chinese Medical Ethics

基　　金：国家“重大新药创制”科技重大专项项目“心脑血管等重大疾病示范性新药临床评价技术平台建设”(2020ZX09201010);国家社会科学基金“大数据医疗及其伦理问题研究”(19FZXB021);中南大学新型冠状病毒感染肺炎防控应急项目。

摘　　要：伦理委员会的审查是开展临床研究的重要环节,突发公共卫生事件背景下的临床研究为伦理委员会的审查工作提出了巨大的挑战。通过借鉴国际突发公共卫生事件的伦理审查经验,提出中国应对突发公共卫事件伦理审查的建议。在应对突发公共卫生事件期间,中国应鼓励区域伦理委员会充分发挥作用,构建伦理审查沟通交流机制,完善突发公共卫生事件伦理审查指南,严格遵循伦理审查标准,明确伦理审查要点,为当下和将来应对此类事件做好准备。The review of ethics committee is an important link to conducting clinical research,clinical research in the context of public health emergencies poses great challenges to the review of ethics committee.Based on the experience of ethical review of international public health emergencies,this paper puts forward some suggestions on ethical review of China’s response to public health emergency.During public health emergencies,China should give play to the leading role of regional ethics committees,build the communication mechanism of ethical review,improve the ethical review guidelines for public health emergencies,strictly follow the ethical review standards,and clarify the key points of ethical review,so as to make preparations for dealing with such incidents now and in the future.

关 键 词：新冠肺炎疫情 突发公共卫生事件 伦理委员会 伦理审查 

分 类 号：R-052[医药卫生]