我国药物临床试验知情同意政策的变迁——从2003版与2020版GCP的对比说起  

Changes of Informed Consent Policy of Drug Clinical Trials in China:The Comparison between GCP 2003 Version and 2020 Version

作　　者：王美霞[1] 李义庭[2] WANG Mei-xia;LI Yi-ting(State Drug Clinical Trial Institution,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京佑安医院国家药物临床试验机构,北京100069 [2]首都医科大学医学人文学院,北京100069

出　　处：《医学与哲学》2020年第15期12-19,共8页Medicine and Philosophy

基　　金：2020年北京市医学伦理管理和审查质量提高项目(科教处2020lunli06)。

摘　　要：以知情同意起源和发展以及《药物临床试验质量管理规范》(Good Clinical Practice,GCP)的整体修改为背景,通过对比新旧版GCP中关于知情同意概念、内容、过程及记录、相关签署人员等方面的变化,结合我国新药临床试验整体发展和国际人用药品注册技术要求国际协调会相关要求,阐明政策变化背后所代表的卫生行政部门和食品药品监督管理部门对临床试验中受试者安全和权益保护关注的核心问题;再通过梳理知情同意常见问题与对策分析,引导研究者在临床试验中正确撰写知情同意书,合乎规范地进行知情告知和同意签署,切实履行受试者保护的主体责任。Under the background of Good Clinical Practice(GCP)revision and update from 2003 version to 2020 version,the items related to informed consent have been revised significantly.By tracking the origin and progress of informed consent and comparing the changes in the concept,content,process,documentation and related signing personnel of informed consent in the new GCP and the old GCP,combined with the overall development of new drug clinical trials in China and ICH-GCP related requirements,this paper clarifies the core issues of safety and rights protection of the subjects in the clinical trials concerned by health administration and Food and Drug Administration.It guides researchers to correctly write informed consent form in the clinical trials by combing common problems and analysis of countermeasures,and conduct the informed notification and consent signing in accordance with the norms,so as to fulfill the subject responsibility of subject protection.

关 键 词：《药物临床试验质量管理规范》 知情同意 受试者保护 

分 类 号：R-05[医药卫生]