中国临床试验受试者权益保护政策与ICH的差异  

Differences between the Protection Policies of Clinical Trial Subjects in China and ICH

作　　者：杨秀巧 林泓 文萍[1] YANG Xiuqiao;LIN Hong;WEN Ping(Institute of Maternal and Child Medicine,Shenzhen Maternity&Child Healthcare Hospital,Shenzhen 518028,China)

机构地区：[1]深圳市妇幼保健院妇幼医学研究所,广东深圳518028

出　　处：《医学与哲学》2024年第20期17-20,25,共5页Medicine and Philosophy

基　　金：2023年深圳市卫生经济学会科研基金(232333);2022年深圳市妇幼保健院科研基金[深妇幼2022(73)号]。

摘　　要：对比了ICH-E6(R2)、征求意见中的ICH-E6(R3)和中国临床试验(GCP)法规中受试者权益保护相关内容的差异,并探讨其对于中国GCP受试者保护立法的意义。采用法规比较分析法,从受试者权益和监管的角度对比ICH和中国GCP法规的差异,并将其与ICH其他成员国对R2的修订情况进行对比讨论。ICH和中国GCP在以下方面存在差异:伦理委员会的跟踪审查、风险质量管理、受试者参与度、补偿赔偿、保险和知情同意。R2、R3和中国GCP在受试者权益保护方面存在差异,中国GCP受试者保护相关法规可在考虑差异的基础上,结合中国国情进行修订。This study compares the differences in subject protection between ICH-E6(R2),the draft ICH-E6(R3),and China's Good Clinical Practice(GCP)regulations,and explores the implications for subject protection legislation in China.A regulatory comparative analysis is conducted to evaluate the differences between ICH and China's GCP regulations from the perspectives of subject rights and regulatory frameworks,and it discusses how other ICH member countries have revised R2.Significant differences are identified between ICH and China's GCP regulations in several key areas,including the ongoing review by ethics committees,risk-based quality management,subject engagement,compensation and indemnity,insurance,and informed consent.There are notable disparities in the protection of subject rights among ICH-E6(R2),ICH-E6(R3),and China's GCP regulations.These differences highlight areas where China's GCP regulations could be amended to better align with international standards while considering the specific conditions of China.

关 键 词：临床试验 受试者保护 国际人用药品注册协会 

分 类 号：R-05[医药卫生]