AAHRPP认证及人体研究保护体系建设  

AAHRPP and human subject protection program construction

作　　者：王晓敏[1] 袁洪[1] 阳国平[1] 李昕[2] 黄志军[1] 刘星[3] 

机构地区：[1]中南大学湘雅三医院临床药理中心 [2]中南大学湘雅三医院血液科 [3]中南大学基础医学院

出　　处：《中国临床药理学与治疗学》2016年第6期716-720,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303014-001);国家社科基金重大项目(11&ZD177);湖南省哲学社会科学基金一般项目(14YBA388);湖南省哲学社会科学基金一般项目(15YBA403)

摘　　要：目前,我国创新药物的临床试验项目和种类逐年增多,临床试验质量和受试者权益保护,已经成为临床研究承担机构关注的重点。然而,我国临床研究中的受试者权益保护体系还不完备,受试者权益受到侵犯的事件时有发生。为此,笔者希望通过美国AAHRPP人体研究受试者保护标准的解读,中南大学湘雅三医院人体研究受试者保护成功机制的分享,推动更多研究机构申请国际认证,从而在更大范围内构建更加有效的受试者保护体系。At present, the innovation drug clinical trials increased year by year. Promote clinical quality and ensure human subject rights are becoming the most common interests of the organizations domestic and overseas. However, our human subject protection system is not complete, the violation of human subject rights happens sometimes in China. For this purpose, we hopes that by interpretation of AAHRPP standards, share the success experience of human subject construction of the Third Xiangya Hospital, to promote more organizations to apply for international accreditation, to construct more effective human subject protection program in the wider areas in China.

关 键 词：AAHRPP认证 人体研究保护体系 受试者保护 

分 类 号：R-052[医药卫生]