人体研究保护体系的建立与AAHRPP认证体会  

Construction Human Research Protection Programs and Experience of AAHRPP Acdeditation

作　　者：杨晓娟[1] 伍晓晓 刘美佑[1] 王璐[1] 彭莉[1] 张颖[1] 贾艳艳[1] 文爱东[2] 

机构地区：[1]第四军医大学西京医院伦理委员会,陕西西安710032 [2]第四军医大学西京医院药剂科,陕西西安710032

出　　处：《医学与哲学（A）》2016年第8期36-40,共5页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：2011年度国家"十二五"重大新药创制计划军队特需专项;项目编号:2011ZXJ09202-013

摘　　要：美国人体研究保护项目认证协会(AAHRPP)认证代表当前全球伦理认证的最高水平。依据AAHRPP认证标准,第四军医大学西京医院建立了一个符合国际标准的人体研究保护体系(HRPPs)。从组成特征、运行状况、效果评价等方面阐述了HRPPs的特征和运转机制,包括:组建相关部门,制定制度文件并贯彻落实;建立培训教育机制;加强研究利益冲突管理;开展临床研究合同审计;通过内部审核评估HRPPs质量、效率和有效性,并促进持续质量改进;通过多种途径加强与受试者的沟通交流。并结合西京医院AAHRPP认证体会阐明了认证重点、难点及可能的认证获益。The Association for the Accreditation of Human Research Protection Program （AAHRPP）accreditation represents the highest ethical accreditation level in the world. A better Human Research Protection Programs（HRPPs） that meets international standards has been built in Xijing Hospital according to AAHRPP accreditation standards. The characteristics and operational mechanism of HRPPs were expounded in this paper from the aspects of composition characteristics, operating conditions and effect assessment, which were mainly composed of setting up the relevant departments, developing and implementing the policies and procedures, establishing training mechanisms, strengthening the management of conflict of interest, carrying out contract audit, evaluating the quality, efficiency and effectiveness of HRPPs through internal audit and promoting continuous quality improvement; strengthening communication with subjects through a variety of ways. Besides, the key points, difficulties and benefits of AAHRPP accreditation were also briefly introduced.

关 键 词：美国人体研究保护项目认证协会 人体研究保护体系 临床试验 受试者保护 

分 类 号：R-052[医药卫生]