机构伦理委员会文件材料“档案化”管理探讨

Discussion on Archiving of Records Management of Institutional Review Board

近年来,机构伦理委员会(以下简称"伦理委员会")文件材料归档工作的规范化日益受到重视,但缺乏文件材料档案管理的相关规范和指南。以档案管理为视角,从文件材料的归档范围、分类方案以及保管期限表等方面着手,对伦理委员会文件材料,包括项目审查和行政管理文件实体和信息化管理提出对策和建议,并就伦理委员会档案管理指南和规范进行相关探讨,力求建立伦理委员会档案管理操作指南和管理规范,实现伦理委员会文件材料"档案化"管理。

In recent years,the standardization of archives management of institutional review board(IRB),named "ethics committee",has received more and more attentions,since there is no standard and guidance of archives management of IRB in practices.This paper proposes suggestions of archives management,including substance and informatization files of protocol review and administration,from the aspects of filing scope,archivies classification and records retention schedule.It also discusses the guidelines of ethics committee archives management,so as to establish the specification of archives management,realize"archiving"of records managment of ethics committee.