伦理委员会审查项目档案资料规范化管理探讨

目前,我国伦理委员会的建设还在逐步规范,伦理委员会审查项目档案的管理也在进一步探索中.从伦理委员会审查项目档案定义、归档文件范围、归档文件要求以及保管期限等方面入手,提出伦理委员会档案应该纳入综合档案管理部门,由专职档案人员负责统一管理,即按档案专业要求进行整理归档、存放和规范化管理.

Discussion on Standardized Management of Ethics Committee Review Archives

At present,the construction of Chinese Ethics Committee is still being standardized,the management of Ethics Committee review archives is also in a further exploration.Based on the discussion on the definition of Ethics Committee review archives,the ranges of archives,requirements of archives and retention period of archives,this paper proposed that Ethics Committee review archives should be part of an comprehensive archival management department,and organized by full-time archivists according to the requirements of archive professional arrangement,namely sorting and file filling,storing and standardized management.