伦理委员会档案管理的现状、法规要求及管理对策

Current situation,legal requirements and management countermeasures of ethics committee archives management

目的通过分析我国伦理委员会档案管理的现状,结合《中华人民共和国档案法实施条例》和伦理审查法规制度对伦理委员会档案管理的要求,提出加强伦理委员会档案管理的对策,以进一步规范伦理委员会档案的管理。方法通过文献研究方法,系统梳理我国伦理委员会档案管理的现状,结合伦理委员会档案管理实践体会,分析我国伦理委员会档案管理中存在的诸多问题及其原因。结果法规制度对伦理委员会档案的要求包括监督管理、建章立制、人员、场地和环境、保管期限、保密及信息化建设。加强伦理委员会档案管理的对策包括严格日常监管,强化管理意识,建立健全科学的管理制度和标准操作规程,设立独立的伦理委员会办公室和专用档案室,严格执行保密制度,加强信息化建设,提高利用率。结论为更好地建设和管理伦理委员会档案,应建立规范的档案管理体系,能有效评估伦理审查质量,确保发挥伦理委员会应有的职能。

ObjectiveTo analyze the current situation of the archives management of ethics committees in China,combine the requirements of the Implementation Regulations of the Archives Law of the People′s Republic of China and the ethics review regulations,and propose countermeasures to strengthen the archives management of ethics committees,thereby further standardizing the archives management of ethics committees.MethodsThrough the literature research method,this study systematically reviewed the current situation of the archives management of ethics committees and analyzed its problems and causes in China in combination with related practice experiences.ResultsThe requirements for ethics committee archives included supervision and management,the establishment of rules and regulations,personnel,site and environment,storage period,confidentiality,and information construction.Countermeasures to strengthen the archives management of ethics committees were suggested including strict daily supervision,strengthening management awareness,establishing and improving the scientific management system and standard operating procedures,setting up independent ethics committee offices and dedicated archives,strictly implementing the confidentiality system,strengthening information construction,and improving utilization rate.ConclusionsTo better construct and manage ethics committee archives,a standardized archives management system should be established to effectively evaluate the quality of ethics review and ensure the proper functions of the ethics committee.