Objective To 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 standardi-zing the archives management of ethics committees.Methods Through 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.Results The requirements for ethics committee archives included supervision and management,the establishment of rules and regulations,personnel,site and environment,storage period,confidentiality,and in-formation 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.Conclusions To 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.
Archives managementEthics committeeLaws and regulationsRequirementStrategy
NETL
NSTL
万方数据
