Current situation, legal requirements and management countermeasures of ethics committee archives management
10.3760/cma.j.cn113565-20240414-00098
- VernacularTitle:伦理委员会档案管理的现状、法规要求及管理对策
- Author:
Pei ZHANG
1
;
Jiyin ZHOU
;
Wenxi WANG
;
Xiaohui QIU
;
Jun CHEN
Author Information
1. 宁波市医疗中心李惠利医院伦理委员会办公室 315000
- Keywords:
Archives management;
Ethics committee;
Laws and regulations;
Requirement;
Strategy
- From:
Chinese Journal of Medical Science Research Management
2024;37(4):269-277
- CountryChina
- Language:Chinese
-
Abstract:
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 standardizing 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 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.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.
