Exploration and Reflection on Informatization Construction in Optimizing the Ethical Review Process
10.12026/j.issn.1001-8565.2023.03.04
- VernacularTitle:信息化建设在优化伦理审查流程中的探索及思考
- Author:
Jing WANG
1
Author Information
1. Ethics Committee, Beijing Hospital of Traditional Chinese Medicine of Capital Medical University, Beijing 100010, China
- Publication Type:Journal Article
- Keywords:
Informatization Construction;
Ethical Review;
Process Management;
Continuous Quality Improvement;
Clinical Research
- From:
Chinese Medical Ethics
2023;36(3):255-262
- CountryChina
- Language:Chinese
-
Abstract:
Currently, the number of clinical research projects continues to grow. Both sponsors and researchers hope to accelerate medical ethical review efficiency, and the regulatory agencies strengthen the control over the ethical review quality. The ethics committee (EC) offices of medical institutions are relatively insufficient in terms of human resource allocation and archiving space. Combined with the development goals of the EC and the requirements of the homogeneity construction of ethical review, it was urgent to optimize the ethics review process and accelerate the efficiency of ethics review through informatization construction. Through informatization construction, the process management of ethical review could be strengthened, the work steps could be simplified, the ethical review level could be improved, and the supervision ability and efficacy of EC on clinical research could be strengthened, which may provide continuous quality improvement strategies and specific optimization measures for the operation and management of the EC, so as to effectively protect the safety, the rights and interests of subjects.
