Guidelines of ethics review for clinical application of medical technology
10.12026/j.issn.1001-8565.2025.01.03
- VernacularTitle:医疗技术临床应用伦理审查指引
- Author:
Jiyin ZHOU
1
;
Mingjie ZI
2
;
Qi LU
3
;
Hui JIANG
4
Author Information
1. Clinical Research Center， The Second Affiliated Hospital of Army Medical University， Chongqing 400037， China
2. Medical Ethics Committee， Xiyuan Hospital of China Academy of Chinese Medical Sciences， Beijing 100091， China
3. Office of Ethics Committee， Renji Hospital， Shanghai Jiao Tong University， Shanghai 200001， China
4. Department of Science and Education， Zhangzhou Affiliated Hospital of Fujian Medical University， Zhangzhou 363000， China
- Publication Type:Journal Article
- Keywords:
clinical application of medical technology;
ethical review;
guideline
- From:
Chinese Medical Ethics
2025;38(1):15-22
- CountryChina
- Language:Chinese
-
Abstract:
Access to the clinical application of medical technology is one of the core institutional contents of medical quality management， involving medical quality assurance， the achievement of patient safety goals， and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research， as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws， regulations， and ethical principles， combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions， a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions， the system of ethics committees and the requirements of review norms， technical plans and their review points， key points for the implementation of informed consent， technical teams and conditions， and other aspects.
