Key points of ethical governance in the clinical application of new biomedical technology
10.12026/j.issn.1001-8565.2025.01.13
- VernacularTitle:生物医学新技术临床应用的伦理治理要点
- Author:
Ping YUAN
1
;
Hongjuan LI
1
;
Xiaojing LI
1
;
Xiuying ZHANG
2
;
Qiongge ZHANG
1
;
Hongyu WANG
1
Author Information
1. Department of Research /Vascular Medicine Center， Peking University Shougang Hospital， Beijing 100144， China
2. Medical Affairs Department， Peking University Shougang Hospital， Beijing 100144， China
- Publication Type:Journal Article
- Keywords:
new biomedical technology;
clinical application;
patient protection;
ethical governance
- From:
Chinese Medical Ethics
2025;38(1):89-94
- CountryChina
- Language:Chinese
-
Abstract:
Given the current ethical issues such as unknown high risks in the clinical application of new biomedical technology， thus， medical institutions need to establish new technology management systems， including clarifying the concept， the assessment and admission mechanism， and ethical management systems of new technology. According to the direction of the development of new technology in the medical institution， the ethics review committee should also perfect the management system of ethics committees and the professional composition of ethics review committee members， improve the ability of ethics committee members to evaluate new biomedical technology， increase the assessment of ethical risks of new technology in the preliminary review stage， strengthen the requirements for emergency plan formulation， as well as set the frequency of the follow-up review based on the risk level of new technology. The ethics review committee should work together with the medical management department to formulate an ethical standardization training system for the clinical application of medical technology in the institution， and regularly conduct training for all staff， to promote medical workers’ understanding of the management requirements of biomedical technologies. Different types of new biomedical technology have different ethical risks. Therefore， the medical management departments and ethics review committees of medical institutions should formulate specific management rules based on the characteristics of new technology types. However， it should be noted that when new biomedical technology generally is first introduced into clinical practice， there are often issues regarding fairness and justice in the use of the technology.
