Research on the decision pathway of investigator-initiated trials ethical review based on risk-benefit assessment
10.12026/j.issn.1001-8565.2025.04.09
- VernacularTitle:基于风险-获益评估的研究者发起的研究伦理审查决策路径研究
- Author:
Aiyi ZHANG
1
;
MingJie ZI
2
;
Hu CHEN
3
;
Zhongguang YU
4
Author Information
1. Clinical Pharmacology Research Center， Peking Union Medical College Hospital， Beijing 100005， China
2. Medical Ethics Committee， Xiyuan Hospital of China Academy of Chinese Medical Sciences， Beijing 100091， China
3. Discipline Construction Office， Cangzhou Central Hospital， Cangzhou 061017， China
4. Respiratory Center， China-Japan Friendship Hospital， Beijing 100029， China
- Publication Type:Journal Article
- Keywords:
investigator-initiated trial;
risk-benefit assessment;
ethical review;
ethics committee
- From:
Chinese Medical Ethics
2025;38(4):462-467
- CountryChina
- Language:Chinese
-
Abstract:
Conducting ethical review of investigator-initiated trials （IIT） is one of the important links to ensure the quality of research projects. Currently， the quality of ethical review for IIT projects is greatly influenced by the personal factors of committee members， which to some extent affects the ethical review committee’s judgments of research risks and benefits. Based on the previously developed Risk-Benefit Assessment Scale for Clinical Research， this paper established an ethical review decision-making pathway based on risk-benefit assessment， that is， proposed the “four-step method” for ethical review risk-benefit assessment， including evaluating the research benefits， assessing the research risks， constructing a risk-benefit matrix， and establishing an ethical review pathway. The “four-step method” helps to reduce the impact of committee members’ subjective/intuitive judgments on the quality of ethical review， assists in promoting the implementation of multi-center ethical review policy， narrows the gap in the quality of ethical review among different medical institutions， and provides clearer guidance for the risk judgments of scientific research management and ethical review departments.
