An instance analysis and discussion on the ethical review of Investigator-Initiated Trials in a grade-A tertiary hospital under the new situation
10.3760/cma.j.cn113565-20241008-00266
- VernacularTitle:新形势下某三甲医院IIT研究伦理审查实例分析及探讨
- Author:
Jingjing WANG
1
;
Qian REN
;
Jie YANG
Author Information
1. 陆军特色医学中心伦理办公室，重庆 400042
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trials (IIT);
Ethics committee;
Ethical review;
Investigator
- From:
Chinese Journal of Medical Science Research Management
2025;38(2):108-113
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To provide reference for improving the ability of Investigator-Initiated Trials (IIT) research ethics review in the new era by analyzing the situation of clinical research projects and ethical review in hospitals under the increasingly standardized management requirements of clinical research.Methods:Taking the IIT projects reviewed by the Ethics Committee of our Institute from 2012 to 2023 as examples, the development trend, types, characteristics and the situation of ethical review were comprehensively compared and analyzed.Results:From 2012 to 2023, the number of IIT projects in our hospital increased rapidly, especially the multi-center and high-risk projects. IIT researches in the field of oncology and neurology are hot topics at present. After the addition of scientific review, the passing rate of ethical review increased. After the promulgation of the new regulations, the application rate of follow-up examination increased to a certain extent.Conclusions:In view of the current types and distribution characteristics of IIT, as well as key weaknesses in ethical review, the ethics Committee should strengthen the qualification management of main researchers and research teams, standardize the annual follow-up review of IIT research through multiple channels such as research ethics education and information platform, promote the establishment of the responsibility system of research liaison officers, and improve the review process of off-label drug use research. High-risk IIT projects should strengthen ethical supervision, case-by-case reporting and tracking system, and vulnerable groups projects should strengthen ethical review and supervision of informed consent process, and explore the establishment of a high-quality ethical management system from the above aspects.
