Exploration on the closed－loop management mechanism for protecting the rights and interests of participants in Investigator－Initiated Trial
10.3760/cma.j.cn113565-20250515-00121
- VernacularTitle:研究者发起的临床研究的研究参与者权益保护闭环管理机制探究
- Author:
Wei LI
1
;
Zhaochen WANG
;
Xinyu CHEN
;
Wei MAO
Author Information
1. 浙江医院 伦理审查委员会，杭州 310013
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trials (IIT);
Research participant;
Human subject;
Protection of rights and interests;
Closed-loop management
- From:
Chinese Journal of Medical Science Research Management
2025;38(5):449-454
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the issues and investigate their sources regarding the rights and interests protection of research participants in investigator-initiated trial (IIT) in China, and to propose a closed-loop management mechanism to strengthen and refine participant protection.Methods:Through policy analysis and literature review, the above challenges and sources were examined. Drawing on the progresses of research management reform and our experience, a closed-loop management mechanism for safeguarding IIT research participants was proposed.Results:Due to deficiencies in ethical review and informed consent, research participants′ rights and interests had not been adequately protected in IIT so far, especially in the aspects of informed consent, free-of-charge, and compensation/liability. These issues included from insufficient top-level design, limited research funds and resources, and the detachment between ethical oversight and research management.Conclusion:To comprehensively strengthen participant protection, the top-level design should be enhanced, supported by research management; key stages throughout the entire research chain-such as project application, approval, publication, and professional promotion-need to be leveraged to establish closed-loop management mechanisms that coordinates ethical review, informed consent, and compensation/liability.
