Research on the efficient interface between scientific review and ethical review of investigator-initiated trials
10.12026/j.issn.1001-8565.2026.01.07
- VernacularTitle:研究者发起的临床研究科学性审查和伦理审查高效对接研究
- Author:
Zengrui ZHANG
1
;
Jiyin ZHOU
2
Author Information
1. Southwest Medical University · School of Clinical Medicine · Affiliated Hospital， Luzhou 646000， China
2. Clinical Medical Research Center， the Second Affiliated Hospital of Army Medical University， Chongqing 400037， China
- Publication Type:Journal Article
- Keywords:
scientific review;
ethical review;
investigator-initiated trial
- From:
Chinese Medical Ethics
2026;39(1):52-57
- CountryChina
- Language:Chinese
-
Abstract:
The Measures for the Administration of Healthcare Organizations Conducting Investigator-Initiated Trials stipulates that conducting interventional research and observational research that accept additional examinations， tests， diagnostics， and other measures beyond the needs of routine diagnosis and treatment or disease prevention and control， which may pose risks exceeding the minimal risk， must undergo both scientific and ethical reviews. Currently， these two reviews tend to be poorly interfaced and inefficient. This paper analyzed the connections and differences between scientific review and ethical review of investigator-initiated trials （IITs）. It also elaborated the existing issues in the process of interfacing scientific review and ethical review from five aspects， encompassing an immature management system， insufficient awareness of scientific review， failure to understand the different purposes of duplicative review on certain contents， unclear review criteria， and limited professional knowledge and a lack of communication among committee members. Recommendations were proposed from eight dimensions， namely， improving the management system and regulatory measures， coordinating the review time， unifying the document submission checklist， establishing an information system for clinical research management， enhancing training for investigators， providing cross-disciplinary training for committee members， improving the communication mechanisms， and jointly developing the review elements for scientific issues. The aim was to facilitate the efficient interface between scientific review and ethical review for IITs， thereby enhancing the quality and efficiency of IIT management.
