中国医学伦理学2026，Vol.39Issue(1)：52-57,6.DOI:10.12026/j.issn.1001-8565.2026.01.07
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
Research on the efficient interface between scientific review and ethical review of investigator-initiated trials
摘要
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.关键词
科学性审查/伦理审查/研究者发起的临床研究Key words
scientific review/ethical review/investigator-initiated trial分类
医药卫生引用本文复制引用
张增瑞,周吉银..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[J].中国医学伦理学,2026,39(1):52-57,6.基金项目
2024年叙永县人民医院西南医科大学科技战略合作项目"基于医疗联合体的泸州市区域伦理委员会建设的探索"(2024XYXNYD16) （2024XYXNYD16）
2022年陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW02) （2022XRW02）
