中国医学伦理学2025，Vol.38Issue(1)：52-57,6.DOI:10.12026/j.issn.1001-8565.2025.01.08
研究者发起的中医药临床研究伦理审查要点
Key points for ethical review of investigator-initiated clinical trials on traditional Chinese medicine
摘要
Abstract
The academic development of traditional Chinese medicine(TCM)originates from numerous clinical practices.The efficacy of TCM,its mechanism of action,and the unique value of TCM have been verified through clinical research,contributing to TCM's inheritance and development.At present,there is an increasing number of investigator-initiated clinical trials(IIT).The IIT projects involving TCM intervention have different designs in terms of basic theory,syndrome differentiation,prescription composition,dosage form,dosage,and other aspects,as well as even posing challenges to the project review of the ethics committee.The basic ethical principles followed by clinical research institutions of modern medicine and TCM are consistent.The ethical review of the IIT projects involving TCM intervention needs to reflect the development laws of TCM itself,as well as conform to the characteristics of TCM and the laws of new drug research and development.TCM medical institutions need to combine their professional characteristics,sort out clinical experience,guide researchers to conduct clinical research on TCM in an orderly manner with a patient-centered and clinical value-oriented,verify the clinical value of TCM's new drugs,and improve the success rate of translating the results of TCM's new drugs.关键词
中医药/研究者发起的临床研究/伦理审查Key words
traditional Chinese medicine/investigator-initiated clinical trial/ethical review引用本文复制引用
王晶..研究者发起的中医药临床研究伦理审查要点[J].中国医学伦理学,2025,38(1):52-57,6.基金项目
首都医科大学2024年教育教学改革研究重点课题"中医临床方法学与流行病学临床教师团队同质化建设研究"(2024JYZ021) （2024JYZ021）
河北省中医药管理局2025年度河北省中医药类科学研究课题"中医医联体临床研究伦理审查体系构建及运行研究"(B2025062) （B2025062）
