新冠肺炎中药临床研究的伦理审查挑战  

Challenges to Ethical Review of Traditional Chinese Medicine Clinical Research on COVID-19

作　　者：何胜荣 周吉银 HE Sheng-rong;ZHOU Ji-yin(Politics Affairs Department,Second Affiliated Hospital,Army Medical University,Chongqing 400037,China)

机构地区：[1]陆军军医大学第二附属医院政治工作处,重庆400037 [2]陆军军医大学第二附属医院国家药物临床试验机构,重庆400037

出　　处：《医学与哲学》2020年第13期37-40,共4页Medicine and Philosophy

基　　金：2019年陆军军医大学人文社会科学基金重点项目(2019XRW04)。

摘　　要：中药在防控新冠肺炎疫情中发挥了重要作用,已有中药方剂获批进入临床试验。鉴于中医药具有整体原则、辨证论治和长期临床实践经验的优点,也存在研究方案设计,疗效评价指标,中药方剂的质量控制和安全性等难点。伦理委员会审查新冠肺炎中药临床研究项目时,应从整体原则、辨证论治、临床基础、研究方案、风险受益评估、知情同意、隐私保护等要点着手,确保受试者权益,提升临床研究质量,助推疫情防控。Traditional Chinese Medicine(TCM)has played an important role in the prevention and control of Coronavirus Disease 2019(COVID-19).Some prescriptions have been approved for clinical trials.TCM indicates both advantage of organic wholeness,treatment based on syndrome differentiation,long-term clinical practice experience,as well as difficulties in research design,efficacy evaluation indicators,quality control and safety of formulae.In reviewing of TCM clinical research protocols of COVID-19,the ethics committee should proceed from the integrity principles,syndrome differentiation,clinical basis,research protocal,risk benefit assessment,informed consent,privacy protection and other aspects,to ensure the rights of participants,and improve the quality of clinical research and promote the prevention and control of COVID-19.

关 键 词：新冠肺炎 中药 临床研究 伦理审查 

分 类 号：R-05[医药卫生]