基于风险受益比的国内外临床研究伦理审查现状研究  

Current Situations of Ethical Review of Clinical Research based on Risk-Benefit Ratio at Home and Abroad

作　　者：余中光[1] 李宗云[2] 李素娟[3] 陈虎[4] 陈燕芬[5] YU Zhongguang;LI Zongyun;LI Sujuan;CHEN Hu;CHEN Yanfen(Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China;Department of Clinical Pharmacy,Harrison International Peace Hospital,Hengshui 053000,China;Division of Regulation,Jinan Central Hospital,Jinan 250013,China;Department of Scientific Research,Cangzhou Center Hospital,Cangzhou 061001,China;Department of Scientific Research,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]中日友好医院呼吸中心,北京100029 [2]哈励逊国际和平医院临床药学科,河北衡水053002 [3]济南市中心医院法规处,山东济南250013 [4]沧州市中心医院科研处,河北沧州061001 [5]中日友好医院科研处,北京100029

出　　处：《中国医学伦理学》2021年第3期323-327,共5页Chinese Medical Ethics

基　　金：中日友好医院院级课题“临床研究伦理审查风险受益比研究”(2017-2-GL-6)。

摘　　要：通过研究整理和分析了国内外临床研究伦理审查法规指南、风险等级分级和风险受益评估模式等文献研究成果,发现国外发达国家在伦理审查风险受益评估和研究风险等级划分方面均有成熟研究,相比之下,国内缺乏最小研究风险的研究,缺乏系统性的伦理审查风险受益评估研究成果。因此,建议在借鉴国际经验基础上,明确临床研究最小风险概念,划分临床研究风险等级,并尝试以呼吸系统疾病为对象,开展基于风险受益比的临床伦理审查新模式研究。Through sorting out and analyzing the domestic and foreign literatures on ethical review guidelines,risk grading and risk benefit assessment model of clinical research,this paper found that there are mature studies on risk benefit assessment and research risk grading of ethical review in foreign developed countries.In contrast,there was a lack of research on minimum research risk and systematic ethical review of risk benefit assessment research results in China.Therefore,on the basis of international experience,it is suggested to define the concept of minimum risk in clinical research,divide the risk level of clinical research,and try to carry out the research on the new model of clinical ethical review based on the risk-benefit ratio with respiratory diseases as the object.

关 键 词：伦理审查 风险评估 风险受益比 临床研究 

分 类 号：R-052[医药卫生]