临床试验安全性均势伦理探讨  

Study on the Ethics of Safety Equipoise in Clinical Trials

作　　者：王聪[1] 徐治立[1] WANG Cong;XU Zhi-li(School of Humanities and Social Sciences,Beihang University,Beijing 100191,China)

机构地区：[1]北京航空航天大学人文社会科学学院,北京100191

出　　处：《医学与哲学（A）》2018年第7期22-25,共4页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：2015年北京市软科学项目(Z151100002615031)

摘　　要：均势原则是临床试验中的一项方法规则,同时也是临床试验研究的伦理规则。均势原则指导下的临床试验仍然存在设计缺陷、忽视安全风险评估、均势判定主体失当等方面的安全性伦理问题。这需要进一步确立安全性均势伦理准则,以强调在临床均势试验研究中不能对受试者造成生命健康方面的明显伤害,包括风险受益全面合理性评估原则、受试者生命安全底线原则以及利益相关者安全责任原则。落实安全性均势伦理原则需要采取多学科协作评估、优化均势判定主体结构及明确判定标准等基本规范策略。Principle of equipoise is both a method and an ethical rule for clinical trials.The safety problems of design defects,absence of risk evaluation and misconduct of equipoise determination subjects still exist in the clinical trials following the principle of equipoise.Thus,it is necessary to further establish the standards of ethics of safety equipoise,which comprise the principle of risk-benefit assessment in a proper and all-round way,the principle of bottom line of trial participant’s life safety and the principle of stakeholder’s safety responsibilities.In order to follow the ethics principle of safety equipoise,the multidisciplinary risk-benefit assessment,optimized structure of equipoise determination subjects and clear standards should be implemented.

关 键 词：临床试验 均势原则 安全性均势伦理 

分 类 号：R-052[医药卫生]