再论明晰医学临床试验研究与医学临床治疗之间界限的意义  

Further on the Significance of Illustrating the Boundary between Medical Experimental Study and Medical Therapy

作　　者：李久辉[1] 胡晓燕[1] 陈晓云[2] 樊民胜[1] 鲁琳[1] 

机构地区：[1]上海中医药大学社会科学部,上海201203 [2]上海中医药大学附属龙华医院伦理委员会,上海200032

出　　处：《中国医学伦理学》2013年第5期595-598,共4页Chinese Medical Ethics

基　　金：2012年上海市教育委员会科研创新重点项目(12ZS110);中药新药(恶性肿瘤等疾病)临床评价研究技术平台(2011ZX09302-006-04)

摘　　要：明晰医学临床试验研究与医学临床治疗之间界限意义的一个重要目的就是明晰医学临床试验研究中的意外事故与医学临床治疗中的意外事故之间的本质区别,循此线索,探索"保护医学临床试验研究中意外事故的受试者(伤害者)的权益和利益的方法"。同时,寻求达成"医学临床试验研究意外事故鉴定委员会对受试者(伤害者)进行鉴定"这一概念和行为的共识,从而达到从制度建设的层面上保障医学临床试验研究中受试者权益和利益的目的。The major purpose of discovering the significance of illustrating the boundary between medical experimental study and medical therapy is to know the essential difference between the accidents in medical experimental study and those in medical therapy. Based on that, find out the methods of protecting the subjects （ and the hurters） rights and interests in the accidents happened in the medical experimental study process. Meanwhile, seek to reach common view on the concept and behavior of identifying the subjects { or the hurters } by the accident iden- tification committee of the medical experimental study, so as to reach the purpose of guaranteeing the rights and interests of the subjects of the medical experimental study on system building basis.

关 键 词：医学临床试验研究 医学临床治疗 医疗事故 医学伦理( 

分 类 号：R-052[医药卫生]