明晰医学临床试验研究中的申办者、研究者及医学伦理委员会的职责  

Respansibilities of Sponsors,Researchers and Medical Ethics Committee in Medical Experimental Study

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

机构地区：[1]上海中医药大学社科部,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6期680-682,共3页Chinese Medical Ethics

基　　金：2012年上海市教育委员会科研创新重点项目资助(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：现代医学临床试验研究的宗旨是:在充分保障受试者权益和利益的前提下,进行符合人类自身发展需要的科学技术研究。显然,保障受试者权益和利益是科学研究的第一要素。现阶段,探索在医学临床试验研究中申办者以契约(保险)的形式保障受试者权益和利益的方法,同时,从根本上解决伦理委员会保障受试者权益和利益的指标—申办者为受试者购买相关保险,二者显得尤为重要,将在临床试验研究受试者权益的保护方面发挥重要作用。The aim of modern medical experimental study is, do scientific and technical studies conforming to the demands of human development on the basis of fully guaranteeing the subjects＇ rights and interests. It is obviously the first priority in making scientific research. Nowadays in our country, Sponsors of the medical experimental study must find out the methods to guarantee the subjects＇rights and interests in the form of agreement （ and insurance ）. Meanwhile, the Sponsors buy relevant insurances for the subjects can fundamentally reach the targets of the ethics committee, that is, to protect the subjects＇rights and interests. The both may play an important role in the protection of the rights and interests in the clinical trial research.

关 键 词：医学临床试验研究 申办者 研究者 受试者 伦理委员会 

分 类 号：R-052[医药卫生]