摘要
鉴于临床试验异于常规的特点,目前的体制不足以保护临床试验受试者的权益。随着临床试验项目在我国的陆续开展和扩大,越来越多的临床试验受试者涉及其中,相关部门应通过立法在临床试验受试者人身损害案件中适用无过错归责原则,以更好地保护临床试验受试者的合法权益。
In view that clinical trial is different from traditional medical treatment procedure, the existing system is inadequate in protecting subjects' safety and legal rights. With the development of clinical trial in China, more and more subjects are involved. Laws should be established to carry out no fault responsibility in injuries of subjects in clinical trials in order to better ensure subjects' legal rights.
出处
《西北医学教育》
2006年第5期536-538,585,共4页
Northwest Medical Education
关键词
临床试验
受试者
无过错责任原则
clinical trial
subject
principle of no fault responsibility