论人体试验中知情同意的法律问题  

The Discussion on the Human Trials in the Informed Consent of the Legal Issues

作　　者：王丹[1] 张广森[1] 强美英[1] 

机构地区：[1]天津医科大学医学人文学院,天津300070

出　　处：《医学与社会》2010年第4期74-76,共3页Medicine and Society

摘　　要：知情同意是受试者一项重要权利。但是近年来人体试验中侵犯受试者知情同意权的事件越来越多。因国内相关法规和规章规定不完备,存在着研究者告知义务不完备、责任承担方式单一等众多问题,所以受试者即使受到损害也无法得到赔偿。本文在明确人体试验和知情同意概念的前提下,针对典型问题加以分析,并提出相关建议,希望能促进人体试验法的建立。Informed consent is an important right for subjects.However,the event that informed consent of subjects are violated in human trials is more and more in recent years.Because the provisions of relevant domestic laws and regulations are not complete,there are an obligation to tell subjects of researchers which is not complete,homogenization of taking responsibility and so many questions,so even if the subjects had been damaged,but they will not be compensated by laws.In this paper,under the premise of a clear concept of human trials and informed consent,we will analyze the problems and make relevant recommendations,and hope to promote the establishment of human trials of legal.

关 键 词：知情同意 人体试验法 

分 类 号：D082[政治法律—政治学]