知情同意权是药物临床试验受试者的基本权利,近年来研究者不充分履行告知义务侵害受试者知情同意权的案件频频发生,但在诉讼中成功维权的案例占比较低,表明我国现有法律规定存在漏洞,很难真实有效地保障受试者的知情权及自主决定权。本文通过对案例网站上现有的药物临床试验的案例进行检索分析,进行类案整理后总结了实践中存在的侵害受试者知情同意权的乱象,并在此基础上提出了整改建议。
<<The right to informed consent is the basic right of subjects in drug clinical trials. In recent years,researchers do not fully fulfill the obligation of disclosure,and cases infringing on the subject’s right to informed consent occur frequently,but there are few successful cases in litigation,indicating that there are loopholes in China’s existing laws and regulations,which is difficult to truly and effectively protect the subject’s right to know and independent decision-making. Through the retrieval and analysis of the existing cases of drug clinical trials on the case website,after sorting out such cases,this paper summarizes the chaos that infringes on the subject’s right to informed consent in practice,and puts forward rectification suggestions on this basis.
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