摘要
在医学人体试验的过程中,研究者对受试者负有一种关爱责任,其直接体现在研究者要尊重患者的知情同意权,向受试者告知其病情、试验的研究背景、研究的目的和方法、受试者有随时退出临床试验的权利等等。文章通过对美国C.E.A诉临床试验研究人员案的详细介绍,指出在任何情况下,研究人员都不能将科学研究的利益置于受试者的生命健康利益之上,且都应当履行详尽的告知义务,以最大限度地保证受试者的权益。
In medical human subject research, researchers bear the liability to care the subjects who participate in their research, which embodies directly in the researchers' respect to their subjects' informed consent, in describing the state of illness to their subjects, in the exposition of the background information,purpose and methods of the research to the subjects, and in respect the subjects' right to quit such clinical research at anytime he or she prefers, and so on. Through the detailed introduction of the legal action of C. E. A.against clinical researchers, this paper indicates that in no case researchers should put the interests of scientific research above the life and health interests of their subjects, and researchers should fulfill their obligation to completely inform their subjects in detail and ensure the interests and the subjects' rights with their greatest effort.
出处
《医学与法学》
2016年第5期63-67,共5页
Medicine and Jurisprudence
基金
2013年国家社科基金项目"以医疗纠纷为视角完善和创新社会建设管理研究"(项目编号:13XSH009)
2014年泸州医学院基金项目"美国人类基因信息隐私权法律制度研究"(项目编号:2014SKZD-002)
2014年四川省教育厅项目"人类基因技术背景下人格权保护研究"(项目编号:14SB0112)的阶段性成果
关键词
非治疗性临床试验
知情同意
受试者利益
non-therapeutic clinical research
informed consent
the interests of subject