摘要
知情同意是人体试验的关键问题,对于受试者利益的保护具有重要意义。在规范人体试验时,我国法律对知情同意有相关规定,但存在一定的缺失和不足。在研究者告知义务方面,对于研究者的说明事项规范有待改进。在受试者同意方面,将行为能力制度运用于受试者的同意能力不适当,有建立"医事上同意能力制度"的必要,且受试者的同意能力应当依据个案判断。知情同意实践中,弱势群体之一孕妇参与人体试验在我国存在立法缺失,应予以补充和完善。
Informed consent is critical to the human subject research and has great significance to human subject＇s interest.Although there are some relevant legal regulations about informed consent,some defects and inadequacies still exist.As to the investigator＇s obligation to notify,instructions and specifications still need improving.As to the subject＇s consent,it is inappropriate to identify his capacity with hais consent.Therefore,it is necessary to establish a system of subjects＇ consent in medical institutions and judge subjects＇ consent through case study.In practice,pregnant women as one of the vulnerable groups,their participating in the human subject research leaves legislative deficiency which should be supplemented and perfected.
出处
《安徽广播电视大学学报》
2010年第4期31-35,共5页
Journal of Anhui Radio & TV University
关键词
人体试验
知情同意
告知义务
human subject research
informed consent
obligation to notity
