摘要
伦理审查委员会(IRB)的法律地位是一个崭新的课题。通过解读我国现行的伦理审查规范,对我国IRB伦理审查活动的合法性、伦理审查结果的法律效力、IRB及研究人员的法律责任等关乎IRB法律地位的问题进行了探讨。考察了美国和瑞典的伦理审查法规,提出应该提高我国伦理审查规范的法律位阶,推行注册制度的建议。
The legal status of Institutional Review Board（IRB） is a new topic. According to China＇ s existing regulations concerning to ethical vetting, this article discussed some issues about the legal status of IRB, such as the legitimacy of ethical vetting, the legal effect of IRB＇s ethic decisions, the legal responsibilities of IRB and its researchers, etc. Based on studying the US and Sweden＇s regulations concerning to ethical vetting, it is suggested that China should promote its legal position of the regulations concerning to ethical vetting and implement a registration system.
出处
《医学与哲学（A）》
CSSCI
北大核心
2009年第8期48-49,71,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词
伦理审查委员会
伦理审查
法律地位
institutional review board, ethical vetting, legal status
