摘要
我国的医疗技术管理立法处于起步阶段。从比较法的角度,提出了我国医疗技术人体试验立法的建议:构建伦理审查委员会审查与行政机关许可的双审制度;国家适度干预伦理审查委员会的设置;主管机关设置与非主管机关设置、外审型与内审型伦理审查委员会建设并行;构建多方位监管模式。
Legislation of medical technology administration has just begun. On the basis of comparison, to put forward the following suggestions: build two-tiered review system,mode of established by the competent government department and of established by non-governmental department go side by side, so is local Independent Review Board( IRB) and non-local 1RB,establish multi-level supervision system.
出处
《医学与哲学(A)》
CSSCI
北大核心
2008年第10期20-22,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
基金
教育部2005年人文社会科学研究项目"探索性医疗技术临床准入的法律规制"
项目编号:05JC820042
关键词
医疗技术人体试验
行政许可
监管
medical technology research involving human subjects, permission, supervision