我国医疗技术人体试验立法的若干思考

On Legislation For Medical Technology Research Involving Human Subjects

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.