我国生物医学研究伦理审查组织立法的检讨与重构

Reconstruction of the Legislation for Clinical Trial Ethical Review Institute

《生物安全法》对生物医学研究提出了伦理审查的要求。国外生物医学研究伦理审查组织主要有以美国为代表的机构内审查模式和以荷兰为代表的机构外审查模式。我国目前采行的同时在研究机构内部和外部设置审查组织的模式无法起到有效保护生物医学研究受试者合法权利的作用。为确保独立性这一伦理审查的首要价值,应当在我国建立中央和地方两级独立伦理审查组织,并由卫生和药品行政管理部门作为伦理审查的监督部门。同时,应建立伦理审查结论的上诉机制,以实现对伦理审查的有效监督。

Inorder to protect subjects’ rights, ethical review institute in clinical trial is required by the Biosecurity Law.There are two models of ethical review institutes,namely the institutional review boards(IRB) as that of the US,and the independent review committee as of the Netherlands. There are both advantages and disadvantages in the two models. The current regulations about ethical review committees in China is not sufficient to protect subjects’ rights effectively;therefore,we should establish an independent ethical review committee system on both central and local levels. It is also essential to make effective supervision of the ethical review as well as set up an appellate system.