瑞典伦理委员会的管理介绍

瑞典伦理委员会的工作模式,除了需遵守欧盟2004年的“指令”外,典型地表现在临床研究向伦理审查机构申请伦理审查的同时,按照瑞典的法律,必须同时向政府监管部门提交申请。其伦理审查机构为一个独立的中央伦理审查机构及6个地方伦理审查机构。关于对伦理委员会的成员组成本文也做了简要介绍。

Ethics Committee Management from the Swedish Perspective

Besides the Directive issued by European Commission on May 1 2004,Sweden also introduced a new legislation on the ethics review on clinical trials at the same time.It is required in the legislation that conduction of clinical trials and other research involving human subjects have to be submitted both to ethics review committee and regulatory agency(Medical Products Agency).The ethical review system is made up of an independent central ethics review board and six local ones.The paper also introduces the staff constitution of the committees.