Kamper-Jørgensen Finn
Statens Institut for Folkesundhed, Svanemøllevej 25, DK-2100 København ø.
Ugeskr Laeger. 2003 Apr 14;165(16):1680-2.
Since 1992 a law based national system of Scientific Ethical Committees has existed. It consists of regional committees supplemented with a Central Committee. The Danish model is characterised by having a majority of lay people in all committees. The law is based on the principle of informed consent. A new law in 2003 will implement the EU directive on Good Clinical Practice. A maximum time of 60 days for the approval of biomedical research projects and approval of multi-centre trials at only one scientific ethical committee will be introduced.
自1992年起，丹麦建立了基于法律的国家科学伦理委员会体系。该体系由地区委员会和一个中央委员会组成。丹麦模式的特点是所有委员会中都有多数非专业人士。该法律基于知情同意原则。2003年的一项新法律将实施欧盟关于《药物临床试验质量管理规范》的指令。将引入对生物医学研究项目审批的最长60天时限，并且多中心试验仅需在一个科学伦理委员会获得批准。
