Department of Philosophy and Bioethics, Jagiellonian University, Medical College, Michalowskiego 12, Krakow 31-126, Poland.
J Med Ethics. 2013 Jun;39(6):408-9. doi: 10.1136/medethics-2012-101228. Epub 2012 Dec 8.
On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it seems that we probably have already lost our chance regarding the consistency and quality of functioning of research ethics committees in the EU.
2012 年 7 月 17 日,欧盟委员会正式通过了一项关于临床试验的新指令提案,将取代并废除现行的 2001/20/EC 指令。修订的主要原因是:(1)该地区临床试验数量减少;(2)对现行指令的严厉批评。拟议的法规可能会简化进行临床试验的规则,并重建临床试验评估的整个体系。然而,对于欧盟研究伦理委员会的运作一致性和质量,我们似乎已经错失良机。