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J Med Ethics 39:408-409 doi:10.1136/medethics-2012-101228
  • Brief report

A European consistency for functioning of RECs? We just lost our chance

  1. Marcin Waligora
  1. Correspondence to Dr Marcin Waligora, Department of Philosophy and Bioethics, Jagiellonian University, Medical College, Michalowskiego 12, Krakow 31-126, Poland; m.waligora{at}uj.edu.pl
  • Received 9 November 2012
  • Accepted 13 November 2012
  • Published Online First 8 December 2012

Abstract

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.