RT Journal Article
SR Electronic
T1 A European consistency for functioning of RECs? We just lost our chance
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 408
OP 409
DO 10.1136/medethics-2012-101228
VO 39
IS 6
A1 Marcin Waligora
YR 2013
UL http://jme.bmj.com/content/39/6/408.abstract
AB 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.