Journal of Medical Ethics 39 (6):408-409 (2013)

Marcin Waligora
Jagiellonian University
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
Keywords Regional Ethics Committees  Ethics Commision  Clinical Trials Directive
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DOI 10.1136/medethics-2012-101228
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Emergency Research Without Consent Under Polish Law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.

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