Letters EU regulation of clinical trials

New European Union regulation of clinical trials puts trial participants at risk

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f665 (Published 06 February 2013) Cite this as: BMJ 2013;346:f665
  1. Joerg Hasford, medical statistician, physician1
  1. 1Arbeitskreis Medizinischer Ethik-Kommissionen in Deutschland e.V., Scharnitzerstr.7 D-82166 Graefelfing, Germany
  1. has-ethik{at}ibe.med.uni-muenchen.de

Gøtzsche did not mention that the new European Union regulation of clinical trials has serious deficiencies from an ethical and trial participant’s point of view.1

The EU Commission’s proposal is fundamentally different from the current EU directive: a comprehensive and independent consideration and vote by a multidisciplinary independent ethics committee are no longer required. This violates international guidelines and ethical codes, such …

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