Letters EU regulation of clinical trials

New European Union regulation of clinical trials is not conflicting on deferred consent in emergency situations

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1163 (Published 26 February 2013) Cite this as: BMJ 2013;346:f1163
  1. Mark Sheehan, Oxford Biomedical Research Centre ethics fellow1
  1. 1Ethox Centre, University of Oxford, Oxford OX3 7LG, UK
  1. mark.sheehan{at}ethox.ox.ac.uk

There is no conflict between the conditions in the proposed regulations as Gamble and colleagues suggest.1 The first stipulation mentions patients and consent from patients; the second refers to patients’ representatives.

It makes sense to distinguish between the two: if consent cannot be obtained from patients, we should ask their representatives for advice on their preferences. If …

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