EU regulation of clinical trials

New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f667 (Published 6 February 2013)
Cite this as: BMJ 2013;346:f667

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  1. Carrol Gamble, deputy director1,
  2. Kerry Woolfall, research fellow2,
  3. Paula Williamson, director3,
  4. Richard Appleton, consultant pediatric neurologist4,
  5. Bridget Young, director of communication skills2
  1. 1Clinical Trials Research Centre, Institute of Child Health, Alder Hey Children’s NHS Foundation Trust, University of Liverpool, Liverpool, UK
  2. 2University of Liverpool, Liverpool, UK
  3. 3MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK
  4. 4Paediatric Neurosciences, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK
  1. c.gamble{at}liv.ac.uk

Further to the deficiencies outlined,1 the proposed EU regulation will again stop research into emergency care.

The European Clinical Trials Directive made no provision for consent in emergency situations, forcing member states to operate at variance with the directive or to accept restriction in emergency care research.

The proposed regulation incorporates deferred consent procedures that allow trial information to …

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