Letters 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 06 February 2013) Cite this as: BMJ 2013;346:f667
  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 be given after its start and informed consent to be obtained later, providing certain criteria are fulfilled. Two of these criteria are conflicting:

  • Owing to the urgency of the situation, caused by a sudden life threatening or other serious medical condition, it is impossible to obtain prior informed consent from the patient and impossible to supply prior information to the patient

  • No legal representative is available.

The first criterion states that the urgency of the situation prevents prospective consent but the second states that availability of a legal representative prohibits deferred consent even in such an urgent situation. The impact of treatment delay while prospective consent is sought or a representative strives to understand trial information and make a decision is not considered.

Seeking consent in emergency care is unethical if it delays trial treatment and obscures or reduces treatment effects.2 Deferred consent is acceptable to most patients and carers,3 and trials have successfully used this approach.4 5 In the new regulations, deferred consent should be based solely on the urgent need to treat.

Ethical dilemmas about seeking deferred consent after a patient’s death,2 6 the potential for creating bias in trial conclusions if the decision to decline consent is associated with a patient’s outcome, and the use of data collected up to the point of seeking consent should be considered.


Cite this as: BMJ 2013;346:f667