Letters EU regulation of clinical trials

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

2013; 346 doi: http://dx.doi.org/10.1136/bmj.f667 (Published 06 February 2013) Cite this as: 2013;346:f667

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

There is no conflict between the conditions in the proposed regulations as suggested by Gamble et. al. The first stipulation mentions patients and consent from patients. The second refers to the patient’s representative.

It makes perfect sense to distinguish between the two: if consent cannot be obtained from the patient themselves then we should look to their representative for advice on the patient’s preferences. If obtaining such advice is impractical, puts the patient at significant risk or jeopardises the clinical value of the research then there are ethical reasons against obtaining it. None of these are ruled out by the proposed regulations.

There is clearly scope for interpreting when a legal representative is ‘available’ and so, how much effort is required by the researchers to determine that this condition is met. This could helpfully be clarified to avoid exactly the kind of variation that currently exists under the Clinical Trials Directive.

Helpfully also, the proposed regulations do not refer to deferred consent. Consent to participate in emergency medicine research is waived not deferred. The consent that is obtained after the emergency has past is consent to continued participation and use of data. The use of the term ‘deferred consent’ is misleading and should be avoided.

The minimal risk and minimal burden criterion in the proposed regulations (“the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject”) is more problematic. As we have seen from debates in the context of research on children, what counts as minimal risk is very unclear and depends heavily on the how we understand the baseline level of risk. In the emergency context the risks are often very high and much is at stake. It is important not to rule out research in these situations. We need good quality, clinically relevant evidence in high risk cases too.

Competing interests: No competing interests

08 February 2013
Mark Sheehan
Oxford BRC Ethics Fellow
The Ethox Centre, University of Oxford
Rosemary Rue Building, Headington, Oxford OX3 7LG
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