Consent in emergency research

The legal basis for consent for research in the incapacitated patient changed on 1st May 2004, when the Medicine for Human Use (Clinical Trials) Regulations 2004 came into force. The new law provides for a legal representative to give consent on behalf of a patient who cannot consent for themselves.¹ A professional legal representative can consent on behalf of an incapacitated patient if no relative or friend is available. For research in emergency care and resuscitation this is obviously a necessity.

One year after the new regulations were incorporated into UK law, we surveyed NHS Trusts to see if they had systems in place for professional legal advisor consent. Telephone calls were made to the research and development departments of 53 randomly selected acute NHS Trusts, representing approximately 25% of acute hospitals.

Responses were obtained from 45 acute NHS Trusts (85%). Three of these trusts (7%) had a procedure in place for professional legal representatives to give consent to patient participation in medical research. A further three (7%) were in the process of setting up a system. None of the hospitals had a training system for their professional legal representatives. Three trusts stated that as a matter of principle they would never allow research on incapacitated patients.

Our survey shows that, 1 year after the introduction of new regulations, most NHS R&D departments do not have a consent system in place to allow research aimed at improving the emergency treatment of incapacitated patients. Emergency medicine researchers report that this has inhibited new trials on the emergency care of incapacitated patients in England and Wales. Even an experienced trial management group running the CRASH2 trial (http://www.crash2.lshtm.ac.uk) is experiencing great difficult setting up a research project in the UK. There is an urgent need for national guidance for R&D departments with specific advice in this area.