BMJ  2007;334:165-166 (27 January), doi:10.1136/bmj.39097.582130.80

Editorials

Clinical trials in emergency situations

New guidance allows patients to be enrolled without prior consent

The first 150 words of the full text of this article appear below.

On 12 December 2006 an amendment of the UK's Medicines for Human Use (Clinical Trials) Regulations 2004 came into force.1 The amendment allows unconscious patients in emergency situations to be enrolled in clinical trials without prior consent provided that this has been approved by the appropriate ethics committee. The amendment has been anxiously awaited by emergency care researchers since these regulations first changed the legal basis for consent for research on medicinal products in the United Kingdom in May 2004.2

Researchers have always been concerned about the effects the regulations might have on clinical trials in emergency situations in patients with impaired consciousness, such as those with head injury, major trauma, or cardiac arrest. The regulations imposed the need for prior consent from a personal or professional legal representative before a patient could be recruited into a clinical trial.

The regulations only applied to trials of drugs. Non-medicinal trials and . . . [Full text of this article]

Haleema Shakur, trials manager, Ian Roberts, professor of epidemiology, Lin Barnetson, data manager, Tim Coats, professor of emergency medicine

1 CRASH Trials Coordinating Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT

crash@lshtm.ac.uk


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This article has been cited by other articles:

  • Cook, D., Moore-Cox, A., Xavier, D., Lauzier, F., Roberts, I. (2008). Randomized Trials in Vulnerable Populations. Clin Trials 5: 61-69 [Abstract]  

Rapid Responses:

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