Clinical trials in emergency situations
BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39097.582130.80 (Published 25 January 2007) Cite this as: BMJ 2007;334:165
- Haleema Shakur, trials manager (crash@lshtm.ac.uk),
- Ian Roberts, professor of epidemiology,
- Lin Barnetson, data manager,
- Tim Coats, professor of emergency medicine
- 1CRASH Trials Coordinating Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT
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 …
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