The problem of informed consent in emergency medicine research.
The CRASH Trial (Corticosteroid Randomisation After Significant Head injury), which started in April 1999 hopes to answer the question of whether or not there is any benefit to giving high dose corticosteroids after significant head injuries. To do this patients are randomised to receive either the standard care for head injuries, as defined by the receiving hospital, or standard care plus a 48 hour infusion of corticosteroids. This is to be started within eight hours of injury, preferably as soon as possible. As all eligible patients will have a reduced level of consciousness informed consent has been deemed unnecessary. In this review the issue of consent in human experimentation is presented with a special emphasis on the problems faced in emergency medicine research, and the way these have been tackled.
Foëx
B A
BA
Department of Accident and Emergency Medicine, Royal Bolton Hospital. bfoex@zen.co.uk
D002986:Clinical Trials as Topic; D004635:Emergency Medicine; D006381:Helsinki Declaration; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D016032:Randomized Controlled Trials as Topic