A review of the Medical Research Council CRASH Trial, a multicenter randomized controlled trial of corticosteroid administration in acute severe head injury, concluded that delays caused by the informed consent process led to "avoidable mortality and probably morbidity in participants" and may also have obscured the benefits of the investigational intervention. The authors argued that if the consent process "delay[s] the start of a trial treatment such that the treatment effect could be reduced or obscured ... seeking consent is actually unethical," even if the subjects are conscious and have relatives available.

Is it agreeable? Under the emergency waiver rules, would IRBs have the authority to waive the informed consent requirement under these circumstances? What about under the general waiver provisions of 45 C.F.R. 46.116(d)?