Editorial

The field of emergency research has come a long way. Once stymied by the difficulties in obtaining informed consent from patients with catastrophic injury or illness, the Food and Drug Administration (FDA) and the Department of Health and Human Services published regulations 21 CFR 50.24 in 1996 to guide the ethical and legal conduct of emer-gency research using exception from informed consent.1 For studies to qualify, subjects must have a life-threatening con-dition, available treatments are unproven or unsatisfactory, valid scientific evidence is needed to determine the safety and efficacy of the intervention, and obtaining informed consent is not feasible.2 Because these critically ill patients are quint-essentially vulnerable subjects, 21 CFR 50.24 incurred extra responsibilities for parties involved in such research including consultation with communities from which subjects would be drawn and public disclosure of information before stud