In such an emergency situation, how is informed consent obtained?
Obtaining an “informed consent” from victims of cardiac arrest is impossible as the participant is unconscious and the family is either not immediately available or extremely distraught. To allow researchers to possibly improve the survival rate of individuals suffering from a life-threatening condition, the US Food and Drug Administration (FDA) has issued guidelines for the consent to be waived in emergency circumstances, as long as the research has the prospect of direct benefit to the patient. In order to be able to do a study using an “emergency waiver of consent” the following requirements established by the FDA must be met. • A life-threatening situation with unproven or unsatisfactory treatment where research is necessary to improve outcome. • Obtaining informed consent is not feasible because the patient is unresponsive and treatment must begin immediately. • Participation in research has the prospect of direct benefit because the situation necessitates an intervention, science
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- In such an emergency situation, how is informed consent obtained?
