Does the cardiac arrest study meet the FDA requirements for waiver of informed consent?
Yes, the Medical College of Wisconsin research study meets these requirements: • A life-threatening situation with unproven or unsatisfactory treatment where research is necessary to improve outcome. Cardiac arrest is an immediately life-threatening condition with unsatisfactory treatment. • Obtaining informed consent is not feasible because the patient is unresponsive and treatment must begin immediately if there is any hope for survival. • Participation in research has the prospect of direct benefit because the situation necessitates an intervention, science supports the potential of direct benefit and the risks of the research are reasonable compared to the medical condition. • The research could not practicably be done without waiver of informed consent. • The potential therapeutic window is short (in the case of cardiac arrest just a few minutes). • The Medical College of Wisconsin Research Board approves the consent document and procedures for the subject or legal representative.
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