Does the HSD/HS study meet the FDA requirements for waiver of informed consent?
Yes, the University of Washington research study meets these requirements: • A life-threatening situation with unproven or unsatisfactory treatment where research is necessary to improve outcome. Blunt trauma causing hypovolemic shock 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 resuscitative fluid must be given within minutes) • The University of Washington’s Human Subject’s Ethics Review Board approves the consent document an
