Research on resuscitation techniques and pharmaceuticals has been problematic, due to the frequent inability to obtain informed consent and the constraints of the decision-making process. Ordinarily, the process of obtaining informed consent for human subject research is designed to assure protection and autonomy of the subject. However, the process of obtaining informed consent is time consuming and requires competence of the subject. Because of these difficulties, the Food and Drug Administration recently issued guidelines under which resuscitation research may be performed, with a waiver of informed consent, under certain conditions. 23 When designing such research protocols, factors to be considered include the patient's wishes (if known), expected safety of the study protocol, expected benefit of the therapeutic intervention, overall expected benefit to society by improved knowledge regarding resuscitation, related animal data, feasibility of surrogate consent, local Institutional Review Board opinion, and local general public opinion, if available.
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