Working through the public disclosure process mandated by use of 21 CFR 50.24 (exception to informed consent): guidelines for success.
New Food and Drug Administration guidelines allow research to be done under an "exception to informed consent." These guidelines mandate advance public disclosure (PD) but provide no specifics for how to accomplish this task. This report outlines the history of informed consent in emergency care situations, highlights the Food and Drug Administration regulations for an exception to informed consent, and describes a stepwise approach with specific details of a PD program for a study using a blood substitute. This descriptive report can serve as a guideline for subsequent emergency care investigators in the development of a strategic plan for PD.
Santora
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Department of Surgery, Allegheny University of the Health Sciences, Philadelphia, PA 19129, USA.
Cowell
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Trooskin
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D000465:Algorithms; D001802:Blood Substitutes / Q000627:therapeutic use; D003256:Community Participation; D003663:Decision Trees; D004638:Emergency Treatment / Q000592:standards*; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016134:Organizational Policy; D010414:Pennsylvania; D012106:Research / Q000592:standards; D012151:Resuscitation / Q000379:methods; D012771:Shock, Hemorrhagic / Q000628:therapy; D013997:Time Factors; D014193:Trauma Centers; D014342:Truth Disclosure; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D001802:Blood Substitutes