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 a dvance public disclosure (PD) but provide no specifics for how to acco mplish this task. This report outlines the history of informed consent in emergency care situations, highlights the Food and Drug Administra tion regulations for an exception to informed consent, and describes a stepwise approach with specific details of a PD program for a study u sing a blood substitute. This descriptive report can serve as a guidel ine for subsequent emergency care investigators in the development of a strategic plan for PD.