logo BDSP

Base documentaire

  1. Working through the public disclosure process mandated by use of 21 CFR 50.24 (exception to informed consent) : Guidelines for success.

    Article, Communication - En anglais

    Annual Meeting of the Eastern Association for the Surgery of Trauma. Sanibel, FL, USA, 1998/01/14.

    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.

    Mots-clés Pascal : Réanimation, Technique, Traitement, Recherche scientifique, Etude expérimentale, Homme, Législation, Médecine légale, Chimiothérapie, Choc, Hémorragie, Traumatisme, Appareil circulatoire pathologie

    Mots-clés Pascal anglais : Resuscitation, Technique, Treatment, Scientific research, Experimental study, Human, Legislation, Legal medicine, Chemotherapy, Shock, Hemorrhage, Trauma, Cardiovascular disease

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 99-0034636

    Code Inist : 002B30A10. Création : 31/05/1999.