Working Through the Public Disclosure Process Mandated by Use of 21 CFR 50.24 (Exception to Informed Consent)
- 1 November 1998
- journal article
- Published by Wolters Kluwer Health in The Journal of Trauma: Injury, Infection, and Critical Care
- Vol. 45 (5) , 907-913
- https://doi.org/10.1097/00005373-199811000-00012
Abstract
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.Keywords
This publication has 4 references indexed in Scilit:
- BASE DEFICIT STRATIFIES MORTALITY AND DETERMINES THERAPYPublished by Wolters Kluwer Health ,1992
- Informed consent for biomedical research in acute care medicineAnnals of Emergency Medicine, 1991
- Early Physiologic Predictors of Injury Severity and Death in Blunt Multiple TraumaArchives of Surgery, 1990
- Deferred ConsentJAMA, 1986