Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's 'Exception from informed consent requirements for emergency research': a special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine.

摘要

In addition to the usual requirement of appropriate study design and institutional review board (IRB) approval, research studies performed under the Food and Drug Administration (FDA) and Department of Health and Human Services regulations regarding "Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research" (21 CFR para.50.24)' require community consultation and public disclosure. This special report discusses the general issues related to consent in emergency circumstances and provides a template to help IRBs implement community consultation and public disclosure appropriately. A portion of the material in this special report was presented as testimony by Dr Halperin on October 11, 2006, at the FDA's public hearing on "Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research."