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(Circulation. 2007;116:1855-1863.)
© 2007 American Heart Association, Inc.

AHA Special Report

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

Henry Halperin, MD, MA, FAHA; Norman Paradis, MD; Vincent Mosesso, Jr, MD; Graham Nichol, MD, MPH, FRCPC, FAHA; Michael Sayre, MD; Joseph P. Ornato, MD, FAHA; Michael Gerardi, MD; Vinay M. Nadkarni, MD, FAHA; Robert Berg, MD, FAHA; Lance Becker, MD, FAHA; Mark Siegler, MD; Megan Collins, MD; Charles B. Cairns, MD, FACEP; Michelle H. Biros, MD, MS; Terry Vanden Hoek, MD; Mary Ann Peberdy, MD

Key Words: AHA Scientific Statement • emergency medical services

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
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 50.24)¹ 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in this special report was presented as testimony by Dr Halperin on October 11, 2006, at the FDA’s public hearing on "Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research."

More than 300 000 Americans die each year due to catastrophic medical and surgical emergencies.^2,3 New interventions based on sound research could save lives. These research studies must be done within an ethical framework that traditionally includes obtaining prospective informed consent from the research subject. The ethical framework for the conduct of human research began with the development of the Nuremberg Code^4,5 in 1949. This code states that (1) informed consent of volunteers must be obtained without coercion of any form, (2) human experiments should be based on prior animal experiments, (3) the anticipated scientific results should justify the experiment, (4) only qualified scientists should conduct medical research, (5) physical and mental suffering should be avoided, and (6) no expectation of death or . . . [Full Text of this Article]

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