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- Title
Aiding Emergency Research Aim of Report on Exceptions to Informed Consent.
- Authors
Mitka, Mike
- Abstract
This article looks at one obstacle to emergency medicine research in the U.S. which comes from the U.S. Food and Drug Administration (FDA) in the form of complicated procedures on exceptions to informed consent. Many patients in the emergency setting are not able to give their consent for experimental procedures that could save their lives. The FDA has issued an acceptable conduct code in these cases that is so obtrusive that the number of studies in emergency medicine has declined rapidly. In response to this situation, the American Heart Association (AHA) has issued a report to help researchers implement the requirements. The details of the recommendations are presented. INSET: Informed Consent and Emergency Care Research.
- Subjects
UNITED States; EMERGENCY medicine; MEDICAL emergencies; MEDICAL ethics; CRITICAL care medicine; INFORMED consent (Medical law); MEDICAL laws; INVOLUNTARY treatment; PRESUMED consent (Medical law); UNITED States. Food &; Drug Administration; AMERICAN Heart Association
- Publication
JAMA: Journal of the American Medical Association, 2007, Vol 298, Issue 22, p2608
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.298.22.2608