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Aiding Emergency Research Aim of Report on Exceptions to Informed Consent
Mike Mitka
JAMA. 2007;298(22):2608-2609.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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Since 1996, when new US federal regulations required researchers and institutional review boards (IRBs) to obtain exceptions from standard informed consent for studies involving patients with emergency or life-threatening conditions, IRBs have been reluctant to approve such research, causing a limited number of such studies to be conducted. But new recommendations that offer a template to help IRBs and researchers designing trials meet these regulations may help remedy this situation.
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New recommendations may facilitate research on patients with medical emergencies who are unable to provide informed consent. (Photo credit: Medicine Today/Getty Images)
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At issue is defining the ethical parameters for conducting research involving patients who cannot give informed consent (due to a medical condition such as cardiac arrest, stroke, or major trauma) but who may benefit from an experimental therapy or procedure, said Mark Siegler, MD, professor of medicine and director of the MacLean Center for Clinical Medical . . . [Full Text of this Article] NEW RECOMMENDATIONS
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