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Ethical and Regulatory Challenges Associated With the Exception From Informed Consent Requirements for Emergency Research—Invited Critique
Lena M. Napolitano, MD
Arch Surg. 2006;141:1024.
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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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The importance of resuscitation and emergency research is without question. The optimal manner in which to conduct this important research is now in question.
In 1996, the US FDA and the DHHS developed regulations allowing research to be performed with emergency exception to informed consent, reviewed in detail by Vaslef and colleagues.
Despite these regulations, there is a growing concern that little emergency and resuscitation research is being performed in the United States when circumstances preclude prospective informed consent. In fact, even when prospective informed consent can be used, fewer patients/surrogates are choosing to participate in such research efforts. If current trends continue, there is concern that within several years it could become nearly impossible to conduct emergency, resuscitation, and critical care research.1
Recent clinical studies using this process have delineated the numerous difficulties, particularly with regard to the ambiguities surrounding the requirements, how best to . . . [Full Text of this Article]
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Ethical and Regulatory Challenges Associated With the Exception From Informed Consent Requirements for Emergency Research: From Experimental Design to Institutional Review Board Approval
Steven N. Vaslef, Charles B. Cairns, and John M. Falletta
Arch Surg. 2006;141(10):1019-1023.
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