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Invited Critique |

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(10):1024. doi:10.1001/archsurg.141.10.1024.
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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

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Moral distress in the resuscitation of extremely premature infants. Nurs Ethics Published online Apr 8, 2014.;
[Informed consent: going through the motions?]. Harefuah 2014;153(2):115-8, 125.
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