Annals of emergency medicine
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This article summarizes the current requirements for a waiver of informed consent for emergency research and analyzes ethical issues that are involved. Researchers who intend to apply for a waiver of informed consent for emergency research must understand that they are asking for the major protector of human subjects, the informed consent process, to be removed. In its absence, other protections are required. ⋯ It is unlikely that even these additional protections can equal that afforded by an adequate consent process. With this understanding, investigators' actions must be in accordance with the highest ethical standards. It is therefore necessary for investigators to know the ethical implications of conducting controlled research without the subjects' consent.
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To arrive at a consensus on the priorities for future research in emergency medical services for children. ⋯ The panel was able to develop a list of important topics for future research in emergency medical services for children that can be used by foundations, governmental agencies, and others in setting a research agenda for such services.
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Little information is available about the effects of CPR in children, although it is known that the outcomes are dismal. Examples of unanswered questions include which advanced life support (ALS) procedures should be performed out-of-hospital, whether high-dose epinephrine improves survival, and the true prevalence of ventricular fibrillation as a presenting rhythm. ⋯ Because pediatric cardiopulmonary arrest is rare, prospective data are difficult to gather, and there are few large published studies. The purpose of this collective review was to review the current body of knowledge regarding survival rates and outcomes in pediatric CPR and, based on this review, to outline a course for future research.
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To perform a population-based study addressing the demography, epidemiology, management, and outcome of out-of-hospital pediatric cardiopulmonary arrest (PCPA). ⋯ This population-based study underscores the need to investigate new therapeutic interventions for PCPA, as well as innovative strategies for improving the frequency of basic CPR for children.
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Beginning November 6, 1996, Food and Drug Administration regulation 21 CFR 50.24 has allowed research without consent in limited circumstances while requiring additional patient protection in the form of community consultation and disclosure. We report our experience in complying with these regulations in Multicenter Vest CPR protocol, the first investigational device study done under this new ruling. ⋯ The consultation process was time-consuming, demanding, and relatively costly. Further clarification of the community consultation standard and additional dialogue on this important topic will help to foster additional research in cardiopulmonary resuscitation.