Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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The 2005 Academic Emergency Medicine Consensus Conference, "Ethical Conduct of Resuscitation Research," was designed with the goal of developing consensus on important issues for human subjects and researchers surrounding the 1996 federal regulations jointly published by the Department of Health and Human Services and the Food and Drug Administration and known as the Final Rule. These regulations, which guide the conduct of research using the emergency exception from informed consent or waiver of informed consent, have been the subject of much debate in the resuscitation research community. ⋯ This report outlines the methods by which individuals and organizations were recruited to participate, how the conference was advertised, and the way in which participants and nonparticipants were encouraged to communicate before and after the conference. The limitations and potential biases of these methods and activities are also presented.
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Under the Final Rule enacted in 1996 by the United States Food and Drug Administration and Office of Health and Human Services, community consultation and public notification are required when emergency research is to be conducted in the absence of prior informed consent by subjects. There is a dearth of published recommendations concerning the degree to which communities must be aware of the existence and parameters of a study for which informed consent might not be obtained prior to enrollment. It is argued that effective community consultation requires empirical measurement of the dynamics of community, and that ordinary notions of community may not capture the populations at greatest risk or those who might for other reasons figure most prominently in community consultation. A pragmatic approach to community consultation would establish benchmarks for such measures, and it is argued that such an approach is possible given the correct empirical measures.
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To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. ⋯ Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue.
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Resuscitation research has been allowed to proceed using waiver of consent when compliance with guidelines is assured. In these circumstances, institutional review boards (IRBs) may request notification of enrolled patients. ⋯ Contact information may be difficult to obtain for up to 20% of out-of-hospital critical patients. In 8% to 13% of cases, patients or designates contacted researchers; most feedback was positive. Frequently, non-study-related information was requested, consuming significant resources. Using this method, fewer than 1% of patients were withdrawn from the studies.
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The survival of patients who present to the emergency department with severe injury or illness is dismal. Resuscitation researchers are interested in advancing the science of resuscitation, and clinical studies must be conducted to determine the best treatment protocols. These studies must reflect good science and must balance individual patient autonomy and safety with scientific progress that benefits society as a whole. ⋯ There is concern and some evidence that the federal guidelines have impeded the advancement of resuscitation science. Several strategies have been suggested to improve the situation. These include 1) better education of resuscitation researchers regarding the federal guidelines, 2) a toolbox for resuscitation researchers clarifying the guidelines, 3) advocacy for the advancement of resuscitation science as a public good, and 4) a national research advisory board that provides unbiased reviews of clinical studies and guidelines for local institutional review boards regarding risks, benefits, and communication strategies for waiver of and exception from consent proposals.