Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Comparative Study
Electronic medical record review as a surrogate to telephone follow-up to establish outcome for diagnostic research studies in the emergency department.
Follow-up for diagnostic research studies might be facilitated if medical record review (MRR) could be used instead of telephone calls. ⋯ Under limited circumstances, accurate clinical follow-up for diagnostic studies conducted in the ED can be obtained by medical record review.
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To explore community attitudes toward the federal regulations that allow investigators to conduct emergency research without obtaining informed consent from participants. ⋯ There is no consensus regarding the definition of "community" or appropriate methods of consultation. Community members' attitudes toward RWC are often shaped by their personal experiences, and their general attitudes often differ from their reactions to specific RWC protocols.
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An objective of the 2005 Academic Emergency Medicine Consensus Conference, "Ethical Conduct of Resuscitation Research," was to identify if consensus exists regarding application of the Food and Drug Administration (FDA) Final Rule allowing an exception from informed consent in resuscitation research. At the start of the consensus conference, 49 attendees participated in a survey containing three sections: 1) demographic questions characterizing respondents, 2) questions regarding application of the FDA Final Rule, and 3) complexities associated with seeking informed consent in an emergency setting. ⋯ Complexities associated with seeking informed consent in emergency departments were prevalent among most institutions represented at the conference. There was general agreement that current efforts to safeguard human subjects are effective, but participants agreed that refinements to and standardization of the FDA Final Rule would facilitate resuscitation research and enhance patient safety.
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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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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.