Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Historical Article
An ethical analysis of exception from informed consent regulations.
Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.
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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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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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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.