Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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The application of basic ethical principles to resuscitation research and other research in the emergency and critical care settings presents a particular challenge. The emergency exception from informed consent (EFIC) rule (21 CFR 50.24 and 45 CFR 46.101[i]) addresses a particular vulnerability: that which occurs when persons cannot consent due to acute loss of decisional capacity. The question arises as to whether populations defined as "vulnerable" are unique within studies to which EFIC applies. ⋯ Topics addressed were 1) the applicability of the term "vulnerable" in research using EFIC; 2) the relationship between vulnerability, exploitability, and capacity; 3) the significance of vulnerability in research design; 4) the adaptation of the informed consent process to the emergency setting; and 5) the role of the institutional review board. Ten consensus recommendations emerged from the discussion. Of particular importance was the endorsement of the idea that research using EFIC is as important in vulnerable populations as in the general population and that the systematic exclusion of vulnerable populations from resuscitation research is inappropriate.
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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.
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In order to set the stage for the later discussion of future directions, this Consensus Conference began by reviewing some of the existing research on conducting resuscitation studies using an exception from informed consent. That research is described in this article. ⋯ Federal regulations have set the bar appropriately high, and this may pose significant difficulties for small sponsors and individual investigators. However, further study of the experiences of subjects, researchers, and the regulatory process is warranted.
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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.