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.
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This article reflects the proceedings of a breakout session, "Using the Regulations in Research" at the 2005 Academic Emergency Medicine Consensus Conference, "Ethical Conduct of Resuscitation Research." There have been two organized studies, and a number of anecdotal reports, describing the decline in cardiac arrest resuscitation research in the United States since the implementation of the Final Rule. Paradis and colleagues found that the volume of human cardiac arrest research published in the United States was significantly less in a four-year period after the Final Rule was adopted as compared to the earlier period. Nichol and colleagues reported that both the absolute number of US-based randomized cardiac arrest trials and the proportion of US-based trials (vs. foreign trials, based on the mailing address of the first author) decreased by about 15% annually. ⋯ A summary table of the federal regulations is provided. Participants discussed what additional information and research about using the regulations would be helpful for the promotion of quality resuscitation and emergency care research in the United States. Areas suggested for further investigation include: impact on the quality as well as quantity of such research; current level of understanding of the regulations by investigators, regulatory/IRB personnel and potential subjects (the general public); costs incurred: additional time required for preparation, approval and conducting community consultation and public disclosure; impact on research on non-life-threatening conditions; value and cost of a registry; use of a standard reporting template for issues regarding meeting the requirements in individual clinical trials; whether more specific guidance would be helpful or restrictive; what constitutes effective community consultation and public disclosure; and whether titration of community consultation and public disclosure based on the risk of the proposed intervention to subjects is feasible and acceptable.