Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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Comparative Study
Impact of the Final Rule on the rate of clinical cardiac arrest research in the United States.
The federal government placed a moratorium on human emergency resuscitation research in 1993 due to concerns related to informed consent. In 1996, the Food and Drug Administration introduced the Final Rule in order to allow clinical resuscitation research to proceed in special cases without prospective informed consent. It is unclear, however, how this change has impacted the performance of this research. ⋯ There has been a significant decrease in the number of published clinical cardiac arrest trials in the US since 1993. In contrast, there has been a significant increase in the number of published EU trials since 1993. The current informed consent requirements may have reduced the number of clinical cardiac arrest studies performed in the US.
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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.
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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 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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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.