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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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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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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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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Medical research involving critically ill and injured subjects unable to provide informed consent can only be conducted under federal regulations that attempt to balance the need to develop lifesaving treatments with protection of research subjects' rights. Regulators, researchers, and medical ethicists have all struggled to define the conditions under which an emergency exception from informed consent is appropriate. ⋯ In May 2005, at the Academic Emergency Medicine Consensus Conference "Ethical Conduct of Resuscitation Research," a breakout session was held on the research conditions that qualify for the emergency exception from informed consent process. Several recommendations emerged: 1) The definition of "life-threatening condition" should be broadly interpreted to include serious disability as well as death. 2) Existing therapies should be considered "unsatisfactory," even if partially effective, when serious risk of morbidity or mortality remains even with the best available treatment or when the adverse effects of the best available treatment are serious. 3) Research with the emergency exception should be performed only if sufficient evidence exists that the proposed intervention has a reasonable chance of benefit. 4) More evaluation is needed to determine the degree to which the current rules impede research. 5) Application of the current regulatory framework for abbreviated or waived consent in emergency research should be encouraged. 6) Further study should also address variability among institutional review boards, the goals of community involvement, and how best to engage and educate the public in research efforts using emergency exception from informed consent.