Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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The challenge of effectively communicating with communities about research is particularly salient for investigators who are conducting emergency research with an exception from informed consent. The authors discuss the ethical basis for the community consultation requirement and describe the nature and extent of the consultative process required to achieve these ethical purposes. The findings of the consensus conference are summarized as follows. 1) The requirements for community consultation and public disclosure for exception from informed consent studies serve important ethical purposes and should be retained. 2) Community consultation allows investigators and institutional review boards to obtain input from the community regarding planned research. ⋯ The practical challenges involved in conducting meaningful community consultation are also discussed: defining the community and its appropriate representatives, methods to actively engage the community, the lack of uniformity among institutional review boards in required community consultation activities, and the lack of measures to evaluate the adequacy and appropriateness of community consultation. The recommendations of the consensus conference regarding future research about community consultation are summarized. Priorities include identifying best practices; defining effectiveness and developing measures to evaluate community consultation; evaluating alternative models and potential infrastructures to facilitate, conduct, and/or oversee effective community consultation processes; and developing educational modules for community members to empower their active participation in discussions about emergency research in their communities.
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Federal regulations allow waiver of informed consent for minimal-risk research (waiver). More than minimal-risk emergency research is allowed with an exception from informed consent (EFIC) under specific guidelines called the Final Rule. Performance of research without consent is controversial; however, chances for public health improvements are significant. ⋯ Almost all medical school IRBs review minimal-risk waiver studies. About half of IRBs at medical schools have reviewed and approved an EFIC study. The higher the NIH funding percentile (more NIH funding), the more likely a site has reviewed EFIC studies, except in the Northeast region.
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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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Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define "protection"; therefore, it is not currently known whether or not subjects are protected under the current rules. 2) Care must be taken to protect not only the individual from harm during research but also to protect society from unregulated research in other countries and an inability to appropriately advance medical knowledge. 3) Some surrogate markers/methods of protection whose efficacies are debatable include data safety monitoring board activity, the community consultation and public notification (CC/PN) process, and institutional review board approval. 4) Minimal-risk studies should be held to different standards of protection than those that involve more significant risk to the subject. 5) A handful of studies have been published regarding community consultation and notification, and the majority are case studies. Those that are specifically designed to discover the most successful methods are hindered by a lack of formal outcomes measures and tend to have negative results. 6) Follow-up data from the CC/PN process should be disclosed to the Food and Drug Administration and incorporated into study designs. 7) Focus groups and/or random-digit dialing have been suggested as promising methods for fulfilling the CC/PN requirements. 8) Studies need to be funded and performed that formally investigate the best means of CC/PN. 9) More funding for this research should be a priority in the emergency medicine and critical care communities. More data regarding terminated studies should be made available to the research community. 10) Quantifiable markers of success for CC/PN must be validated so that research may determine the most successful methods. 11) Data regarding subjects' and family members' experiences with exception from informed consent studies need to be obtained.
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Under the Final Rule enacted in 1996 by the United States Food and Drug Administration and Office of Health and Human Services, community consultation and public notification are required when emergency research is to be conducted in the absence of prior informed consent by subjects. There is a dearth of published recommendations concerning the degree to which communities must be aware of the existence and parameters of a study for which informed consent might not be obtained prior to enrollment. It is argued that effective community consultation requires empirical measurement of the dynamics of community, and that ordinary notions of community may not capture the populations at greatest risk or those who might for other reasons figure most prominently in community consultation. A pragmatic approach to community consultation would establish benchmarks for such measures, and it is argued that such an approach is possible given the correct empirical measures.