Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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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.
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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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Differences in interpretation of the Final Rule for exception from informed consent (EFIC) requirements for emergency research result in inconsistencies in implementation and difficulties for some institutional review boards (IRBs) to approve such research. During a consensus workshop organized by the editorial board of Academic Emergency Medicine, participants discussed how IRBs balance the risks to human subjects in EFIC research, the conduct of community consultation and its role in IRB decision making, and future directions to improve and research EFIC effects. Areas of consensus and diversity of opinion were identified. ⋯ While IRBs must approve EFIC research based on their own local environment, additional guidelines from regulatory agencies may be helpful. In general, current treatments for EFIC conditions are unsatisfactory and many are unproven. A group of peer reviewers can act as consultants to IRBs that do not have this expertise.
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To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. ⋯ Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue.
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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.