In reply

Abstract

We appreciate the international perspective offered by Dr. Kierzek et al. The regulations surrounding exception from informed consent research in the United States are designed to protect patients, yet they have been inconsistently interpreted and implemented. These inconsistencies challenge researchers in maintaining public/patient trust, as well as in conducting high-quality research. Researchers and institutional review board members have observed that stringent regulations pose a barrier to conducting research.1DeIorio N.M. McClure K.B. Nelson M.J. et al.Institutional review board experience using exception from informed consent.J Empir Res Hum Res Ethics. 2007; 2: 323-330Crossref Google Scholar Although the study we published was particular to the Portland, OR, Resuscitation Outcomes Consortium site, the differences in regulatory body approach to the study and the requirements for community consultation and public notification varied widely among the 8 US Resuscitation Outcomes Consortium sites, representing differing institutional review board interpretations of the same regulations. Some sites conducted extensive public disclosure campaigns and had hundreds of opt-out requests, whereas others had far less stringent requirements and relatively small numbers of opt-out requests. The variation in approaches among Resuscitation Outcomes Consortium sites has been previously published.2Tisherman S.A. Powell J.L. Schmidt T.A. et al.Regulatory challenges for the Resuscitation Outcomes Consortium.Circulation. 2008; 118: 1585-1592Crossref PubMed Scopus (28) Google Scholar, 3Bulger E.M. Schmidt T.A. Cook A.J. et al.The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent.Ann Emerg Med. 2009; 53: 341-350Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar The international regulatory differences have also been apparent in comparing US and Canadian site timelines for implementing these studies.4Brasel K.J. Bulger E. Cook A.J. et al.Hypertonic resuscitation: design and implementation of a prehospital intervention trial.J Am Coll Surg. 2008; 206: 220-232Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar We agree that lack of standardization by regulatory bodies, as well as lack of consensus among researchers and ethicists, is problematic. We hope that our study provides some insight into the effect and potential influence of media in exception from informed consent trials, yet we recognize the critical need for much more research into these regulatory processes and persons affected by them. Consensus and standardization both within the United States and internationally would simplify procedures for institutional review boards and researchers, as well as improve public trust. To that end, we echo Dr. Kierzek's urging of all researchers conducting exception from informed consent trials to participate in an ongoing dialogue with ethicists and regulatory bodies to develop consistent interpretation of the guidelines and a more standardized national and international approach. As observed by Dr. Kierzek, emergency research with exception from informed consent depends on trust between researchers, medical providers, and patients/families. This trust is important in ensuring an appropriate balance between addressing major public health issues and maintaining the highest ethical standards in protecting human subjects participating in emergency research studies. We hope that growing experiences in emergency research nationally and abroad will allow for a consensus approach to evidence-based regulations that can be consistently implemented regardless of the country in which such research is undertaken. Local Media Influence on Opting Out From an Exception From Informed Consent TrialAnnals of Emergency MedicineVol. 56Issue 3PreviewWe read with interest the paper by Nelson et al on local media influence on opting out from an exception from informed consent.1 According to the authors, researchers make great efforts to inform and consult the community about emergency research and waiver of consent, but without known evidence of effectiveness. These requirements for public disclosure and community consultation are unique to the United States.2 We would like to provide an international perspective on this topic. Full-Text PDF Have We Killed the Golden Hour of Trauma?Annals of Emergency MedicineVol. 57Issue 1PreviewThe study by Newgard et al1 in the March issue of Annals proposed to set the record straight on the “golden hour” of trauma, one of the best-holding dogmas in medicine.2 They measured the association between emergency medical services (EMS) intervals and mortality among 3,656 trauma patients with substantial abnormal vital signs/mental status, transported by 146 EMS agencies to 51 trauma centers across the United States and Canada. They found no correlation. The associated capsule mentioned that “… time may be less crucial than once thought. Full-Text PDF