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answer a critical research question and patient populations, and disease prevalence varies with the regional, urban, and socioeconomic mix of patients that use a particular ED. The results of single-site research protocols are often not completely applicable to other emergency care settings. Multidisciplinary or multisite emergency care research networks can enable the conduct of valid, adequately powered, and generalizable emergency care research. Some successful ED research programs have developed and implemented comprehensive screening programs using research assistants and are inexpensive and offer credit or reallife experience in exchange for their assistance (9). Such programs can be very effective but often require significant efforts on the part of the investigators for study orientation and training and even small incentives and rewards for staff. Having a research workforce that is separate from those providing clinical care has the advantage of clear division of duties. Clinical personnel are often supportive of research but want help and do not want to collect data and perform measurements for researchers while trying to simultaneously provide high-quality, safe, and efficient care in the ED. Regulatory barriers present in emergency care research are difficult to overcome and require a great deal of experience and effort. This should not discourage young investigators but rather encourage them to seek advice and support from more experienced investigators and from their institutional research officers and IRB members. A well-thought-out plan and preemptive conversation in advance of submitting a research protocol can save a lot of time and effort and multiple rounds of protocol review and resubmission. The literature contains many studies on informed consent in the emergency setting including studies that have operated under federal regulations that allow investigators to forego prospective informed consent under special emergency circumstances. Emergency care researchers are advised to carefully review these regulations and speak with experienced investigators prior to going forward with a proposed study that they believe meets these criteria. Modified informed consent under emergency circumstances has also been proposed as a better mechanism to address literacy and other issues that arise around informed consent. It is important to realize that these strategies need further study and may be rejected by local regulatory and legal communities. Creating a culture of multidisciplinary collaboration and forming novel interdisciplinary relationships are necessary steps for the successful planning and execution of an emergency care research protocol. All participating investigators must acknowledge the importance of time-sensitive disease physiology and interventions that fall outside traditional, specialtyspecific silos. Emergency care researchers should strive to educate colleagues on these 24 CHAPTER 4 — KEY ISSUES IN EMERGENCY CARE RESEARCH specifics because their buy-in is critical. Historically, many ED-based studies are designed so that the analysis is limited to short-term outcomes such as physiological surrogate endpoints, resource endpoints such as discharge rates, or, at most, in-hospital mortality (3). Studies and networks that collect clinical and economic outcomes data that demonstrate longer-term gains in health from emergency care interventions are likely to have greater impact and to advance the field. To obtain these kinds of outcome data, there must be effective data linkages, starting with out-of-hospital care, continuing through the ED phase of care, extending through hospitalization, and incorporating outpatient assessments of outcome status (3). As cost-effectiveness research becomes more important, emergency care researchers will be required to demonstrate improvements in long-term disease morbidity, hospital readmission, downstream diagnostic testing, and overall health care resource utilization (3). Flexibility and adaptability are important traits of the successful emergency care research investigator. The dynamic, highly stressful environment of the ED make it extremely challenging to consistently perform high-quality research. Emergency care investigators who are committed to continuous improvement of the processes of screening, enrollment, informed consent, protocol adherence, meticulous data collection, and data sharing as well as collaboration and hard work will be rewarded with the satisfaction of conducting research under some of the most challenging conditions and with the knowledge that they have made a substantial impact on the future care of emergency patients. REFERENCES 1. Koroshetz WJ, NIH Task Force on Research in the Emergency Setting. NIH and research in the emergency setting: progress, promise, and process. Ann Emerg Med. 2010;56(5):565-567. 2. Neumar RW. The Zerhouni challenge: defining the fundamental hypothesis of emergency care research. Ann Emerg Med. 2007;49(5):696-697. 3. Courtney DM, Neumar RW, Vekatesth AK, et al. Unique characteristics of emergency care research: scope, populations, and infrastructure. Acad Emerg Med. 2009;16:990-994. 4. D’Onofrio G, Jauch E, Jagoda A, et al. NIH Roundtable on Opportunities to Advance Research on Neurologic and Psychiatric 

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