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the current NIH organizational structure, which is disease centered (5). More than any other area of concern, regulatory barriers are often cited as a substantial barrier to overcome in the conduct of emergency care research. There are specific regulatory statutes that govern research in emergency settings (6, 7). The application of these regulations (waiver of informed consent and emergency exception from informed consent for research under special emergency circumstances) to a given research protocol can be resource and labor intensive. Many local institutional review boards do not have experience with these regulations and, in some cases, local state laws may preempt their use (5). In addition, the Federal Wide Assurance (FWA) program may discourage nonresearch entities such as EMS agencies or community hospitals from participating in NIH-funded research; both are often integral parts of the emergency care system (5). Emergency patients are uniquely vulnerable to a loss of autonomy in the research process by virtue of being acutely ill or injured, physiologically unstable, emotionally unstable, or economically or socially disadvantaged. All of these conditions may be magnified because of the need for unscheduled care. The informed consent process in the emergency setting must be designed to accommodate vulnerable patients — those with diminished capacity — who may in some cases be the majority of eligible patients for an emergency care research study. Informed consent under these circumstances raises many questions such as who makes the determination of vulnerability or is there a role for surrogate consent? This is often a gray area with little to no regulatory guidance but it is extremely important to include such patients in research studies. Examples of conditions that are associated with increased vulnerability and reduced capacity are traumatic brain injury, long bone fractures with pain, respiratory distress, and any risk for impending physiological deterioration (sepsis, multisystem trauma, acute myocardial infarction, cardiac dysrhythmia). The broad diversity of ED patient populations contributes to the challenges of recruitment into research protocols. Glickman found that most eligible patients who were able to provide consent participated in emergency care research at about a 70% rate overall, which compared favorably to rates reported for other outpatient clinical settings, for both noninterventional and interventional studies (8). However, there were a number of significant challenges identified that resulted in an inability to enroll a number of otherwise eligible patients, particularly among pediatric, geriatric, and minority patient populations. Pediatric and geriatric patients had the lowest enrollment rates. Unique challenges in the consent process exist for each of these age groups and include issues like altered mental status, the lack of availability of legal surrogates for consent, and parental permission requirements for dual-parent consent depending on risk level and assent from the child (8). Previous research has also demonstrated underrepresentation of minorities in clinical research, although the reasons for higher rates of refusal among blacks and other groups in these studies are poorly understood and likely multifactorial. There are issues related to trust of health care providers and experience with research in general. Academic urban EDs see a disproportionate number of underrepresented minority patients and disparities in enrollment may have important implications for the interpretation and generalizability of clinical trial results. Local institutional review boards often have extensive requirements for enrollment of non–English-speaking patients including foreign-language and back-translation of consent documents and research protocols and on-site Spanish-speaking personnel for informed consent discussions, both of which are costly and resource intensive. Sponsors may be unwilling or unable to provide funding for such research-related activities (8). CHAPTER 4 — KEY ISSUES IN EMERGENCY CARE RESEARCH 23 OPPORTUNITIES AND FUTURE DIRECTIONS Recognition of the unique challenges of emergency care research is the first step in ensuring continued vital emergency care research activity, and it is critical that emergency care researchers work with sponsors, institutional review boards, emergency medicine colleagues, and other health care providers to educate them about these unique challenges in an attempt to develop creative solutions. Solutions for overcoming barriers are driven by the same unique attributes of the emergency setting. EDs are gateways, the patients are often unknown, their problems are urgent, and contact with the emergency service is brief or episodic. This poses unique problems for identification, consent, and tracking of research subjects that can be enhanced by the development of a research infrastructure that provides tools and innovative strategies. For example, the incorporation of innovative informatics technologies can identify patients across sites from multiple EDs and can boost screening and enrollment procedures. Collaborative research networks can leverage patient cohorts, financial resources, and share data (4). It is unusual for a single institution to be able to recruit sufficient numbers of eligible patients to definitively 

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