ABSTRACT
The complexity of the care environment, the emergent nature, and the severity of patient injury make conducting clinical trauma research challenging. These challenges hamper the ability to investigate potentially life-saving research that aims to deliver pharmacotherapeutics, test medical devices, and develop technologies that may improve patient survival and recovery. Regulations intended to protect research subjects impede scientific advancements needed to treat the critically ill and injured and balancing these regulatory priorities is challenging in the acute setting. This scoping review attempted to systematically identify what regulations are challenging in conducting trauma and emergency research. A systematic search of PubMed was performed to identify studies published between 2007 and 2020, from which 289 articles that address regulatory challenges in conducting research in emergency settings were included. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Most articles identified were editorial/commentary (31%) and published in the USA (49%). Regulatory factors addressed in the papers were categorized under 15 regulatory challenge areas: informed consent (78%), research ethics (65%), institutional review board (55%), human subjects protection (54%), enrollment (53%), exception from informed consent (51%), legally authorized representative (50%), patient safety (41%), community consultation (40%), waiver of informed consent (40%), recruitment challenges (39%), patient perception (30%), liability (15%), participant incentives (13%), and common rule (11%). We identified several regulatory barriers to conducting trauma and emergency research. This summary will support the development of best practices for investigators and funding agencies.
ABSTRACT
BACKGROUND: In its 2016 report on trauma care, the National Academies of Sciences, Engineering, and Medicine called for the establishment of a National Trauma Research Action Plan to strengthen and guide future trauma research. To address this recommendation, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care. We describe the gap analysis and high priority research questions generated from the National Trauma Research Action Plan panel on injury prevention. METHODS: Experts in injury prevention research were recruited to identify current gaps in injury prevention research, generate research questions and establish the priority of these questions using a consensus-driven Delphi survey approach from December 2019 through September 2020. Participants were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability with both military and civilian representatives. Participants were encouraged, but not required, to use a Patient/Population, Intervention, Comparison, and Outcome format to generate research questions: Patient/Population; Intervention; Compare/Control; Outcome model. On subsequent surveys, participants were asked to rank the priority of each research question on a nine-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as 60% or greater of panelists agreeing on the priority category. RESULTS: Twenty-eight subject matter experts generated 394 questions in 12 topic areas. By round 3 of the Delphi, 367 (93.1%) questions reached consensus, of which 169 (46.1%) were determined to be high priority, 196 (53.4%) medium priority, and 2 (0.5%) low priority. Among the 169 high priority questions, suicide (29.6%), firearm violence (20.1%), and violence prevention (18.3%) were the most prevalent topic areas. CONCLUSION: This Delphi gap analysis of injury prevention research identified 169 high priority research questions that will help guide investigators in future injury prevention research. Funding agencies and researchers should consider these gaps when they prioritize future research. LEVEL OF EVIDENCE: Therepeutic/Care Management; Level IV.