J. M. Podbielski1, E. E. Fox1, J. B. Holcomb1, J. A. Harvin1, C. E. Wade1 1McGovern Medical School at UTHealth,Surgery/McGovern Medical School,Houston, TX, USA
Introduction: Clinical trials in trauma often require the use of exception from informed consent (EFIC). Despite federal regulations for emergency research under EFIC existing for 20 years, there is little information about EFIC best practices in the literature. In our extensive experience coordinating multicenter randomized trials in trauma populations, EFIC requirements regarding community consultation and public disclosure and the interpretation of the requirements by local institutional review boards (IRB) vary widely. This analysis describes the variation in community consultation and public disclosure activities in one multicenter trial.
Methods: 12 North American Level 1 trauma centers participated in the Pragmatic, Randomized Optimal Platelet and Plasma Ratios Trial (PROPPR) utilizing the EFIC process. The sites were required to conduct community consultation and public disclosure based on their local IRB requirements. The clinical coordinating center provided templates for a power point presentation for in-person meetings, script for telephone surveys and a press release to all sites to revise as needed for their site-specific IRB requirements. All results were reviewed by the local IRBs and HRPO prior to final approval to begin enrollment.
Results:67% of the responding centers’ local IRBs required more than one method to complete the community consultation process. The number of methods required ranged from 2 to “as many as possible” with an average of 4. Methods included in-person meetings, telephone surveys, social media (Facebook and/or Twitter), presentations at community events (festivals, health fairs), radio and TV interviews, advertising, articles, websites, and flyers or advertisement in public areas (buses, subways, schools, fitness centers). The most frequently used method was printed media formats (75%) followed by in-person meetings (67%), and advertisements and websites (58% each). 50% utilized social media and telephone surveys. The average time from initiation of community consultation to final approval after community consultation was completed was 116 days with a range from 62 to 204 days. Costs ranged from $0 to $30,000 with a mean of $10,600, not including personnel effort. The research coordinators concluded that social media and booths/presentations at community events are the most effective way to reach a larger percentage of the general population.
Conclusion:High levels of variation in community consultation/public disclosure methods and costs related to EFIC exist among institutions participating in a multicenter trial. Providing information to as many people as possible is essential therefore using multiple methods of notification can expedite the process and possibly reduce cost and effort.