Effective Community Consultation for Prehospital EFIC Research: Lessons from a 20-Site Pediatric Trial.

objectivesResearch in the prehospital setting is frequently conducted with federal Exception from Informed Consent (EFIC). An EFIC requires community consultation (CC) and public disclosure (PD) to inform community members about research plans and create opportunities for community feedback and study modification prior to approval. There is limited research on the relative effectiveness of varying CC and PD strategies, particularly with increasing utilization of social media. We sought to characterize the frequency of use and reach of specific CC/PD strategies in the Pediatric Dose Optimization for Seizure in EMS (PediDOSE) trial, assess their relative effectiveness, and offer guidance to future EFIC studies on optimal strategies and potential pitfalls in conducting CC/PD.

methodsWe completed a retrospective review of the CC/PD plans and summary reports from all 20 sites in the PediDOSE trial. We used descriptive statistics to determine the frequency and reported reach of specific CC/PD strategies. We also described sites' modifications of their initial CC/PD plans.

resultsAll sites completed the required CC/PD activities, which began in October 2021. Sites conducted 52 CC meetings; meeting with community groups had the lowest attendance (median 9, IQR 2-11) and were the most frequently canceled. Most sites (16/20) utilized social media for CC/PD; however, only 4 sites use paid social media advertisements. Paid advertising had greater reach on Facebook than posts to existing institutional followers (median reach 13992 paid vs 2504 free) at reasonable cost. All sites created PD materials and conducted CC surveys in Spanish; a majority of sites (11/20) reported actively recruiting minoritized populations for inclusion in CC/PD activities with variable success.

conclusionsBased on our experience we recommend the following: EFIC studies should utilized paid social media for PD. Studies should establish standardized metrics for success of social media campaigns before beginning CC/PD activities. community meetings for CC should be conducted with inclusion of all relevant stakeholder groups, and sites should consider using social media to augment CC activities. Investigators of EFIC studies involving children should develop explicit plans to engage children and minoritized populations in CC/PD.