Abstract TMP5: Social Media Campaign with Traditional Community Consultation for Successful Exception from Informed Consent Approval - the SEGA Trial Experience

Abstract

Introduction/Background: Patients with severe stroke deficits due to large vessel occlusion are unable to provide consent and thus routinely excluded from emergency research participation – breaching the ethical principle of justice. The Food and Drug Administration has issued regulations for Exception from Informed Consent (EFIC) to facilitate research on potentially life-saving interventions in emergencies. We describe our novel approach to EFIC approval for an ongoing randomized trial that compares two anesthetic modalities for endovascular therapy (EVT) – sedation versus general anesthesia – the SEGA trial (Clinicaltrials.gov NCT-03263117). Methods: Partnering with our Institutional Review Board (IRB), we used a multifaceted approach to inform the Houston, Texas metropolitan area about EFIC in SEGA. In addition to in-person community consultations and surveys with focus groups (stroke survivors, advisory councils, etc.), we created a novel social media campaign on Facebook to users ≥ 25 years old within a 50-mile radius from the Texas Medical Center. Advertisements linked to a university-created SEGA trial website that included details on EFIC regulations, trial aims, survey questions, and opt-out procedures. A press release was issued with information about the trial and links to the webpage. Results: Between 6/17-9/17, we held 7 community consultations, placed Facebook ads, and issued a press release with trial information and website. Total of 193 individuals (65% female; average age 46.7 ± 16.6) participated in focus group community consultations. Of the 144 (75%) that completed surveys, 98% agreed to have themselves or a family member enrolled in SEGA under EFIC. Facebook ads had 134,481 views (52% female; 60% ≥ 45 years old) followed by 1,630 clicks to learn more and 1,130 website views (56% regional and 44% national). Users spent an average of 3 minutes and 51 seconds on the webpage. The IRB received zero emails requesting additional information or to opt-out. Conclusion: Our novel community consultation method reached far more potential stroke patients than traditional in-person EFIC focus groups. We propose this method as a standard practice for trials seeking such approval.