Utilizing social media for community consultation and public disclosure in exception from informed consent trials.

BACKGROUND: The U.S. Food and Drug Administration and Department of Health and Human Services outline regulations allowing an Exception From Informed Consent (EFIC) for research conducted in an emergency settings. Acute care clinical trials utilizing EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials. METHODS: We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC TXA). As part of the CC/PD process, we developed research study advertisements using the social media website Facebook. The Facebook advertisements directed users to a regional study website that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics. RESULTS: During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times, (12 displays per target population) with 374 individuals selected the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15-24 (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement, spent > 3 minutes on the study website [3min - 49 min]. Commonly accessed webpages were "Contact Us" (PROPPR 5.5%, TXA 7.7%), "Study-specific FAQs" (PROPPR 2.4%), ROC-TXA 6.7%) and "Opt-Out of Research" (PROPPR 2.5%, ROC-TXA 3.8%). Of 51 total individuals viewing the opt-out of research information (PROPPR 19, ROC-TXA 32), Time spent on that specific page was modest (PROPPR 62 seconds, ROC-TXA 55 seconds), with no individuals requesting to opt-out of either study participation. CONCLUSION: In clinical trauma trials, using EFIC, social media may provide a viable option for facilitating the CC/PD process. LEVEL OF EVIDENCE: Descriptive Study, Level IV. (C) 2016 Lippincott Williams & Wilkins, Inc.

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