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

Abstract

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.

Impact of Social Media on Community Consultation in Exception From Informed Consent Clinical Trials

“…Our findings are similar to those of Stephens et al, who used social media to inform the Birmingham, Alabama community of the PROPPR and TXA trials. 5 The investigators were able to use social media to reach a similar number of people as traditional community meetings but at a lower cost (traditional EFIC $39/person versus social media EFIC $3/person). It is unclear how costs were calculated in that study, but the large reduction in costs when incorporating social media is consistent with our findings.…”

“…In an effort to address this burden, the investigative team and university IRB developed a pilot hybrid EFIC model by combining traditional community consultation meetings with modern means of communicationesocial media. 4,5 This hybrid model was created with the dual goals of increasing the ability to reach more potential patients than community meetings allow and decreasing the cost of obtaining EFIC. This hybrid model was then used to obtain EFIC for an ongoing, comparative effectiveness clinical trial on damage control laparotomy (ClinicalTrials.gov NCT02706041).…”

A Novel Emergency Department‐based Community Notification Method for Clinical Research Without Consent

“…Additional possible and creative approaches to public disclosure might include the use of social media to disseminate information regarding EFIC research. The use of computer message boards and chat groups to facilitate community notification and public disclosure has not, to our knowledge, been extensively explored . These methods may be criticized as targeting younger, tech‐savvy community members, but employed as an arm of a comprehensive public disclosure effort, might provide the two‐way information exchange necessary for effective community consultation.…”

Getting Started: A Social Media Primer

“…Social media has also been used for obtaining exception from informed consent (EFIC) for trials that could not be conducted without such a waiver. 43,44 However, there is limited published experience with using social media to obtain EFIC. 43,45 One study reported using Facebook for obtaining EFIC at their institution for a multicenter trauma resuscitation trial.…”

“…43,45 One study reported using Facebook for obtaining EFIC at their institution for a multicenter trauma resuscitation trial. 44 Moving forward, strategies for identifying and reaching the appropriate target audience and for measuring success are needed. 46…”