Preliminary Experience With Social Media for Community Consultation and Public Disclosure in Exception From Informed Consent Trials

Abstract

Each year in the United States, >300 000 individuals suffer cardiopulmonary arrest and >2 000 000 suffer a serious traumatic injury requiring hospitalization.1,2 Clinical advances in these fields have been limited because of the paucity of scientific evidence guiding resuscitation practices. Prospective clinical trials are important for advancing the knowledge base in these areas, but because of the emergent nature of these conditions and the inability of critically ill subjects to provide informed consent, investigators must often conduct clinical trials of cardiac arrest and trauma under federal regulations for Exception From Informed Consent (EFIC).3 Editorial see p 206 The US Department of Health and Human Services and the Food and Drug Administration have issued guidelines for the execution of clinical studies using the EFIC process.3 One of the key steps for EFIC research is community consultation and public disclosure (CC/PD), a process that connotes consultation between the investigative team, the appropriate institutional review boards, representatives of the communities where the research will be conducted, and communities likely to have the condition. However, the regulations provide little guidance on how to accomplish these key goals. Although traditional methods for CC/PD include public meetings and telephone-based surveys, the ability of these modalities to access the target populations, to effectively deliver information, and to elicit useful feedback remains unclear.4 Internet-based social media has emerged as a popular and powerful new modality for communication internationally. The objective of this study was to describe our preliminary experience using social media to facilitate the CC/PD process for cardiopulmonary arrest and trauma trials using EFIC. ### Study Design The activities for this study, including the use of social media for CC/PD, were approved by the Institutional Review Board of the University of Alabama at Birmingham. We devised a social media interface to facilitate the CC/PD process for …