The Community Engagement, Bioethics, and Outreach (CEBO) Core focuses on expanding the inclusion of rural populations in acute care research projects requiring urgent initiation of therapy. In a rural state such as Maine, urban regions concentrate academic medical resources into a few locations that may be many hours from rural communities and regional hospitals. Patients outside these urban centers are at a significant disadvantage regarding access to tertiary-level care and participation in medical research. Contributing factors to this disparity include lack of awareness of ongoing research, geographic and transportation barriers, lower numbers of eligible participants, and few clinician researchers. These challenges are pronounced for time- pressured research for life-altering medical problems such as stroke, cardiac arrest, and neonatal asphyxiation. Ensuring appropriate human subject protection and enhancing rural enrollment requires informed and experienced researchers, but these essential resources are limited in our urban centers, and critically lacking in our rural healthcare environment. Patients with these acute conditions are often not awake or medically stable enough to provide informed consent, and it is often too late to enroll them hours later when legally authorized representatives arrive at receiving tertiary care centers. To address these challenges, the Department of Health and Human Services developed the Exception From Informed Consent (EFIC) pathway, allowing research to proceed without consent under strict conditions, including robust community consultation and public disclosure prior to initiating the study. Little research has addressed the implications of rurality on EFIC - it is not known whether EFIC is as effective for rural communities as for urban settings, whether EFIC increases recruitment from rural areas, and whether rural patients prefer EFIC or emerging options such as remote teleconsent. The CEBO Core will address these issues to support the COBRE Project Leaders pursuing acute care research in rural and urban settings across Maine. The core will: 1) Provide direct assistance to COBRE Project Leaders in recruitment strategies, consent processes, and document preparation for IRB submission; 2) Engage rural community members (patients, clinicians and other stakeholders) to better understand their perspectives, preferences, and barriers to participation in research requiring urgent treatment, and the ethical tradeoffs associated with different approaches to enrollment; and 3) Enhance research training, regulatory compliance, and proper research conduct among COBRE Project Leaders, early career researchers and mentors at Maine Medical Center, and emerging clinical researchers at rural sites engaged in these COBRE projects by developing research networks and associated educational programs to support expanded acute care clinical research.
