Operational Challenges of EMS-Based Clinical Trials

Description: Conducting clinical research in emergency medical services (EMS) environments presents a unique set of operational, regulatory, and ethical challenges not typically encountered in traditional hospital-based studies. This presentation examines the realities of performing clinical trials in uncontrolled prehospital settings—where high-acuity patients, limited time, environmental variability, and fluctuating levels of consciousness frequently complicate enrollment, data capture, and protocol adherence. Attendees will gain insight into how EMS agencies and research teams can navigate these barriers while ensuring the protection of human subjects and the integrity of research outcomes. This session also reviews the complexities of consent in the field, including exceptions from informed consent (EFIC), community consultation requirements, and special considerations for studies involving patients with impaired decision-making capacity. The presentation highlights strategies for managing documentation challenges, maintaining data accuracy under stress, and optimizing coordination with receiving hospitals to ensure continuity of research follow-up. Finally, the talk will outline Institutional Review Board (IRB) expectations for EMS-based studies, emphasizing compliance with federal regulations, ethical safeguards, and the necessity of operationally realistic protocol design.