Ethical considerations for conducting a randomized controlled trial in transport.

Although recent studies support the rapid transfer of patients experiencing time-sensitive emergencies, limited data exist to support the use of air transport for nonurgent patient transfers. The nature of medical transport and the heterogeneity of patients who are transferred present unique challenges in designing and conducting clinical research trials that could contribute to the evidence-based decision making for patient care and transport. The current regulatory framework presents several barriers to conducting such research in the medical transport setting. We present a hypothetic study that randomizes patients to either ground or air transport as an exemplar. We discuss informed consent, risk, and the impracticality of conducting community consultations in a medical transport setting. Finally, recommendations for potential changes to current regulations are presented. These are directed at facilitating the conduct of emergency research through a system of oversight that integrates characteristics of quality improvement and health services research.