Informed Consent for Research: A Survey of Current Practices in Osteopathic Academic Emergency Medicine Departments

Abstract

Background: The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research. Objectives: To identify commonalities and differences in informed consent practices for research employed in academic EDs.Methods: Between July 1, 2006 and June 30, 2007 an on-line survey was sent to the residency directors of thirty seven academic emergency medicine residency training programs identified through the American College of Osteopathic Emergency Physicians (ACOEP). Residency directors had the opportunity to complete the survey on-line or in person at the annual Program Directors meeting in Naples, Florida. Results: Thirty (81%) responded. The average number of simultaneous clinical ED-based research projects reported was 5.7 (95% CI: + 1.52). Over three quarter (77.5%) of respondents reported that emergency medicine (EM) residents are responsible for obtaining consent from research subjects. Eight (26.6%) participating institutions do not require documentation of an individual’s knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from human subjects.Conclusions: It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by human subjects and further study is needed to determine the compliance of this consent process with federal guidelines. * Marcin Kociuba was an emergency medicine resident at the time of data collection. Dr. Arthur Calise served as residency director and his trainer. This work was performed as a joint project between the emergency departments at Yale New Haven Hospital and Saint Michael’s Medical Center. Dr. Monico received the Donaghue Initiative in Biomedical and Behavioral Research Ethics Award for the time period between July 1, 2006 and June 30, 2007. The award made this research possible.