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Informed Consent for Research
Calise, Arthur Monico, Edward Kociuba, Marcin Calabro, Joseph
Calise, Arthur
Monico, Edward
Kociuba, Marcin
Calabro, Joseph
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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.
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2009
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With permission of the license/copyright holder