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Informed Consent for Research: Current Practices in Academic Emergency Medicine
Authors:Edward Monico  MD  JD    Gregory Luke Larkin  MD  MS  MSPH    Linda Degutis  DrPH
Institution:From the Section of Emergency Medicine, Department of Surgery (EM, GLL, LD), and the Yale Center for Public Health Preparedness (LD), Yale University, New Haven, CT.
Abstract:Background:  The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research.
Objectives:  The objective was 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 online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME).
Results:  Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research 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 research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines.
Keywords:informed consent  emergency medicine research  disclosure  consent procedures
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