Monico Edward, Larkin Gregory Luke, Degutis Linda
Section of Emergency Medicine, Department of Surgery, Yale University, New Haven, CT, USA.
Acad Emerg Med. 2008 Jun;15(6):573-6. doi: 10.1111/j.1553-2712.2008.00098.x.
The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research.
The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs.
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).
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.
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.
急诊科环境给研究获得知情同意的过程带来了独特障碍。
目的是确定学术性急诊科研究中知情同意实践的异同。
在2006年7月1日至2007年6月30日期间，向通过毕业后医学教育认证委员会（ACGME）确定的142个学术性急诊医学（EM）住院医师培训项目的研究主任发送了在线调查问卷。
71人（50%）回复。报告的同时进行的基于急诊科临床研究项目的平均数量为7.3个（95%置信区间[CI]=5.53至9.07）。近一半（49.3%）的受访者报告称，EM住院医师负责获取同意。29个（41.4%）参与机构在允许住院医师从研究对象处获取同意之前，不要求记录其对特定研究方案和同意程序的了解情况。
在学术性急诊科，临床研究人员依靠值班医护人员从潜在研究对象处获取研究知情同意是常见做法。这种做法引发了关于研究对象所获信息充分性的问题，需要进一步研究以确定这种同意程序是否符合联邦指导方针。
