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A retrospective analysis of institutional review board and informed consent practices in EMS research
1Department of Emergency Medicine, Medical College of Pennsylvania, Philadelphia.
Study Objective:
To assess the frequency of institutional review board (IRB) review and informed consent in emergency medical services (EMS) research.
Design:
Two-year, retrospective review of published EMS research.
Measurements And Main Results:
One hundred two studies were analyzed. Seventy-one (70%) were exempt from IRB review; 31 (30%) were not exempt. Seventeen nonexempt studies (55%) did not obtain IRB review. Eight of these did not specify a consent method; one used implied consent and eight used volunteers. Volunteers gave informed consent in one study. Of the 14 nonexempt studies with IRB approval, seven did not specify a consent method. Two used informed consent, one received an informed consent waiver, one used verbal consent, and three involved volunteers. Written parent permission was used once when volunteers were minors.
Conclusion:
IRB review is often omitted by EMS investigators. This raises ethical concerns about EMS research. Investigators should document their consent method or approval to use an informed consent waiver in their manuscripts. A consent method should be specified for volunteers.