Kim D T, Spivey W H
Department of Emergency Medicine, Medical College of Pennsylvania, Philadelphia.
Ann Emerg Med. 1994 Jan;23(1):70-4. doi: 10.1016/s0196-0644(94)70011-7.
To assess the frequency of institutional review board (IRB) review and informed consent in emergency medical services (EMS) research.
Two-year, retrospective review of published EMS research.
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.
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.
评估机构审查委员会(IRB)审查以及在紧急医疗服务(EMS)研究中知情同意的频率。
对已发表的EMS研究进行为期两年的回顾性审查。
分析了102项研究。71项(70%)可免于IRB审查;31项(30%)不可豁免。17项不可豁免的研究(55%)未获得IRB审查。其中8项未明确说明同意方法;1项采用默示同意,8项采用志愿者方式。在1项研究中志愿者给予了知情同意。在14项获得IRB批准的不可豁免研究中,7项未明确说明同意方法。2项采用知情同意,1项获得知情同意豁免,1项采用口头同意,3项涉及志愿者。当志愿者为未成年人时,曾有1次使用了书面家长许可。
EMS研究人员常常省略IRB审查。这引发了对EMS研究的伦理担忧。研究人员应在其稿件中记录他们的同意方法或使用知情同意豁免的批准情况。应为志愿者明确规定同意方法。