Case Western Reserve University, School of Nursing, 19000 Euclid Ave, Cleveland, OH 44106, USA.
J Med Ethics. 2011 Feb;37(2):118-22. doi: 10.1136/jme.2010.037226. Epub 2010 Nov 11.
Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results.
保护人类参与者是生物医学研究的一个基本方面。我们报告了一项卫生服务研究的活动，其中有三个机构审查委员会（IRB）、三个法律部门和一个研究管理部门提供建议，并要求更改研究方法。遵守 IRB 的要求可能具有挑战性，但也可能对研究结果产生不利影响。多个 IRB 强制要求的多项方案变更导致研究方法无法反映在临床环境中进行药物使用筛查的方式。IRB 对参与者保护的看法与研究人员需要使用确保研究结果临床相关性的研究方法之间存在直接冲突。
