Feldman James A, Rebholz Casey M
Boston Medical Center, One Boston Medical Center Place, Department of Emergency Medicine, Boston, MA 02118, USA.
J Empir Res Hum Res Ethics. 2009 Mar;4(1):63-9. doi: 10.1525/jer.2009.4.1.63.
EVALUATING THE EFFECTIVENESS OF A Reserch Ethics Committee or Institutional Review Board (IRB) continues to be a difficult task. There are limited data that examine the perceptions of members of IRBs about their own performance or methods that would allow comparison among IRB panels at a single institution or between institutions. We piloted an anonymous survey instrument that examined members' attitudes about the efficiency, procedures and outcomes of IRB meetings and developed a process for presentation and discussion of these results with panel members. This quality improvement process was initially completed with one panel, and then replicated with two other IRB panels at one institution. This allowed comparison of perceived IRB performance across panels at a single institution. Further research is required to determine the association between IRB members' perception of performance and other measures of IRB effectiveness and to examine the perceived performance of IRBs by other research stakeholders.
评估研究伦理委员会或机构审查委员会(IRB)的有效性仍然是一项艰巨的任务。用于考察IRB成员对自身表现看法的数据有限,也缺乏能在单一机构内或不同机构的IRB小组之间进行比较的方法。我们试用了一种匿名调查工具,该工具考察成员对IRB会议效率、程序和结果的态度,并制定了一个向小组成员展示和讨论这些结果的流程。这一质量改进过程最初在一个小组完成,然后在同一机构的另外两个IRB小组中重复进行。这使得能够在单一机构内比较各小组对IRB表现的认知。还需要进一步研究以确定IRB成员对表现的认知与IRB有效性的其他衡量指标之间的关联,并考察其他研究利益相关者对IRB表现的认知。