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The Myth of Community Differences as the Cause of Variations Among IRBs

机译:社区差异的神话是内部评级法之间差异的原因

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Although variations among institutional review boards (IRBs) have been documented for 30 years, they continue, raising crucial questions as to why they persist as well as how IRBs view and respond to these variations. Methods: In-depth, 2-hour interviews were conducted with 46 IRB chairs, administrators, and members. The leadership of 60 U.S. IRBs were contacted (every fourth one in the list of the top 240 institutions by NIH funding). IRB leaders from 34 of these institutions were interviewed (response rate = 55%). Results: The interviewees suggest that differences often persist because IRBs think these are legitimate, and regulations permit variations due to differing “community values.” Yet, these variations frequently appear to stem more from differences in institutional and subjective personality factors, and from “more eyes” examining protocols, trying to foresee all potential future logistical problems, than from the values of the communities from which research participants are drawn. However, IRBs generally appear to defend these variations as reflecting underlying differences in community norms. Conclusions: These data pose critical questions for policy and practice. Attitudinal changes and education among IRBs, principal investigators (PIs), policymakers, and others and research concerning these issues are needed.
机译:尽管机构审查委员会(IRB)之间的差异已有30年的记录,但它们仍在继续,这引发了关于其为何持续存在以及IRB如何看待和应对这些差异的关键问题。方法:对46名IRB主席,管理人员和成员进行了为期2小时的深入访谈。已与60个美国IRB的领导进行了联系(在NIH资助的前240个机构中,排名第四的是第四位)。来自这些机构中34个机构的IRB领导进行了访谈(回复率= 55%)。结果:受访者认为差异经常会持续存在,因为IRB认为差异是合法的,并且法规允许因“社区价值”不同而有所差异。然而,这些变化通常似乎更多地是由于制度和主观人格因素的差异,以及试图预见所有未来可能存在的后勤问题的“更多的眼睛”检查协议,而不是源自研究参与者所处社区的价值。但是,IRB通常似乎可以捍卫这些差异,因为它们反映了社区规范中的根本差异。结论:这些数据为政策和实践提出了关键问题。内部评级委员会,主要研究人员(PIs),政策制定者等之间的态度变化和教育,以及有关这些问题的研究是必要的。

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