The Myth of Community Differences as the Cause of Variations Among IRBs.
The Myth of Community Differences as the Cause of Variations Among IRBs.
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DOI：
10.1080/21507716.2011.601284
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发表时间：
2011
期刊：
影响因子：
--
通讯作者：
Klitzman R
中科院分区：
文献类型：
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作者：
Klitzman R
尽管机构审查委员会(IRBs)之间的差异已有30年的记录，但它们仍在继续，这就提出了关键问题，即它们为什么持续存在，以及IRBs如何看待和应对这些差异。对46名IRB主席、管理人员和成员进行了长达2小时的深入访谈。我们联系了60家美国IRBs的领导层(在NIH资助的前240家机构中，每四家就有一家)。采访了其中34家机构的IRB领导人(回复率=55%)。受访者表示，分歧经常存在，因为IRBs认为这些是合法的，而法规允许因不同的“社区价值观”而存在差异。然而，这些差异往往似乎更多地源于制度和主观人格因素的差异，以及试图预见所有潜在的未来后勤问题的“更多眼睛”审查方案，而不是来自研究参与者所在社区的价值观。然而，IRBs通常似乎为这些差异辩护，认为它们反映了社区规范的根本差异。这些数据对政策和实践提出了关键问题。需要在IRBs、首席调查员(PI)、政策制定者和其他人中进行态度转变和教育，并进行有关这些问题的研究。
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. 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%). 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. 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.