将机构审查委员会之间差异的原因归结为社区差异的误区。
The Myth of Community Differences as the Cause of Variations Among IRBs.
作者信息
Klitzman Robert
机构信息
Columbia University.
出版信息
AJOB Prim Res. 2011;2(2):24-33. doi: 10.1080/21507716.2011.601284.
BACKGROUND
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.
背景
尽管机构审查委员会（IRB）之间的差异已有30年的记录，但这些差异仍在持续，引发了关于它们为何持续存在以及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。联系了60个美国IRB的负责人（按美国国立卫生研究院资助排名前240的机构名单中的每第四个）。其中34个机构的IRB负责人接受了访谈（回复率=55%）。
结果
受访者表示，差异往往持续存在是因为IRB认为这些差异是合理的，而且法规允许因“社区价值观”不同而存在差异。然而，这些差异似乎更多地源于机构和主观性格因素的不同，以及有“更多双眼睛”审查方案、试图预见所有潜在的未来后勤问题，而不是源于研究参与者所来自社区的价值观。然而，IRB通常似乎为这些差异辩护，称其反映了社区规范的潜在差异。
结论
这些数据对政策和实践提出了关键问题。IRB、主要研究者（PI）、政策制定者及其他人员需要在态度上做出改变并接受教育，同时需要开展有关这些问题的研究。
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