The ethics police?: IRBs' views concerning their power.
The ethics police?: IRBs' views concerning their power.
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DOI：
10.1371/journal.pone.0028773
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Klitzman R
中科院分区：
文献类型：
--
作者：
Klitzman R
近年来，irb和主要研究者（pi）之间的紧张关系已经上升，需要了解这些冲突，它们的潜在原因，以及可能的解决方案。研究人员经常抱怨irb，但irb如何看待和回应这些批评尚不清楚。我对46位主席、管理人员和会员进行了深入的、半结构化的采访，每次采访两小时。我联系了全国60个IRB的领导（NIH资助的前240个机构中每四分之一），并采访了其中34个机构的IRB领导（回复率= 55%）。受访者认为，内部审查委员会和私人机构对这些冲突的性质和原因的看法可能非常不同，相互误解，加剧了紧张局势。受访者经常认识到，他们被pi视为拥有权力，但许多内部审查委员会认为自己没有权力（例如，因为他们“只是遵循规定”，他们的过程是“开放的”，非个人的和公正的，他们自己受制于更高的行政机构），或者拥有权力，但感觉它很小，和/或合理（例如，因为它基于首要目标和“社区价值”，内部审查委员会试图帮助pi）。关于irb是否有或应该有权力的问题出现了，如果有，是什么样的，多少，什么时候。有几个因素可能影响这些紧张关系。本研究首次探讨了内部人如何感知和理解与pi之间的冲突和权力关系，表明内部人和pi在看待各自的角色和关系方面可能存在差异，从而加剧了紧张关系。这些问题对内部审查委员会和个人利益相关者有重要的影响——提高他们对这些冲突的认识和理解（例如，内部审查委员会可能拥有自由决定权）以及所涉及的潜在原因，并增加对有关内部审查委员会功能和与个人利益相关者互动的这些领域的研究、实践和政策的关注。
In recent years, tensions between IRBs and principal investigators (PIs) have risen, posing the needs to understand these conflicts, their underlying causes, and possible solutions. Researchers frequently complain about IRBs, but how IRBs perceive and respond to these criticisms is unclear. I conducted in-depth, semi-structured interviews of two hours each with 46 chairs, administrators, and members. I contacted the leadership of 60 IRBs around the country (every fourth one in the list of the top 240 institutions by NIH funding) and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Interviewees suggest that IRBs and PIs may view the nature and causes of these conflicts very differently and misunderstand each other, exacerbating tensions. Interviewees often recognized that they were seen by PIs as having power, but many IRBs saw themselves as not having it (e.g., because they are “merely following the regulations,” and their process is “open,” impersonal and unbiased, and they are themselves subject to higher administrative agencies), or as having it, but feeling it is small, and/or justified (e.g., because it is based on overriding goals and “the community values,” and IRBs are trying to help PIs). Questions emerge as to whether IRBs do or should have power, and if so, what kind, how much, and when. Several factors may affect these tensions. This study, the first to explore how IRBs perceive and understand conflicts and power relationships with PIs, suggests how IRBs and PIs may differ in viewing their respective roles and relationships, exacerbating tensions. These issues have critical implications for IRBs and PIs—to enhance their awareness and understanding of these conflicts (e.g., that IRBs may have discretionary power) and the underlying causes involved, and for increasing attention to research, practice, and policy concerning these areas of IRB functioning and interactions with PIs.
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影响因子：
4.1
作者：
Ahmed, AH;Nicholson, KG
通讯作者：
Nicholson, KG
影响因子：
3
作者：
Burris, Scott
通讯作者：
Burris, Scott
影响因子：
2
作者：
Keith-Spiegel, P;Koocher, GP
通讯作者：
Koocher, GP
影响因子：
1.8
作者：
SMITH, DA;VISHER, CA;DAVIDSON, LA
通讯作者：
DAVIDSON, LA
影响因子：
2.7
作者：
Klitzman R
通讯作者：
Klitzman R