"Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.
"Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.
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DOI：
10.1371/journal.pone.0022796
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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：
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作者：
Klitzman R
研究中的利益冲突（COIs）越来越受到人们的关注，但关于机构审查委员会（irb）如何看待和处理这些冲突，出现了许多问题。我对46位美国IRB主席、管理人员和成员进行了2小时的深入访谈，探讨了COI和其他与研究诚信相关的问题。我联系了60个IRB的负责人（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负责人（回复率为55%）。数据分析采用标准的定性方法，以扎根理论为依据。irb面对pi、机构和irb本身的金融和非金融coi。IRB成员可能寻求帮助，或与主要研究者（pi）竞争。非财务COI也经常表现为“间接财务”冲突，其基础不是对自己的收益（或损失），而是对同事或更大的机构的收益（或损失）。irb面临着识别和管理这些COI的挑战，并且经常觉得它们可以更有效。irb对其潜在COI的管理各不相同，有冲突的成员可能会在讨论中观察、参与和/或投票。个人内部审查委员会成员经常自行判断是否回避。在解决这些问题时出现了挑战，因为机构和pi需要资金，财务信息被认为是机密的，而COI可能是无意识的。本研究首次定性地探讨了irb如何面对coi，并探讨了irb如何面对非金融coi，研究表明，irb面临几种类型的金融和非金融coi，涉及他们自己、pi和机构，并做出了不同的反应。这些数据对实践和政策具有重要意义。向受试者披露间接和非财务coi可能不可行，部分原因是irb而非pi存在冲突。在协议审查中，IRB成员应该在何时以及如何回避参与、观察和/或投票，需要考虑指导方针和澄清。
Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be “indirect financial” conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves from participating, observing, and/or voting.