From anonymity to "open doors": IRB responses to tensions with researchers.
From anonymity to "open doors": IRB responses to tensions with researchers.
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DOI：
10.1186/1756-0500-5-347
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发表时间：
2012-07-03
影响因子：
1.8
通讯作者：
Klitzman R
中科院分区：
文献类型：
--
作者：
Klitzman R
美国和其他地方的IRB与研究人员之间的紧张关系有所加剧，并可能影响研究人员是否、如何以及在何种程度上遵守道德准则。然而，IRB 是否、如何、何时以及为何应对这些冲突却很少受到系统性关注。我联系了 60 个美国 IRB（NIH 资助的 240 家机构中的四分之一），并采访了 34 个机构的领导（回复率 = 55%）以及另外 12 名成员和管理人员。 IRB 经常尝试以多种方式应对与研究人员的紧张关系并改善关系，但在方式、时间和程度（例如，正式和非正式的结构、内容和互动基调）方面差异很大。 IRB 的范围从开放、可访问到更加遥远和匿名，其“公关工作”和外展的数量和类型各不相同。许多董事会寻求提高与 PI 沟通的数量、质量和帮助，但具体方式有所不同。 IRB 的会议范围从开放式到封闭式，并且可能设有诊所和时事通讯。备忘录的有用性和语气可能有所不同（例如，使用“魅力”）。 IRB 寻求对 PI 进行教育、向他们展示基本道德原则的程度也有很大差异。但这些努力需要时间和资源，因此 IRB 对 PI 投诉的回应程度各不相同。这项研究首次探讨了 IRB 应对紧张局势以及与 PI 互动的机制，表明这些委员会寻求以不同的方式应对与 PI 的冲突——包括正式和非正式的方式，包括沟通的形式和内容。这项研究对未来的实践、研究和政策具有重要意义，表明不仅需要更多关注 IRB 与 PI 沟通的内容，还需要更多关注沟通的方式（即互动的语气和性质）。 IRB 可以通过多种方式改善与 PI 的关系：使用更多的“门户开放”而不是匿名、参与外展（例如通过诊所）、增强互动的语气和内容、对 PI 进行基本道德教育，并尽可能主动地帮助 PI。提高对这些问题的认识可以帮助美国和其他地方的IRB和研究人员。
Tensions between IRBs and researchers in the US and elsewhere have increased, and may affect whether, how, and to what degree researchers comply with ethical guidelines. Yet whether, how, when, and why IRBs respond to these conflicts have received little systematic attention. I contacted 60 US IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. IRBs often try to respond to tensions with researchers and improve relationships in several ways, but range widely in how, when, and to what degree (e.g., in formal and informal structure, content, and tone of interactions). IRBs varied from open and accessible to more distant and anonymous, and in the amount and type of “PR work” and outreach they do. Many boards seek to improve the quantity, quality, and helpfulness of communication with PIs, but differ in how. IRBs range in meetings from open to closed, and may have clinics and newsletters. Memos can vary in helpfulness and tone (e.g., using “charm”). IRBs range considerably, too, in the degrees to which they seek to educate PIs, showing them the underlying ethical principles. But these efforts take time and resources, and IRBs thus vary in degrees of responses to PI complaints. This study, the first to explore the mechanisms through which IRBs respond to tensions and interactions with PIs, suggests that these committees seek to respond to conflicts with PIs in varying ways – both formal and informal, involving both the form and content of communications. This study has important implications for future practice, research, and policy, suggesting needs for increased attention to not only what IRBs communicate to PIs, but how (i.e., the tone and the nature of interactions). IRBs can potentially improve relationships with PIs in several ways: using more “open doors” rather than anonymity, engaging in outreach (e.g., through clinics), enhancing the tone as well as content of interactions, educating PIs about the underlying ethics, and helping PIs as much and proactively as possible. Increased awareness of these issues can help IRBs and researchers in the US and elsewhere.