Institutional Review Board Use of Outside Experts: A National Survey.
Institutional Review Board Use of Outside Experts: A National Survey.
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DOI：
10.1080/23294515.2022.2090459
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发表时间：
2022-10
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机构审查委员会(IRB)的专业知识必然受到董事会规模可控的限制。因此，法规允许IRBs依赖外部专家进行审查。然而，关于IRBs是否、何时、为什么以及如何使用外部专家，人们知之甚少。我们对美国IRBs进行了一项全国性调查，以确定对外部专家的利用情况。我们的研究使用描述性的横断面设计，以了解IRBs如何与这些专家接触，并确定最经常需要外部专业知识的领域。调查回复率为18.4%，55.4%的受访者报告其机构的IRB使用外部专家。几乎所有报告使用外部专家的受访者都表示，他们每月不会这样做一次，但每年偶尔会这样做(95%)。确定外部专家的最常见方法是找到一位先前已知的主题专家(83.3%)。最常见的是，受访者寻求咨询不是现有成员拥有的科学专业知识(69.6%)。几乎所有IRBs使用过外部专家的受访者都报告了对IRB审查过程的总体积极影响(91.5%)。在我们的样本报告中，刚刚超过一半的IRBs使用了外部专家；其中，外部专家被描述为有帮助，但总体上他们的使用频率很低。许多IRBs报告说根本不依赖外部专家。这就提出了一个重要问题，即与外部专家的哪种类型的接触应被视为促进最高质量审查的最佳方式。例如，很少有答复者寻求社区咨询委员会的协助，该委员会可以解决社区观点方面的专门知识差距。需要进一步探索，以了解如何优化外部专家对内部审查委员会的使用，包括如何认识到何时缺乏专门知识，内部审查机构在使用外部专家方面面临哪些障碍，以及外部专家审查如何影响内部审查委员会的决策和审查质量。
Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts. We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside expertise is most frequently requested. The survey response rate was 18.4%, with 55.4% of respondents reporting their institution’s IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%). Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality.