Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.
Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.
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DOI：
10.1017/cts.2023.517
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发表时间：
2023
影响因子：
2.6
通讯作者：
Bierer, Barbara E.
中科院分区：
文献类型：
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作者：
Green, Jonathan M.;Goodman, Polly;Kirby, Aaron;Cobb, Nichelle;Bierer, Barbara E.
对通用规则和NIH政策的修订要求使用单一的机构审查委员会（sIRB）来审查大多数联邦资助的多中心研究，目的是简化审查过程。然而，自2018年首次实施以来，许多IRB和机构继续在实施这一要求的物流方面苦苦挣扎。在本文中，我们报告了2022年举行的研讨会的结果，以研究为什么sIRB审查仍然存在问题，并提出可能的解决方案。研讨会与会者指出了几个主要障碍问题，包括研究小组的新责任、持续重复的审查程序、各机构之间的政策和做法缺乏协调、联邦机构没有提供额外的指导以及政策要求需要更大的灵活性。要解决这些问题，就需要为研究小组提供更多的资源和培训，需要机构领导人承诺统一做法，需要决策者严格评估要求，并在适用性方面提供灵活性。
Revisions to the Common Rule and NIH policy require the use of a single Institutional Review Board (sIRB) for the review of most federally funded, multisite research, with the intent of streamlining the review process. However, since initial implementation in 2018, many IRBs and institutions continue to struggle with the logistics of implementing this requirement. In this paper, we report the findings of a workshop held in 2022 to examine why sIRB review remains problematic and propose possible solutions. Workshop participants identified several issues as major barriers, including new responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and practices across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. Addressing these problems will require providing additional resources and training to research teams, the commitment of institutional leaders to harmonize practice, and policymakers to critically evaluate the requirement and provide flexibility in applicability.
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影响因子：
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作者：
Corneli A;Dombeck CB;McKenna K;Calvert SB
通讯作者：
Calvert SB
影响因子：
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作者：
Lidz CW;Pivovarova E;Appelbaum P;Stiles DF;Murray A;Klitzman RL
通讯作者：
Klitzman RL
影响因子：
2.6
作者：
Johnson, Ann R.;Singleton, Megan Kasimatis;Ozier, Julie;Serdoz, Emily;Beadles, Jennifer G.;Maddox-Regis, Janelle;Mumford, Sarah;Burr, Jeri;Dean, J. Michael;Ford, Daniel E.;Bernard, Gordon R.
通讯作者：
Bernard, Gordon R.
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