Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.
Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.
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DOI：
10.1080/23294515.2020.1818877
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发表时间：
2021-01
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电子机构审查委员会系统（eIRBs）已成为确保遵守人类研究保护计划（HRPP）和IRB要求的一个组成部分。尽管如此，这些系统中很少有被配置为管理美国国立卫生研究院（NIH）为多中心研究规定的单一IRB（sIRB）过程。我们采访了103 sIRB管理人员，主席，成员和工作人员与sIRB多中心研究审查的经验。我们观察到调整现有eIRB系统以适应sIRB过程的三个主要障碍：（1）现有系统不是为sIRB设计的，也没有配置为管理sIRB职责，（2）它们不能互操作，（3）缺乏改进现有系统的资源。我们的研究结果表明，作为sIRB的IRB将需要对其电子系统进行重大更改，以适应sIRB流程。这些困难威胁到IRB关注伦理问题而不是官僚问题的能力，以及多中心试验的效率。
Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.