Achieving Ethically Appropriate and Effective Local Context Review by Single IRBs

项目总结/摘要 国家卫生研究所（NIH）政策的最新变化要求使用单一的 机构审查委员会（sIRB）对大多数联邦资助的多中心研究。这一政策变化， 它可以提高研究效率，同时加强对研究的保护。 参与者虽然有几项研究已经研究了sIRB对效率的影响，但关键是 关于它们对研究参与者的道德保护的影响，仍然存在问题。 在sIRB审查中维护研究参与者伦理保护的一个关键挑战是 sIRB是否以及如何收集和纳入当地情况的知识。关切 可能影响研究伦理行为的当地背景知识包括以下方面的知识： 研究者、研究环境、开展试验的资源和能力以及问题 与招募目标当地患者人群的脆弱性或担忧相关。 NIH关于sIRB的政策指示参与研究中心将“相关信息”传达给 sIRB关于当地环境。然而，在目标和目标方面没有共同的一致意见， 当地背景审查的内容，或如何针对特定研究类型进行审查，或 设置，以最好地满足提高效率，同时保持保护的双重目标。作为 因此，各地点在如何考虑当地环境方面存在相当大的差异，这引起了人们对以下问题的关注： 是否遗漏了重要问题，或者，一些网站的当前 程序对启动具有社会价值的研究造成了不必要的障碍。 拟议的生物伦理学研究项目将综合规范分析、政策审查和 主要利益相关者的经验数据，以制定有关目标、内容和 地方背景审查的范围。在目标1中，我们将制定一个地方目标的概念模型 背景审查、其内容以及评估其相关性或适当性的标准 具体的研究背景。这个模型将通知我们的目标2工作，在其中我们将使用修改后的 德尔菲程序，以制定专家知情的指导，说明地方背景审查应 它应该如何适应具体的研究。这项研究的贡献将是 意义重大，因为它将为sIRB的有效和道德行为奠定必要的基础 审查.这样做将有助于推动NIH更广泛的承诺，以提高质量， 临床研究的效率。

PROJECT SUMMARY/ABSTRACT Recent changes to National Institutions of Health (NIH) policy mandate the use of a single institutional review board (sIRB) for most federally funded multi-site studies. This policy change, it was argued, could increase research efficiency while enhancing protections for research participants. Although several studies have examined the impact of sIRBs on efficiency, critical questions remain regarding their impact on ethical protections for research participants. A key challenge for maintaining ethical protections of research participants in sIRB review is whether and how sIRBs can collect and incorporate knowledge of the local context. Concerns about local context that may affect the ethical conduct of research include knowledge about investigators, research settings, the resources and capacity to conduct a trial, and issues related to the vulnerabilities or concerns of local patient populations targeted for recruitment. NIH policies on sIRBs instruct participating sites to communicate “relevant information” to the sIRB regarding local context. However, there is no shared agreement as to the goals and content of local context review, or how this review should be tailored to particular study types or settings to best meet the twin goals of promoting efficiency while maintaining protections. As a result, there is considerable variation in how sites consider local context, raising concerns as to whether important issues are being missed, or, alternatively, whether some sites’ current processes introduce unnecessary barriers to the initiation of socially valuable research. The proposed bioethics research project will synthesize normative analysis, policy review, and empirical data from key stakeholders to develop guidance regarding the goals, content, and scope of local context review. In Aim 1, we will develop a conceptual model of the goals of local context review, its content, and the criteria by which to assess its relevance or appropriateness to specific study contexts. This model will inform our Aim 2 work, in which we will use a modified Delphi process to develop expert-informed guidance about what local context review should entail, and how it should be tailored to specific studies. The contribution of this research will be significant because it will lay the essential groundwork for efficient and ethical conduct of sIRB review. In doing so this will help advance the NIH’s broader commitment to enhance the quality and efficiency of clinical research.