Achieving Ethically Appropriate and Effective Local Context Review by Single IRBs

项目摘要/摘要 最近国家卫生机构(NIH)政策的变化要求使用单一的 大多数联邦资助的多站点研究的机构审查委员会(Sirb)。这一政策变化， 有人认为，在加强对研究的保护的同时，可以提高研究效率 参与者。尽管有几项研究考察了sIRBs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，问题仍然存在。 在sirb审查中维护研究参与者的道德保护的一个关键挑战是 小岛屿发展中国家是否以及如何能够收集和纳入有关当地情况的知识。令人担忧的问题 关于可能影响研究道德行为的当地背景的知识包括 调查人员、研究环境、进行试验的资源和能力以及问题 与针对招募目标的当地患者群体的脆弱性或担忧有关。 NIH关于sIRBs的政策指示参与站点向 关于当地环境的SIRB。然而，对于目标和目标，并没有达成共识 本地背景审查的内容，或该审查应如何针对特定研究类型或 设置以最大限度地满足提高效率和维护保护的双重目标。作为一名 因此，在网站如何考虑当地背景方面存在相当大的差异，这引发了人们对 重要的问题是否被遗漏了，或者，或者，一些网站的当前 这一过程给启动具有社会价值的研究带来了不必要的障碍。 拟议的生物伦理学研究项目将综合规范分析、政策审查和 来自关键利益相关者的经验数据，以制定关于目标、内容和 地方背景审查的范围。在目标1中，我们将开发一个地方政府目标的概念模型 背景审查、其内容以及评估其相关性或适当性的标准 到特定的研究背景。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 德尔福流程，制定专家知情的指导意见，说明当地背景审查应 需要，以及如何为具体研究量身定做。这项研究的贡献将是 意义重大，因为它将为SIRB的高效和道德行为奠定必要的基础 复习一下。这样做将有助于推进NIH提高质量的更广泛承诺 和临床研究的效率。

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.