Achieving Ethically Appropriate and Effective Local Context Review by Single IRBs

由单一 IRB 实现道德上适当且有效的当地情况审查

• 批准号: 10594273
• 负责人: Daniel Ernest Ford
• 金额: $ 16.38万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-31 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594273
• 关键词: Affect; Agreement; Bioethics; Clinical Research; Data; Ethics; Funding; Goals; Health; Health Policy; Institution; Institutional Review Boards; Knowledge; Modeling; Participant; Policies; Process; Research; Research Design; Research Personnel; Research Project Grants; Resources; Site; Social Values; Target Populations; Twin Multiple Birth; Variant; Work; patient population; recruit

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.

项目概要/摘要 国家卫生机构 (NIH) 政策的最新变化强制要求使用单一的 大多数联邦资助的多地点研究的机构审查委员会（sIRB）这一政策变化， 有人认为，可以提高研究效率，同时加强对研究的保护 尽管一些研究已经检验了 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疑问。 在 sIRB 审查中维持研究参与者的道德保护的一个关键挑战是 sIRB 是否以及如何收集和整合当地情况的知识。 关于可能影响研究道德行为的当地背景包括以下知识 研究人员、研究环境、进行试验的资源和能力以及问题 与招募目标的当地患者群体的脆弱性或担忧有关。 NIH 关于 sIRB 的政策指示参与站点向相关机构传达“相关信息” 然而，sIRB 就当地情况并未达成共识。 当地背景审查的内容，或者该审查应如何针对特定的研究类型或 设置以最好地实现提高效率和维持保护的双重目标。 结果，站点考虑当地环境的方式存在很大差异，引起了人们的担忧 是否遗漏了重要问题，或者某些网站当前是否 过程会给启动具有社会价值的研究带来不必要的障碍。 拟议的生物伦理学研究项目将综合规范分析、政策审查和 来自主要利益相关者的经验数据，用于制定有关目标、内容和目标的指导 在目标 1 中，我们将开发本地目标的概念模型。 背景审查、其内容以及评估其相关性或适当性的标准 该模型将为我们的目标 2 工作提供信息，其中我们将使用修改后的模型。 德尔福流程制定专家知情指导，说明当地情况审查应进行哪些内容 以及如何针对具体研究进行调整。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 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。