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.

项目摘要/摘要 国家卫生机构（NIH）政策的最新变更要求使用一个 大多数联邦资助的多站点研究的机构审查委员会（SIRB）。此政策更改， 有人认为，可以提高研究效率，同时增强研究的保护 尽管几项研究检查了SIRB对效率的影响，但关键 关于他们对研究参与者的道德保护的影响仍然存在的问题。 维持SIRB评论中研究参与者的道德保护的主要挑战是 SIRB是否以及如何收集和纳入当地环境的知识。关注 关于可能影响研究道德行为的当地环境，包括有关 研究人员，研究环境，进行试验的资源和能力以及问题 与针对招募的当地患者人群的脆弱性或关注点有关。 SIRBS上的NIH政策指示参与网站将“相关信息”传达给 关于本地环境的SIRB。但是，关于目标和 本地环境审查的内容，或应如何针对特定研究类型量身定制此审查或 设置最佳实现在维持保护的同时促进效率的双重目标的设置。作为 结果，网站如何考虑本地环境存在很大差异，引起了人们对 是否错过了重要的问题，还是某些网站的当前 过程为社会宝贵的研究倡议带来了不必要的障碍。 拟议的生物伦理学研究项目将综合正常分析，政策审查和 主要利益相关者的经验数据，以制定有关目标，内容和内容的指导 本地环境审查的范围。在AIM 1中，我们将开发一个本地目标的概念模型 上下文审查，其内容以及评估其相关性或适当性的标准 在特定的研究环境中。该模型将告知我们的目标2工作，我们将使用修改后 Delphi流程以开发有关本地环境审查应有的专家指导 需要如何对特定研究量身定制。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基础 审查。这样做将有助于提高NIH的更广泛的承诺，以提高质量 和临床研究的效率。