Using real world decisions to develop a modified central IRB model

使用现实世界的决策来开发修改后的中央 IRB 模型

• 批准号: 8840421
• 负责人: TODD W RICE
• 金额: $ 37.05万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8840421
• 关键词: Address; Agreement; Cognitive; Commit; Data; Data Analyses; Effectiveness; Ensure; Ethics; Evaluation; Foundations; Funding; Future; Human; Informatics; Institution; Institutional Review Boards; Investigation; Lead; Leadership; Learning; Legal; Letters; Measures; Medical; Methods; Metric; Mission; Modeling; Modification; Movement; Multicenter Studies; Natural experiment; Office for Human Research Protections; Online Systems; Outcome; Outcome Measure; Physician Executives; Policies; Predisposition; Procedures; Process; Process Measure; Protocols documentation; Reliance; Research; Research Infrastructure; Research Personnel; Rice; Secure; Solutions; System; Time; Trust; Work; base; contextual factors; design; empowered; evidence base; experience; human subject; human subject protection; improved; operation; programs; public health relevance; satisfaction; stem; study characteristics

DESCRIPTION (provided by applicant): The IRB review of multicenter studies has known inefficiencies, produces variable outcomes, and may not sufficiently protect human subjects. One proposed solution has been the utilization of central IRB (CIRB) review; however, existing CIRB models have significant scalability issues and lack empirical evidence of effectiveness due to low utilization. Understanding how and why IRBs decide what IRB review model is best within the study context is essential to designing a model that accommodates these decisions. Given that the suitability of a multicenter study for CIRB or an alternative IRB review model may vary widely, a single IRB review model may not be sufficient for a study with multiple, diverse institutions. The existing infrastructure supporting IRBshare can be leveraged to accommodate multiple IRB review models - including shared review, central review, and local review - and provide a real world platform for subsequently capturing data in the course of operations. It is hypothesized that empowering institutions with the opportunity to choose the model that contextually works best-based on the institutional and study characteristics-will encourage greater utilization that can in turn improve the ethical quality and efficaciousness of multisite IB review. The choices, utilization, process, and rationale for selecting an IRB review model for a given study when multiple review options are available ("IRBchoice") will be analyzed using qualitative and quantitative measures and analyses. SPECIFIC AIMS: 1) To use an adapted informatics system and coordinated program to track real world decisions and capture the rationale used when selecting an IRB reliance model, including the facilitators and barriers to utilizing alternative IRB review models at the institutional, legal, HRPP/IRB, investigator, and study levels; 2) To compare the alternative review models on key process and outcome measures: a) ethical quality, b) efficiency of the review process, and c) satisfaction with the review process by multiple stakeholders (IRB, sponsor/funder, investigator/study team); and 3) To develop and share policies and procedures to mitigate ethical or logistical issues and maximize efficiency related to the dynamic use of alternative review models including the CIRB model.

描述（由申请人提供）：IRB 对多中心研究的审查已知效率低下，产生不同的结果，并且可能无法充分保护人类受试者。一项提议的解决方案是利用中央 IRB (CIRB) 审查；然而，现有的 CIRB 模型存在严重的可扩展性问题，并且由于利用率低而缺乏有效性的经验证据。了解 IRB 如何以及为何决定哪种 IRB 审查模型在研究背景下最好，对于设计适应这些决策的模型至关重要。鉴于 CIRB 或替代 IRB 审查模型的多中心研究的适用性可能差异很大，单一 IRB 审查模型可能不足以用于多个、不同机构的研究。可以利用支持 IRBshare 的现有基础设施来适应多种 IRB 审核模式（包括共享审核、集中审核和本地审核），并为随后在运营过程中捕获数据提供一个真实的平台。据推测，让机构有机会根据机构和研究特点选择最适合具体情况的模型，将鼓励更多的利用，从而提高多地点 IB 审查的道德质量和有效性。当有多个审查选项可用时（“IRB选择”），将使用定性和定量测量和分析来分析为给定研究选择IRB审查模型的选择、利用、过程和理由。具体目标： 1) 使用适应的信息学系统和协调计划来跟踪现实世界的决策并捕获选择 IRB 依赖模型时使用的基本原理，包括在机构、法律、HRPP/ IRB、研究者和研究级别； 2) 比较关键流程和结果衡量的替代审核模型：a) 道德质量，b) 审核流程的效率，以及 c) 多个利益相关者（IRB、申办者/资助者、研究者/研究团队）对审核流程的满意度）； 3) 制定和共享政策和程序，以减轻道德或后勤问题，并最大限度地提高与动态使用替代审查模型（包括 CIRB 模型）相关的效率。