Using real world decisions to develop a modified central IRB 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，结果多变，可能不能充分保护人类受试者。一种建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。了解研究所如何以及为什么在研究背景下决定什么IRB审查模式是最好的，对于设计一个适应这些决定的模型是至关重要的。鉴于CIRB的多中心研究或替代IRB审查模式的适用性可能有很大差异，单一的IRB审查模式可能不足以满足多个不同机构的研究。支持IRBShare的现有基础设施可用于适应多种IRB审查模式--包括共享审查、中央审查和本地审查--并为随后在运营过程中捕获数据提供现实世界的平台。根据假设，授权机构有机会根据机构和研究特点选择在背景下最有效的模式，将鼓励更多地利用，进而提高多站点IB审查的道德质量和有效性。将使用定性和定量的测量和分析来分析在有多个审查选项的情况下为特定研究选择IRB审查模式的选择、利用、过程和理由(“IRBChoice”)。具体目标：1)使用适应的信息学系统和协调程序来跟踪现实世界的决策，并捕捉在选择IRB依赖模式时所使用的理论基础，包括在机构、法律、HRPP/IRB、调查者和研究层面使用替代IRB审查模式的促进者和障碍；2)比较替代审查模式在关键过程和结果指标上的差异：a)伦理质量，b)审查过程的效率，以及c)多个利益相关者(IRB、赞助者/资助者、调查者/研究团队)对审查过程的满意度；以及3)制定和分享政策和程序，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式有关的效率，包括CIRB模式。

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.