Using real world decisions to develop a modified central IRB model

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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.