IRB reliance: An informatics approach

Abstract

Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.

Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience

“…Establishing the threshold criteria for an NRR distinction could be tweaked as we get a better appreciation for the types of protocols (or investigators) that consume larger amounts of IRB effort, perhaps by looking at those applications that have the greater number of requests for corrections before final approval. This can be determined through continued evaluation of the metrics available within our electronic IRB management system (Obeid et al, 2016) which tracks key performance indicators and provides detailed data extracts for each application.…”