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. 2016 Apr:60:58-65.
doi: 10.1016/j.jbi.2016.01.011. Epub 2016 Jan 28.

IRB reliance: An informatics approach

Jihad S Obeid  1 , Randall W Alexander  2 , Stephanie M Gentilin  2 , Brigette White  2 , Christine B Turley  3 , Kathleen T Brady  2 , Leslie A Lenert  2
Affiliations

IRB reliance: An informatics approach

Jihad S Obeid et al. J Biomed Inform. 2016 Apr.

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.

Keywords: Clinical research; Data model; IRB; Informatics; Reliance; Workflow.

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Figures

Figure 1
Figure 1
Map of South Carolina showing the five Health Sciences South Carolina supported organizations currently participating in the IRB collaborative and Clemson University where the eIRB production server is hosted.
Figure 2
Figure 2
The core data model showing some of the data elements of IRB application and processes common to all the participating institutions.
Figure 3
Figure 3
Institution Harmonization – This diagram shows the customization and overlap of data elements in each of the sections of the IRB application. The pages that display the IRB forms within each section were used as the units of measure.
Figure 4
Figure 4
A simplified workflow diagram of the IRB system showing the cooperative review process across participating institutions.
Figure 5
Figure 5
A screenshot of the interface for cooperative review study history.
See this image and copyright information in PMC

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