Reducing the Single IRB Burden: Streamlining Electronic IRB Systems. Issue 1 (25th September 2020)

• Record Type: Journal Article
• Authors: Murray, Alexandra; Pivovarova, Ekaterina; Klitzman, Robert; Stiles, Deborah F.; Appelbaum, Paul; Lidz, Charles W.
• Is Part Of: AJOB empirical bioethics. Volume 12:Issue 1(2021)
• Page Start: 33
• Page End: 40
• Publication Date: 2020-09-25
• Subjects: Electronic IRB systems (eIRB) -- single IRB (sIRB) -- institutional review boards (IRB) -- interoperability -- research ethics; Bioethics -- Periodicals; Bioethics -- Research -- Periodicals; Bioethics -- Methodology -- Periodicals; Medical ethics -- Periodicals; 174.205
• DOI: 10.1080/23294515.2020.1818877
• Languages: English
• ISSNs: 2329-4515

Abstract

Abstract: Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.