Alexandra Murray, Ekaterina Pivovarova, Robert Klitzman, Deborah F Stiles, Paul Appelbaum, Charles W Lidz
AJOB empirical bioethics 2021 Jan-MarElectronic 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.
Alexandra Murray, Ekaterina Pivovarova, Robert Klitzman, Deborah F Stiles, Paul Appelbaum, Charles W Lidz. Reducing the Single IRB Burden: Streamlining Electronic IRB Systems. AJOB empirical bioethics. 2021 Jan-Mar;12(1):33-40
PMID: 32976069
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