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Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Authors :
Murray, Alexandra
Pivovarova, Ekaterina
Klitzman, Robert
Stiles, Deborah F.
Appelbaum, Paul
Lidz, Charles W.
Source :
AJOB Empirical Bioethics; Jan-Mar2021, Vol. 12 Issue 1, p33-40, 8p
Publication Year :
2021

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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
23294515
Volume :
12
Issue :
1
Database :
Complementary Index
Journal :
AJOB Empirical Bioethics
Publication Type :
Academic Journal
Accession number :
147951221
Full Text :
https://doi.org/10.1080/23294515.2020.1818877