Improving Compliance With Institutional Review Board Continuing Review Requirements

Bibliographic Data

ID12807458
AuthorsMin‐Fu Tsan (0000-0002-0142-1873, McGuireWoods, corresponding author), Yen Nguyen (0000-0001-7111-031X)
Year2019
Volume14
Issue4
Pages365-371
Publication date2019-03-20
Open AccessYes
TypeARTICLE
VenueJournal of Empirical Research on Human Research Ethics (JOURNAL)
Journal identifiersISSN: 1556-2646 • E-ISSN: 1556-2654
PublisherSAGE Publishing (PUBLISHER • US)
DOI10.1177/1556264619837108
PMID30894051
OpenAlexW2923204813
LanguageEN
Citations received2
References cited3

Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 implemented remedial action plans. Using data from 2011 through 2018, we demonstrated that 70% of these facilities' lapse rates remain significantly improved. In contrast, none of the 10 facilities with their lapse rates that were higher than the national averages in 2 out of 3 years from 2011 to 2013 and that did not implement remedial action plans showed any improvement. Thus, implementation of effective remedial measures in facilities with high lapse rates can result in long-lasting improvement in the majority of these facilities

Business · Compliance (psychology · Institutional review board · Medical education · Political science · Remedial action · Remedial education · Veterans Affairs · Biomedical Ethics and Regulation · Ethics in Clinical Research · Health Systems, Economic Evaluations, Quality of Life · Law · Medicine · Psychology

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