Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.
exempt protocols
expedited review
full board review
institutional review board
levels of review
Journal
Journal of empirical research on human research ethics : JERHRE
ISSN: 1556-2654
Titre abrégé: J Empir Res Hum Res Ethics
Pays: United States
ID NLM: 101273949
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
pubmed:
13
9
2020
medline:
18
9
2021
entrez:
12
9
2020
Statut:
ppublish
Résumé
How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.
Identifiants
pubmed: 32917103
doi: 10.1177/1556264620956795
pmc: PMC8823949
mid: NIHMS1770875
doi:
Types de publication
Journal Article
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
407-414Subventions
Organisme : HSRD VA
ID : I01 HX000839
Pays : United States
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