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The impact of central IRB's on informed consent readability and trial adherence in SPRINT

BACKGROUND: Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and p...

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Autores principales: Tamariz, Leonardo, Gajardo, Mitscher, Still, Carolyn H., Gren, Lisa H., Clark, Elizabeth, Walsh, Sandy, Whittle, Jeff, Nord, John, Ramsey, Thomas, Contreras, Gabriel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6627564/
https://www.ncbi.nlm.nih.gov/pubmed/31338481
http://dx.doi.org/10.1016/j.conctc.2019.100407
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author Tamariz, Leonardo
Gajardo, Mitscher
Still, Carolyn H.
Gren, Lisa H.
Clark, Elizabeth
Walsh, Sandy
Whittle, Jeff
Nord, John
Ramsey, Thomas
Contreras, Gabriel
author_facet Tamariz, Leonardo
Gajardo, Mitscher
Still, Carolyn H.
Gren, Lisa H.
Clark, Elizabeth
Walsh, Sandy
Whittle, Jeff
Nord, John
Ramsey, Thomas
Contreras, Gabriel
author_sort Tamariz, Leonardo
collection PubMed
description BACKGROUND: Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs. METHODS: We conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed last 3-month visit. RESULTS: Sixty-one percent of all SPRINT sites used a CIRB as their IRB of record. The adjusted mean grade reading level for CIRB consents was 13.4 (95% CI 12.6–13.8) compared to 12.3 (95% CI 12.1–13.1) for non CIRB consents (p = 0.07). CIRB sites had similar rates of withdrawal of consent and loss to follow-up as non-CIRB sites; subjects missing the last appointment of the study were more likely to come from sites regulated by a CIRB. The Veterans Affairs CIRB had the lowest rate of withdrawal of consent (1.9%) and the lowest rate of missed appointments (1.9%) among CIRBs. CONCLUSIONS: Niether CIRB-regulated sites nor IRB regulated sites enforce the recommended readability level of the informed consent documents. Sites regulated by both IRBs had similar participant trial adherence.
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spelling pubmed-66275642019-07-23 The impact of central IRB's on informed consent readability and trial adherence in SPRINT Tamariz, Leonardo Gajardo, Mitscher Still, Carolyn H. Gren, Lisa H. Clark, Elizabeth Walsh, Sandy Whittle, Jeff Nord, John Ramsey, Thomas Contreras, Gabriel Contemp Clin Trials Commun Article BACKGROUND: Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs. METHODS: We conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed last 3-month visit. RESULTS: Sixty-one percent of all SPRINT sites used a CIRB as their IRB of record. The adjusted mean grade reading level for CIRB consents was 13.4 (95% CI 12.6–13.8) compared to 12.3 (95% CI 12.1–13.1) for non CIRB consents (p = 0.07). CIRB sites had similar rates of withdrawal of consent and loss to follow-up as non-CIRB sites; subjects missing the last appointment of the study were more likely to come from sites regulated by a CIRB. The Veterans Affairs CIRB had the lowest rate of withdrawal of consent (1.9%) and the lowest rate of missed appointments (1.9%) among CIRBs. CONCLUSIONS: Niether CIRB-regulated sites nor IRB regulated sites enforce the recommended readability level of the informed consent documents. Sites regulated by both IRBs had similar participant trial adherence. Elsevier 2019-07-06 /pmc/articles/PMC6627564/ /pubmed/31338481 http://dx.doi.org/10.1016/j.conctc.2019.100407 Text en © 2019 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Tamariz, Leonardo
Gajardo, Mitscher
Still, Carolyn H.
Gren, Lisa H.
Clark, Elizabeth
Walsh, Sandy
Whittle, Jeff
Nord, John
Ramsey, Thomas
Contreras, Gabriel
The impact of central IRB's on informed consent readability and trial adherence in SPRINT
title The impact of central IRB's on informed consent readability and trial adherence in SPRINT
title_full The impact of central IRB's on informed consent readability and trial adherence in SPRINT
title_fullStr The impact of central IRB's on informed consent readability and trial adherence in SPRINT
title_full_unstemmed The impact of central IRB's on informed consent readability and trial adherence in SPRINT
title_short The impact of central IRB's on informed consent readability and trial adherence in SPRINT
title_sort impact of central irb's on informed consent readability and trial adherence in sprint
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6627564/
https://www.ncbi.nlm.nih.gov/pubmed/31338481
http://dx.doi.org/10.1016/j.conctc.2019.100407
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