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Using single IRB consultations to meet the educational needs of investigative teams

Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes...

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Autores principales: Johnson, Ann R., Pautler, Mary, Burr, Jeri S., Abdelsamad, Nael, VanBuren, John M., Rigtrup, Lisa M., Dean, J. Michael, Rothwell, Erin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9403494/
https://www.ncbi.nlm.nih.gov/pubmed/36033361
http://dx.doi.org/10.1016/j.conctc.2022.100971
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author Johnson, Ann R.
Pautler, Mary
Burr, Jeri S.
Abdelsamad, Nael
VanBuren, John M.
Rigtrup, Lisa M.
Dean, J. Michael
Rothwell, Erin
author_facet Johnson, Ann R.
Pautler, Mary
Burr, Jeri S.
Abdelsamad, Nael
VanBuren, John M.
Rigtrup, Lisa M.
Dean, J. Michael
Rothwell, Erin
author_sort Johnson, Ann R.
collection PubMed
description Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.
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spelling pubmed-94034942022-08-26 Using single IRB consultations to meet the educational needs of investigative teams Johnson, Ann R. Pautler, Mary Burr, Jeri S. Abdelsamad, Nael VanBuren, John M. Rigtrup, Lisa M. Dean, J. Michael Rothwell, Erin Contemp Clin Trials Commun Article Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process. Elsevier 2022-08-11 /pmc/articles/PMC9403494/ /pubmed/36033361 http://dx.doi.org/10.1016/j.conctc.2022.100971 Text en © 2022 The Authors https://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
Johnson, Ann R.
Pautler, Mary
Burr, Jeri S.
Abdelsamad, Nael
VanBuren, John M.
Rigtrup, Lisa M.
Dean, J. Michael
Rothwell, Erin
Using single IRB consultations to meet the educational needs of investigative teams
title Using single IRB consultations to meet the educational needs of investigative teams
title_full Using single IRB consultations to meet the educational needs of investigative teams
title_fullStr Using single IRB consultations to meet the educational needs of investigative teams
title_full_unstemmed Using single IRB consultations to meet the educational needs of investigative teams
title_short Using single IRB consultations to meet the educational needs of investigative teams
title_sort using single irb consultations to meet the educational needs of investigative teams
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9403494/
https://www.ncbi.nlm.nih.gov/pubmed/36033361
http://dx.doi.org/10.1016/j.conctc.2022.100971
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