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A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months

BACKGROUND: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute’s central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol s...

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Autores principales: Abedin, Zainab, Teller, Alan, Ruotolo, Brenda, Muhammad, Kawthar, Stiles, Deborah F., Ferreira, Rui, Green, Nancy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755161/
https://www.ncbi.nlm.nih.gov/pubmed/33367154
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author Abedin, Zainab
Teller, Alan
Ruotolo, Brenda
Muhammad, Kawthar
Stiles, Deborah F.
Ferreira, Rui
Green, Nancy
author_facet Abedin, Zainab
Teller, Alan
Ruotolo, Brenda
Muhammad, Kawthar
Stiles, Deborah F.
Ferreira, Rui
Green, Nancy
author_sort Abedin, Zainab
collection PubMed
description BACKGROUND: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute’s central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review. MATERIALS AND METHODS: Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25–30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service. RESULTS: Survey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days. CONCLUSION: National concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement.
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spelling pubmed-77551612020-12-22 A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months Abedin, Zainab Teller, Alan Ruotolo, Brenda Muhammad, Kawthar Stiles, Deborah F. Ferreira, Rui Green, Nancy Int J Acad Med Article BACKGROUND: The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute’s central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review. MATERIALS AND METHODS: Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25–30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service. RESULTS: Survey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days. CONCLUSION: National concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement. 2020 2020-06-29 /pmc/articles/PMC7755161/ /pubmed/33367154 Text en https://creativecommons.org/licenses/by-sa/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. For reprints contact: reprints@medknow.com
spellingShingle Article
Abedin, Zainab
Teller, Alan
Ruotolo, Brenda
Muhammad, Kawthar
Stiles, Deborah F.
Ferreira, Rui
Green, Nancy
A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months
title A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months
title_full A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months
title_fullStr A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months
title_full_unstemmed A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months
title_short A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months
title_sort personalized institutional review board liaison service: evaluation over its initial 30 months
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755161/
https://www.ncbi.nlm.nih.gov/pubmed/33367154
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