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Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations

BACKGROUND: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles tha...

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Autores principales: AlFattani, Areej, AlBedah, Norah, AlShahrani, Asma, Alkawi, Ammar, AlMeharish, Amani, Altwaijri, Yasmin, Omar, Abeer, AlKawi, M. Zuheir, Khogeer, Asim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10334562/
https://www.ncbi.nlm.nih.gov/pubmed/37430255
http://dx.doi.org/10.1186/s12910-023-00928-7
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author AlFattani, Areej
AlBedah, Norah
AlShahrani, Asma
Alkawi, Ammar
AlMeharish, Amani
Altwaijri, Yasmin
Omar, Abeer
AlKawi, M. Zuheir
Khogeer, Asim
author_facet AlFattani, Areej
AlBedah, Norah
AlShahrani, Asma
Alkawi, Ammar
AlMeharish, Amani
Altwaijri, Yasmin
Omar, Abeer
AlKawi, M. Zuheir
Khogeer, Asim
author_sort AlFattani, Areej
collection PubMed
description BACKGROUND: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. METHOD: This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. RESULTS: Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. CONCLUSION: Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12910-023-00928-7.
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spelling pubmed-103345622023-07-12 Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations AlFattani, Areej AlBedah, Norah AlShahrani, Asma Alkawi, Ammar AlMeharish, Amani Altwaijri, Yasmin Omar, Abeer AlKawi, M. Zuheir Khogeer, Asim BMC Med Ethics Research BACKGROUND: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. METHOD: This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. RESULTS: Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. CONCLUSION: Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12910-023-00928-7. BioMed Central 2023-07-10 /pmc/articles/PMC10334562/ /pubmed/37430255 http://dx.doi.org/10.1186/s12910-023-00928-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
AlFattani, Areej
AlBedah, Norah
AlShahrani, Asma
Alkawi, Ammar
AlMeharish, Amani
Altwaijri, Yasmin
Omar, Abeer
AlKawi, M. Zuheir
Khogeer, Asim
Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations
title Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations
title_full Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations
title_fullStr Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations
title_full_unstemmed Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations
title_short Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations
title_sort institutional review boards in saudi arabia: the first survey-based report on their functions and operations
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10334562/
https://www.ncbi.nlm.nih.gov/pubmed/37430255
http://dx.doi.org/10.1186/s12910-023-00928-7
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