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Are institutional review boards prepared for active continuing review?

Continuing review is an important responsibility of Institutional Review Boards (IRBs). Though being mentioned by many of the national and international guidelines, it is carried out routinely only in UK. The reasons may be inadequate training, overworked IRBs, less enthusiasm among the IRB members,...

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Detalles Bibliográficos
Autores principales: Shetty, Yashashri C., Jadhav, Kshitij S., Saiyed, Aafreen A., Desai, Akshay U.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3915362/
https://www.ncbi.nlm.nih.gov/pubmed/24551581
http://dx.doi.org/10.4103/2229-3485.124553
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author Shetty, Yashashri C.
Jadhav, Kshitij S.
Saiyed, Aafreen A.
Desai, Akshay U.
author_facet Shetty, Yashashri C.
Jadhav, Kshitij S.
Saiyed, Aafreen A.
Desai, Akshay U.
author_sort Shetty, Yashashri C.
collection PubMed
description Continuing review is an important responsibility of Institutional Review Boards (IRBs). Though being mentioned by many of the national and international guidelines, it is carried out routinely only in UK. The reasons may be inadequate training, overworked IRBs, less enthusiasm among the IRB members, cost bearing, etc. So, the oversight mechanism at the local site, which is the responsibility of IRB is not fulfilled. Are there any solutions to overcome these difficulties? The IRBs should have a Standard operating procedure for continuing review, members can be regularly trained, institutions can create their own internal Data and Safety Monitoring Boards who will only monitor studies where monitoring systems are non-existing and there can be budget allocated at the start of the study by the sponsor or the institution. In this way, we can try to safeguard the rights and well-being of the study participants.
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spelling pubmed-39153622014-02-18 Are institutional review boards prepared for active continuing review? Shetty, Yashashri C. Jadhav, Kshitij S. Saiyed, Aafreen A. Desai, Akshay U. Perspect Clin Res Ethics Continuing review is an important responsibility of Institutional Review Boards (IRBs). Though being mentioned by many of the national and international guidelines, it is carried out routinely only in UK. The reasons may be inadequate training, overworked IRBs, less enthusiasm among the IRB members, cost bearing, etc. So, the oversight mechanism at the local site, which is the responsibility of IRB is not fulfilled. Are there any solutions to overcome these difficulties? The IRBs should have a Standard operating procedure for continuing review, members can be regularly trained, institutions can create their own internal Data and Safety Monitoring Boards who will only monitor studies where monitoring systems are non-existing and there can be budget allocated at the start of the study by the sponsor or the institution. In this way, we can try to safeguard the rights and well-being of the study participants. Medknow Publications & Media Pvt Ltd 2014 /pmc/articles/PMC3915362/ /pubmed/24551581 http://dx.doi.org/10.4103/2229-3485.124553 Text en Copyright: © Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Ethics
Shetty, Yashashri C.
Jadhav, Kshitij S.
Saiyed, Aafreen A.
Desai, Akshay U.
Are institutional review boards prepared for active continuing review?
title Are institutional review boards prepared for active continuing review?
title_full Are institutional review boards prepared for active continuing review?
title_fullStr Are institutional review boards prepared for active continuing review?
title_full_unstemmed Are institutional review boards prepared for active continuing review?
title_short Are institutional review boards prepared for active continuing review?
title_sort are institutional review boards prepared for active continuing review?
topic Ethics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3915362/
https://www.ncbi.nlm.nih.gov/pubmed/24551581
http://dx.doi.org/10.4103/2229-3485.124553
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