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Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective
BACKGROUND: For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be t...
Autores principales: | , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2010
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2921081/ https://www.ncbi.nlm.nih.gov/pubmed/20673343 http://dx.doi.org/10.1186/1472-6963-10-223 |
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author | Ezzat, Hanna Ross, Sue von Dadelszen, Peter Morris, Tara Liston, Robert Magee, Laura A |
author_facet | Ezzat, Hanna Ross, Sue von Dadelszen, Peter Morris, Tara Liston, Robert Magee, Laura A |
author_sort | Ezzat, Hanna |
collection | PubMed |
description | BACKGROUND: For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. METHODS: The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. RESULTS: Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. CONCLUSIONS: For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review. |
format | Text |
id | pubmed-2921081 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-29210812010-08-13 Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective Ezzat, Hanna Ross, Sue von Dadelszen, Peter Morris, Tara Liston, Robert Magee, Laura A BMC Health Serv Res Research Article BACKGROUND: For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. METHODS: The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. RESULTS: Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. CONCLUSIONS: For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review. BioMed Central 2010-07-30 /pmc/articles/PMC2921081/ /pubmed/20673343 http://dx.doi.org/10.1186/1472-6963-10-223 Text en Copyright ©2010 Ezzat et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Ezzat, Hanna Ross, Sue von Dadelszen, Peter Morris, Tara Liston, Robert Magee, Laura A Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
title | Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
title_full | Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
title_fullStr | Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
title_full_unstemmed | Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
title_short | Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
title_sort | ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2921081/ https://www.ncbi.nlm.nih.gov/pubmed/20673343 http://dx.doi.org/10.1186/1472-6963-10-223 |
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