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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...

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Autores principales: Ezzat, Hanna, Ross, Sue, von Dadelszen, Peter, Morris, Tara, Liston, Robert, Magee, Laura A
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
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.
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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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