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Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

Ezzat, H; Ross, S; von Dadelszen, P; Morris, T; Liston, R; Magee, LA; CPN Collaborative Group, CPN (2010) Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective. BMC Health Services Research, 10. p. 223. https://doi.org/10.1186/1472-6963-10-223
SGUL Authors: von Dadelszen, Peter

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Abstract

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.

Item Type: Article
Additional Information: © 2010 Ezzat et al; licensee BioMed Central Ltd. 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.
Keywords: Canada, Ethics Committees, Forms and Records Control, Hospitals, Public, Humans, Total Quality Management, CPN Collaborative Group, Humans, Ethics Committees, Hospitals, Public, Forms and Records Control, Total Quality Management, Canada, Health Policy & Services, 1117 Public Health And Health Services, 0807 Library And Information Studies
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: BMC Health Services Research
Language: eng
Dates:
DateEvent
30 July 2010Published
Publisher License: Creative Commons: Attribution 2.0
Projects:
Project IDFunderFunder ID
MAG-CPCanadian Institutes of Health Researchhttp://dx.doi.org/10.13039/501100000024
PubMed ID: 20673343
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/107498
Publisher's version: https://doi.org/10.1186/1472-6963-10-223

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