Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective
- Equal contributors
1 Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, V6 H 3N1, Canada
2 Department of Obstetrics and Gynaecology, University of Calgary, Calgary, T2N 2T9, Canada
3 Department of Family Medicine, University of Calgary, Calgary, T2N 4N1, Canada
4 Department of Community Health Sciences, University of Calgary, Calgary, T2N 2T9, Canada
5 Department of Surgery, University of Calgary, Calgary, T2N 2T9, Canada
6 Department of Medicine, University of British Columbia, Vancouver, V5Z 1M9, Canada
7 Department of Health Care and Epidemiology, University of British Columbia, Vancouver, V6T 1Z3, Canada
8 Child and Family Research Institute of British Columbia, Children's & Women's Health Centre of BC, Vancouver, V5Z 4H4, Canada
BMC Health Services Research 2010, 10:223 doi:10.1186/1472-6963-10-223Published: 30 July 2010
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.
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.
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.
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.