title: Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.
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.
authors.affiliation: Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, V6 H 3N1, Canada.
authors.forename: Hanna
authors.initials: H
authors.lastname: Ezzat
authors.forename: Sue
authors.initials: S
authors.lastname: Ross
authors.forename: Peter
authors.initials: P
authors.lastname: von Dadelszen
authors.forename: Tara
authors.initials: T
authors.lastname: Morris
authors.forename: Robert
authors.initials: R
authors.lastname: Liston
authors.forename: Laura A
authors.initials: LA
authors.lastname: Magee
mesh_terms: D002170:Canada; D017041:Ethics Committees / Q000458:organization & administration*; D005568:Forms and Records Control / Q000592:standards*; D006779:Hospitals, Public; D006801:Humans; D017749:Total Quality Management / Q000941:ethics / Q000458:organization & administration*