When conducting clinical trials in Canada, a Sponsor must generally possess, for each clinical trial site, a Research Ethics Board Attestation (REBA), which provides administrative information regarding the research ethics board (REB) as well as a certification that its composition, operations and decisions are in compliance with Canadian regulations.
A REBA must also be completed for each clinical trial site whenever the clinical trial application is amended (for example when modifications have been incorporated to the Clinical Study Protocol). Therefore the completion, collection, and tracking of the REBAs may represent an administrative challenge in the context of a multicenter trial for both the Sponsor and the Sites.
As part of its commitment to keeping studies on TRACKTM and to reduce the record-keeping burden on Sponsors/CROs and Sites, Veritas IRB has incorporated the Health Canada ‘Research Ethics Board Attestation’ (REBA) text into its Approval Forms. This is permitted by Health Canada, which specifies that the IRB Approval Form ‘does not need to include all the elements contained in Part 1, Part 2 and Part 3 of the REBA Form’.
Veritas IRB incorporates the REBA text into its Approval Forms only for the unconditional approval of a research Site – or for the implementation of a Protocol Amendment at the Site – for research being conducted under a Health Canada No Objection Letter (NOL). There is no equivalent requirement for device research being conducted under a Health Canada Investigational Testing Authorization (ITA).
For multicenter trials, the REBA text is incorporated only into Veritas IRB’s Site-specific Approval Forms, and not into any of the central- or study-level Approval Forms, because the REBA is Site-specific in nature. Section 3 of the REBA text states: ‘…for the trial which is to be conducted by the qualified investigator named above at the specified clinical trial site…’
