There are three levels of Review for Amendments (see TCPS2(2018) Article 6 [6.12]). In general, amendments to protocols that initially received delegated approval will continue to receive delegated or administrative review. For studies that were initially reviewed and approved by the Full Board, administrative changes or changes that are of minimal risk to participants will receive delegated or administrative review, and approval at the discretion of the Chair of the REB. Administrative and delegated approvals are reported to the REB at the regular REB meetings and are documented in the REB minutes.
- Administrative reviews are for amendments which pose no change to the ethical considerations of the project. These are reviewed and approved on behalf of the REB by the Manager, Research Ethics.
- Delegated review is for minimal and low risk protocol amendments. These are reviewed by one or more members of the REB.
- Full Board review is for amendments that are not eligible for delegated or administrative review and/or must have the Full Board review for reporting to regulatory agencies. These types of amendments usually involve an increased the risk to the participants engaged in the project.