REB's review process/Review of ethics applications
Review is conducted in accordance with TCPS guidelines based on the general principle of proportionate review. Minimal risk occurs when potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participants in the research to be no greater than those encountered by the participant in those aspects of his or her everyday life that relate to the research.
Type of review
Full Board Review
Research, which involves greater than minimal risk, notable deception, and/or biomedical procedures, is reviewed by the full REB. Major study amendments and adverse events (at the decision of the Chair) will also be review at those monthly meeting.
Studies can be reviewed in a delegated fashion if the study does not involve more than minimal risk. Delegated review is also conducted for most amendments, adverse events and annual renewals. Applications which qualify for delegated review are reviewed by a subcommittee of the REB consisting of the Chair and REB manager and, if needed with the addition of one or two REB members because they have an expertise relevant to project being evaluated. Delegated review occurs outside the monthly meetings and are reported to the next meeting of the full REB.
In accordance with the SOP 402.002 Hôpital Montfort REB decisions are adopted by consensus or by a majority. The REB may make one of the four following determinations as a result of its review of research and documentation submitted for initial or continuing review, the decision is transmitted in writing to the research team:
• Approval: The protocol and accompanying documents are approved as submitted.
- Approval with Modifications/Clarifications: The REB may decide that a Protocol may be approved provided that certain conditions are met or required changes are made.
- Deferral: The REB defer their decision on the protocol if it does not have sufficient information to arrive at a determination, or if the REB requires extensive revisions to any part of the research. The application will be reviewed at a future Full Board meeting when the additional information or revisions are received.
- Disapproval: The REB may reject the protocol when it fails to meet the ethical standards for approval and where revision is unlikely to enable the REB to reach a positive determination,
Should you have any questions or require an explanation do not hesitate to communicate with the research ethics Office (REO).