For Researchers by Researchers – Relevant REB Review
1. Submission Requirements (CTA / IND Trials – Phase I – III)
The following is a general list of items needed. Each trial may need additional information based on the nature of the trial and the “invasiveness” of the therapeutic maneuver. For sites joining an already approved trial, some of these documents will already be on file.
2. Submission Requirements (Non-CTA Trials – Phase IV)
Sponsors and Investigators often wonder if Phase IV trials require REB approval. These trials do not require submission or approval from Health Canada, so why do they need REB approval?
What To Expect After Submission
The Board Review
When the initial, continuing, or modification submission does not meet the criteria for approval, the REB considers the research to have extensive deficiencies. They will then issue a “disapprove” determination with a summary of reasons and recommendations if any.
Veto on a Research Changes
Once the Board makes a “disapprove” determination on a change in research, this modification cannot be implemented. The Board expects the research will continue as previously approved.
You may request reconsideration of a “disapprove” determination and provide additional information to the Board for consideration. The investigator may appear before the Board in person or via teleconference if desired.
The Board issues a “defer” determination when the provided information does not meet the criteria for approval. They will request additional information to decide further.
Determination: Conditionally Approve
When your initial, continuing, or modification submission meets the criteria for approval with minor/prescriptive changes or requirements, the board issues a "conditionally approve" determination.
You will receive written notification of the conditions promptly after the review. Once you send the requested information, your submission will be re-reviewed. You will receive your approval documents when this additional process is complete and all the information is confirmed.
The study, changes in research, or other submitted material are not approved until we confirm that any/all of the condition(s) are satisfied. You are not authorized to begin research-related activities until you receive final approval documents.
The Board issues an “approve” determination when your initial, continuing, or modification submission meets the criteria for approval. This approval is based on board-required consent form modifications. We’ll provide a finalized consent form with the required modifications. Then we will send you a Health Canada compliant Approval Package
The Outcome Documentation
When your study has been reviewed, we’ll prepare and send the outcome documents to you with all designated contacts, such as:
Reach Out to Our Research Review Board
For additional information about the requirements and process of our research review, feel free to get in touch with us today. It would be our pleasure to respond to your questions.