Researchers are obliged to follow the procedures outlined in the protocol/proposal approved by the Research Ethics Board (REB). If the researcher or sponsor recognizes the need for modification to the protocol/proposal he/she is obliged to file a protocol amendment with the REB prior to implementing the change.
This guideline outlines:
Examples of amendments that require REB review include, but are not limited to, changes in: key personnel (e.g. principal investigators, co-investigators, study physicians); research protocol objectives; advertising materials (flyers, radio spots, etc.); research procedures; participant populations (e.g., age range); location where research will be conducted; consent/assent form; recruitment procedures; date for completion of study; procedures for monitoring safety data. etc.
Complete and review the Bannatyne Campus REB “Submission Requirement Checklists for Amendments, Additions or Changes to Approved Studies Delegated Review or Full Board Review.
All changes, with the exception of changes in personnel, must be submitted on the Bannatyne Campus Research Ethics Board Amendment Form (pdf).
For changes in study personnel complete Change in Study Personnel Form (pdf). A checklist of required documents is outlined on the form.
Additions to amended documents must be underlined or in bold text and any deletions indicated by strikethrough.
Remember to revise the version date in footer of each page of amended consent forms or title page on supporting documents.
If a "No Objection Letter" (NOL) from Heath Canada (HC) was received for the initiation of the clinical trial, then a copy of the "NOL" from HC for proposed changes to the protocol must be submitted before the REB will approve the proposed amendment or an appropriate justification from the sponsor is outlined in the submission.
REQUIRED FORMS FOR HREB AND BREB
Amendment Form (pdf)