6. Protocol Changes

No substantive changes to a cleared study may be initiated until cleared by the REB, unless the change is made urgently to avert serious harm to a participant or any other person, and the change is submitted as soon thereafter as possible. 

For a fuller description of the REB’s policy on Changes to Protocol, including a description of substantive research, see the CUREB Policy on Review of Changes to Protocol.

To request approval for a study change, prepare and submit a Change to Protocol Form and upload to cuResearch. Outline the changes and include any attachments (e.g., new versions of any research documents, including the submission form, recruitment materials, consent forms, or data collection instruments required to be revised as a result of the proposed Changes.