Clinical Trials Committee  |  Amending a Study

Any changes to approved research must be reviewed and approved by HREBA before the changes become effective, except in situations where an immediate risk needs to be eliminated.

HREBA uses an electronic platform, IRISS, to receive and process all submissions for ethics review; IRISS uses the term ‘modification’ to refer to an amendment. Step by step instructions on how to modify a study using IRISS are available on the HREBA IRISS resource page.

Note that if an amendment requires a Health Canada Clinical Trial Application – Amendment (CTA-A), the CTA-A must be authorize by Health Canada prior to implementation of the amendment (as per the Health Canada guidance document). HREBA requires that the No Objection Letter (NOL) from Health Canada is submitted for acknowledgment – either with the initial modification submission, or separately in a future submission. If submitted separately:

• If there are no conditions on the NOL, the IRISS modification will be approved administratively as a minor modification.
• If there are conditions on the NOL, it will require delegated review. Do not implement the amendment until this review is complete.

Amendments to the protocol (including consent form changes) that present greater than minimal risk to the participants are to be reviewed at a convened full committee meeting. It is at the Chair’s or Vice Chair’s discretion as to whether an amendment should be reviewed by the full committee or sent for delegated review.

Last Edited: 06 Nov 2019