Research Western

Post-Approval Events

Ongoing Maintenance of your Protocol

Post-Approval Forms Available on ROMEO

As of March 1, 2014, all Health Sciences Research Ethics Board (HSREB) post-approval (any submission completed following initial approval of a research study) forms will be available on, and must be submitted via, ROMEO. Hard copy forms will no longer be accepted after March 31, 2014. The Office of Research Ethics will NOT accept online submissions (initial and post-approval forms) unless:

The submission will not be accepted for review if these conditions are not met. These guidelines are in conformity with requirements for continuing ethical review as set out in the Tri-Council Policy Statement, and in compliance with regulations governing clinical trials (Health Canada regulations for the investigational use of drugs, radiopharmaceuticals, biologics, natural health products and medical devices), ICH GCP E6, and where relevant, the U.S. Code of Federal Regulations.

NEW HSREB Post-Approval Policies:

NEW HSREB Post-Approval Online Forms:

Which Post-Approval Submissions will receive a Formal Approval Letter?

A formal approval letter will only be issued for the following post approval submissions:

Which Post-Approval Submissions will receive an Acknowledgment of Receipt?

An Acknowledgment of Receipt email will be issued for the following submissions:

An Acknowledgment of Receipt email will NOT be issued for CER Form submissions. The sender is instructed to check ROMEO that this submission has been processed and document “proof of submission” to indicate on their records that the document has been submitted to the HSREB.

Letter of Attestation

Principal Investigator (PI) and Co-Investigator (CoI)

Any post-approval form that is not submitted directly by the PI requires a separate Letter of Attestation. A Letter of Attestation is completed by the PI authorizing the submission.  An Attestation Letter must be included as an attachment.  All Letters of Attestation must include the following information:

Study Personnel Amendments

Change in Principal Investigator (PI) and Co-Investigator (Co-I)

Changes in PI and Co-I require a submission of an Amendment Form via ROMEO. Please remember to upload tracked and clean copies of any previously approved documents that have changed due to the amendment.

Change in study personnel other than the PI and Co-I

Changes in study personnel (non-PI/Co-I) may be submitted via email to the ORE. If changes in personnel are submitted via email the email must come from the Principal Investigator or the request will not be acknowledged. Send any non-PI/Co-I personnel change requests to:

Required Documentation:

An email from PI with the following information: