|Update to Initial Approval Requirements for Trials Not Under a CTA
Canadian Cancer Trials Group has updated its policy with regards to initial ethics review requirements for trials that are not conducted under a Clinical Trial Application (CTA) with Health Canada. This change is effective immediately and applies to all Canadian centres.
Specifically, for trials that are not conducted under a CTA and are not NCI US-affiliated, while Canadian Cancer Trials Group may recommend a specific level of approval, the REB is responsible for determining the appropriate level of review in accordance with the Tri-Council Policy Statement principle of proportionate approach to REB review and local REB policies. The REB's decision supercedes Canadian Cancer Trials Group's recommendation in this instance.
Further information is available in the memo posted on the ethics website. As well, the information on the initial ethics approval webpage has also been updated. If you have any questions, please contact your centre's ethics research associate.
Update to Annual Re-Approval Requirements
Canadian Cancer Trials Group has updated its policy regarding annual re-approvals in response to the updated OHRP Guidance on IRB Continuing Review of Research. This policy is effective immediately, and applies to all Canadian centres.
These changes primarily involve the effective date of initial approval for all trials, and the use of expedited review procedures for NCI US-affiliated trials.
Effective date (all trials):
Previously, initial annual re-approval was due within 1 year from the date of the full board meeting during which the study was reviewed. As a result of this update, the initial annual re-approval is required within 365 days of the effective date of initial approval. Specifically, unless an earlier expiry date is stated by the REB, the first annual re-approval will be due 365 days after the date of final approval. This applies to all Canadian Cancer Trials Group trials.
Use of expedited review procedures (NCI US-affiliated trials):
Centres are permitted to use expedited review procedures for research that (a) only involves procedures described in expedited review categories (1) through (9) and (b) is found by the reviewers to involve no more than minimal risk to the subjects.
Centres are now required to complete the new Confirmation of Expedited Review Procedure Form when using expedited review procedures for NCI US affiliated trials. Please note that expedited annual re-approvals are considered insufficient for NCI US affiliated trials until this form is received by Canadian Cancer Trials Group (completion of this form is not required for expedited annual re-approvals previously received and processed by Canadian Cancer Trials Group). This form and guidance on when/how to complete it can be found on the Canadian Cancer Trials Group ER website.
Further information is available in the memo posted on the ethics website. As well, the information on the annual re-approval web page has also been updated. If you have any questions, please contact your centre's ethics research associate.