Canadian Cancer Trials Group Bulletins

Ethics Regulatory

Initial Local Consent Form Review Process

Following consultation with the Centre Representatives Executive Committee and the CRA Steering Committee about our informed consent (IC) approval processes, Canadian Cancer Trials Group is instituting a change in the review process for initial consent forms.

Effective April 21, 2009, it is no longer mandatory that centres send their initial local consent forms to the Central Office for review prior to REB approval. It remains mandatory that centres send amended consent forms to the Central Office for review prior to REB approval (except when the Canadian Cancer Trials Group "letter to investigators" indicates otherwise) if any additional changes have been made by the centre, or if any of the changes required by an amendment/administrative update have not been made.

As before, the REB approved consent form must contain all mandatory required elements and be consistent with the protocol and Canadian Cancer Trials Group policy. If the REB approved consent is missing any mandatory required elements or contains information that is not correct with respect to the protocol or comply with Canadian Cancer Trials Group policies, the consent will need to be revised and re-approved by the local REB prior to activation.

Please refer to the memo posted at for further details.

If you have any questions about this, please contact Christopher Boot, Ethics Research Associate, at