Canadian Cancer Trials Group Bulletins

Ethics Regulatory

Informed Consent Memorandum from the NCI US/CTEP

The Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute in the United States (NCI US) has issued a memorandum regarding changes in informed consent documents in NCI/CTEP-sponsored clinical trials. The memorandum specifies that when new or modified risk information is identified and a protocol amendment to the informed consent document is necessary, enrollment of new trial participants is suspended until the designated Research Ethics Board (REB) has reviewed and approved the changes to the informed consent and accompanying protocol document.

When protocol amendments that include changes to the risk section of the informed consent document are distributed to sites, Canadian Cancer Trials Group will include instructions regarding the suspension of patient enrollment until local REB approval is received. In the event of such an amendment, patients currently on study may continue to receive treatment unless otherwise informed. If patients on study are to be informed of the new or modified risk information while the amendment is undergoing REB review, instructions will be provided in the amendment cover letter.

Non-NCI US affiliated Studies:

Protocol amendments that are sent to sites will continue to contain instructions regarding implementation. This will include the level of REB approval required, instructions about informing patients (both patients who are already enrolled and those considering participation), if applicable, and the REB documentation required at Canadian Cancer Trials Group. Unless otherwise stated, enrollment of new participants may continue while the amendment is being reviewed by the local REB, irrespective of whether there are changes in the informed consent document.

NCI US Affiliated Trials:

As above, protocol amendments that are sent to sites will continue to contain instructions regarding implementation. For protocol amendments that contain new or modified risk information to the informed consent document that is considered to represent a minor alteration in the overall risk-benefit for new participants, enrollment of new participants will be suspended. Unless otherwise stated, such amendments to the informed consent document can undergo expedited review provided the Chair of the designated REB is in agreement. Instructions about informing patients already on study will be included as appropriate. When REB approval of the amendment is received, new patients must be consented to the trial with this REB approved consent. A copy of the REB approval and a copy of the REB approved consent form must be sent to Canadian Cancer Trials Group and a copy kept at the site for auditing purposes.

Details regarding the effective date of accrual suspension will be conveyed to sites on a trial by trial basis as this becomes known, and further refinements in our global processes around specific details are also under review. We appreciate that this change in policy may have significant effects on Canadian accrual to NCI/CTEP-sponsored trials. We further appreciate your patience while we work on the details affected by this change in policy.