All research studies, databases/registries or specimen repositories, etc. that received initial approval from a Bannatyne Campus Research Ethics Board (REB) must be resubmitted for annual approval to the appropriate REB no later than 4 weeks prior to the expiry date noted on the initial certificate of final approval.   This includes all research studies, databases or specimen repositories, etc. that may be closed to accrual/enrolment and/or where there is ongoing follow-up of study participants (e.g. continued collection of mortality/morbidity information related to the initial study, research databases/registries, etc.)

Studies that do not involve participant participation, for example, secondary use of data, must be submitted for renewal up until the point that the data acquisition is completed. Local research databases/registries or specimen repositories should submit an application for annual approval up until the point the data or specimens are destroyed.

The Bannatyne Campus REB office must be notified of closure via the Bannatyne Campus Research Ethics Board Final Study Status Report of any study previously submitted for ethical review regardless of whether the study received final approval or not.

Tips when requesting Annual Approval

All requests for annual approval, including research approved by the HREB and BREB, must be submitted using the Bannatyne Campus Research Ethics Office "Annual Study Status Report".

Submit the request for annual approval 4-6 weeks prior to the expiry date noted on the initial certificate of approval or last annual approval certificate to ensure there is no lapse in approval.

If recruitment is ongoing, include one copy of the consent form presently in use for review and approval.

Amendments/Changes to an Approved Protocol

Researchers are obliged to follow the procedures outlined in the protocol/proposal approved by the Research Ethics Board (REB). If the researcher or sponsor recognizes the need for modification to the protocol/proposal he/she is obliged to file a protocol amendment with the REB prior to implementing the change.

This guideline outlines:

the necessary information that is required of the applicant when submitting a request to the REB; and
details the operating procedures of the Bannatyne Campus REBs review process related to amendments.

Tips when submitting Amendments/Changes to a protocol

All changes must be submitted on the Bannatyne Campus Research Ethics Board  "Request for Amendment/Changes to a Previously Approved Study" form.

Additions to amended documents must be underlined or in bold text and any deletions indicated by strikethrough.

Remember to revise the version date in footer of each page of amended consent forms or title page on supporting documents.

When are NOL's required for amendments?

If a "No Objection Letter" (NOL) from Heath Canada (HC) was received for the initiation of the clinical trial, then a copy of the "NOL" from HC for proposed changes to the protocol must be submitted before the REB will approve the proposed amendment or an appropriate justification from the sponsor is outlined in the submission.

Protocol Deviation Reporting Requirements

As per ICH GCP 4.5.2 "The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g. change in monitor(s), change of telephone number(s).

This guideline outlines the requirements for submitting information concerning a protocol deviation that had not received prior approval by a Bannatyne Campus Research Ethics Board, as required under ICH GCP 4.5.2, because the deviation was necessary in order to ensure subject safety, was of an inadvertent nature, or was administrative in nature.

Updated on January 20, 2011