Research Ethics Board - Continuing Ethics Review By The CHEO REB

Reporting Form Annual Renewal
Reporting Form Major Modification
Reporting Form Study Closure

The following are general guidelines for the submission to the Board of modifications to existing protocols and annual renewals. 

Minor modifications to existing protocols (reviewed and approved by the Chair). Two complete copies of these modifications are required. 

A description of all minor modifications made to research protocols after final approval (e.g.; minor changes to the informed consent document or recruitment, changes in Primary CHEO Site Investigator or CHEO co-investigators, etc.) should be submitted to the board.  The Chair alone also reviews scientific modifications to protocols involving more than minimal risk (to the degree that these changes do not affect the therapy provided).  Occasionally, scientific changes are of such extent that they require full board review.  This decision is made on a case-by-case basis by the chair. 

Modifications should be clearly identified in bold lettering.  If changes to the informed consent document are required, both a bolded and two unbolded copies of the modified consent form must be submitted.  The Chair of the Board can approve minor modifications on behalf of the REB and will sign off the revised documents and forward one copy to the Research Assistant/Coordinator or Primary CHEO Site Investigator. 

Major Modifications (reviewed and approved by the full Board).  (18 complete copies are require) 

Major modifications on protocols presenting more than minimal risk to subjects are reviewed and approved by the full board (e.g., scientific and therapy changes, substantive changes to the informed consent document).  The major modifications should be submitted using the Major modification submission form, on page 46.

Changes to clinical drug trials that fall under Division 5 of the Food and Drugs Act require a Health Canada Non-Objection Letter.  The REB will only approve of major modifications of this type after the NOL has been issued.  Under limited circumstances, the REB can waive the requirement for the Amendment Health Canada Non-Objection letter prior to activation of the protocol modification. The waiver is based on section C.050.008 of the Division 5 Food and Drugs Act, which allows safety-based protocol modifications to be activated immediately providing that the sponsor notifies Health Canada of such.

Changes in supportive therapy on clinical drug trials falling under the Division 5 of the Food and Drugs Act do not require a Health Canada Non-Objection Letter. 

In all other circumstances, the amendment NOL should be submitted to the REB upon receipt.

Modifications should be clearly identified in bold lettering in the protocol or in an accompanying letter.  If changes to the informed consent document are required, these should also be clearly identified in bold lettering.  Documentation regarding major study modifications should be submitted to the board for distribution to the members, using the same deadlines outlined for initial protocol review.  

Annual Renewals

The full Board reviews annual Renewals for protocols involving more than minimal risk, which are also funded by the U.S. (18 copies of the annual renewal form [see page 43], consent and progress report, and one copy including the most recent protocol are required and are to be submitted at the same deadlines as for full Board protocols).

The Chair alone reviews annual renewals for all remaining studies (an original and one copy including the annual renewal form, consent, progress report, and the most recent protocol).  The Chair alone also reviews studies that are permanently closed to accrual but in which patients are followed. 

The annual renewal report should be submitted to the Board one month prior to the date indicated on the final approval notice.  The report should include the following: 

• Description of subject accrual.

• Any changes in research design, procedures, and sample characteristics (including any and all changes to the informed consent document).

• Any untoward or adverse event having occurred during the research.

• Data analyses or other reviews regarding study risks and inconveniences (DSMB reports; interim analyses).  

• Any changes to the investigators or the contractual agreement between the Sponsor and the Primary CHEO Site Investigator.

Process for Closing a Protocol