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Expedited review

All new applications are reviewed by the full Board unless they qualify for expedited review. Investigators do not need to request an expedited review. All applications are automatically assessed for expedited review upon receipt by the REB office.

SickKids Expedited Review Criteria

• The study is non-invasive. Harms cannot include; e.g., breaking of skin, noxious procedures, invasive questionnaires in vulnerable circumstances/context, or significant nuisance or inconvenience that are proposed specifically for the research alone.
• The study involves administering a brief survey over the telephone or at the time of a routine clinic visit.
• The study involves taking limited volumes of additional blood samples at the time of the clinically-indicated blood drawing, or limited MRI time extension. The allowable amount will be based on the age, weight, and health of the subjects.
• The study involves taking limited volumes of peripheral blood that requires a special blood draw from healthy consenting adults. 
• The study consists of a comparison of standard therapies, confirmed by peer review, and does not involve invasive outcome assessment. 
• The study of charts or databases is retrospective in nature.
• The study involves no direct subject contact, may involve waste or leftover tissue, blood, urine, excreta etc. and only aggregate data is being reported. Exceptions: studies involving fetal waste tissue or genetic material must be submitted for full Board review.
• The study involves non-invasive product testing, Phase IV drug or medical device testing, or quality assurance activities that require REB approval.
• If the project is being funded by a commercial sponsor, full Board review may be required.
• The pilot study has received approval and the full study proposed only varies in the recruitment numbers, and is not being funded by a commercial sponsor.

Process for Review

Applications which qualify for expedited review (except as noted below) are submitted on a long application form. They are reviewed by a subcommittee of two REB members normally consisting of the Chair and Vice-chair. In the absence of a Vice-chair, alternating members participate as the second reviewer, based on their expertise. Approvals are reported to the next meeting of the full REB. Members may request a copy of the full protocol, and in the event that the full Board does not confirm the approval, the study will be halted until all issues are resolved.

Applications for health chart or database research (i.e., secondary use of data) are submitted on a specialized application (short) form and are approved by the Chair. If necessary, the Chair will recruit additional expertise from the REB to review the application. Health chart research does not require prior REB-delegated scientific review. These approvals are reported to the next meeting of the full REB. Applications may be forwarded to the full Board for review if the Chair deems it necessary.

Applications for tissue based research which do not involve genetic testing are submitted on a specialized application form and are approved by the Chair. The Chair may recruit additional expertise from the REB to review the application at his discretion. These approvals are reported to the next meeting of the full REB. Members may request a copy of the full protocol, and in the event that the full Board does not confirm the approval, the study will be halted until all issues are resolved.