Full Board review
REB Composition & Meetings
The membership is designed to reflect professional and scientific values, the values of SickKids, and those of the broader community. All deliberations are conducted with sensitivity to diverse community values, the protection of human subjects, and the promotion of ethical research.
The SickKids REB exceeds the minimum composition requirements as set out in regulatory and guidance documents which stipulates at least five members including expertise in bioethics, the law, methods or areas of research, and a community member. Presently the Board consists of 20 members including three community members. The membership meets twice monthly, typically on the second and fourth Fridays of each month for five hours. The Coordinator staffs these meetings and prepares the minutes. Meeting decisions are reached by consensus.
Submission of New Applications
Applications that require full Board review must be submitted, with all necessary supporting documents, to the REB office. Applications are reviewed by office staff and if key information is missing the application will be returned to the investigator for completion.
Because of the increasing volume of new applications, the number of new applications that will be reviewed at each bimonthly meeting will be capped in order to allow for a thorough review. As a result, investigators are strongly encouraged to submit their applications early. The impact of capping will be evaluated in several months time.
Bimonthly Meeting Review
Each new application is assigned a primary and secondary reviewer from the membership based on expertise, interest and meeting workload assignment. The primary reviewer assumes responsibility for summarizing the application, detailing for the Board any outstanding issues or concerns, and negotiating with the investigator final revisions on behalf of the full Board following meeting review. Secondary reviewers complement and fulfill the work of the primary reviewer in the primary reviewer's absence.
For protocols which involve significant risk or raise unique ethical issues, the investigator may be asked to attend the meeting to discuss the application. All decisions are reached following the investigator's departure from the meeting.
Within three days of the Board meeting detailed follow-up letters are sent from the Coordinator reflecting the outcome of the Board's review and identifying the primary reviewer's contact information.
It is the responsibility of the investigator to initiate contact with the primary reviewer and to ensure the review process is concluded. Investigators must complete the review process within three months of the date of the Board's follow-up letter or the file will be closed and archived by office staff.
Reconsideration
If a satisfactory solution is not reached between the investigator and the primary reviewer, the investigator may be invited, or request to be invited, to the next full meeting to discuss the outstanding issues. A follow-up letter summarizing the outcome of the Board's deliberations will be sent to the investigator.
Appeals Process
In the event that the REB rejects a submission by an investigator, the investigator may appeal this decision to the Toronto Academic Health Sciences Committee on Human Subjects Research Review which will act as the REB Appeal Committee.
More information on the appeals process.
Annual Study Re-approval
Approvals are for a one year term and investigators must renew their studies annually for the life of the study or the file will be closed and archived by the office staff.
Investigators are mailed notification of study re-approval requirements eight weeks in advance of the anniversary month of the original approval. Upon receipt of the completed renewal form, the Chair reviews the form for acceptance and the study is included on the meeting agenda for full Board approval.
Requests for study re-approval at year five must be accompanied by a completed scientific re-review. This will confirm that there has been nothing reported in the literature that would impact on the study design or continuation since its original approval. Study re-approval letters are automatically generated and mailed to investigators following the Board meeting.