Reviews
Scope
All research conducted by staff at SickKids, irrespective of where the research will be conducted, where the subjects will be recruited, or where the funds will be administered must obtain prior SickKids REB written approval before the study may commence (ref. TCPS 1.14). This includes human data, remains, cadavers, tissues, biological fluids, or fetal waste tissue.
Quality improvement projects may require approval. Please refer to the Quality Improvement Projects Policy or contact Marie Pinard, Quality & Risk Management Department at ext. 8290.
Criteria
Research on children can be ethically justified only when:
* the research is scientifically sound
* prior similar research has been conducted successfully in adults (where possible)
* the research does not expose subjects to more than minimal risk without the potential for direct benefit to them
* there is an adequate process for informed consent along with the child's assent (where applicable)
* there is justice and fairness in selection of children
Annual Approval
All approvals are for one year. Investigators are automatically notified by e-mail six (6) weeks in advance of the anniversary meeting to submit a completed renewal form. A completed renewal form is required for annual reapproval to occur. Non-responses will be interpreted to mean that the study has been abandoned and the REB office will proceed to close and archive the file.
Proportionate Review
Review is conducted in accordance with TCPS guidelines based on the general principle of proportionate review; i.e., the more invasive the research, the greater should be the care in assessing the research. (TCPS Article 1.6).
Health chart research (i.e., secondary use of data) is reviewed by the REB Chair and additional expertise from the REB, if necessary. These approvals are reported to the next meeting of the full REB.
Expedited review (other than health chart research) Applications which qualify for expedited review are reviewed by a subcommittee of the REB consisting of the Chair and ViceChair. In the absence of a ViceChair, alternating members participate as a second reviewer, based on their expertise. Expedited review is also conducted for most amendments, adverse events and annual renewals. Expedited review occurs outside the monthly meetings upon receipt and are therefore not bound by the monthly meeting dates. Expedited approvals are reported to the next meeting of the full REB.
Full Board review is provided for all other new applications, and major study amendments and adverse events (at the decision of the Chair) at the monthly meeting.
Multi-site research
In instances where multi-site REB approval is necessary, investigators are strongly encouraged to submit their project to the SickKids REB first. Several University of Toronto affiliated REBs will conduct an expedited review of the project, once SickKids approval has been obtained.
Letters of support from external institutions where subjects will be recruited must be included with the SickKids application
Student research projects
Student projects undergo the same rigor of review as all other research projects and only undergo expedited review if the project fulfills the criteria for expedited review.
Graduate students must include evidence of support from the Chair of their academic review committee as part of their submission.
When in doubt, please contact the REB office staff to confirm the required level of review.