Quality Improvement & Compliance (QuIC) Reviews consist of four sub-components that examine the entire research process by focussing on the researcher, the REB review process, and/or the REB records and documentation maintained at each UBC-affiliated REB.
1. Routine On-site Reviews
The QuIC Manager conducts these random reviews of studies that have been approved by any of the seven UBC-affiliated REBs. The review ensures the study is compliant with the REB-approved protocol as well as with relevant institutional, national, and international regulatory policies and/or guidelines for the conduct of research involving human subjects.
The findings from a routine on-site review are shared with the Principal Investigator and his or her research staff. Should additional attention be required, the findings may also be shared with the Associate Director Research Ethics and reported to the relevant REB to determine whether corrective action is necessary.
2. Directed On-Site Reviews
These reviews are conducted by the QuIC Manager at the request of an REB, the Vice President Research & International, or the Associate Director Research Ethics. Such requests are issued in response to a specific concern about the conduct of the study. A directed review uses the same procedures as a routine review.
The findings of a directed review are shared with the Principal Investigator and his or her research staff, the REB and senior research administration, if warranted. If the REB determines that the identified deficiencies warrant suspension or termination of the research, the REB develops a plan for follow-up that may involve another QuIC review, monitoring of the informed consent process, or other procedures.
3. PI Self-Audit Reviews
These voluntary reviews are undertaken by the PI or his or her research staff. A PI may also be prompted to perform a self-assessment review at the invitation of the REB, Vice President Research & International, or Associate Director Research Ethics .
The Self-Audit Tool for Research Personnel includes questions and information pertaining to federal regulations governing human research protections, local REB policies and procedures, and International Conference on Harmonisation (ICH) GCP guidelines.
Based upon the results of the self-audit, the QuIC Manager can suggest corrective actions to the PI in areas of improvement. The REB will not be notified of results from a PI self-audit review unless the results reveal significant deficiencies in the protection of human subjects, or if the REB initially directed the PI to complete the self-audit.
4. Administrative Assessment Reviews
The QuIC Manager conducts these reviews at the discretion of the Associate Director Research Ethics and/or the Vice President Research & International. Administrative assessment reviews involve a thorough examination of an REB's records and are conducted to help improve its performance.
The results of an administrative assessment are shared with the Associate Director Research Ehtics. The results may impact current practices and may require additional educational activities for REB members, investigators and research personnel, or members of the Office of Research Ethics.
