Post-Approval Monitoring: Making it Stick


Problem statement: There was a lack of monitoring and review of animal research after the approval phase. We developed and successfully instituted a post-approval monitoring/review program that is fair, comprehensive, and provides value to both researchers and research administrators.

Description of research: The post-approval review (PAR) program at the University of Toronto was developed in response to a need to evaluate the conduct of animal-based research projects after approval. Before the program was created, there was no formal mechanism in place to perform randomized, in-depth audits of research after approval. As a large, decentralized institution with ~200 principal investigators (PIs) submitting approximately 500 animal use protocols to five IACUCs, it was recognized that a formal system was required to systematically and fairly assess the work done after approval and ensure compliance with the regulations, as well as provide value to the PIs in the sharing of information and best-practices. The PAR program was developed after a detailed review of similar programs at peer institutions was undertaken, and the program was designed to avoid issues that were seen in other programs. The PAR program has been underway for less than two years, and during that time 91 labs have been audited by a single full-time staff member who coordinates the program. The program has been found to be well-received by researchers, and it has afforded compliance staff the opportunity to efficiently find and correct minor issues before they escalate. Due to its design, the program is well-suited for implementation at a diverse range of institutions.

Additional information: In the Canadian context, post-approval monitoring is an emerging regulatory requirement, but across the country there are few well-developed programs. The program at the University of Toronto is robust, well-functioning, and highly efficient. It may be of interest to other institutions that are in the midst of designing their own PAR program.