Assistant Research Integrity Officer Oregon Health & Science University Beaverton, Oregon, United States
Background The Oregon Health and Science University (OHSU) Animal Care and Use Program (ACUP) has about 350 IACUC protocols and spans 3 campuses, including the Oregon National Primate Research Center. Historically, OHSU’s post-approval monitoring (PAM) program included IACUC protocol continuing review, rolling laboratory inspections, and follow-up on non-compliance and adverse events. When the USDA ended its requirement for Annual Review (AR), OHSU’s ACUP took the opportunity to bolster its PAM program by repurposing the electronic AR form into a PAM tool.
Program Description The IACUC uses a custom electronic “eIACUC” platform, which notifies users when their AR is due at the end of Year 1 and Year 2 of the 3-year life of their IACUC protocol. In 2021, OHSU’s AR form was modified to ask Principal Investigators (PIs) to attest to a series of program- and protocol-specific statements. These statements affirmed PIs familiarity with their protocols, regulations, and the institution’s policies and guidance, and included hyperlinks to related IACUC policies for easy access. Monthly, the PAM Specialist chose ~20% of submissions for further analysis, with emphasis on protocols with USDA species and those assigned pain Category E. Submissions were compared against the parent IACUC protocols for which they were submitted. The PAM Specialist reviewed staff training, anesthesia, intraoperative, and/or postoperative records. These reviews sometimes generated follow-up contacts to confirm processes were in place to adequately monitor animal work and ensure animal welfare. The PAM Specialist educated research staff on topics ranging from training requirements and husbandry procedures to recordkeeping, and provided templates for improved documentation. A summary of findings was presented to the IACUC and Institutional Official during semiannual Program Evaluation. Summary data included total annuals submitted and reviewed, findings and the species and pain categories of the associated protocols reviewed. Communications with researchers were also summarized.
Program Assessment Research staff have been receptive to the new program. Inconsistencies discovered in recordkeeping have led to IACUC protocol clarifications & refinements. No protocol non-compliances were identified. Though still in its infancy, we are recognizing some real benefits to this initiative. These include increased face time with our research community, an increase in protocol familiarity on behalf of research staff and more consistent communication with researchers over the life of their protocols. We are also able to reinforce both OHSU’s policies and federal regulations, and assure the IACUC and Institutional Official that our PAM program is robust. We recognize that there are areas for improvement. The emphasis on reviewing Annuals associated with “higher profile” protocols, including pain Category E and those with USDA species, means other protocols could slip through the cracks. Our ACUP consists primarily of non-USDA rodent protocols assigned pain category D, so we will likely need to reevaluate our selection strategy in the future. Finally, summaries are somewhat subjective and we will need to determine how to best obtain long-term objective metrics for reporting to the IACUC and Institutional Official.
Discussion The OHSU PAM program must be adaptable to the complexity of its Animal Care and Use Program. This new tool, adapted from an existing electronic form, has expanded the IACUC office’s outreach to the research community. We are considering further expanding use of this tool to strengthen communications with laboratories that require regular oversight. We believe this PAM tool could be adapted to other animal care and use programs, connecting IACUCs to their research communities, thus providing continuing education on the policies and regulations guiding the work they perform.
