101 - Customized Risk-Based Post-Approval Monitoring Sessions to Improve Animal Welfare Related Compliance

Background:  The Guide 8th Edition says that continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. PAMs of animal activities can be achieved in multiple ways. Here we show one component of the PAM program which includes a risk-based evaluation of protocols to determine outreach strategies.

Program

Description:  The risk-based evaluation includes criteria such as procedure types, use of biological/chemical/radioactive materials, inclusion of departures, etc. After a protocol is determined to be of high risk, the PAM meeting is initiated by the IACUC office. At the end of 2023, as part of continuing process review, changes were made to improve the meeting outcomes and the buy-in of the research teams. Follow up emails were sent to the research team after the PAM meeting. This process was further improved by developing a Case Report Form that compiles all the information the team will focus on during the meeting. The form helps the PAM team prepare for the meeting and helps the team receive structured feedback. Based on PIs and lab member’s feedback, the most game-changing action was providing them with the summary of the PAM and follow-up items as suggestions for improvement.

Program

Assessment:  Part of the continuing process review of the PAM program was to observe the trends in inspection findings at the end of the reporting period. We identified that teams who had just started activities with animals were having minor deficiencies due to lack of knowledge of policies, or other reasons. The risk-based approach allowed to identify newly approved protocols through the signing of an attestation document, reminding teams of their obligations, then, setting up meetings with the teams to focus on items to be discussed with the PI and the lab members during the PAM and providing them with a table summary that includes all discussion points and follow ups. A thorough audit of the protocol is done to evaluate anesthetic and analgesic regimens, monitoring criteria, alignment with institutional policies, and ensuring completion of post-approval training. This new approach has allowed a shift in the focus of the PAMs from being primarily done for cause to being able to focus on new investigators based on risk associated with their animal research activities impacting animal welfare.

Limitations: Limitations on the risk-based assessment of animal activities include logistics (e.g., timing of the PAM with start of lab’s animal activities), personnel rotating through the lab, and those present during the PAM meeting may not be the same as those performing the procedures. Other limitations are specific to unique or novel disease models that are difficult to monitor and where there is no clear guidance or resources available to evaluate the progression to endpoint.

Discussion:  Consistently reviewing findings and pinning areas for improvement allows for better use of time and resources. These types of findings are presented to the IACUC Committee, the Associate Vice President of the Office of Research Compliance and Regulatory Affairs and the Institutional Official (IO) through the Semiannual Report to the IO. We learned that providing a detailed checklist and summary to the labs with which we perform PAMs has decreased non-compliances and increase lab practices and engagement with the IACUC office. We envision using this practice to continue to evaluate each lab that uses animals in research at our institution.