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

Background: The 8th Edition of the Guide states continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. PAM sessions are a way that this oversight can be achieved. A component of this PAM program includes a risk-based evaluation of protocols to determine outreach strategies.

Program

Description: At the end of 2023, changes were made to improve PAM session outcomes and the buy-in of research teams. After a protocol was deemed to be high risk, the PAM session was initiated. The PAM team determined risk-based criteria as new PIs having major survival surgeries and/or invasive survival procedures, new PIs using biological, chemical, or radioactive materials and new PIs having inclusion of departures, etc. Follow up emails were sent to lab members after the conclusion of the PAM session. This process was further improved by developing a Case Report Form that compiled all the information the PAM team would need to focus on during the session and provided detailed summaries to lab members once the session was over. Based on PIs and lab member’s feedback, the most game-changing action was providing this summary and all follow-up items as suggestions for improvement on the Case Report Form.

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 the PAM team to identify newly approved protocols through the signing of an attestation document, reminding labs of their obligations when handling animal subjects. After the letter is returned, a thorough audit of the protocol is done by the PAM team to evaluate anesthetic and analgesic regimens, monitoring criteria, alignment with institutional policies, and ensuring completion of post-approval training. After the PAM, a summary of the discussion with all follow ups is provided to the lab. This new approach has allowed a shift in the focus of the PAM sessions from being primarily done for cause to being able to focus on new investigators based on risks 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 sessions with start of lab’s animal activities), personnel rotating through the lab, and those present during the PAM session 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). We learned that providing a detailed Case Report Form to labs has decreased non-compliances and increased engagement with the IACUC office. We determine this information through our protocol system and can see decreasing and increasing metric trends. We envision using this practice to continue to evaluate each lab that uses animals in research at our institution.