Research Regulatory Analyst (Post-Approval Monitoring Coordinator) University of Florida CITRA, Florida, United States
Background: Our previous PAM program revolved around protocol discussion. There was no formal mechanism to assess research activities after approval, provide recommendations for refinement, or discuss policy changes. A self-evaluation revealed a need for more communication between departments, an absence of monitoring PAM activities, and minimal evaluation of procedures performed.
Program
Description: The re-designed PAM program entails visiting labs while approved procedures occur and focuses on education and communication. Visits are scheduled with the lab personnel responsible for the hands-on animal care but may include Principal Investigators, Lab Managers, and Veterinarians.
We have two full-time PAM Coordinators with strong lab, vet tech, and training backgrounds. The PAM program relies heavily on communication with the training, husbandry, Environmental Health and Safety, and veterinary departments. Before conducting a PAM visit, the coordinator contacts each department so they may relay any concerns. During the visit, procedures are observed and compared to the approved protocol. Additionally, drug logs, surgical records, and training logs are reviewed. PAM Coordinators send a report of the results to the Principal Investigator and study personnel involved. Findings may be resolved by appropriate training, reverting to the procedures described in the approved protocol, or amending the existing protocol.Fully compliant labs receive a congratulatory email that is sent to the Principal Investigator and study personnel involved in the visit.
Program
Assessment: In the first two years, visits focused on high-risk areas such as survival surgeries, USDA-regulated species, and previous deficiencies. Over 300 visits have been conducted in the third year, spanning multiple disciplines and species.
A satisfaction survey is sent out after visits to receive principal investigtaor feedback. The results are used to continually improve the program so that it may benefit both the IACUC and the Research Staff. Trends are monitored via an Excel database, and PAM Coordinators meet with the Training Core, Veterinary Staff, and IACUC Committee to discuss how to address them. This has led to a strong collaboration between the departments and allows quicker program adaptation. Using survey and metric results, procedure-specific checklists have been developed, and a policy outlining the authority of the PAM program has been implemented.
Survey results show that the program has been well-received by researchers and opened opportunities for discussion between labs and all branches of the animal care program. Metric results have provided opportunities for quick identification and correction of minor issues before they escalate.
Limitations: The biggest hurdle for the program is obtaining principal investigator's willingness to participate in the in-person observations of their activities. Additionally, finding the line between addressing concerns and being too fastidious takes time and practice. We found that an evaluation survey sent out after PAM allowed those involved to voice their opinions and provide recommendations to better the program.
Discussion: Observational-based PAM, compared to an administrative focus, allow in-time comparisons of practices versus approved proved procedures, the formation of stronger relationships between the IACUC and Research Staff, and swift correction of potential concerns.
Our recommendation is to begin monitoring high-risk protocols that involve procedures that cause pain or distress, surgical and anesthetic procedures, USDA species, and protocols with previous deficiencies. Maintain metrics, utilize satisfaction surveys, and continually discuss the results with all departments involved to adapt the program to the institution's needs.
