82 - IACUC post approval monitoring program – an essential quality control tool.

Background:
The need to implement a Post-Approval Monitoring (PAM) program at the institute was to establish a program of continuing IACUC oversight of approved protocols and provide support to investigators to maintain compliant and ethical conduct of research involving animals. The primary goal of the PAM program was (A) To ensure all animal studies are being conducted as approved by the IACUC and investigators have adequate knowledge of protocols and animal welfare. (B) To identify areas where additional training of research team members would be beneficial. (C) To encourage investigators/research team members to engage in open discussion with IACUC.

Program

Description:
PAM visits are scheduled at a time when animal research activity is planned, and all members actively involved with animal study can be present. The research team gets a PAM checklist before the visit. During the visit, the activities of the research team are assessed with a Q&A template with respect to the approved protocol. All aspects of the protocol are covered, including animal handling, pre-procedure preparations, aseptic techniques, post-procedure care including animal health evaluation and treatments. In addition, personnel training logs, breeding logs and controlled drug logs are carefully reviewed. Questions posed by the research team are answered or a plan to provide an answer is defined. If deemed necessary additional training for research team members are arranged. PAM findings are presented and discussed with the committee members at the IACUC meeting. Committee members’ suggestions are incorporated and follow up visits are made if required.

Program assessment:
A common deficiency shared by multiple labs in year 2022 was the absence of personnel training records/documentation. This was identified as a minor deficiency that was promptly corrected. This finding prompted the development of an SOP requiring that personnel training be documented along with trainer information. The SOP was posted on the IACUC website and shared with Principal Investigators. A template to document all personnel training on protocol specific procedures was also shared. Subsequent PAMs have encountered far fewer labs with this deficiency. In 2024, minor deficiencies identified were expired drugs in storage (but not administered to animals) and inadequate aseptic surgical techniques. The labs were advised to get fresh supplies and instructed in the proper disposal of the expired products. Additional training was arranged for lab personnel on aseptic techniques. Furthermore, it was decided that labs will be notified every quarter of a year to dispose expired drugs and get fresh supplies. Identifying these deficiencies during PAM and taking immediate corrective action prevented major non-compliances from occurring. In addition, a culture of trust has been promoted resulting in self-reporting of deficiencies and protocol violations in many cases. PAM and IACUC’s continued oversight have resulted in heightened awareness on humane care of research animals.

Limitations of the program:
PAM visits are currently scheduled and announced. A checklist for PAM is sent along with the initial scheduling request for PAM so labs know what to expect. The procedures to be observed and personnel who will perform those are decided by the lab. Unannounced PAM visits might provide a more accurate means to assess laboratory behavior, and this might be of value for labs with a history of animal research non-compliance. In addition, identifying newly trained personnel for procedure observation may be beneficial and will not only evaluate their skill, but also identify any lapse in training. This could potentially lead to identifying deficiencies early and prevent protocol violation or non-compliances from happening.

Discussion:
PAM is an effective quality control tool to ensure that all animal activities are being conducted as approved in protocols and that all regulatory/ethical measures are being followed. The visits provide an opportunity to evaluate and assure that investigators performing the studies are proficiently trained and qualified to do so. PAM visits help to maintain an open line of communication between investigators and the IACUC office. PAM contributes to early identification of minor deficiencies thereby allowing corrections to be quickly implemented. PAM can identify potential issues that affect research data reproducibility and be an opportunity to remind investigators of the inter-dependence between compliance and research validity. To help with the added administrative burden associated with PAM, the institution has designated personnel to coordinate, conduct and report PAM findings.