The Augusta University Post Approval Monitoring (PAM) Program serves as a mechanism to ensure that work with live animals is conducted in accordance with all applicable federal laws, regulations, and policies, as well as the recommendations within the Guide for the Care and Use of Laboratory Animals. The PAM program reports monthly to the IACUC but operates independent from the IACUC. PAM facilitates communication between the research faculty and staff, DLAS, and the IACUC to ensure animal welfare in the pursuit of progressive science. PAM visits are intended to be collegial and supportive of animal based research on our campus and are designed to assist in preparing laboratories for regulatory visits.
Scheduled Reviews – Protocols will be pooled by priority (USDA pain category, multiple survival surgeries, etc.). Annually, approximately 10% of approved protocols (from each pool) are planned to be randomly chosen for a scheduled PAM laboratory visit. Principal Investigators (PIs) will be notified via email to schedule the visit and will be sent a pre-meeting checklist to prepare their staff for the meeting.
Unscheduled Reviews – Informal laboratory visits; these visits serve as a way to provide reminders to PIs to follow the IACUC approved procedures in the protocols, as well as appropriate procedures regarding animal care and welfare.
For-Cause Reviews – Laboratory visits that serve to support a systematic or formal inquiry, requested by the Attending Veterinarian or the IACUC, to discover and examine the facts of an incident or allegations of misconduct related to the use of animals.
Continuing Reviews – Review of animal use protocols and federal grants for congruency.
Semiannual Reviews – The Post Approval Monitor may assist the IACUC during the semiannual program review by visiting laboratories according to the schedule set by the IACUC office.
At the end of each visit, the PAM representative will discuss observations made during the visit with the PI and research personnel. Following the visit, the representative will draft and send an initial report to the PI, to provide an opportunity for the lab to respond with clarifications before the formal report is prepared.
Final reports will include PAM recommendations for corrective actions (e.g. an AUP amendment) regarding any findings of protocol deviation or other compliance issues. Reports will be presented to the Director of Veterinary Services and monthly to the IACUC.
All records and reports created by the PAM will be kept on file in the DLAS office.
WHAT IS POST-APPROVAL MONITORING?
Post-approval monitoring (PAM) is a review of the animal use protocols, study procedures, and study-related documents to ensure compliance with applicable University and federal regulations governing welfare of research animal subjects. Post-approval monitoring helps ensure the welfare of animal research subjects, provides education to researchers, and identifies strengths and areas for improvement in research practice at Augusta University.
IS THIS PART OF THE IACUC SEMI-ANNUAL REVIEW?
No, this is a separate process. The PAM Specialist reports directly to the DLAS Veterinary Director, and monthly reports are submitted to the IACUC.
WHY SHOULD I LOOK FORWARD TO A PAM VISIT?
Aside from helping to ensure that your lab is performing the study procedures according to your design, PAM visits can help by increasing your lab’s knowledge and understanding of DLAS and IACUC policies and procedures, as well as by preparing your lab for visits by members of the IACUC and various accreditation and regulatory agencies. It is also an opportunity for the PI and research staff to ask questions and request clarification on matters related to DLAS and IACUC polices and to provide feedback about the PAM review process.
WHAT SHOULD I EXPECT?
For Scheduled Reviews, the PAM representative will email you a form letter requesting an appointment with you and your lab staff within a specified time frame. After an appointment is set, the PAM will send a confirmation meeting invitation that will include a “PI Self-Assessment” to help you and your staff prepare for the visit. The initial form letter will describe, in more detail, what to expect during and after the visit.
For Unscheduled Reviews, the PAM representative will arrive unannounced, but the review will be similar to the Scheduled Review process, including an “exit briefing” with the PI to address any observations noted during the visit.
WHAT IF I FIND AN ISSUE IN MY LAB WHILE REVIEWING THE "PI SELF-ASSESSMENT" TOOL?
Issues of AUP divergence should be addressed by the PI at the time of finding. The PI should relay the information, and how it was addressed, to the PAM during the scheduled visit. The PAM will make a note of the pro-active actions taken by the PI.
WHAT IF THE PAM FINDS AN ISSUE DURING THE VISIT?
If the issue was detected during the “PI Self-Assessment” and a plan is in place for correction, no action will be taken. A finalized report will be sent to the PI within 10 business days.
All minor issues and potential solutions will be discussed at the end of the meeting during the “Exit Briefing.” The PI will have an opportunity to respond to the PAM findings with a plan to correct the minor issues. After the completion of the plan, the PAM review will be considered corrected and closed. The finalized review will be provided to the PI within 10 business days of receiving the documented corrections.
Significant issues will be noted by the PAM in the meeting documentation and addressed with the PI during the Exit Briefing. The PAM will place all reports into a file that can be reviewed by DLAS and the IACUC. Monthly reports are submitted to the IACUC.