Continuing oversight of animal activities is a federal requirement of institutions that utilize animals in teaching, testing and research activities. The Post Approval Monitoring Program fulfills this obligation of the Institutional Animal Care and Use Committee (IACUC) to perform post approval monitoring of animal protocols for regulatory agencies, United States Department of Agriculture (USDA) and the Office of Laboratory Animal Welfare (OLAW). The PAM program will also assess the Animal Resource Center (ARC) husbandry practices.
In addition, the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) recommended increased monitoring of animal use activities and improvements in personnel training. Since 99 of the top 100 NIH-funded institutions are accredited by AAALAC, UTMB took note. AAALAC accreditation is an international symbol of quality, and demonstrates UTMB not only meets the minimum standards required by law, but also takes extra steps to achieve excellence in animal care.
UTMB must demonstrate to regulatory agencies, sponsors, legislative bodies and the public that its animal research program has sufficient oversight and integrity. The PAM program is designed to provide these assurances. When scientific research involves animals, reliable results depend on proper and consistent animal care. Animal protocols are approved with the principles of humane care and use of animals in mind. These principles are promulgated by regulatory bodies, and compliance is mandatory.
UTMB’s PAM Program
is designed to interact with the research staff in a collegial, educational manner. The program helps to ensure the well-being of the research animals as well as provide opportunities to refine IACUC protocols through protocol review and observation.
Every animal research laboratory is visited by the program’s Protocol Advisors and Liaisons (PALs). These visits consist of Protocol Discussions with lab staff, observations of animal procedures, and debriefing meetings when needed. All active protocols are assessed on a regularly scheduled basis, but may also be reviewed at the request of the IACUC. Outcomes
of these visits are beneficial to the researcher by either confirming that procedures are humane and compliant, or, identifying protocol ‘drift’ and helping to amend protocols to prevent future concerns.
The PAM program strives to correct protocol issues internally so that regulatory agency inspectors are less likely to find problems. Should PAM find that animals are harmed due to major deviation from protocol, IACUC or ARC may suspend that lab’s animal work until the practice is corrected. This is one of the responsibilities of IACUC and ARC, as mandated by federal regulations. If a regulatory agency identifies the non-compliant situation, it may revoke research privileges for the entire campus. It is better for IACUC to suspend research in a single non-compliant lab than for a regulatory body to stop research in the entire institution due to the disregard for compliance in a single lab. IACUC suspensions of lab work are infrequent occurrences and the result of egregious non-compliance.
Observations by PAM staff can include determining if:
- Procedures being performed are in accordance with IACUC approved protocols;
- The personnel performing these procedures are listed on the protocol;
- Anesthetics, analgesics, antibiotics and other medications are being used in accordance with the protocol;
- Survival surgery is aseptic;
- Euthanasia procedures and the method for ensuring death are protocol compliant;
- Training records for laboratory personnel are complete;
- Drug use is documented and animal medical records are kept;
- All substances and sterile supplies used are within expiration dates.
These visits do not replace the IACUC's semi-annual lab visit and facility review.
The PAM program offers these services:
- Updates in animal program information through laboratory staff meetings
- Comparison of IACUC protocols with procedures to maintain compliance and animal welfare
- Review protocols/amendments prior to IACUC submission
- Annual training course on writing IACUC protocols and other topics related to animal research
PAM Laboratory Visit Checklist
Writing an IACUC Protocol
IACUC Protocol Essentials Annual Training