Going Beyond Traditional Post-Approval Monitoring

Post-approval monitoring (PAM) has traditionally been, and in many ways still is, seen as a program to monitor protocols after approval. At PRIM&R’s 2018 IACUC Conference (IACUC18), I attended a fascinating session titled “Quality Assurance Beyond Post-Approval Monitoring”. The session explored the idea that PAM, should be looked at as monitoring of the animal care and use program not just monitoring of the animal protocols. I have always been interested in quality assurance and quality management and the ideas in this session were very exciting! The notion that a formal PAM program could improve compliance across the animal care and use program in multiple facets is truly energizing.

There are several areas in which this new quality assurance view of PAM can be implemented in programs. Perhaps the first area to begin PAM of the animal care and use program is a complete review of all policies, guidelines, and standard operating procedures. A review of these documents should be conducted with an eye towards eliminating unnecessary regulatory burden, improving clarity, and increasing efficiency. Often having small working groups that include a faculty scientist, perhaps from the IACUC, can be helpful. This can increase investigator education and reduce burden by eliminating unnecessary policies and making current policies clearer and more concise.

Next, metrics and statistics can be used to more closely examine processes, including turn-around times for protocol and amendment reviews, and establish patterns of non-compliance found during facility inspections. Once established, these metrics can help the IACUC identify the areas on which to focus its time and resources.

Additionally, an effective PAM of the animal care and use program does not overlook examining the husbandry processes. Examinations of standard operating procedures, in cooperation with husbandry leadership, may lead to improved quality of care and efficiency. Examination of equipment in husbandry areas and laboratories should also be included, as they affect the quality of the animal care.

Finally, don’t overlook programs such as the use of controlled substances in research. Incorporating regular inspections of controlled substance license holders and their records is another area that can make up part of your animal care and use program PAM.

Post-approval monitoring or PAM should encompass more than just protocol reviews. The good news is that many of us are already doing many of the quality assurance items I suggested above in some fashion. What is needed is to change our view of PAM and its function. I plan to look at all of the quality assurance activities I have been doing (i.e., regular reviews of guidelines and standard operating procedures, controlled substance inspections), as well as new ones I can incorporate into my program (i.e., metrics). The result will be a new program that goes beyond traditional PAM. I hope I have inspired you to do the same!

Elaine Joseph, PhD, is a Compliance Analyst at the University of Toledo. She currently manages the IACUC and IBC for the University of Toledo, as well as performing grant reviews. She has been in regulatory compliance for over 14 years. Prior to working in regulatory compliance, Dr. Joseph received her doctorate in Zoology from Miami University of Ohio.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

IACUC18 Conference Proceedings are now available for purchase. PRIM&R’s 2019 IACUC Conference (IACUC19), will take place April 1-3 in Bellevue, WA, in conjunction with the NWABR Regional IACUC Conference on April 4. We are currently accepting session proposals (until August 24, 2018) and poster abstracts (until October 5, 2018) for IACUC19.