Post approval monitoring: Balancing risks and benefits

by Farah Moulvi, MSPH, PRIM&R Blog Squad

PRIM&R is pleased to bring you live posts from the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R’s conferences. Read on to find out what’s happening on the ground in Chicago!

Although late in the afternoon, the session titled Formal and Informal Approaches to Post-Approval Monitoring featured a lively discussion about post-approval monitoring (PAM). This topic was also presented at the pre-conference course for IACUC administrators and compliance staff titled Essentials for IACUC Administrators.

PAM is a process that was developed and instituted at various academic research institutions in order to support the humane care and use of animals. PAM’s intent is to provide institutions with an ongoing mechanism for ensuring compliance with animal care and use policies, guidelines and laws. This, in turn, ensures the humane care and use of animals in research, testing, and teaching activities. The essential components for program development are planning, communication, management, and assessment.

Monitoring the use of live vertebrate animals in research, teaching and testing after IACUC approval is currently a hot topic in the IACUC research community. Each institution or organization must determine, independently, whether the risks of not instituting a PAM program outweigh the benefits of developing, instituting, and overseeing one.
Among the myriad resources available on the internet, one useful example is the Institute for Laboratory Animal Research (ILAR) Journal.

Much of the literature on animal research suggests the need for PAM:

PAM is not a substitute or replacement for the IACUC’s required responsibilities such as semiannual review, outside facility inspections, new protocol review, annual/triennial protocol review, and non-compliance and allegation investigations. Some may assert that these procedures already compose an informal PAM program, as they all serve to help maintain an institution’s compliance.

There are various approaches to conducing formal and informal PAM. One proactive approach emphasizes education and training through constructive engagement. Some institutions monitor high-risk areas such as survival surgeries, activities involving procedures for pain, distress and or discomfort, use of regulated USDA species, activities involving use of anesthesia and or analgesia, and protocols previously sited for a deficiency or repeat deficiencies. Other institutions monitor a random selection of IACUC-approved protocols. Either way, it is critical for an institution to have clear written polices and standard operating procedures for an effective PAM program.

A one-size approach will not fit all institutions and organizations. Each institution should adapt PAM models to fit their needs. PAM is a system of self regulation; in order for it to work effectively, a robust culture of institutional responsibility and commitment to compliance is needed. Each institution needs to balance support for high-quality research with the maintenance of a high standard of humane care and use of animals.

In order to achieve this goal, institutional stake holders (i.e. the institutional official, attending clinical veterinarian, IACUC chairperson/members, IACUC administrators) should be involved prior to the institution of a PAM program.

For those of you already engaging in PAM, keep up the good work and continue to share your resources, knowledge and experiences. For those who don’t have a PAM process in place, I encourage you to give it some thought and determine what approaches may work for your institution. Please feel free to share your thoughts with me online or offline.