What is Post Approval Monitoring?

PAM has become a standard practice in laboratory animal program oversight. According to the Guide, PAM activity may be accomplished through a variety of methods

At Rice University, PAM is accomplished by a combination of the following:

  • Semi-annual facility inspections and follow-up visits
  • Continuing protocol review (for more frequent review as determined at initial approval; de novo review every three years)
  • Review of protocol amendment modifications
  • Animal Resources Facility (ARF) routine husbandry and health rounds
  • Review of Unanticipated Research Outcomes (Guidelines)
  • Review of Investigation of Noncompliance Reportable Events (Guidelines)
  • Other reports from investigators to the IACUC (e.g., pilot study reports)
  • Program improvements resulting from federal and accreditation site visits
  • Routine protocol-specific post-approval monitoring assessments

What are some of the benefits that an investigator may gain from the PAM process?

The most important goal of the routine PAM is to monitor congruence between laboratory practices and corresponding IACUC-approved protocol(s) to assure animal well-being and regulatory compliance. Principal Investigators also gain supportive feedback if protocol drift is identified and will be provided with helpful resources for improvement and prevention.

The PAM process may involve laboratory/site visits to observe animal procedures being performed, record-keeping evaluation, confirmation of proper personnel training, and discussions related to animal activities in IACUC-approved protocol. The process is meant to provide a resource for the research community, facilitate science, and protect the Institution.

How are the research protocols selected?

All active IACUC-approved protocols are subject to post-approval monitoring. Protocols may be prioritized or subject to more frequent monitoring based on risk factors such as:

  • Classified as Pain/Distress Category D or E
  • Approved for multiple survival surgeries
  • Approved departures from the Guide and/or Animal Welfare Act.
  • Studies involving species regulated by the United States Department of Agriculture (USDA).
  • Procedures that are new, invasive, or complex to the lab
  • Animal housing outside of the vivarium
  • Personnel that may need further training or proficiency verification
  • Repeated non-compliance or animal welfare issues.

While protocols with less invasive procedures are primarily selected at random, the IACUC, during the initial or continuing review of the protocol, may request a monitoring assessment.

How often will routine monitoring occur?

  • The IACUC Liaison will select no more than 10% of active protocols for routine PAMs during a 12-month period. PIs with “for cause” PAMs might not be included in routine PAM selections.
    • A PI may experience multiple PAMs, if a routine PAM has been previously completed and the IACUC requests a “for cause” PAM for a specific reason.
  • If at any time during the routine PAM session, an animal welfare concern is identified, it will be immediately reported to the IACUC and Executive Director for review.

What will happen during a monitoring visit?

The PAM session will include an interview with the Principal Investigator and key research personnel working directly with animals.

The PAM process may involve laboratory/site visits to observe animal procedures being performed, record-keeping evaluation, confirmation of proper personnel training, and discussions related to animal activities in IACUC-approved protocol. The process is meant to provide a resource for the research community, facilitate science, and protect the Institution.

Factors to be monitored include, but are not limited to, the following:

  • Review and compliance with the IACUC-approved protocol
    • Personnel
    • Study procedures
    • Proficiency in technical procedures (surgeries, substance administration, etc.)
    • Anesthetic and analgesic use
    • Pre-surgical and post-surgical care
    • Euthanasia
    • Laboratory cleanliness and adherence to disinfection SOPs
    • New personnel training and continuing education for complex procedures such as surgery
  • Species/strains, ages, and numbers of animals used
  • Accurate recordkeeping:
    • maintenance of accurate records for anesthetics, analgesics, and other substances administered
    • maintenance of a dose-by-dose log for the administration of controlled substances
    • maintenance of appropriate surgical, post-operative, and experimental procedure records
    • Documentation of food and fluid intake for animals on food or water control
    • Breeding records, if applicable
    • Proper equipment maintenance (anesthesia vaporizers, anesthetic gas scavenging, guillotines, etc.)
  • Overall understanding of Rice IACUC Guidelines: https://research.rice.edu/compliance/iacuc/guidelines

How long will the assessment take?

If documentation is complete and organized, the PAM checklist review will take approximately an hour or less. However, depending on the complexity of the protocol procedures, subsequent appointments may be required to observe procedures to complete a comprehensive assessment of the level of protocol compliance.

How should study teams prepare for the monitoring visit?

The most effective way to prepare for a PAM visit is to carefully and objectively read your approved protocol and ensure that you and your staff perform the research activities described and approved by the IACUC.

Remember, the goal of post approval monitoring is not to “catch” you doing something you aren’t supposed to be doing. Instead, it is designed to facilitate research by ensuring it is conducted where the conditions of federal regulations and University policy are met and by assisting researchers to identify and correct any deficiencies.

What results can study teams expect from the monitoring visit?

Once the PAM observation has been completed, the IACUC Liaison will enter the PAM session and observation information into the RCS database.

  • Potential suggestions based on the IACUC Liaison's observations may include protocol modifications that can refine procedures, recommendations of additional training for research personnel, refinement of monitoring logs and/or improve outcomes, opportunity for improvements through teachable moments, and sharing current best practices.
  • The PI will receive a PAM closure letter summarizing the information discussed and if there are any potential noncompliance concerns.
  • The IACUC Liaison will report all PAM sessions to the IACUC.
  • If, at any time during the routine PAM session, an animal welfare concern is identified, it will be immediately reported to the IACUC and Executive Director for review.

What if the PI is unable to attend the scheduled PAM meeting?

The preferred option would be to meet at a mutually agreeable time for both the IACUC Liaison and the PI, accompanied by personnel working directly with animals. If the PI cannot attend, the PI may designate a representative for the PAM review.