IACUC Policy # 370: Post Approval Monitoring Program

1) Policy

A. The purpose of the Post Approval Monitoring (PAM) program is to regularly monitor research and teaching activities involving live, vertebrate animals and ensure compliance with all applicable regulations and policies while maintaining accreditation with AAALAC International.

B. PAM is considered a form of continuous IACUC review. According to The Guide for the Care and Use of Laboratory Animals 8th Edition (pg.33): “Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies.”

C. Deficiencies or deviations from approved IACUC protocols and amendments will be noted and corrective actions and timelines will be established. Any animal welfare concerns will be immediately reported to the Attending Veterinarian (AV), the IACUC Chair, and the Director of Research Assurance.

D. The goals of the PAM program are to enhance animal welfare by:

• Acting as an educational resource for the academic and scientific community.
• Fostering a positive relationship for collaborative dialogue to exchange information between the IACUC and those who carry out research and teaching activities.
• Helping researchers remain compliant with the requirements of funding agencies, regulatory bodies, and institutional policies while ensuring that protocol activities are conducted as outlined in an approved IACUC protocol.

2) Procedures

A.  Regulations used for PAM visits:

• Animal Welfare Act and Regulations
• PHS Policy on Humane Care and Use of Laboratory Animals
• The Guide for Care and Use of Laboratory Animals
• AVMA Guidelines on Euthanasia
• Guide for the Care and Use of Agricultural Animals in Research and Teaching
• Cornell Animal Care and Use Procedures (ACUPs)
• IACUC Policies, SOPs, and Guidelines

B.  PAM Overview

1. The PAM program is designed to be minimally disruptive to ongoing work in the animal space. Assessments should be viewed as a collegial training opportunity to support the health and well-being of animals and refine research and teaching procedures.
2. PAM is generally performed by a Research Compliance Liaison who is considered to be a PAM expert in assessing compliance with regulations, approved protocols, and procedural documents. On some occasions, PAM may also be performed by CARE veterinarians in coordination with the Research Compliance Liaison. Other subject matter experts may be included in the PAM process.

C.  Selection Process

1. All active Cornell University IACUC protocols are eligible for review. Protocols may also be reviewed at the request of any member of the IACUC, at the recommendation of the Attending Veterinarian (AV), or as a result of an external regulatory inspection/site visit.
2. Protocols that fall within the following categories may be subject to more frequent review:

• Studies classified as Pain Category D and E,
• Studies or research groups that have experienced past compliance issues.

D. PAM visits

1. PAM will typically include an in-person meeting with the PI and senior laboratory staff to facilitate dialogue and to meet the goals of the PAM program. All individuals listed on the protocol(s) are encouraged to attend.
2. PAM visits include any or all the following:

      A.  Protocol and Records Review & Discussion

• Entrance interview with PI and/or senior laboratory management
• Review of currently approved protocol(s)
• Audit of personnel qualifications and training logs and Animal User Health and Safety Program (AUHSP) clearance
• Review of procedure records for consistency with approved protocols
• Review of animal use/experiment areas to evaluate proper animal care
• Review of animal number and experimental records
• Review of protocol exemptions

      B.  Procedure Observations

• Observation of the presence and condition of equipment and supplies required to safeguard the care of the research animals
• Pre- and post-procedure care
• Animal manipulations
• Transportation of animals between housing and use locations
• Review of non-pharmaceutical substances and drug expiration dates
• Review of euthanasia methods (if applicable)

      C.  Surgical Observations

• Surgical area appropriateness
• Sanitation procedures
• Controlled drug inventory and use
• Emergency protocols for adverse events
• Anesthesia equipment
• Anesthetic and analgesic regimens
• Conduct of major surgeries
• Post-operative care

E.  Scheduling a PAM Visit

1. The Principal Investigator will be sent an e-mail explaining the reason for the request and providing details about the PAM visit planned and who will be attending.
2. A mutually agreeable time for the PAM visit will be established. Pertinent documentation may be requested prior to the visit.
3. A compliance checklist will be provided to the PI prior to the in-person visit.

F.  Preparing for the PAM Visit

1. Prior to the PAM visit, PAM personnel will review relevant protocols and IACUC policies and guidelines.
2. PAM personnel will compare procedures described in the approved protocols with current regulatory requirements and standards.
3. It is strongly recommended that the PI and staff members review relevant IACUC protocols, policies and guidelines, and the compliance checklist.

G.  Conducting the PAM visit

1. Post Approval Monitoring will consist of an assessment of a team’s adherence to approved protocols and may include observation of select surgeries and procedures. Typically, the visit will be scheduled for one hour, but will depend on the visit’s focus. The compliance checklist will be used as an outline during the visit
2. Exit Briefing

      a. The PAM personnel will provide an exit briefing to the PI and/or members of the laboratory to ensure the accuracy of the observations.

      b. This communication will recognize successful performance and if necessary, identify possible deviations from protocols or problematic areas that may require corrective action.

      c. PAM personnel may make reasonable and practical suggestions for correcting non-compliance.

      d. Recommendations made by PAM personnel at the time of the exit briefing are not considered final until reviewed and discussed by the PAM subcommittee (see below) and/or IACUC.

  3. Post-visit Communication

      a. Any animal welfare concerns will be immediately reported to the AV, the IACUC Chair, and the Director of Research Assurance.

      b. A PAM report will be prepared to be reviewed by the PAM subcommittee which includes, the Director of Research Assurance, the Attending Veterinarian, and the IACUC Chair or their delegates. This subcommittee will determine whether any reported issues require a full IACUC review, and if so, the IACUC will determine whether the issues are reportable to regulatory agencies.

      c. The PI is given the opportunity to make improvements by refining techniques and/or by submitting an amendment to the IACUC.

      d. A finalized copy of the PAM report will be provided to the PI.

  4. Reporting

      a. The Research Compliance Liaison will present a report to the IACUC, at least twice a year, outlining the PAM visits that were performed.

      b. If deemed necessary, the IACUC may require a follow-up PAM visit.

3. References

      A. Animal Welfare Act and Regulations 

      https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_508_comp_versio n.pdf

      B. PHS Policy on Humane Care and Use of Laboratory Animals 

      https://grants.nih.gov/grants/olaw/references/phspolicylabanimals.pdf

      C. The Guide for Care and Use of Laboratory Animals: Eighth Edition 

      https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf

      D. AVMA Guidelines on Euthanasia (2020) 

      https://www.avma.org/sites/default/files/2020-02/Guidelines-on-Euthanasia-2020.pdf

      E. Guide for the Care and Use of Agricultural Animals in Research and Teaching

      https://www.asas.org/docs/default-source/default-document- library/agguide_4th.pdf?sfvrsn=56b44ed1_2