Post Approval Monitoring (PAM) Program

SUBJECT:

Post Approval Monitoring (PAM) Program

 Effective Date:
9/26/2025 		Policy Number:
10.4.28
Ìý Supersedes:
N/A 		Page 1 of 4
Ìý Responsible Authorities:
Principal Investigator
Vice President, Research
Institutional Animal Care and Use Committee
Associate Vice President for Research,
Research Integrity
  1. Background

    The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals requires IACUCs to conduct continuing review of previously approved ongoing activities with animals. The Guide for the Care and Use of Laboratory Animals, 8th ed., requires continuing IACUC oversight of animal activities which can be accomplished through a variety of mechanisms. The Post-Approval Monitoring (PAM) program at ÌÇÐÄVlog (ÌÇÐÄVlog) meets the requirements of the PHS Policy and the Guide for continuing review and oversight by the IACUC through direct observation of facilities and procedures, review of records, and discussions with personnel thereby providing researchers with education and resources, and fostering positive, collaborative communication between the IACUC and the research community.

  2. Purpose

    The purpose of this policy is to establish the framework for ÌÇÐÄVlog's Post-Approval Monitoring (PAM) program. PAM is intended to:

    • Confirm congruence between approved IACUC protocols and actual practices.
    • Foster a culture of collaboration, transparency, and continuous improvement across ÌÇÐÄVlog's animal care and use program.
    • Promote animal welfare through early identification and correction of areas in need of improvement.
    • Provide an educational resource for research personnel regarding regulatory, institutional, and best practice requirements.
    • Identify institutional gaps to inform improvements in policies, SOPs, training, and researcher support.
  3. Definitions

    Post-Approval Monitoring (PAM) – Ongoing oversight activities conducted by the IACUC, veterinary staff, or RI personnel to confirm that animal activities are carried out in accordance with approved IACUC protocols, amendments, and applicable regulations.

    Satellite Animal Housing Facility – any location where animals are housed outside the CM-managed centralized facilities for more than 12 hours.

  4. Policy and Procedures

    ÌÇÐÄVlog's IACUC is responsible for the implementation and oversight of the Post-Approval Monitoring (PAM) program. ÌÇÐÄVlog's PAM program includes, but is not limited to, the following activities:

    • Semiannual facility inspections
      Conducted in accordance with IACUC policy 10.4.1b., Institutional Animal Care and Use Committee: Role and Function. All areas where animals are housed or brought for procedures will be inspected semi-annually using the standards set forth in The Guide for the Care and Use of Laboratory Animals. Deficiencies are communicated to PIs for correction within appropriate timelines.
    • Triennial protocol review
      Protocols active beyond initial three year approval must undergo complete re-review, as detailed in policy 10.4.1c, Protocol and Amendment Review.
    • Protocol amendment review and submission
      Significant changes must be reviewed and approved before implementation. The amendment process is outlined in policy 10.4.1c., Protocol and Amendment Review.
    • Daily animal care and observation
      Conducted by animal care staff in centralized facilities or research personnel in satellite housing locations per applicable SOPs.
    • Site visits to laboratories or satellite facilities
      PAM site visits may be performed by members of the IACUC, the AV, research integrity office personnel or other personnel. Visits may include observation of animal procedures (e.g., surgery, handling, behavioral testing) to verify continued compliance with IACUC approved protocols and procedures. Site visits will be performed as described in applicable guidelines.
    • Required monthly reporting by satellite facility PIs
      Satellite facility PIs provide monthly reports to the IACUC per IACUC policy 10.4.4 Satellite Animal Housing Facilities.
  5. Outcomes of PAM activities

    Summaries of PAM activities are provided to the IACUC on a regular basis to identify institutional trends, assess overall compliance, and support external reviews. Minor issues may be resolved through guidance and follow-up. Significant or repeated noncompliance is referred to the IACUC and may result in reporting to oversight agencies, in accordance with institutional policy and regulatory requirements.

  6. Accountability

    The Principal Investigator (PI) will be responsible for:

    • Ensuring that all animal activities are conducted in accordance with the approved IACUC protocol.
    • Cooperating fully with PAM activities, including providing access to records, personnel, and facilities as requested.
    • Implementing corrective actions identified through PAM activities in a timely manner.

    The IACUC will be responsible for:

    • Overseeing the implementation and effectiveness of the PAM program.
    • Reviewing reports of PAM activities and determining whether corrective or reporting actions are required.
    • Ensuring that PAM is conducted in a manner consistent with federal regulations, institutional policy, and accreditation standards.

    The Research Integrity office will be responsible for:

    • Coordinating and conducting PAM site visits
    • Maintaining PAM records, reports, and documentation in accordance with ÌÇÐÄVlog policy.
    • Providing education and resources to research personnel during PAM activities.
    • Following up on investigator responses and verifying completion of corrective actions.
    • Conducting regular assessments of the PAM program and recommending changes to the IACUC.
  7. Policy Renewal Date

    9/26/2028

  8. References

    Guide for the Care and Use of Laboratory Animals, 8th edition, 2011
    PHS Policy on the Humane Care and Use of Laboratory Animals

POLICY APPROVAL

Initiating Authority

Gregg B. Fields, Ph.D., Vice President for Research
10/9/2025

Executed signature pages are available in the Initiating Authority Office