1. Institutional Animal Care and Use Committee (IACUC)
Post Approval Monitoring Training Module

2. This training module contains coverage of the following topics:
Post Approval Monitoring Training Module
Contents
This training module contains coverage of the following topics:
What is Post Approval Monitoring?
Goals
Regulatory basis
Process
Logistics
Questions

3. Post Approval Monitoring Training Module
Definitions
Post Approval Monitoring is a program through which the IACUC can ensure and document program integrity, compliance with regulations and guidelines, and adherence to the approved protocol. PAM can serve as a facilitator for information exchange between researchers, and the IACUC and vice versa. PAM can provide assurance to regulatory agencies and VA TECH that animal experiments are monitored for compliance with approved IACUC protocols.

4. PAM Goals Ensure animal well being Protect the Institution
Post Approval Monitoring Training Module
PAM Goals
Ensure animal well being
Protect the Institution
Ensure regulatory compliance
Resource for the research community
Facilitate science and help achieve compliance

5. PAM Goals This is what VT would like to avoid.
Post Approval Monitoring Training Module
PAM Goals
This is what VT would like to avoid.

6. Post Approval Monitoring Training Module
PAM Goals
And this ….

7. What PAM is NOT the Animal Cops a replacement for the IACUC
Post Approval Monitoring Training Module
What PAM is NOT
the Animal Cops
a replacement for the IACUC
required by the USDA, PHS or AAALAC, but it is strongly recommended

8. Regulatory Basis for PAM
Post Approval Monitoring Training Module
Regulatory Basis for PAM
USDA Title 9; section 2.31 CFR: IACUC Functions
Public Health Service (PHS)
The ‘Guide for the Care and Use of Laboratory Animals
U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training

9. Regulatory Basis for PAM
Post Approval Monitoring Training Module
Regulatory Basis for PAM
USDA Title 9; section 2.31 CFR: IACUC Functions
Review, at least once every 6 months, the research facility’s and the program for the humane care and use of animals…
…Investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees…

10. Regulatory Basis for PAM
Post Approval Monitoring Training Module
Regulatory Basis for PAM
Public Heath Service (NIH)
1. … Review at least once every 6 months the institution’s program for humane care and use of animals…
2. … The IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the “Guide” unless acceptable justification for a departure is present. Further the IACUC shall determine that the research project conforms with the institution’s assurance…

11. Regulatory Basis for PAM
Post Approval Monitoring Training Module
Regulatory Basis for PAM
Public Heath Service (NIH)
3. The IACUC shall conduct continuing review of activities covered by this Policy at appropriate intervals as determined by the IACUC…
4. The IACUC may suspend an activity that is previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution’s Assurance…

12. PAM Process Who will be involved? Post Approval Monitoring Officer
Post Approval Monitoring Training Module
PAM Process
Who will be involved?
Post Approval Monitoring Officer
Principal Investigator and Lab/Research Staff (always)
Animal Care Technicians/Veterinarians
IACUC Staff/Committee (rarely)

13. PAM Process Types of Audits For-Cause (Complaint Based) Random
Post Approval Monitoring Training Module
PAM Process
Types of Audits
For-Cause (Complaint Based)
Random

14. Post Approval Monitoring Training Module
PAM Process
For-Cause
Reporting concerns about animal use or abuse is provided at the IACUC website:
The IACUC has an established procedure for investigating and resolving complaints.

15. Random, who will be selected?
Post Approval Monitoring Training Module
PAM Process
Random, who will be selected?
Any active protocol can be randomly selected
Any protocol at the discretion of the IACUC and Veterinary staff
Any protocol complimentary to IACUC semi-annual inspections

16. Post Approval Monitoring Training Module
PAM Logistics
PI’s and laboratories will be contacted and a visit scheduled
A PAM visit generally takes 1 hour (if you are prepared)
PAM Findings are documented
Discuss findings with PI and research staff
Suggestions on amendment submissions are made if necessary

17. Areas that will be reviewed
Post Approval Monitoring Training Module
PAM Logistics
Areas that will be reviewed
Is the Protocol Notebook Available to all study team members?
Training of Personnel
Study Procedures
Animal Numbers
Euthanasia
Record Keeping
Animal Facility

18. PAM Logistics Care and Use Tool
Post Approval Monitoring Training Module
PAM Logistics
Care and Use Tool

19. IACUC Record Keeping Requirements
Post Approval Monitoring Training Module
IACUC Record Keeping Requirements
Health records must convey necessary information to all people involved in an animal’s care and must be sufficiently comprehensive to demonstrate the delivery of adequate health care. Health records must be held for at least 1 year after the disposition or death of the animal. Descriptions of any illness, injury, distress, and/or behavioral abnormalities and the resolution of any noted problem. Dates, details, and results (if appropriate) of all medically-related observations, examinations, tests, and treatments, including the name, dose, route, frequency, and duration of treatment with drugs or other medications.

20. PAM Logistics Sample Animal Use Log
Post Approval Monitoring Training Module
PAM Logistics
Sample Animal Use Log

21. PAM Logistics Sample Animal Use Log
Post Approval Monitoring Training Module
PAM Logistics
Sample Animal Use Log

22. PAM Logistics After the visit A final report is issued to the PI
Post Approval Monitoring Training Module
PAM Logistics
After the visit
A final report is issued to the PI
If findings are significant the IACUC Administrator, Attending Veterinarian, and IACUC will receive a report.
Follow up and support:
Training
Protocol amendments if needed
Occasional letters to agencies are issued

23. Common Problem Areas Exceeding animal numbers approved
Post Approval Monitoring Training Module
Common Problem Areas
Exceeding animal numbers approved
Unapproved euthanasia method
Protocol drift
Failure to add new personnel
Failure to monitor animals post procedurally
Failure to maintain adequate breeding records
Failure to post the protocol # in the animal holding area

24. Questions? http://www.researchcompliance.vt.edu/index.php
Post Approval Monitoring Training Module
Questions?