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

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

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.

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

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.

Post Approval Monitoring Training Module PAM Goals And this ….

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

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

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…

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…

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…

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)

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

Post Approval Monitoring Training Module PAM Process For-Cause Reporting concerns about animal use or abuse is provided at the IACUC website: http://www.acc.vt.edu/ACCmain1.html#abuse The IACUC has an established procedure for investigating and resolving complaints.

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

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

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

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

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.

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

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

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

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

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