institutional animal care and use committee (iacuc ) post approval monitoring training module
TRANSCRIPT
Institutional Animal Care and Use
Committee (IACUC)
Post Approval Monitoring Training Module
•What is Post Approval Monitoring?
•Goals
•Regulatory basis
•Process
•Logistics
•Questions
This training module contains coverage of the following topics:
Contents
Post Approval Monitoring Training Module
Definitions
Post Approval Monitoring Training Module
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
Post Approval Monitoring Training Module
• 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
And this ….
Post Approval Monitoring Training Module
What PAM is NOT
Post Approval Monitoring Training Module
• 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
•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
Post Approval Monitoring Training Module
USDA Title 9; section 2.31 CFR: IACUC Functions
Regulatory Basis for PAM
1. Review, at least once every 6 months, the research facility’s and the program for the humane care and use of animals…
2. …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…
Post Approval Monitoring Training Module
Public Heath Service (NIH)
Regulatory Basis for PAM
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…
Post Approval Monitoring Training Module
Public Heath Service (NIH)
Regulatory Basis for PAM
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 ProcessWho will be involved?
Post Approval Monitoring Training Module
• Post Approval Monitoring Officer
•Principal Investigator and Lab/Research Staff (always)
•Animal Care Technicians/Veterinarians
• IACUC Staff/Committee (rarely)
PAM ProcessTypes of Audits
Post Approval Monitoring Training Module
•For-Cause (Complaint Based)•Random
Reporting concerns about animal use or abuse is provided at the IACUC website:
PAM Process
Post Approval Monitoring Training Module
http://www.acc.vt.edu/ACCmain1.html#abuse
The IACUC has an established procedure for investigating and resolving complaints.
For-Cause
Random, who will be selected?
PAM Process
Post Approval Monitoring Training Module
• 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
• 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
PAM Logistics
Post Approval Monitoring Training Module
• Is the Protocol Notebook Available to all study team members?
• Training of Personnel
• Study Procedures
• Animal Numbers
• Euthanasia
• Record Keeping
• Animal Facility
Areas that will be reviewedPAM Logistics
Post Approval Monitoring Training Module
Care and Use Tool
PAM Logistics
IACUC Record Keeping
Requirements
Post Approval Monitoring Training Module
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
Post Approval Monitoring Training Module
Sample Animal Use Log
PAM Logistics Sample Animal Use Log
Post Approval Monitoring Training Module
Post Approval Monitoring Training Module
• 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
PAM Logistics After the visit
Common Problem Areas
Post Approval Monitoring Training Module
• 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