Transcript Center for Comparative Medicine Post Approval Monitoring

Institutional Animal
Care and Use
Committee (IACUC)
Post Approval Monitoring Training Module
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.
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
Post Approval Monitoring Training Module
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
• the Animal Cops
• a replacement for the IACUC
• required by the USDA, PHS or
AAALAC, but it is strongly
recommended
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
Post Approval Monitoring Training Module
Regulatory Basis for PAM
USDA Title 9; section 2.31 CFR: IACUC Functions
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
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…
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…
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)
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.
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 semiannual 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
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
Post Approval Monitoring Training Module
PAM Logistics
Care and Use Tool
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.
Post Approval Monitoring Training Module
PAM Logistics
Sample Animal Use Log
Post Approval Monitoring Training Module
PAM Logistics
Sample Animal Use Log
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
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
Post Approval Monitoring Training Module
Questions?
http://www.researchcompliance.vt.edu/index.php