Transcript PAM Program - Northwestern University

Post-Approval Monitoring
Program
Discussion Areas
• What is Post-Approval Monitoring?
• Why should we do this?
• Who will be involved?
• Logistics
• History
• Questions?
Post-Approval Monitoring (PAM)
• PAM is a program through which IACUC can
ensure and document program integrity,
compliance with regulations and guidelines, and
adherence to protocol.
• PAM can serve as a facilitator or conduit for
information exchange between researchers and
the IACUC.
• PAM can serve as the eyes and ears of the
IACUC.
PAM can provide assurance to
regulatory agencies and
Northwestern University that
animal experiments are monitored
for compliance with approved
IACUC protocols.
Goals
• Ensure animal well being
• Protect the Institution
• Resource for the research community
• Facilitate science
• Ensure regulatory compliance
What PAM is NOT
• NOT Animal Cops
• NOT a replacement for the IACUC
• NOT required by the USDA or PHS
• NOT a “must” of AAALAC
• NOT new ground or a new regulation
Regulatory Basis
• USDA: 2.31 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
USDA: 2.31 IACUC Functions
1. Review, at least once every 6 months, the
research facility’s program for the humane care
and use of animals…
2. Inspect, at least once every 6 months, all of the
research facilities, including animal study
areas…
3. …The IACUC may determine the best
means of conducting evaluations of the
research facility’s programs and facilities…
4. …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…
Public Health Service
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…
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…
The ‘Guide’
1. …IACUC, also referred to as “the committee,” to oversee
and evaluate the institution’s animal program,
procedures, and facilities to ensure that they are
consistent with the recommendations in this Guide…
2. Its (the IACUC) functions include inspection of facilities;
evaluation of programs and animal-activity areas;
submission of reports to responsible institutional officials;
review of proposed uses of animals in research, testing,
or education (i.e., protocols); and establishment of a
mechanism for receipt and review of concerns involving
the care and use of animals at the institution.
3. Performance standards define an outcome in detail
and provide criteria for assessing that outcome, but
do not limit the methods by which to achieve that
outcome. This performance approach requires
professional input and judgment to achieve outcome
goals.
4. ...the IACUC should pay particular attention to
animal well-being through continuing evaluation of
outcomes.
5. Assessment of animal space needs should be a
continuing process.
6. A continuing and thorough assessment of surgical
outcomes should be performed to ensure appropriate
procedures are followed… In the event of
modification, assessment of outcomes should be
even more intense and might have to incorporate
criteria other than the obvious clinical morbidity and
mortality.
U.S. Government Principles for the
Utilization and Care of Vertebrate
Animals Used in Testing,
Research, and Training
VIII. Investigators and other personnel shall be
appropriately qualified and experienced for
conducting procedures on living animals.
Adequate arrangements shall be made for
their in-service training…
Who will be involved?
• Quality Assurance and Training Staff
• IACUC Staff/Committee
• Animal Health Technicians/Veterinarians
• PI’s and Lab/Research Staff
Who will be selected?
• All active protocols
• Random selection
• At the discretion of the IACUC and veterinary
staff
• Complimentary to IACUC semi-annual
inspections
Upon Selection…
• Know the lab and the protocols
• Labs will be contacted and visits scheduled
• PAM team will visit laboratory
• Document findings
• Discuss findings with PI and research
staff
Examples of Areas that will be
Reviewed
• Protocol and Personnel
• Study Procedures
• Anesthesia
• Surgery
• Post-Surgical Care
• Euthanasia
• Record Keeping
• Laboratory
After PAM Team visit
• Written draft of visit to PI/research personnel
• Final report: PI, research personnel, IACUC,
Attending Veterinarian
• Files of reports maintained by PAM Team
• Follow up and support:
- Training
- Protocol modifications if needed
PAM Program Updates
• The NU PAM Program began in 2006
• The PAM processes will continue to evolve as
the program grows
• Changes will be made as necessary with
implementation of the new electronic PAM
software
Questions or
Comments?