Transcript Center for Comparative Medicine Post Approval Monitoring

Post Approval Monitoring
Program
Presented by Carolyn Malinowski
Manager, Quality Assurance and
Training
Discussion Areas
• What is Post Approval Monitoring
• Why should we do this
• Who will be involved
• Logistics
• Implementation
• Questions
Post-Approval Monitoring (PAM)
• PAM is a program through which ACUC/CCM
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 between researchers and ACUC/CCM
• PAM can serve as the eyes and ears of the
ACUC
PAM can provide assurance to
regulatory agencies and
Northwestern University that
animal experiments are
monitored for compliance with
approved ACUC 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 ACUC
• 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
• ACUC Staff/Committee
• Animal Health Technicians/Veterinarians
• PI’s and Lab/Research Staff
Note: all CCM staff will report directly to the ACUC
for all matters concerning PAM
Who will be selected?
• All active protocols
• Random selection
• At the discretion of the ACUC and
veterinary staff
• Complimentary to ACUC semi-annual
inspections
• Initial Goal: one inspection per week
Upon Selection…
• Know the lab and the protocols
• Labs will be contacted and visits scheduled
• Compliance Liaison (CL) team visit
• 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 CL Team visit
• Written draft of visit to PI/research
personnel
• Final report: PI, research personnel, ACUC,
Attending Veterinarian
• Files of reports maintained by CLA
• Follow up and support:
- Training
- Protocol modifications if needed
Implementation
• Tentative plan to begin PAM program in
January 2006
• Initial plan to visit one lab per week
• Much of it will be established as the
program progresses
• Changes will be made as necessary
Questions or
Comments