Transcript Document

A Retrospective/Prospective Evaluation
of KUMC’s Post-Approval
Monitoring Program
Michael D. Taylor, PhD
Office of Animal Welfare
External Assessment of KUMC’s
Animal Care and Use Program
• “The KUMC animal care and use program has
a history of professional, humane, and
successful animal care and use that was
punctuated by a period of serious
programmatic concerns several years ago.”
• “During the 2014 visit, the Consultant
observed several important programmatic
changes that have strengthened the program’s
integrity & defense against allegations of
mismanagement and overzealous regulators.”
Consultant Report 2014
External Assessment of KUMC’s
Animal Care and Use Program
• “The Consultant commends the
institutions for successes since the past
review.”
• “The Consultant believes that focused
directional refinement is now necessary for
continued programmatic maturation.”
Consultant Report 2014
External Assessment of KUMC’s
Post-Approval Monitoring Program
• “The evidence of work and positive impact
upon the program by the Post Approval
Monitor was remarkable.”
• “The (PAM) program’s success may
become its undoing without a focused
strategic plan for continued development.”
Consultant Report 2014
KUMC’s PAM: Shifting Gears
“Identify and correct
problems”
“Identify and recognize
compliance”
Back to the Beginning
• “…all who care for, use, or produce animals for
research, testing, or teaching must assume
responsibility for their well-being.”
• “The goal of the Guide is to promote the humane
care and use of laboratory animals by providing
information that will enhance animal well-being,
the quality of research, and the advancement of
scientific knowledge that is relevant to both
humans and animals.”
Guide for the Care and Use
of Laboratory Animals
8th Edition
Regulatory Obligations
• “The use of laboratory animals is governed by
an interrelated, dynamic system of regulations,
policies, guidelines, and procedures.”
• “Taken together, the practical effect of these
laws, regulations and policies is to establish a
system of self-regulation and regulatory
oversight that binds researchers and institutions
using animals.”
Guide for the Care and Use
of Laboratory Animals
8th Edition
What is PAM?
• “Continuing IACUC oversight of animal activities
is required by federal laws, regulations, and
policies.”
• “Post-approval monitoring (PAM) is considered
here in the broadest sense, consisting of all types of
protocol monitoring after the IACUC’s initial
protocol approval.”
Guide for the Care and Use
of Laboratory Animals
8th Edition
“If you’re not keeping score,
you’re just practicing.”
Average Rate of Compliant ACUP PAM
Reviews
105.0
95.0
85.0
75.0
65.0
55.0
45.0
35.0
25.0
15.0
5.0
-5.0
Vince Lombardi, Green Bay Packers 1959-1968
You Don’t Know Where You’re Going
Until You Know Where You’ve Been
Average Rate of Compliant ACUP PAM
Reviews
105.0
95.0
85.0
75.0
65.0
55.0
45.0
35.0
25.0
15.0
5.0
-5.0
y = -0.1251x2 + 5.4394x + 10.366
R² = 0.6513
“Those who cannot remember the past
are condemned to repeat it.”
Predicted Rate of Compliant ACUP PAM
Reviews
105.0
95.0
85.0
75.0
65.0
55.0
45.0
35.0
25.0
15.0
5.0
y = -0.1251x2 + 5.4394x + 10.366
R² = 0.6513
-5.0
George Santayana, Reason in Common Sense, 1905-1906
“Fanaticism consists in redoubling your
efforts when you have forgotten your aim.”
Average Rate of Compliant ACUP PAM
Reviews
105.0
95.0
85.0
75.0
65.0
55.0
45.0
35.0
25.0
15.0
5.0
-5.0
George Santayana, Reason in Common Sense, 1905-1906
“…the only thing we have to fear
is…fear itself…”
• “The IACUC has not conducted an appropriate
review of animal activities for protocol XXXXXXXX to ensure that the investigators are
following the protocols as approved.” (Repeat
NCIs, USDA Inspection Report 9/4/12)
• “…the program was beginning to experience a
plateau in the overall activities and believes it is
time to re-assess and re-adjust…” (Consultant
Report 2013)
Franklin D. Roosevelt; Inaugural Address; March 4, 1933
Redoubled Effort
How did PAM change?
Average Rate of Compliant ACUP PAM
Reviews
105.0
95.0
85.0
75.0
65.0
55.0
45.0
35.0
25.0
15.0
5.0
-5.0
You Find What You Are
Looking For
Focus on Intensive Review of Laboratory
Animal Care and Use Records
Advantage: A very effective approach to identifying
and correcting protocol drift.
You Find What You Are
Looking For
Focus on Intensive Review of Laboratory
Animal Care and Use Records
Disadvantages:
• Labor-intensive (identification/correction
monopolizes time, inefficient)
• Isolation (office-based PAM)
• Potential for co-dependency and resentment
(micromanagement)
Taking Aim
• “The goal of the Guide is to promote
the humane care and use of laboratory
animals by providing information
that will enhance animal well-being,
the quality of research, and the
advancement of scientific knowledge
that is relevant to both humans and
animals.”
Guide for the Care and Use
of Laboratory Animals
8th Edition
Taking Aim
• “The level of formality and intensity of PAM
should be tailored to institutional size and
complexity, an in all cases should support a culture
of care focusing on the animals’ well-being.”
• “Regardless of the methods used or who conducts
and coordinates the monitoring, PAM programs
are more likely to succeed when the institution
encourages an educational partnership with
investigators.”
Guide for the Care and Use
of Laboratory Animals
8th Edition
Taking Aim
“Reactive,
Fear-Based PAM”
“Proactive,
Confidence-Base PAM”
New Directions
• Shift the focus of PAM away from documentation
analysis to observation of approved procedures.
• Collect categorical data from observations to
define training activities.
• Recognize success.
• Implement KUMC’s Animal Research Coordinator
(ARC) Certification Program.
New Directions
• Shift the focus of PAM away from documentation
analysis to observation of approved procedures.
• Pre-observation Interview: “What has
occurred with the animal(s) prior to and will
occur following the procedure?”
• PAM Procedures Observation: “Is the
procedure, as performed, consistent with the
written protocol, institutional SOPs and
Policies, and The Guide?”
8/14
9/14
10/14
11/14
Total
1
2
5
0
2
1
2
2
0
2
0
2
6
33%
1
2
5
0
2
1
2
2
0
2
0
2
6
33%
Commendation Rate
Total PAM ACUPs
Reviewed
Commendations
Timely Response
Euthanasia
Anesthesia and
Analgesia
Pain and Distress
Surgery
Clinical Care and
Management
Preventative Medicine
Program Oversight
Procurement and
Transport
7/14
Housing and
Management
6/14
Personnel Management
Month
New Directions
• Collect categorical data from observations to
define training activities.
PAM Report to IACUC; June 2014
New Directions
• Recognize success.
Commendations June 2014
PI
Department
Activity Reviewed
ACUP
Date
Fariba Behbod
Pathology;
Reproductive Health
Staple Removal
2013-2175
6/23/14
Adam Krieg
Clinical Sciences;
Reproductive Health
Animal Identification;
Genotype Biopsy
2013-2155
6/30/14
PAM Report to IACUC; June 2014
“Whatever we expect
with confidence becomes
our own self-fulfilling
prophecy.”
Brian Tracy