Post on 05-Jan-2016
A Retrospective/Prospective Evaluation of KUMC’s Post-
Approval Monitoring Program
Michael D. Taylor, PhDOffice 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 Animals8th 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 Animals8th 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 Animals8th Edition
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Average Rate of Compliant ACUP PAM Reviews
“If you’re not keeping score, you’re just practicing.”
Vince Lombardi, Green Bay Packers 1959-1968
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f(x) = − 0.125144731519871 x² + 5.43942979573264 x + 10.3661401557285R² = 0.651280854964165
Average Rate of Compliant ACUP PAM Reviews
You Don’t Know Where You’re Going Until You Know Where You’ve Been
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f(x) = − 0.125144731519871 x² + 5.43942979573264 x + 10.3661401557285R² = 0.651280854964165
Predicted Rate of Compliant ACUP PAM Reviews
“Those who cannot remember the past are condemned to repeat it.”
George Santayana, Reason in Common Sense, 1905-1906
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Average Rate of Compliant ACUP PAM Reviews
“Fanaticism consists in redoubling your efforts when you have forgotten your aim.”
George Santayana, Reason in Common Sense, 1905-1906
“…the only thing we have to fear is…fear itself…”
Franklin D. Roosevelt; Inaugural Address; March 4, 1933
• “The IACUC has not conducted an appropriate review of animal activities for protocol XXXX-XXXX 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)
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65.0
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85.0
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105.0
Average Rate of Compliant ACUP PAM Reviews
Redoubled EffortHow did PAM change?
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 Animals8th 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 Animals8th 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?”
New Directions• Collect categorical data from observations
to define training activities.
Month
Personnel Management
Program Oversight
Housing and Management
Procurement and Transport
Preventative Medicine
Clinical Care and Management
Surgery
Pain and Distress
Anesthesia and Analgesia
Euthanasia
Timely Response
Commendations
Total PAM ACUPs Reviewed
Commendation Rate
6/14 1 2 5 0 2 1 2 2 0 2 0 2 6 33%
7/14
8/14
9/14
10/14
11/14
Total 1 2 5 0 2 1 2 2 0 2 0 2 6 33%
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