2. Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM
Associate Director

3. Institutional Responsibility
To create an environment for a synergy between research and animal care.

4. Components of a Quality Animal Care and Use Program
The Research Team
Institutional Official
Researchers
IACUC
Animal Care Staff (AV and technical staff)
Policies, Procedures, Resources and Facilities

5. Role of the IO Be informed about the program Be engaged in the program
Sustained and visible support
In a position to influence institutional priorities
Can assure sufficient monetary and personnel resources are allocated

6. Role of the IACUC
Clearly articulate policies and procedures so that everyone understands expectations
Implement regulations using scientifically sound, performance-based standards
Establish effective training programs that are realistic
Assure the public of quality animal care

7. Role of Veterinarian and Staff
Ensure adequate and proper animal care and use
Work in concert with the IACUC and Investigators
Exercise professional judgment to facilitate the science in the context of animal welfare

8. The Scientist’s Role J. R. Haywood, Ph. D
The Scientist’s Role J.R. Haywood, Ph.D., Chairman, Department of Pharmacology and Toxicology Michigan State University
Plan research in the context of quality animal care
Accept the responsibility
Work to strengthen your animal care and use program
Engage in the process
IACUC participation
Know the regulations

9. The Scientist’s Role J. R. Haywood, Ph. D
The Scientist’s Role J.R. Haywood, Ph.D., Chairman, Department of Pharmacology and Toxicology Michigan State University
Be willing to communicate with administrators, regulators, and Congress
Embrace change
Be proactive

10. Animal Care and Use Program Components
AV & Staff
Administration
IACUC
Investigator
Each component must make its contribution so that the whole is greater than the sum of the parts.

11. In a Successful Animal Care and Use Program…
…each person in each component of an animal care program must know and understand his or her contribution as it relates to the whole effort.

12. Keys to Successful AAALAC Accreditation
Ensure adequate veterinary care and compliance oversight
Ensure clear lines of authority
Ensure strong institutional commitment to the animal care and use program

13. Roles and responsibilities of the Institutional Official
The Journey and Perspective of a New IO
Stan Nosek, Vice Chancellor, Administration, UC Davis

14. Program Accountability
IO – An individual who signs, and has the authority to sign the institution’s Assurance, making a commitment on behalf of the institution that the requirements of the PHS Policy on Humane Care and Use of Laboratory Animals will be met.

15. First Challenge: Acronyms
PHS
OLAW
NIH
IACUC
AAALAC
ARENA
AALAS
ARENA/OLAW IACUC Guidebook

16. The Office of Laboratory Animal Welfare has a Guide: EI EI O
Examining the Intricacies and Expectations of the Institutional Official (EI EI O)
The Office of Laboratory Animal Welfare has a Guide: EI EI O

17. Mission
To ensure the ethical and sensitive care and use of animals in research, teaching and testing.

18. Our Grand VISION
Through self-regulation and oversight, we will develop and maintain a model animal care program.

19. Program Values Humane Treatment of Animals
Benefits of animal research to human and animal health
Stewardship
Training
Striving for Excellence

20. The Institutional Official’s Role
Taken from Arena IACUC 101 5/9/02
Key Components of an Effective Animal Care and Use Committee presentation
Marky Pitts – UC San Diego
Molly Greene – University of Texas Health Science Center, San Antonio

21. Recognized and Respected Authority
Must have the administrative and operational authority to commit institutional resources to ensure compliance with the PHS Policy

22. Committed to a Quality Program
Provides leadership to achieve the desired result
Provides a high level of service
Makes decisions based on our commitment to become a model animal care program

23. Provides Sufficient Resources
Occupational Health & Safety
Personnel
Training
Technology/ Equipment
Maintenance of Facilities

24. Ensures Compliance

25. Supports Education
Understanding of the mission and values – the destination and the route identified to get there
Invests in people through ongoing training and development that is aligned with program priorities

26. Partners IACUC committee members
IACUC professional and administrative staff
Attending Veterinarian

27. Full Support IO needs the full support of the CEO
IACUC Chair needs the full support of the IO

28. The IO Provides Leadership and Support in to achieve the Mission

29. But it requires a team effort to get there !

30. The Roles and Responsibilities of the IACUC
Richard C. Van Sluyters, O.D., Ph.D. Associate Dean, School of Optometry
& IACUC Chair University of California, Berkeley

31. The Institutional Animal Care and Use Program
Institutional Official (IO)
Attending Veterinarian (Vet)
Institutional Animal Care and Use Committee (IACUC)

32. IACUC
“If Columbus had an advisory committee he would probably still be at the dock.”
Justice Arthur Goldberg,

33. IACUC
“What is a committee? A group of the unwilling, picked from the unfit, to do the unnecessary.”
Richard Long Harkness, 1907

34. IACUC Oversees and evaluates entire animal care and use program
Ensures compliance with Guide, Policy, AWRs
Represents institution and community
Serves as local oversight arm for APHIS/AC, NIH/OLAW, AAALAC

35. Well-Balanced Program

36. Imbalanced Program

37. The “Weak” IACUC Chair rotates annually
Inadequate relief/support for Chair
Members only serve 1 year
Few members who are PIs

38. The “Weak” IACUC Insufficient staff Insufficient/no office space
Insufficient funding
Inadequate computer expertise/equipment

39. The “Weak” IACUC Inadequate/no member training Inept protocol review
Staff “runs” the committee/meetings
Designated member review only
PHS applications not reviewed

40. The “Weak” IACUC Deficient recordkeeping (minutes, protocols, reports)
Delegated facility inspections
Inadequate semiannual facility
inspections/program reviews

41. The “Overpowering IACUC”
(no such thing!)

42. The “Overpowering IACUC”
IACUC ignores Vet’s recommendations
Dictatorial Chair
Overzealous facility inspections/program reviews

43. The “Overpowering IACUC”
IACUC’s policies handcuff PIs, Vet, IO
Inflexibility (rigid deadlines, rules, etc.)
Refusal to use performance standards
Refusal to consider exceptions to the
Guide

44. AAALAC Site Visits
A retrospective analysis of recent AAALAC site visit findings indicates how the IACUC “leg” of the animal care and use program needs to be strengthened.

45. Impact of the 1996 Guide on site visit findings

46. AAALAC Site Visit Deficiencies

47. IACUC Site Visit Findings

48. IACUC Deficiencies in Rank Order
Protocol Review
Semiannual Evaluations
Committee Composition & Member Participation
Policies & Documentation
Training

49. Protocol Review
Husbandry exceptions to Guide (e.g. wire-bottom cages, cage cleaning intervals)
Justification for the numbers of animals used
Expedited review
Review of amendments/addenda
Alternatives to painful procedures (Policy #12)
* Management/evaluation of pain and distress *

50. Protocol Review: Management/evaluation of pain and distress (By far the greatest number of mandatory items related to protocol review)
Inadequate justification for withholding analgesia
Inconsistency in evaluating pain categories or inadequate evaluation of potential for pain and distress
Humane endpoints

51. Semiannual Evaluations
Evaluation of animal activity areas
Classification of deficiencies as “minor” or “significant”
Schedule and plan for correction
Follow-up to ensure schedule and plan met

52. Committee Composition & Member Participation:
Nonaffiliated member not appointed
Nonaffiliated member not attending meetings
Nonaffiliated member not participating in semiannual evaluations

53. Policies and Documentation
Lack of policies/guidelines for common experimental procedures (e.g., ascites production, use of adjuvants, tail snips)
Failure to review policies/guidelines regularly
Failure to record committee deliberations

54. Training
Failure to train (or to document the training of) IACUC members
Failure to train (or to document the training of) researchers

55. Well-Balanced Program

56. “The trouble with using experience as a guide is that the final exam often comes first and then the lesson.”
Anonymous

57. The Roles and Responsibilities of the Attending Veterinarian
Kathy Laber, D.V.M., M.S., DACLAM
Director, Animal Resource Program
Ralph H. Johnson VA Medical Center

59. Veterinary Oath
“…I solemnly swear to use my scientific knowledge and skill for the benefit of society through the protection of animal health, the relief of animal suffering, the conservation of animal resources, the promotion of public health and the advancement of medical knowledge.”

60. AAALAC’s Perspective You must Good if you could
This is the outcome we want—you decide

61. Guide-Table of Contents
Institutional Policies and Responsibilities
General Intro: Veterinary Care
IACUC: Veterinary Care
Environment, Housing &Management
Veterinary Medical Care
Physical Plant

62. Role of the Attending Veterinarian (AV)
Institutional Responsibilities: Two Charges
‘generally’ give ACUP responsibility to vet trained in LAS—’or’ another qualified professional…qualified vet MUST be associated with program

63. Issues: Inadequate veterinary involvement in program
Role of the AV
Institutional Responsibilities:
‘generally’ give ACUP responsibility to vet trained in LAS—’or’ another qualified professional…qualified vet MUST be associated with program
Issues: Inadequate veterinary involvement in program

64. Role of the AV Institutional Responsibilities: 2 Charges
Adequate veterinary care MUST be provided…have the authority to oversee adequacy of ‘other’ aspects of animal care and use
Note: AWA/PHS Policy: “..direct or delegated authority for activities involving animals”

65. Role of the AV Institutional Responsibilities:
Adequate veterinary care MUST be provided…have the authority to oversee adequacy of ‘other’ aspects of animal care and use
Issues: Professional oversight not sufficiently intense and/or coordinated to ensure routine vet care, husbandry, physical plant oversight

66. Role of the AV IACUC Veterinary Medical Care-Chapter 3
Appropriate sedation, analgesia, and anesthesia
Post-procedure care and surgical care
Euthanasia
Oversee institutions program/procedures/facilities
Veterinary Medical Care-Chapter 3
Attending Veterinarian Definition

67. Issues: CONFLICT or DISENGAGEMENT
Role of the AV
IACUC Role- overlaps with
Veterinary Medical Care Responsibilities
Attending Veterinarian Definition
Issues: CONFLICT or DISENGAGEMENT

68. Role of the AV Width: Oversee activities involving animals
Depth: Laboratory Animal Management Zoonosis Control, Disease Management, Hazard Containment, Preventive Medicine, A&A, Surgery/Postsurgical Care, Euthanasia

69. Role of the AV in Lab Animal Management
Physical Environment: housing, space, light, noise
Behavioral Management: structural, social, activity
Husbandry: food, water, bedding, sanitation, pest, emergency plan
Population Management: records, animal I.D.

70. Physical Environment SPACE

71. Behavioral Management
Enrichment Program
Increased emphasis— need veterinary input
Structural environment
Social environment

72. Husbandry
Sanitation
Implement
Validate

73. Population Management
Animal Identification

74. Role of Attending Veterinarian in Occupational Health & Safety
Zoonosis Control
Issues:
Provide training/ information on allergies/ zoonosis

75. Role of Attending Veterinarian in Occupational Health & Safety
Hazard Containment
Issues:
Identification of hazards Awareness i.e. signage
Assessing risk from hazards
Provide/use PPE

76. Role of Attending Veterinarian in Disease Management
Issues:
Failure to report/id health problems
Ineffective sentinel programs
Inadequate daily animal surveillance
Inadequate record keeping

77. Role of Attending Veterinarian in Surgical Programs
Issues:
Inadequate monitoring and documentation of surgical and post-operative care
Lack of aseptic technique

78. Role of Attending Veterinarian in Anesthesia & Analgesia
Issues:
No or inappropriate A&A use, lack of oversight

79. Attending Veterinarians Role in Euthanasia
Issues:
Inappropriate methods of euthanasia, i.e. dry ice CO2, other animals present etc…

80. Roles and Responsibilities of AV
Manager, Director,
Clinician, Surgeon, Architect, Inventor, Investigator
Responsibilities: The Animal Care and Use Program as shared with the IACUC

81. Issues and Challenges in Centralized and De-Centralized Programs Joseph D. Thulin, DVM, MS, DACLAM
Attending Veterinarian and Manager
Veterinary Services
3M Company, St. Paul, MN, USA

82. Disclaimer
AAALAC International does not require a specific management structure for accreditation of the animal care and use program, except to the extent that some aspects of the organizational structure are recommended by the Guide or prescribed by applicable regulations and/or policies.
AAALAC International accredited units include institutions with either centralized or decentralized management and oversight of the animal care and use program.

83. Centralized vs. Decentralized
What is meant by these terms?
It is not always clear.

84. Typical unit with centralized management
Singular management for the animal resource (whether one or multiple facilities)
Direct line of reporting into the responsible institutional administrator/IO
One IO, one IACUC, one institutional/attending veterinarian

85. Sample Centralized Program

86. Units with decentralized management
Multiple organizational units responsible for providing animal care and/or oversight (whether one or multiple facilities)
Indirect reporting lines into the responsible institutional administrator/IO
Sometimes multiple IACUCs, AVs, or IOs

87. Sample Decentralized Program

88. Many programs are a hybrid, having both centralized and decentralized components.

89. Hybrid Program A

90. Hybrid Program B

91. Centralized or Decentralized?

92. Some questions…
Is there a relationship between management structure (centralized vs. decentralized) and outcomes of AAALAC site visits?
Are there certain programmatic areas in which the management structure impacts (positively or negatively) an institution’s ability to meet AAALAC accreditation standards and/or regulatory expectations?
In what ways does the management structure influence the functioning of the IO, IACUC, and AV?

93. Some answers…
Very few hard data
No shortage of opinion and anecdote

94. What are the problem areas for programs in general?
AAALAC trends data (1999 – 2002) show:
Approximately 25% of site re-visits resulted in less than Continued Full Accreditation.
Approximately 70% of the deficiencies were in the “Institutional Policies and Responsibilities” group (Guide Chap 1)
Institutional oversight/IACUC
Occupational Health and Safety Program
Program of Adequate Veterinary Care
Personnel Qualifications and Training

95. Survey of Present and Emeritus Members of the Council on Accreditation
Opinion poll sent to all current COA members and some Emeritus members.
Asked to provide opinions/commentary on management structure (centralized or decentralized) as it relates to achieving and maintaining AAALAC accreditation.

96. A majority of respondents expressed greater concern for decentralized than for centralized programs.

97. Areas of vulnerability for decentralized programs
Veterinary care and oversight
Occupational health and safety
IACUC function/oversight
Animal environment/housing/management
Other (satellites/labs, institutional resources, physical plant, record keeping, security, training)

98. Challenges for the Decentralized Program
Establishing CONSISTENCY among/across units
Penetrance of IACUC oversight, veterinary oversight and care, and OHSP
Standards of care
Distribution of staffing and resources (“haves and have-nots”)
Leadership
Training
Record Keeping
Negative competition among units

99. Challenges for the Decentralized Program (cont)
Ensuring no organizational barriers for IO, IACUC, and AV
Pairing responsibility with authority
Ability to implement corrective actions
Encouraging programmatic engagement and balance

100. Sample Decentralized Program

101. Challenges for the Decentralized Program (cont)
Managing conflicts of interest
Investigator provided animal husbandry
Investigator provided veterinary care

102. Areas of vulnerability for the centralized program
Institutional policies and responsibilities
Institutional oversight/IACUC
Program of adequate veterinary care
Occupational health and safety program
The same as for decentralized programs!

103. Challenges for the Centralized Program
Establishing and maintaining programmatic engagement and balance among the organizational pillars IO
IACUC AV

104. The IO, IACUC, and AV must function as a team!

105. Challenges for the Centralized Program (cont)
Maintaining flexibility and ability to support diverse needs
Diversity in species
Diversity in programs

106. Challenges for the Centralized Program (cont)
Achieving excellence and avoiding complacency
You’ve achieved consistency in the program… but is it the consistent high quality desired?

107. Summary
The type of organizational structure (centralized or decentralized) may affect the quality of the animal care and use program.
Centralized and decentralized programs face the same overall challenge -
Achieving and maintaining a uniformly high quality animal care and use program.
However, the specific challenges and necessary approaches may be quite different.

108. “Any structure can and does work when the people involved want it to work and are willing to work together for the greater good.”

109. Thanks to:
Council on Accreditation
AAALAC Staff
Lori Wieder

110. Industry Perspective Michael Ballinger, D.V.M., M.S., DACLAM
Director, Global Animal Research Programs
Amgen Inc.
President, Council on Accreditation
AAALAC International

111. What are Industry Animal Programs?
Pharmaceutical/Biotech/Animal Health/Devices
Chemical Co’s w/ in-house Industrial Toxicology
Contract Lab (CRO)
Animal Supplier/Breeder

112. Industry Animal Programs Have Distinct Differences
Advantages and Disadvantages
Broad range of financial resources
Different regulatory drivers
Most all are “for profit” by definition

113. General Distinctions of Industry Programs
Regulatory Oversight and Focus differs from academia
“Repetitive” protocols are common
“Committee” oversight doesn’t easily fit management model
Profitability is the bottom line

114. Unique Regulatory Oversight
Many industry programs do not have PHS Animal Welfare Assurance
Others have no USDA oversight (some Biotechs and mice/rat suppliers)
Many have only USDA & AAALAC oversight (no PHS)

115. FDA GLP’s are the Primary Regulatory Focus (CRO’s and Pharma)
Creates confusion on “hierarchy” of regulatory mandates
May tempt organizations to apply GLP/GMP demands to general animal programmatic areas (far outside the FDA’s areas of concerns)

116. Quality Assurance is a Major Focus
FDA driver for Med/Chem & CRO’s
Product Quality driver for animal suppliers

117. Repetitive and Screening Animal Protocols Common
Justifying animal use numbers is challenge
May be totally driven by chemical throughput
Emphasis should be on study design for individual trial
Endpoints for safety/toxicology protocols are special challenge

118. How Does IACUC Role Fit Into Corporate or Small Business Model?
Top-down, hierarchical management
Committee oversight shoehorned into the hierarchy and power structure
IO – IACUC relationship must be well defined (beyond regulatory guidance)

119. Fiscal Management – “for profit”
May make capital investments more timely
Animal care operations may be very lean (in lean times)
Administrative & Support staff often a difficult justification

120. Pharmaceutical/Biotech Picture
Broad range in size and scope of programs
Small single site
Multi-site, multi-national
Animal use focus varies
Health vs. non-health products
Human vs. animal health
Pure research
Applied research
Safety Assessment (toxicology)
FDA GLP’s are the overwhelming regulatory focus

121. Pharma/Biotech Picture
Multi-site, multi-state is common setting w/ big Pharma
USDA has recently demanded single IO, single USDA registration, and a single annual report from several multi-site Pharma companies
Most multi-site Pharma’s (w/ significant geographic separation and independent management) have elected to limit IACUC oversight to single site (or group of closely associated sites)

122. IO – Pharma/Biotech
IO’s relative position in management hierarchy varies w/ Co.
Some have senior R&D executive as IO (and direct line management responsibility for all animal use under the IO’s control)
Other units use mid-level executive as IO without direct control of all users.
Senior Exec model makes oversight simpler

123. IACUC – Pharma/BT
How is committee authority perceived in power structure?
IACUC service may be a challenge due to the business drivers and demands for research results, e.g., new compound discovery and successful commercial launch.
Committee (of any type) membership not commonly viewed as career enhancing in Pharma/BT in contrast to academia.

124. IACUC Chair – Pharma/BT
IACUC leadership often either an R&D lower level executive or a senior scientist
Chair role is some settings is becoming appreciated as a position of significant power in the Pharma R&D
Other settings - it is quite the opposite.
Off-site CE for chair and members may be a challenge

125. AV – Pharm/BT I AV role well developed.
AV commonly reports to the Drug Safety executive but major users (Discovery or research) often report via different executive.
Reporting relationship may or may not create challenges for AV authority.

126. AV – Pharma/BT II AV commonly leads a centralized vivarium staff.
Decentralized animal care is rare in this setting.
Although it still exists, territorialism is less prevalent in industry – resources are “corporate” rather than purchased/supported by PI grants.

127. AV – Pharma/BT III
Role and authority of AV versus Tox Study Director (SD)
Especially challenging when SD has DVM/VMD
Study pathologist’s role (independent of AV)

128. CRO-Specific Challenges
CRO – Sponsor relationship creates special challenges
Sponsor may send challenging protocols to CRO
Economic/business pressure to do study as dictated by sponsor must be balanced w/ CRO IACUC’s ethical responsibilities
AV role is a special challenge
Compliance record (especially w/ USDA, FDA and AAALAC) is key selling point to sponsors. Compliance is under scrutiny by QA reps from sponsor organizations, but focus is usually GLP-centric

129. CRO IO
Typically a senior manager or executive (depending on size and complexity of unit).
CRO IO commonly has management control of all animal users.

130. CRO IACUC Challenges Independence (versus business drivers)
Composition (AWA limits on # from dept)
Leadership
Demand for quick turnaround

131. CRO IACUC May be the most challenging setting for an animal committee.
Virtually all protocols are specified by the folks paying the bills (sponsors).
Quick turnaround is a major demand by sponsor.
Independent review is challenge in a CRO setting. At least one CRO uses an outside chair (scientist from nearby college) to help w/ this challenge.

132. AV - CRO
A real balancing act to be the attending veterinarian in a busy contract lab.
Lack personal contact or relationship w/ sponsors’ scientists may limit influence.
AV often only involved w/ sponsor when adverse events occur.
Tough timing for an “introduction”

133. Industry Programs for Animal Care and Use Differ from Academia
Much of CE for IACUC & IO is driven by PHS Assurance issues
Unique settings demand unique and novel solutions
One size does NOT fit all

134. Simple Test for All of These Settings & Challenges
Who is the animal advocate in the program/facility?
Does the animal advocate have a voice?
Can the animal advocate challenge the status quo?