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Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM

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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

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: “ 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

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?


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