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 TeamInstitutional OfficialResearchersIACUCAnimal 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 supportIn a position to influence institutional prioritiesCan assure sufficient monetary and personnel resources are allocated
6 Role of the IACUCClearly articulate policies and procedures so that everyone understands expectationsImplement regulations using scientifically sound, performance-based standardsEstablish effective training programs that are realisticAssure the public of quality animal care
7 Role of Veterinarian and Staff Ensure adequate and proper animal care and useWork in concert with the IACUC and InvestigatorsExercise 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 UniversityPlan research in the context of quality animal careAccept the responsibilityWork to strengthen your animal care and use programEngage in the processIACUC participationKnow 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 UniversityBe willing to communicate with administrators, regulators, and CongressEmbrace changeBe proactive
10 Animal Care and Use Program Components AV & StaffAdministrationIACUCInvestigatorEach 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 oversightEnsure clear lines of authorityEnsure 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 IOStan 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 PHSOLAWNIHIACUCAAALACARENAAALASARENA/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 MissionTo ensure the ethical and sensitive care and use of animals in research, teaching and testing.
18 Our Grand VISIONThrough 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 healthStewardshipTrainingStriving for Excellence
20 The Institutional Official’s Role Taken from Arena IACUC 101 5/9/02Key Components of an Effective Animal Care and Use Committee presentationMarky Pitts – UC San DiegoMolly 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 resultProvides a high level of serviceMakes decisions based on our commitment to become a model animal care program
23 Provides Sufficient Resources Occupational Health & SafetyPersonnelTrainingTechnology/ EquipmentMaintenance of Facilities
25 Supports EducationUnderstanding of the mission and values – the destination and the route identified to get thereInvests in people through ongoing training and development that is aligned with program priorities
26 Partners IACUC committee members IACUC professional and administrative staffAttending 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
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, AWRsRepresents institution and communityServes as local oversight arm for APHIS/AC, NIH/OLAW, AAALAC
48 IACUC Deficiencies in Rank Order Protocol ReviewSemiannual EvaluationsCommittee Composition & Member ParticipationPolicies & DocumentationTraining
49 Protocol ReviewHusbandry exceptions to Guide (e.g. wire-bottom cages, cage cleaning intervals)Justification for the numbers of animals usedExpedited reviewReview of amendments/addendaAlternatives 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 analgesiaInconsistency in evaluating pain categories or inadequate evaluation of potential for pain and distressHumane endpoints
51 Semiannual Evaluations Evaluation of animal activity areasClassification of deficiencies as “minor” or “significant”Schedule and plan for correctionFollow-up to ensure schedule and plan met
52 Committee Composition & Member Participation: Nonaffiliated member not appointedNonaffiliated member not attending meetingsNonaffiliated 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 regularlyFailure to record committee deliberations
54 TrainingFailure to train (or to document the training of) IACUC membersFailure to train (or to document the training of) researchers
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 ResponsibilitiesGeneral Intro: Veterinary CareIACUC: Veterinary CareEnvironment, Housing &ManagementVeterinary Medical CarePhysical 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 AVInstitutional Responsibilities:‘generally’ give ACUP responsibility to vet trained in LAS—’or’ another qualified professional…qualified vet MUST be associated with programIssues: 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 useNote: 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 useIssues: 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 anesthesiaPost-procedure care and surgical careEuthanasiaOversee institutions program/procedures/facilitiesVeterinary Medical Care-Chapter 3Attending Veterinarian Definition
67 Issues: CONFLICT or DISENGAGEMENT Role of the AVIACUC Role- overlaps withVeterinary Medical Care ResponsibilitiesAttending Veterinarian DefinitionIssues: 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, noiseBehavioral Management: structural, social, activityHusbandry: food, water, bedding, sanitation, pest, emergency planPopulation Management: records, animal I.D.
74 Role of Attending Veterinarian in Occupational Health & Safety Zoonosis ControlIssues:Provide training/ information on allergies/ zoonosis
75 Role of Attending Veterinarian in Occupational Health & Safety Hazard ContainmentIssues:Identification of hazards Awareness i.e. signageAssessing risk from hazardsProvide/use PPE
76 Role of Attending Veterinarian in Disease Management Issues:Failure to report/id health problemsIneffective sentinel programsInadequate daily animal surveillanceInadequate record keeping
77 Role of Attending Veterinarian in Surgical Programs Issues:Inadequate monitoring and documentation of surgical and post-operative careLack 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, InvestigatorResponsibilities: 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 ManagerVeterinary Services3M Company, St. Paul, MN, USA
82 DisclaimerAAALAC 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/IOOne IO, one IACUC, one institutional/attending veterinarian
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/IOSometimes multiple IACUCs, AVs, or IOs
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 dataNo 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/IACUCOccupational Health and Safety ProgramProgram of Adequate Veterinary CarePersonnel 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 oversightOccupational health and safetyIACUC function/oversightAnimal environment/housing/managementOther (satellites/labs, institutional resources, physical plant, record keeping, security, training)
98 Challenges for the Decentralized Program Establishing CONSISTENCY among/across unitsPenetrance of IACUC oversight, veterinary oversight and care, and OHSPStandards of careDistribution of staffing and resources (“haves and have-nots”)LeadershipTrainingRecord KeepingNegative competition among units
99 Challenges for the Decentralized Program (cont) Ensuring no organizational barriers for IO, IACUC, and AVPairing responsibility with authorityAbility to implement corrective actionsEncouraging programmatic engagement and balance
101 Challenges for the Decentralized Program (cont) Managing conflicts of interestInvestigator provided animal husbandryInvestigator provided veterinary care
102 Areas of vulnerability for the centralized program Institutional policies and responsibilitiesInstitutional oversight/IACUCProgram of adequate veterinary careOccupational health and safety programThe same as for decentralized programs!
103 Challenges for the Centralized Program Establishing and maintaining programmatic engagement and balance among the organizational pillarsIOIACUCAV
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 needsDiversity in speciesDiversity in programs
106 Challenges for the Centralized Program (cont) Achieving excellence and avoiding complacencyYou’ve achieved consistency in the program… but is it the consistent high quality desired?
107 SummaryThe 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 AccreditationAAALAC StaffLori Wieder
110 Industry Perspective Michael Ballinger, D.V.M., M.S., DACLAM Director, Global Animal Research ProgramsAmgen Inc.President, Council on AccreditationAAALAC International
111 What are Industry Animal Programs? Pharmaceutical/Biotech/Animal Health/DevicesChemical Co’s w/ in-house Industrial ToxicologyContract Lab (CRO)Animal Supplier/Breeder
112 Industry Animal Programs Have Distinct Differences Advantages and DisadvantagesBroad range of financial resourcesDifferent regulatory driversMost 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 modelProfitability is the bottom line
114 Unique Regulatory Oversight Many industry programs do not have PHS Animal Welfare AssuranceOthers 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 mandatesMay 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’sProduct Quality driver for animal suppliers
117 Repetitive and Screening Animal Protocols Common Justifying animal use numbers is challengeMay be totally driven by chemical throughputEmphasis should be on study design for individual trialEndpoints for safety/toxicology protocols are special challenge
118 How Does IACUC Role Fit Into Corporate or Small Business Model? Top-down, hierarchical managementCommittee oversight shoehorned into the hierarchy and power structureIO – IACUC relationship must be well defined (beyond regulatory guidance)
119 Fiscal Management – “for profit” May make capital investments more timelyAnimal 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 programsSmall single siteMulti-site, multi-nationalAnimal use focus variesHealth vs. non-health productsHuman vs. animal healthPure researchApplied researchSafety Assessment (toxicology)FDA GLP’s are the overwhelming regulatory focus
121 Pharma/Biotech Picture Multi-site, multi-state is common setting w/ big PharmaUSDA has recently demanded single IO, single USDA registration, and a single annual report from several multi-site Pharma companiesMost 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/BiotechIO’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/BTHow 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 scientistChair role is some settings is becoming appreciated as a position of significant power in the Pharma R&DOther 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 IIIRole and authority of AV versus Tox Study Director (SD)Especially challenging when SD has DVM/VMDStudy pathologist’s role (independent of AV)
128 CRO-Specific Challenges CRO – Sponsor relationship creates special challengesSponsor may send challenging protocols to CROEconomic/business pressure to do study as dictated by sponsor must be balanced w/ CRO IACUC’s ethical responsibilitiesAV role is a special challengeCompliance 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 IOTypically 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)LeadershipDemand 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 - CROA 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 issuesUnique settings demand unique and novel solutionsOne 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?