the same as for decentralized programs!
TRANSCRIPT
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Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAMAssociate Director
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Institutional Responsibility
To create an environment for a synergy between research and animal care.
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Components of a Quality Animal Care and Use ProgramThe Research Team
Institutional OfficialResearchersIACUCAnimal Care Staff (AV and technical staff)
Policies, Procedures, Resources and Facilities
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Role of the IO
Be informed about the programBe engaged in the programSustained and visible support
In a position to influence institutional prioritiesCan assure sufficient monetary and personnel
resources are allocated
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Role of the IACUCClearly 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
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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
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The Scientist’s RoleJ.R. Haywood, Ph.D., Chairman, Department of Pharmacology and Toxicology Michigan State University
Plan research in the context of quality animal care
Accept the responsibilityWork to strengthen your animal care and use
programEngage in the process
IACUC participationKnow the regulations
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The Scientist’s RoleJ.R. Haywood, Ph.D., Chairman, Department of Pharmacology and Toxicology Michigan State University
Be willing to communicate with administrators, regulators, and Congress
Embrace changeBe proactive
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Animal Care and Use Program Components
Each component must make its contribution so that the whole is greater than the sum of the parts.
IACUC
AV & Staff
Investigator
Administration
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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.
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Keys to Successful AAALAC AccreditationEnsure adequate veterinary care and
compliance oversight
Ensure clear lines of authority
Ensure strong institutional commitment to the animal care and use program
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Roles and responsibilities of the Institutional OfficialThe Journey and Perspective of a New IO
Stan Nosek, Vice Chancellor, Administration, UC Davis
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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.
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First Challenge: AcronymsPHSOLAWNIH IACUCAAALACARENAAALASARENA/OLAW IACUC Guidebook
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Examining the Intricacies and Expectations of the Institutional Official (EI EI O)
The Office of Laboratory Animal Welfare has a Guide: EI EI O
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MissionTo ensure the
ethical and sensitive care and use of animals in research, teaching and testing.
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Our Grand VISIONThrough self-
regulation and oversight, we will develop and maintain a model animal care program.
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Program ValuesHumane Treatment of
AnimalsBenefits of animal
research to human and animal health
StewardshipTrainingStriving for
Excellence
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The Institutional Official’s Role
Taken from Arena IACUC 101 5/9/02 Key Components of an Effective Animal
Care and Use Committee presentationMarky Pitts – UC San DiegoMolly Greene – University of Texas Health
Science Center, San Antonio
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Recognized and Respected AuthorityMust have the
administrative and operational authority to commit institutional resources to ensure compliance with the PHS Policy
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Committed to a Quality ProgramProvides leadership to
achieve the desired result Provides a high level of
serviceMakes decisions based on
our commitment to become a model animal care program
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Provides Sufficient ResourcesOccupational Health
& SafetyPersonnel TrainingTechnology/
EquipmentMaintenance of
Facilities
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Ensures Compliance
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Supports EducationUnderstanding 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
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PartnersIACUC committee
membersIACUC professional
and administrative staff
Attending Veterinarian
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Full Support
IO needs the full support of the CEO
IACUC Chair needs the full support of the IO
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The IO Provides Leadership and Support in to achieve the Mission
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But it requires a team effort to get there !
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The Roles and Responsibilities of the IACUC
Richard C. Van Sluyters, O.D., Ph.D. Associate Dean, School of Optometry & IACUC ChairUniversity of California, Berkeley
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The Institutional Animal Care The Institutional Animal Care and Use Programand Use ProgramInstitutional Official (IO)Attending Veterinarian (Vet)Institutional Animal Care and Use
Committee (IACUC)
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IACUC
“If Columbus had an advisory committee he would probably still be at the dock.”
Justice Arthur Goldberg, 1908-1990
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IACUC
“What is a committee? A group of the unwilling, picked from the unfit, to do the unnecessary.”
Richard Long Harkness, 1907
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IACUC
Oversees and evaluates entire animal care and use program
Ensures compliance with Guide, Policy, AWRs
Represents institution and communityServes as local oversight arm for
APHIS/AC, NIH/OLAW, AAALAC
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Well-Balanced Program
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Imbalanced Program
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The “Weak” IACUC
Chair rotates annuallyInadequate relief/support for ChairMembers only serve 1 yearFew members who are PIs
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The “Weak” IACUC
Insufficient staff Insufficient/no office space Insufficient fundingInadequate computer expertise/equipment
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The “Weak” IACUC
Inadequate/no member training Inept protocol reviewStaff “runs” the committee/meetingsDesignated member review onlyPHS applications not reviewed
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The “Weak” IACUC
Deficient recordkeeping (minutes, protocols, reports)Delegated facility inspectionsInadequate semiannual facility inspections/program reviews
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The “Overpowering IACUC”The “Overpowering IACUC”(no such thing!)
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The “Overpowering IACUC”
IACUC ignores Vet’s recommendationsDictatorial ChairOverzealous facility
inspections/program reviews
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The “Overpowering IACUC”
IACUC’s policies handcuff PIs, Vet, IOInflexibility (rigid deadlines, rules, etc.)Refusal to use performance standardsRefusal to consider exceptions to the Guide
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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.
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Impact of the 1996 Guide on site visit findings
01020304050607080
IACUC MANDATORY IACUC SUGGESTION
PRE 1996POST 1996
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AAALAC Site Visit Deficiencies
010
203040
50607080
1999 2000 2001 2002
Institutional Policies
Laboratory AnimalManagementVeterinary MedicalCarePhysical Plant
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IACUC Site Visit Findings
0
5
10
15
20
25
30
35
1999 2000 2001 2002
PercentMandatory Item
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IACUC Deficiencies in Rank Order
Protocol ReviewProtocol Review Semiannual EvaluationsSemiannual Evaluations Committee Composition Committee Composition
& Member Participation & Member Participation Policies & DocumentationPolicies & Documentation TrainingTraining
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Protocol ReviewHusbandry 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 *
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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
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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
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Committee Composition & Member Participation:Nonaffiliated member not appointed
Nonaffiliated member not attending
meetings
Nonaffiliated member not participating in
semiannual evaluations
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Policies and DocumentationLack 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
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Training
Failure to train (or to document the training of) IACUC members
Failure to train (or to document the training of) researchers
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Well-Balanced Program
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“The trouble with using experience as a guide is that the
final exam often comes first and then the lesson.” Anonymous
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The Roles and Responsibilities of the Attending Veterinarian
Kathy Laber, D.V.M., M.S., DACLAMDirector, Animal Resource Program Ralph H. Johnson VA Medical Center
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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.”
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AAALAC’s PerspectiveYou mustGood if you couldThis is the outcome
we want—you decide
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Guide-Table of Contents1) Institutional Policies and Responsibilities
General Intro: Veterinary CareIACUC: Veterinary Care
2) Environment, Housing &Management3) Veterinary Medical Care4) Physical Plant
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Role of the Attending Veterinarian (AV)Institutional Responsibilities: Two Charges1. ‘generally’ give ACUP responsibility to
vet trained in LAS—’or’ another qualified professional…qualified vet MUST be associated with program
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Role of the AV
Institutional Responsibilities: 1. ‘generally’ give ACUP responsibility to
vet trained in LAS—’or’ another qualified professional…qualified vet MUST be associated with program
Issues: Inadequate veterinaryinvolvement in program
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Role of the AV
Institutional Responsibilities: 2 Charges2. 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”
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Role of the AV
Institutional Responsibilities:2. 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 coordinatedto ensure routine vet care, husbandry,
physical plant oversight
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Role of the AVIACUC
• Appropriate sedation, analgesia, and anesthesia• Post-procedure care and surgical care • Euthanasia• Oversee institutions program/procedures/facilities
Veterinary Medical Care-Chapter 3• Appropriate sedation, analgesia, and anesthesia• Post-procedure care and surgical care • Euthanasia
Attending Veterinarian Definition• Oversee institutions program/procedures/facilities
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Role of the AV
IACUC Role- overlaps withVeterinary Medical Care ResponsibilitiesAttending Veterinarian Definition
Issues: CONFLICT or DISENGAGEMENT
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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
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Role of the AV in Lab Animal ManagementPhysical Environment:
housing, space, light, noiseBehavioral Management:
structural, social, activityHusbandry: food, water, bedding,
sanitation, pest, emergency planPopulation Management: records, animal I.D.
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Physical Environment
SPACE
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Behavioral Management
Enrichment Program Increased emphasis—
need veterinary inputStructural environmentSocial environment
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Husbandry
SanitationImplementValidate
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Population Management
Animal Identification
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Role of Attending Veterinarian in Occupational Health & Safety
Zoonosis ControlIssues:Provide
training/information on allergies/zoonosis
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Role of Attending Veterinarian in Occupational Health & Safety
Hazard ContainmentIssues:
Identification of hazards Awareness i.e. signage
Assessing risk from hazards
Provide/use PPE
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Role of Attending Veterinarian in Disease ManagementIssues:Failure to report/id
health problemsIneffective sentinel
programsInadequate daily
animal surveillance Inadequate record
keeping
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Role of Attending Veterinarian in Surgical Programs
Issues:Inadequate
monitoring and documentation of surgical and post-operative care
Lack of aseptic technique
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Role of Attending Veterinarian in Anesthesia & Analgesia
Issues:No or inappropriate
A&A use, lack of oversight
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Attending Veterinarians Role in Euthanasia
Issues:Inappropriate
methods of euthanasia, i.e. dry ice CO2, other animals present etc…
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Roles and Responsibilities of AVRoles:
Manager, Director, Clinician, Surgeon,
Architect, Inventor, Investigator
Responsibilities:The Animal Care and Use Program as shared with the IACUC
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Issues and Challenges in Centralized and De-Centralized ProgramsJoseph D. Thulin, DVM, MS, DACLAMAttending Veterinarian and ManagerVeterinary Services3M Company, St. Paul, MN, USA
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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.
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Centralized vs. Decentralized
What is meant by these terms?It is not always clear.
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Typical unit with centralized managementSingular 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
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Sample Centralized Program
IACU C
A n im a l H usb an d ry S ta ff C lin ica l V e te rin ary S ta ff
Attending VeterinarianD ire c to r/M a n a g er
A n im a l R eso u rce De p a rtm e n t
Institutional Offic ial
C h ie f E xe cu tive O ff ice r
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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
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Sample Decentralized Program
A n im a l C a re U n it A
D r. X Y Z 's M o u se C o lo ny
D ire c to r A
A n im a l C a re U n it B
D ire c to r B
A n im a l C a re U n it C
D r. A B C 's C a t C o lo ny
D ire c to r C
V ice P re s ide n t A
IACU C
Attending Veterinarian
V ice P re s ide n t BInstitutional Official
C h ie f E xe cu tive O fficer
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Many programs are a hybrid, having both centralized and decentralized components.
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Hybrid Program A
Anim al Care Unit A
Dr. XYZ's M ouse Colony
D ire c to r A
Anim al Care Unit B
D ire c to r B
Anim al Care Unit C
Dr. ABC's Cat Colony
D ire c to r C
V ice P re s ide n t A
IACU C
Central Anim al Care Unit
Attending VeterinarianP ro g ram D irec to r/M a n a g er
V ice P re s ide n t BInstitutional Offic ial
C h ie f E x e c utive O ffic e r
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Hybrid Program B
Dr. DEF's Frog Colony
Dr. XYZ's M ouse Colony
D ire c to r A
Dr. GHI's Sheep Barn
D ire c to r B
Dr. JKL's Inhalation Lab
Dr. ABC's Cat Colony
D ire c to r C
V ice P re s ide n t A
IACU C
Central Anim al Care Unit
Attending VeterinarianP ro g ram D irec to r/M a n a g er
V ic e P re s ide n t BInstitutional Offic ial
C h ie f E x e c utiv e O ff ice r
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Centralized or Decentralized?
Anim al Program Com m ittee Institutional Veterinarian
IACUC A
A n im a l C a re U n it A
Attending Veterinarian A
V ice P re s ide n t A
IACUC B
A n im a l C a re U n it B
Attending Veterinarian B
V ic e P re s id e n t B
IACUC C
A n im a l C a re U n it C
Attending Veterinarian C
V ice P re s ide n t C
IACUC D
A n im a l C a re U n it D
Attending Veterinarian D
V ic e P re s id e n t D
C h ie f A d m in is tra tive O ff ic e rInstitutional Official
C h ie f E x e cu tiv e O ffic e r
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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?
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Some answers…Very few hard dataNo shortage of opinion and anecdote
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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
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Survey of Present and Emeritus Members of the Council on AccreditationOpinion 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.
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A majority of respondents expressed greater concernfor decentralized than for centralized programs.
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Areas of vulnerability for decentralized programsVeterinary care and oversightOccupational health and safetyIACUC function/oversightAnimal environment/housing/managementOther (satellites/labs, institutional resources,
physical plant, record keeping, security, training)
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Challenges for the Decentralized Program1. 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
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Challenges for the Decentralized Program (cont)2. Ensuring no organizational barriers for IO,
IACUC, and AV Pairing responsibility with authority Ability to implement corrective actions Encouraging programmatic
engagement and balance
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Sample Decentralized Program
A n im a l C a re U n it A
D r. X Y Z 's M o u se C o lo ny
D ire c to r A
A n im a l C a re U n it B
D ire c to r B
A n im a l C a re U n it C
D r. A B C 's C a t C o lo ny
D ire c to r C
V ice P re s ide n t A
IACU C
Attending Veterinarian
V ice P re s ide n t BInstitutional Official
C h ie f E xe cu tive O ff ice r
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Challenges for the Decentralized Program (cont)
3. Managing conflicts of interest Investigator provided animal husbandry Investigator provided veterinary care
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Areas of vulnerability for the centralized programInstitutional policies and responsibilities
Institutional oversight/IACUCProgram of adequate veterinary careOccupational health and safety program
The same as for decentralized programs!
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Challenges for the Centralized Program1. Establishing and maintaining
programmatic engagement and balance among the organizational pillars
IO IACUC AV
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The IO, IACUC, and AV must function as a team!
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Challenges for the Centralized Program (cont)2. Maintaining flexibility and ability to
support diverse needs Diversity in species Diversity in programs
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Challenges for the Centralized Program (cont)3. Achieving excellence and avoiding
complacency You’ve achieved consistency in the program…
but is it the consistent high quality desired?
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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.
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“Any structure can and does work when the people involved want it to work and are willing to work together for the greater good.”
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Thanks to:Council on AccreditationAAALAC StaffLori Wieder
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Industry PerspectiveMichael Ballinger, D.V.M., M.S., DACLAMDirector, Global Animal Research ProgramsAmgen Inc.President, Council on AccreditationAAALAC International
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What are Industry Animal Programs?Pharmaceutical/Biotech/Animal
Health/DevicesChemical Co’s w/ in-house Industrial
Toxicology Contract Lab (CRO)Animal Supplier/Breeder
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Industry Animal Programs Have Distinct DifferencesAdvantages and DisadvantagesBroad range of financial resourcesDifferent regulatory driversMost all are “for profit” by definition
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General Distinctions of Industry ProgramsRegulatory Oversight and Focus differs
from academia“Repetitive” protocols are common“Committee” oversight doesn’t easily fit
management modelProfitability is the bottom line
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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)
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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)
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Quality Assurance is a Major Focus
FDA driver for Med/Chem & CRO’sProduct Quality driver for animal suppliers
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Repetitive and Screening Animal Protocols CommonJustifying 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
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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)
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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
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Pharmaceutical/Biotech PictureBroad range in size and scope of programs
Small single siteMulti-site, multi-national
Animal use focus variesHealth vs. non-health productsHuman vs. animal healthPure researchApplied researchSafety Assessment (toxicology)
FDA GLP’s are the overwhelming regulatory focus
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Pharma/Biotech PictureMulti-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 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)
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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
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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.
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IACUC Chair – Pharma/BTIACUC 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&D
Other settings - it is quite the opposite. Off-site CE for chair and members may be
a challenge
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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.
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AV – Pharma/BT IIAV 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.
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AV – Pharma/BT III
Role and authority of AV versus Tox Study Director (SD)Especially challenging when SD has
DVM/VMDStudy pathologist’s role (independent of AV)
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CRO-Specific ChallengesCRO – 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
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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.
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CRO IACUC Challenges
Independence (versus business drivers)Composition (AWA limits on # from dept)LeadershipDemand for quick turnaround
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CRO IACUCMay 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.
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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”
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Industry Programs for Animal Care and Use Differ from AcademiaMuch of CE for IACUC & IO is driven by
PHS Assurance issuesUnique settings demand unique and novel
solutionsOne size does NOT fit all
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Simple Test for All of These Settings & ChallengesWho 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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www.aaalac.org