Kathryn Bayne, M.S., Ph.D., D.V.M.,
DACLAM
Associate Director
Institutional Responsibility
To create an environment for a synergy
between research and animal care.
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
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
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
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
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
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
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.
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.
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
Roles and responsibilities
of the Institutional Official
The Journey and Perspective of a New IO
Stan Nosek, Vice Chancellor,
Administration, UC Davis
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.
First Challenge: Acronyms
PHS
OLAW
NIH
IACUC
AAALAC
ARENA
AALAS
ARENA/OLAW IACUC Guidebook
Examining the Intricacies and
Expectations of the Institutional
Official (EI EI O)
The Office of Laboratory Animal Welfare
has a Guide: EI EI O
Mission
To ensure the
ethical and sensitive
care and use of
animals in research,
teaching and
testing.
Our Grand VISION
Through selfregulation and
oversight, we will
develop and maintain
a model animal care
program.
Program Values
Humane Treatment of
Animals
Benefits of animal
research to human
and animal health
Stewardship
Training
Striving for
Excellence
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
Recognized and
Respected Authority
Must have the
administrative and
operational authority to
commit institutional
resources to ensure
compliance with the PHS
Policy
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
Provides Sufficient Resources
Occupational Health
& Safety
Personnel
Training
Technology/
Equipment
Maintenance of
Facilities
Ensures
Compliance
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
Partners
IACUC committee
members
IACUC professional
and administrative
staff
Attending Veterinarian
Full Support
IO needs the full
support of the CEO
IACUC Chair needs
the full support of the
IO
The IO Provides Leadership and
Support in to achieve the Mission
But it requires a team
effort to get there !
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
The Institutional Animal Care
and Use Program
Institutional Official (IO)
Attending Veterinarian (Vet)
Institutional Animal Care and Use
Committee (IACUC)
IACUC
“If Columbus had an advisory committee
he would probably still be at the dock.”
Justice Arthur Goldberg, 1908-1990
IACUC
“What is a committee? A group of the
unwilling, picked from the unfit, to do the
unnecessary.”
Richard Long Harkness, 1907
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
Well-Balanced Program
Imbalanced Program
The “Weak” IACUC
Chair rotates annually
Inadequate relief/support for Chair
Members only serve 1 year
Few members who are PIs
The “Weak” IACUC
Insufficient staff
Insufficient/no office space
Insufficient funding
Inadequate computer expertise/equipment
The “Weak” IACUC
Inadequate/no member training
Inept protocol review
Staff “runs” the committee/meetings
Designated member review only
PHS applications not reviewed
The “Weak” IACUC
Deficient recordkeeping (minutes,
protocols, reports)
Delegated facility inspections
Inadequate semiannual facility
inspections/program reviews
The “Overpowering IACUC”
(no such thing!)
The “Overpowering IACUC”
IACUC ignores Vet’s recommendations
Dictatorial Chair
Overzealous facility
inspections/program reviews
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
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.
Impact of the 1996 Guide
on site visit findings
80
70
60
50
PRE 1996
POST 1996
40
30
20
10
0
IACUC MANDATORY
IACUC SUGGESTION
AAALAC Site Visit Deficiencies
80
70
60
Institutional Policies
50
Laboratory Animal
Management
Veterinary Medical
Care
Physical Plant
40
30
20
10
0
1999
2000
2001
2002
IACUC Site Visit Findings
35
30
25
20
Percent
Mandatory Item
15
10
5
0
1999
2000
2001
2002
IACUC Deficiencies in Rank Order
 Protocol Review
 Semiannual Evaluations
 Committee Composition
& Member Participation
 Policies & Documentation
 Training
Protocol Review
Husbandry exceptions to Guide (e.g. wirebottom 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 *
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
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
Committee Composition
& Member Participation:
Nonaffiliated member not appointed
Nonaffiliated member not attending
meetings
Nonaffiliated member not participating in
semiannual evaluations
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
Training
Failure to train (or to document the training
of) IACUC members
Failure to train (or to document the training
of) researchers
Well-Balanced Program
“The trouble with using
experience as a guide is that the
final exam often comes first and
then the lesson.”
Anonymous
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
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.”
AAALAC’s Perspective
You must
Good if you could
This is the outcome
we want—you decide
Guide-Table of Contents
1) Institutional Policies and Responsibilities
General Intro: Veterinary Care
IACUC: Veterinary Care
2) Environment, Housing &Management
3) Veterinary Medical Care
4) Physical Plant
Role of the
Attending Veterinarian (AV)
Institutional Responsibilities: Two Charges
1. ‘generally’ give ACUP responsibility to
vet trained in LAS—’or’ another qualified
professional…qualified vet MUST be
associated with program
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 veterinary
involvement in program
Role of the AV
Institutional Responsibilities: 2 Charges
2. 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”
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 coordinated
to ensure routine vet care, husbandry,
physical plant oversight
Role of the AV
IACUC
• 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
Role of the AV
IACUC Role- overlaps with
Veterinary Medical Care Responsibilities
Attending Veterinarian Definition
Issues: CONFLICT or DISENGAGEMENT
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
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.
Physical Environment
SPACE
Behavioral Management
Enrichment Program
Increased emphasis—
need veterinary input
Structural environment
Social environment
Husbandry
Sanitation
Implement
Validate
Population Management
Animal
Identification
Role of Attending Veterinarian
in Occupational Health & Safety
Zoonosis Control
Issues:
Provide
training/
information on
allergies/
zoonosis
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
Role of Attending Veterinarian
in Disease Management
Issues:
Failure to report/id
health problems
Ineffective sentinel
programs
Inadequate daily
animal surveillance
Inadequate record
keeping
Role of Attending Veterinarian
in Surgical Programs
Issues:
Inadequate
monitoring and
documentation of
surgical and postoperative care
Lack of aseptic
technique
Role of Attending Veterinarian
in Anesthesia & Analgesia
Issues:
No or inappropriate
A&A use, lack of
oversight
Attending Veterinarians
Role in Euthanasia
Issues:
Inappropriate
methods of
euthanasia, i.e. dry
ice CO2, other
animals present etc…
Roles and Responsibilities of AV
Roles:
Manager, Director,
Clinician, Surgeon,
Architect, Inventor,
Investigator
Responsibilities:
The Animal Care and Use
Program as shared with
the IACUC
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
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.
Centralized vs. Decentralized
What is meant by these terms?
It is not always clear.
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
Sample Centralized Program
Chief Executive Officer
Institutional Official
IACUC
Attending Veterinarian
Director/Manager
Animal Resource Department
Animal Husbandry Staff
Clinical Veterinary Staff
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
Sample
Decentralized
Vice President A
Program
Director A
Animal Care Unit A
Dr. XYZ's Mouse Colony
Director B
Animal Care Unit B
Director C
Animal Care Unit C
Dr. ABC's Cat Colony
Chief Executive Officer
Vice President B
Institutional Official
IACUC
Attending Veterinarian
Many programs are a hybrid,
having both centralized and
decentralized components.
Hybrid Program A
Chief Executive Officer
Vice President A
Director A
Animal Care Unit A
Vice President B
Institutional Official
IACUC
Attending Veterinarian
Program Director/Manager
Dr. XYZ's Mouse Colony
Director B
Animal Care Unit B
Director C
Animal Care Unit C
Dr. ABC's Cat Colony
Central Animal Care Unit
Hybrid Program B
Chief Executive Officer
Vice President A
Director A
Dr. DEF's Frog Colony
Vice President B
Institutional Official
IACUC
Attending Veterinarian
Program Director/Manager
Dr. XYZ's Mouse Colony
Director B
Dr. GHI's Sheep Barn
Director C
Dr. JKL's Inhalation Lab
Dr. ABC's Cat Colony
Central Animal Care Unit
Centralized or
Decentralized?
Chief Executive Officer
Chief Administrative Officer
Institutional Official
Animal Program Committee
Institutional Veterinarian
Vice President A
IACUC A
Vice President B
IACUC B
Attending Veterinarian A
Attending Veterinarian B
Animal Care Unit A
Animal Care Unit B
Vice President C
IACUC C
Vice President D
IACUC D
Attending Veterinarian C
Animal Care Unit C
Attending Veterinarian D
Animal Care Unit D
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?
Some answers…
Very few hard data
No shortage of opinion and anecdote
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
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.
A majority of respondents
expressed greater concern
for decentralized than for
centralized programs.
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)
Challenges for the
Decentralized Program
1. 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 havenots”)
 Leadership
 Training
 Record Keeping
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
Sample Decentralized
Program Vice President A
Director A
Animal Care Unit A
Dr. XYZ's Mouse Colony
Director B
Animal Care Unit B
Director C
Animal Care Unit C
Dr. ABC's Cat Colony
Chief Executive Officer
Vice President B
Institutional Official
IACUC
Attending Veterinarian
Challenges for the Decentralized
Program (cont)
3. Managing conflicts of interest
 Investigator provided animal husbandry
 Investigator provided veterinary care
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!
Challenges for the
Centralized Program
1. Establishing and maintaining
programmatic engagement and
balance among the organizational
pillars
 IO
 IACUC
 AV
The IO, IACUC, and
AV must function as
a team!
Challenges for the
Centralized Program (cont)
2. Maintaining flexibility and ability to
support diverse needs
 Diversity in species
 Diversity in programs
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?
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.
“Any structure can and does work
when the people involved want it
to work and are willing to work
together for the greater good.”
Thanks to:
Council on Accreditation
AAALAC Staff
Lori Wieder
Industry Perspective
Michael Ballinger, D.V.M., M.S., DACLAM
Director, Global Animal Research Programs
Amgen Inc.
President, Council on Accreditation
AAALAC International
What are Industry
Animal Programs?
Pharmaceutical/Biotech/Animal
Health/Devices
Chemical Co’s w/ in-house Industrial
Toxicology
Contract Lab (CRO)
Animal Supplier/Breeder
Industry Animal Programs
Have Distinct Differences
Advantages and Disadvantages
Broad range of financial resources
Different regulatory drivers
Most all are “for profit” by definition
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
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)
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)
Quality Assurance is a Major Focus
FDA driver for Med/Chem & CRO’s
Product Quality driver for animal suppliers
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
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)
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
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
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)
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
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.
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
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.
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.
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)
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 GLPcentric
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.
CRO IACUC Challenges
Independence (versus business drivers)
Composition (AWA limits on # from dept)
Leadership
Demand for quick turnaround
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.
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”
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
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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