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

Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAMAssociate 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 TeamInstitutional OfficialResearchersIACUCAnimal Care Staff (AV and technical staff)

Policies, Procedures, Resources and Facilities

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

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

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 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

program

Engage in the process IACUC participationKnow the regulations

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

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

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 AccreditationEnsure 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: AcronymsPHSOLAWNIH IACUCAAALACARENAAALASARENA/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 self-regulation and oversight, we will develop and maintain a model animal care program.

Program ValuesHumane Treatment of

AnimalsBenefits of animal

research to human and animal health

StewardshipTrainingStriving 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 presentationMarky Pitts – UC San DiegoMolly Greene – University of Texas Health

Science Center, San Antonio

Recognized and Respected AuthorityMust have the

administrative and operational authority to commit institutional resources to ensure compliance with the PHS Policy

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

Provides Sufficient Resources

Occupational Health & Safety

Personnel TrainingTechnology/

EquipmentMaintenance of

Facilities

Ensures Compliance

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

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 ChairUniversity of California, Berkeley

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)

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 communityServes as local oversight arm for

APHIS/AC, NIH/OLAW, AAALAC

Well-Balanced Program

Imbalanced Program

The “Weak” IACUC

Chair rotates annuallyInadequate relief/support for ChairMembers only serve 1 yearFew members who are PIs


Insufficient staff Insufficient/no office space Insufficient fundingInadequate computer expertise/equipment


Inadequate/no member training Inept protocol reviewStaff “runs” the committee/meetingsDesignated member review onlyPHS applications not reviewed


Deficient recordkeeping (minutes, protocols, reports)Delegated facility inspectionsInadequate semiannual facility inspections/program reviews

The “Overpowering IACUC”The “Overpowering IACUC”

(no such thing!)

The “Overpowering IACUC”

IACUC ignores Vet’s recommendationsDictatorial ChairOverzealous facility

inspections/program reviews

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

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

0

10

20

30

40

50

60

70

80

IACUC MANDATORY IACUC SUGGESTION

PRE 1996

POST 1996

AAALAC Site Visit Deficiencies

0

10

20

30

40

50

60

70

80

1999 2000 2001 2002

Institutional Policies

Laboratory AnimalManagementVeterinary MedicalCarePhysical Plant

IACUC Site Visit Findings

0

5

10

15

20

25

30

35

1999 2000 2001 2002

PercentMandatory Item

IACUC Deficiencies in Rank Order

Protocol ReviewProtocol Review Semiannual EvaluationsSemiannual Evaluations Committee Composition Committee Composition

& Member Participation & Member Participation Policies & DocumentationPolicies & Documentation TrainingTraining

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 *

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., DACLAMDirector, 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 mustGood if you couldThis 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 veterinaryinvolvement 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 coordinatedto ensure routine vet care, husbandry,

physical plant oversight

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

Role of the AV

IACUC Role- overlaps withVeterinary Medical Care ResponsibilitiesAttending 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 ManagementPhysical Environment:

housing, space, light, noiseBehavioral Management:

structural, social, activityHusbandry: food, water, bedding,

sanitation, pest, emergency planPopulation Management: records, animal I.D.

Physical Environment

SPACE

Behavioral Management

Enrichment Program Increased emphasis—

need veterinary inputStructural environmentSocial environment

Husbandry

SanitationImplementValidate

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 ManagementIssues:Failure to report/id

health problemsIneffective sentinel

programsInadequate daily

animal surveillance Inadequate record

keeping

Role of Attending Veterinarian in Surgical Programs

Issues:Inadequate

monitoring and documentation of surgical and post-operative 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, DACLAMAttending Veterinarian and ManagerVeterinary Services3M Company, St. Paul, MN, USA

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.

Centralized vs. Decentralized

What is meant by these terms?It is not always clear.

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

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 D e p a rtm e nt

Institutional Official

C h ie f E xe cu tive O ffice r

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 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


V ice P re s ide n t BInstitutional Offic ial


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

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


IACU C

Central Anim al Care Unit

Attending VeterinarianP ro g ram D irec to r/M a n a g er



Hybrid Program B

Dr. DEF's Frog Colony

Dr. XYZ's M ouse Colony

D ire c to r A

Dr. G HI'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


IACU C

Central Anim al Care Unit

Attending VeterinarianP ro g ram D irec to r/M a n a g er



Centralized or Decentralized?

Anim al Program Com m ittee Institutional Veterinarian

IACUC A


Attending Veterinarian A


IACUC B


Attending Veterinarian B

V ice P re s ide n t B

IACUC 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 ice P re s ide n t D

C h ie f A d m in is tra tive O ff ice rInstitutional Official


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 dataNo 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/IACUCOccupational Health and Safety ProgramProgram of Adequate Veterinary CarePersonnel 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 concernfor decentralized than for centralized programs.

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)

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

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


D r. X Y Z 's M o u se C o lo ny

D ire c to r A


D ire c to r B


D r. A B C 's C a t C o lo ny

D ire c to r C


IACU C




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 programInstitutional policies and responsibilities

Institutional oversight/IACUCProgram of adequate veterinary careOccupational health and safety program

The same as for decentralized programs!

Challenges for the Centralized Program1. 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?

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.

“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 AccreditationAAALAC StaffLori Wieder

Industry Perspective

Michael Ballinger, D.V.M., M.S., DACLAMDirector, Global Animal Research ProgramsAmgen Inc.President, Council on AccreditationAAALAC 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 DisadvantagesBroad range of financial resourcesDifferent regulatory driversMost 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 modelProfitability 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’sProduct Quality driver for animal suppliers

Repetitive and Screening Animal Protocols CommonJustifying animal use numbers is

challengeMay be totally driven by chemical throughputEmphasis 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 managementCommittee oversight shoehorned into the

hierarchy and power structureIO – IACUC relationship must be well

defined (beyond regulatory guidance)

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

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

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)

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

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.

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

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 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.

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)

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

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)LeadershipDemand for quick turnaround

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.

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”

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

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?

www.aaalac.org

Documents

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