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 Scientists 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 Scientists 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 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 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 institutions 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.
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 Values Humane Treatment of Animals Benefits of animal research to human and animal health Stewardship Training Striving for Excellence
The Institutional Officials 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
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,
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
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 Overpowering IACUC IACUCs 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
AAALAC Site Visit Deficiencies
IACUC Site Visit Findings
IACUC Deficiencies in Rank Order Protocol Review Protocol Review Semiannual Evaluations Semiannual Evaluations Committee Composition & Member Participation Committee Composition & Member Participation Policies & Documentation Policies & Documentation Training Training
Protocol Review Husbandry exceptions to Guide (e.g. wire- bottom cages, cage cleaning intervals) Justification for the numbers of animals used Expedited review Review of amendments/addenda Alternatives to painful procedures (Policy #12) * Management/evaluation of pain and distress *
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
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.
AAALACs Perspective You must Good if you could This is the outcome we wantyou 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 LASor 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 LASor 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 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, 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
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
Many programs are a hybrid, having both centralized and decentralized components.
Hybrid Program A
Hybrid Program B
Centralized or Decentralized?
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 institutions 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 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
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 Youve 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 Cos 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 doesnt 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 GLPs are the Primary Regulatory Focus (CROs 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 FDAs areas of concerns)
Quality Assurance is a Major Focus FDA driver for Med/Chem & CROs 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 GLPs 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 Pharmas (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 IOs 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 IOs 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 pathologists 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 IACUCs 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) 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?