Ethical Care and Use of Animals

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Ethical Care and Use of Animals
James W. Hicks, Ph.D. Chair Institutional Animal
Care and Use Committee
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Why Worry about Animals?

• Emotionally-charged issue
• Opinions sometimes based on emotion or
  misinformation
• Required by Law
• Its the right thing to do
• Morally and Ethically
• Scientific Validity

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Animal Rights vs. Animal Welfare
Animal Rights vs. Animal Welfare

• Animal Rights
• Animals and man share equal rights-- personhood
  for animals
• All sentient beings deserve equal moral
  consideration
• Animal-based research is never justified, nor is
  pet ownership, food or fiber production, etc.
• A rat is a pig is a dog is a boy. Theyre all
  animals. Ingrid Newkirk, PETA

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Animal Rights vs. Animal Welfare
Animal Rights vs. Animal Welfare

• Animal Welfare
• Animals and man are not equal, animals do not
  have the same rights as people
• Stewardship Man has an obligation to protect the
  welfare of animals (ie provide food and shelter,
  limit pain and suffering, treat when injured,
  etc.)
• Foundation of contemporary animal welfare
  regulations and guidelines

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Ethical Arguments for Animal Use

• Nuremberg Code of Ethics in Medical Research
• ... be designed and based on results of animal
  experimentation and a knowledge of the natural
  history of the disease
• Declaration of Helsinki
• Medical research involving human
  subjectsgenerally accepted scientific
  principlesand, where appropriate, animal
  experimentation.
• -World Medical Association, 1964

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Animals in Research

• The use of animals is a privilege, not a right
• Society grants permission to use animals with the
  expectation that health benefits may be derived,
  and
• The perceived value to society must balance the
  adverse effects imposed on individual animals.

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Animal Welfare Laws, Regulations Standards

• Animal Welfare Act (AWA) USDA Animal Welfare
  Regulations
• PHS Policy - Health Research Extension Act (HREA)
• The Guide for the Care and Use of Laboratory
  Animals (The Guide)
• AAALAC Accreditation

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1966
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1966
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1966
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Life Magazine--1966

• Raid of a Baltimore, MD animal dealer by Humane
  Society of the United States (HSUS)
• 29 charges of animal cruelty brought against
  Lester Brown
• Congress put forth eight bills to outlaw inhumane
  treatment of animals

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Pet Protection Act

• 1966 Congress enacted the Pet Protection Act
• Protected against theft of pets by research
  dealers
• Gave authority to USDA to enforce and administer
  the Act
• Provided protection to dogs, cats, rabbits,
  monkeys, guinea pigs and hamsters

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Pet Protection Act (contd)

• Established humane standards for treatment of
  animals
• Set licensing requirements for animal dealers
• Required annual USDA inspections of dealers and
  research institutions

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1985 Animal Welfare Act Amendment

• Establishment of an Institutional Animal Care and
  Use Committee (IACUC)
• Requirements for veterinary consult and oversight
• Requirements for canine exercise and non-human
  primate psychological enrichment
• Requirements for consideration of alternatives to
  animal use and painful procedures and avoidance
  of unnecessary duplication of already-conducted
  studies

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United States Department of Agriculture

• Enforces and administers the Animal Welfare Act
  (AWA)
• Enforces the AWA through Animal Welfare
  Regulations (AWRs)
• 9 CFR Chapter 1, Parts 1-3
• Provides clarification of AWRs through Animal
  Care policies

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USDA Regulations

• Set requirements for committee (IACUC)
  composition and function
• Provide performance standards for
• veterinary care
• animal husbandry
• animal transportation
• Covers all warm-blooded animals
• excludes rats, mice and birds

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NIH Office of Laboratory Animal Welfare

• Health Research Extension Act is the legislative
  mandate for Public Health Service (PHS) policy
• Covers all vertebrate animals
• NIH funded institutions must adhere to the PHS
  Policy
• Office of Laboratory Animal Welfare is
  responsible for assuring compliance with PHS
  policy

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Key Elements of the Federal Regulations

• Justify why animals are necessary
• Minimize pain and distress
• Personnel must be qualified to perform their
  duties
• Provide appropriate husbandry and care
• Use of appropriate euthanasia methods

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Ethical Guidance

• 1996 NASA Principles for Ethical Care Use of
  Animals
• Sundowner Report
• Principles of Humane Experimental Technique by W.
  M. Russell and R. L. Burch, 1959

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NASA Principles - Sundowner Report

• Respect for Life
• All living creatures deserve respect
• Societal Benefit
• Some valuable return in exchange for the
  sacrifice of the animals life
• Non-maleficience
• Do no harm
• Pain, distress and discomfort to the animals must
  be minimized

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Principles of Humane Experimental Technique

• The 3 Rs
• Replacement
• Use of live animals as the research model should
  be replaced if possible
• Refinement
• Procedures should be refined to minimize pain,
  distress and discomfort
• Reduction
• Number of animals should be reduced to the
  minimum necessary to achieve scientific
  significance without increasing pain and distress

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The Guide

• Performance Standards
• Institutional policies and responsibilities
• Animal environment, housing, and management
• Veterinary medical care
• Physical plant (facilities)

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AAALAC Accreditation

• Association for the Assessment and Accreditation
  of Laboratory Animal Care (AAALAC, International)
• Private, non-profit organization that promotes
  the humane treatment of animals in science
  through a voluntary accreditation program
• AAALAC International uses The Guide for the Care
  and Use of Laboratory Animals as the basis for
  assessing and accrediting animal care and use
  programs.
• Accreditation represents quality in an
  institutions animal care program, promotes
  scientific validity, and demonstrates a
  commitment to the humane care and use of lab
  animals

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UCI Policies

• Campuswide General Policies
• Use of Vertebrate Animals in Research and
  Teaching
• Offsite Research Activities
• Regulatory Noncompliance Policy
• IACUC Policies and Guidelines
• ULAR Guidance

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ORA and the IACUC

• Office of Research Administration
• Research Graduate Studies
• Sponsored Projects
• Research Protections
• Administrative and technical support to the
  regulatory committees and the Institutional
  Official
• Office of Record for UCI
• Education, training, and compliance oversight

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Institutional Animal Care and Use Committee
(IACUC)

• Required by the AWRs, PHS Policy and The Guide
• Provides local (institutional) oversight of
  animal use in research, teaching and testing
• Members appointed by the Institutional Official
  (Vice Chancellor for Research)

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Institutional Animal Care and Use Committee

• Campus committee charged with oversight of UCIs
  animal program
• Member Composition
• Faculty with animal expertise
• Attending Veterinarian
• Non-scientific member
• Unaffiliated member
• Biosafety officer

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The IACUCs Role

• Review and approve activities involving animals
  at UCI (protocol review)
• Review the animal program and inspect all
  facilities every 6 months
• Review concerns involving animal use
• Investigate issues of non-compliance
• Report to regulatory agencies

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Why Do We Review Protocols?

• The protocol is
• The written documentation of all procedures to be
  performed on live animals
• The means by which adherence to the federal
  animal welfare regulations is assessed
• The document that confirms the ethical treatment
  of animals used in the research

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What Activities Require Review?
Definition

• Any live, vertebrate animal used or intended for
  use in research, research training,
  experimentation, or biological testing or for
  related purposes.
• -PHS Policy

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IACUC Protocol Review

• Rationale for the use of animals
• Justification of the species and number of
  animals
• Conduct of experiments
• Unnecessary duplication of experiments
• Appropriate sedation, analgesia, anesthesia
• Adequate training of personnel

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Top Ten Reasons Protocols are Tabled or Deferred

• 10. Three-Year Renewals No progress report or
  other rationale for continuing the research.
• 9. Project overview is too technical or does not
  describe the potential benefits of the research.
• 8. Database searches for alternatives to animal
  use and painful procedures and to rule out
  unnecessary duplication are not adequately
  documented.
• 7. Responsibilities, experience and/or training
  of research team members is not described.

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Top Ten Reasons (continued)

• 6. Incomplete descriptions of the surgical and
  non-surgical procedures .
• 5. Inadequate detail about the post-procedural
  monitoring and care, including the use of
  post-procedural analgesics.
• 4. Inadequate description of expected clinical
  signs, potential for pain and distress, and
  assessment criteria.

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Top Ten Reasons (continued)

• 3. Use of animals, the species selection or the
  requested number of animal is not justified in
  relation to the overall design of the study.
• 2. The actual procedures to be performed
  involving live animals are unclear or
  inconsistent with the experimental design.
• 1. Experimental design is not adequately
  described, based on the underlying hypothesis of
  the project.

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Other IACUC Responsibilities

• Modifications to Existing Protocols
• Annual and three-year renewals
• Program Evaluation
• Facility Inspections

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The IACUC Website

• Start at http//www.rgs.uci.edu/ora/
• Click on Animal Care and Use Program
• Website includes
• Forms
• Instructions
• Contact information
• Links to University Lab Animal Resources and
  Environmental Health Safety

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University Laboratory Animal Resources (ULAR)

• Functions
• Veterinary care health surveillance
• Daily husbandry/care
• Animal procurement
• Facility maintenance
• Including vivarium access
• Transgenic Mouse Facility

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Veterinary Services

• Veterinary care of all research animals on campus
• Report to the IACUC regarding issues related to
  the animal care program
• Training for research personnel in animal
  handling, basic procedures, etc.
• Complete listing of services at ULAR website
  http//www.rgs.uci.edu/ular/index.htm

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Animal Procurement

• Approved commercial vendors
• Reliable colony health information and low risk
  of contamination to other research animals on
  campus
• Animals may enter vivaria directly upon arrival,
  no quarantine required
• Animals from Unapproved Sources
• High risk of infectious agents
• Quarantine required

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Environmental Health and Safety

• Lab Animal Occupational Health Program
• Health Surveillance for Researchers
• Required for all personnel with ANY exposure to
  lab animals
• Animal Research Health Surveillance Form
  http//www.ehs.uci.edu/occhlth.html
• Personal Protective Equipment
• Controlled Substances Monitoring
• http//www.ehs.uci.edu/programs/occhlth/control.ht
  ml

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RGS On-Line Tutorial

• Fulfills the federal requirement for investigator
  education
• Covers the basics of animal care and use
• Required for submission of animal protocols
• all research personnel, including faculty
  sponsor, must complete tutorial
• Requires log-in as an authenticated user
  (UCINetID and password)