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Why do we need animal experiments?
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Animal rights

• Animal Rights is a philosophical view that
  animals have rights similar or the same as
  humans.
• There is no rational basis for saying that a
  human being has special rights. A rat is a pig
  is a dog is a boy. Theyre all mammals.
• Animal rights supporters reject all animal use,
  no matter how humane .

• Ingrid Newkirk, founder of People for the Ethical
  Treatment of Animals

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Animal welfare

• "... a human responsibility that encompasses all
  aspects of animal well-being, including proper
  housing, management, nutrition, disease
  prevention and treatment, responsible care,
  humane handling, and, when necessary, humane
  euthanasia."

• The American Veterinary Medical Association

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What is laboratory animal?
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What is laboratory animal?

• AWA
• The term "animal" means live dogs, cats,
  monkeys (nonhuman primate mammals), guinea pigs,
  hamsters, and rabbits.
• Guide
• Laboratory animals include any vertebrate
  animal (e.g., traditional laboratory animals,
  farm animals, wildlife, and aquatic animals) used
  in research, teaching, or testing.

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Animal Protection Law

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Animal Protection Law

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Animal Protection Law

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How to treat animal well?

• Goal of the Guide
• To promote the humane care of animals used in
  biomedical and behavioral research, teaching, and
  testing.
• Objective of the Guide
• enhance animal well-being,
• the quality of biomedical research, and
• the advancement of biologic knowledge that is
  relevant to humans or animals.

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Institutional Animal Care and Use Committee
Guidebook

• A. The IACUC
• A.1. Timeline, Background and History
• A.2. Authority, Composition and Functions
• A.3. Operation and Administration
• A.4. Training for Members
• A.5. Legal Concerns

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Institutional Animal Care and Use Committee
Guidebook

• A.1. Timeline
• 1950 Formal establishment of Animal Care Panel.
• 1963 First edition of the Guide for the Care and
  Use of Laboratory
• Animals (Guide) developed by the Animal
  Care Panel.
• 1965 Incorporation of the American Association
  for the Accreditation of
• Laboratory Animal Care (AAALAC).
• 1966 Congress passed the Laboratory Animal
  Welfare Act (PL 89-544)
• and the USDA was named the responsible
  agency.
• 1967 Animal Care Panel changed its name to the
  American Association
• for Laboratory Animal Science (AALAS).
• 1971 NIH Policy on Humane Care and Use of
  Laboratory Animals for
• PHS Supported Institutions.
• 1973 First Public Health Service (PHS) Policy on
  Humane Care and Use
• of Laboratory Animals.
• 1979 PHS Policy required each animal-using
  grantee institution to have
• a PHS Assurance and a committee to
  maintain oversight of its
• animal care program.
• 1985 Health Research Extension Act (P.L.99-158)
  passed by Congress.

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Institutional Animal Care and Use Committee
Guidebook

• A.1. Timeline (conti.)
• 1985 Animal Welfare Act Amendments passed by
  Congress.
• 1990 The structure of the Office for Protection
  from Research Risks
• (OPRR) was changed to establish a
  Division of Animal Welfare.
• 1992 First Institutional Animal Care and Use
  Committee Guidebook was
• developed ARENA and OPRR.
• 1996 7th Edition of the Guide for the Care and
  Use of Laboratory Animals
• revised by an ILAR committee and
  published by the NRC.
• 1996 AAALAC became the Association for the
  Assessment and
• Accreditation of Laboratory Animal Care
  International.
• 2000 OPRR Division of Animal Welfare was
  separated from OPRR and
• became the Office of Laboratory Animal
  Welfare (OLAW), NIH.
• 2002 ARENA/OLAW Institutional Animal Care and Use
  Committee
• Guidebook. Second edition..

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Program of Education and Training for New IACUC
Members

• Objectives
• 1. To introduce members to the role of the IACUC
  and its evolution
• 2. To provide the basic information necessary for
  IACUC members to discharge their responsibilities
• 3. To provide a forum for response to, and
  discussion of, members concerns and questions

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Program of Education and Training for New IACUC
Members

• Syllabus
• The IACUC Genesis and chronology
• U.S. Government Principles
• Criteria for membership
• Authority of the IACUC
• Proposal (protocol) submission and review
• IACUC review criteria
• Monitoring of approved protocols

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Program of Education and Training for New IACUC
Members

• Protocol changes (amendments)
• Records
• Semiannual reviews
• Handling animal welfare concerns
• Institutional Official (IO)
• Community

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Program of Education and Training for IACUC
Members

• Objectives
• 1. To increase members knowledge, understanding
  and awareness
• 2. To keep members current on
• Laws (federal, state, local)
• Regulations (proposed, promulgated/issued)
• Guidelines
• Developments and trends
• Institutional policies
• 3. To address issues, concerns and questions
  raised by IACUC members,institutional staff, and
  the community.

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Program of Education and Training for IACUC
Members

• Syllabus
• Questions and concerns brought to the attention
  of the IACUC
• Official directives
• Publications
• Notices of, and reports from, conferences,
  seminars, etc.
• Animal facility staff and/or veterinarians
  observations and recommendations
• Facility inspections and program evaluations
• Problem situations

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Institutional Animal Care and Use Committee
Guidebook

• B. Oversight of the Animal Care and Use Program
• B.1. Program and Facility Review
• B.2. Animal Environment, Housing and Management
• B.2.a. General
• B.2.b. Animal Environment
• B.2.c. Husbandry
• B.2.d. Facility Maintenance
• B.2.e. Emergency, Weekend and Holiday Care

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Facility Review

• All animal housing facilities must be inspected
  in the semiannual review.

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Facility Review

• Categories to be Inspected
• sanitation,
• food and water provisions,
• animal identification,
• waste disposal,
• animal health records,
• controlled and/or expired drugs,
• environmental control,
• occupational health and safety concerns,
• staff training,
• knowledge of applicable rules and regulations,
  and
• security.

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B.2. Animal Environment, Housing and Management

• The Guide states
• Proper housing and management of animal
  facilities are essential to animal well-being, to
  the quality of research data and teaching or
  testing programs in which animals are used, and
  to the health and safety of personnel. A good
  management program provides the environment,
  housing, and care that permit animals to grow,
  mature, reproduce, and maintain good health
  provides for their well-being and minimizes
  variations that can affect research results.
  Specific operating practices depend on many
  factors that are peculiar to individual
  institutions and situations. Welltrained and
  motivated personnel can often ensure high quality
  animal care, even in institutions with less than
  optimal physical plants or equipment.

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Institutional Animal Care and Use Committee
Guidebook

• B.2.f. Behavioral Management for Laboratory
  Animals
• B.3. Role of the Veterinarian
• B.4. Occupational Health and Safety
• B.5. Personnel Training and Education
• B.6. Emergency Preparedness
• B.6.a. Security and Crisis Management
• B.6.b. Disaster Planning

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B.3. Role of the Veterinarian

• immunization against infectious pathogens
• surveillance of colonies for specific infectious
  microbial agents
• disease prophylaxis utilizing pharmaceutical
  agents
• isolation and quarantine of incoming animals and
• separate housing of animals according to species,
  source or different background microbial floras.

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B.3. Role of the Veterinarian

• Specific areas requiring the veterinarians
  attention and guidance are
• the selection and utilization of suitable
  anesthetic and analgesic agents and methods of
  euthanasia
• appropriate selection of species for research
  projects and
• proper performance of surgical procedures and
  adequate preoperative, surgical, and
  post-operative care.

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Occupational Health and Safety Program

• Training should include information about
• zoonoses,
• chemical safety,
• microbiologic and physical hazards (e.g.,
  allergens, radiation),
• hazards associated with experimental procedures,
• handling of waste materials, and
• personal hygiene.

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Institutional Animal Care and Use Committee
Guidebook

• C. Review of Proposals
• C.1. Fundamental Issues
• C.2. Protocol Review Criteria
• C.2.a. Alternatives Replacement, Reduction
• and Refinement
• C.2.b. Euthanasia
• C.2.c. Humane Endpoints
• C.2.d. Minimization of Pain and Distress
• C.2.e. Personnel Qualifications
• C.2.f. Veterinary Review and Consultation

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The 3 Rs

• Alternatives are framed within the context of the
  3 Rs articulated originallyby Russell and Burch
  in 1959 they include
• 1. Replacement, or utilizing non-animal models
• 2. Reduction of numbers of animals used and
• 3. Refinement, or elimination or reduction of
  unnecessary pain and distress in animals.

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• The following topics should be considered in the
  preparation and review of animal care and use
  protocols
• Rationale and purpose of the proposed use of
  animals.
• Justification of the species and number of
  animals requested. Whenever possible, the number
  of animals requested should be justified
  statistically.
• Availability or appropriateness of the use of
  less-invasive procedures, other species, isolated
  organ preparation, cell or tissue culture, or
  computer simulation (see Appendix A,
  "Alternatives").
• Adequacy of training and experience of personnel
  in the procedures used.
• Unusual housing and husbandry requirements.
• Appropriate sedation, analgesia, and anesthesia.
  (Scales of pain or invasiveness might aid in the
  preparation and review of protocols see Appendix
  A, "Anesthesia, Pain and Surgery.")
• Unnecessary duplication of experiments.
• Conduct of multiple major operative procedures.
• Criteria and process for timely intervention,
  removal of animals from a study, or euthanasia if
  painful or stressful outcomes are anticipated.
• Postprocedure care.
• Method of euthanasia or disposition of animal.
• Safety of working environment for personnel.

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Review of Proposals

• Proposal Review Procedures
• Full committee review
• Designated member review

• Categories of IACUC Actions
• Approval
• Modifications required to secure approval
• Withhold approval
• Defer or table review

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Pain management
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Do animals experience pain?

• No direct evidence
• Subtle behavioural responses
• Complex learning to avoid noxious stimuli
• Self-administration of analgesics in chronic pain
  conditions
• Response to analgesics
• Assessment central

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Why treat pain?

• Legal and ethical reason
• Beneficial for the animal
• Beneficial for reserach
• Rapid return to normal function
• A higher survival rate
• Counteract physiological changes
• Thoracic and abdominal pain affect ventilation
• Reduction in food and water consumption

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Pain management

• Prevention preemptive approach
• Recognition of pain
• Choice of substance
• Drug dose and duration

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Recognition of pain

• Signs to look for
• General appearance and condition
• Attitude, posture and movements
• Interactions with cage mates
• Reactions to manipulation
• Food and water consumption
• Production of faeces and urine
• Species-typical signs of pain and distress
• Procedure-specific signs

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Postoperative pain

• Peripheral sensitization
• Central sensitization
• Amplification of pain sensation
• Surgery
• Inflammatory pain
• Neuropathic pain
• Prevention by preemptive analgesia

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Management of postoperative pain

• Preemptive analgesia
• Good surgical technique
• Sterile technique
• Supportive therapy
• Soft food
• Long drinking nipples
• Soft bedding
• Warm environment
• Avoid social isolation

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Management of postoperative pain cont.

• Minor procedures
• single dose of an opioid or NSAID sufficient
  (preoperatively when possible)
• More invasive surgery
• Continue treatment for up to 24-36h
• After major surgery
• Continue analgesic administration for
• 36-72 hours
• Combination therapy
• Opioid
• NSAID
• Local analgesia

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USDA classifications for pain-associated project
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USDA classifications for pain-associated project

• Classification A This category is no longer in
  use.
• Classification B
• Classification C
• Classification D
• Classification E

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USDA classifications for pain-associated project

• Classification B
• Animals being bred, conditioned, or held for use
  in teaching, testing, experiments, research, or
  surgery, but not yet used for such purposes.

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USDA classifications for pain-associated project

• Examples
• Breeding colonies of any animal species that are
  held in legal sized caging and handled in
  accordance with the Guide and other applicable
  regulations. Breeding colony includes parents
  and offspring.
• Newly acquired animals that are held in proper
  caging and handled in accordance with applicable
  regulations.
• Animals held under proper conditions or wild
  animals that are being observed.

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USDA classifications for pain-associated project

• Classification C
• Animal upon which testing, research, experiments,
  or tests will be conducted involving no pain,
  distress, or use of pain-relieving drugs.

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USDA classifications for pain-associated project

• Examples
• Procedures performed correctly by trained
  personal such as administration of
  electrolytes/fluids, administration of oral
  medication, blood collection from a common
  peripheral vein per standard veterinary practice
  or catherization of same, standard radiography,
  parenteral injections of non-irritating
  substances.
• Euthanasia performed in accordance with the
  recommendations of the most recent AVMA Panel on
  Euthanasia, utilizing procedures that produce
  rapid unconsciousness and subsequent humane
  death.

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USDA classifications for pain-associated project

• Classification D
• Animals upon which experiments, teaching,
  research, surgery, or tests will be conducted
  involving accompanying pain or distress to the
  animals and for which the use of appropriate
  anesthetic, analgesic, or tranquilizing drug will
  be used.

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USDA classifications for pain-associated project

• Examples
• Surgical procedures conducted by trained
  personnel in accordance with standard veterinary
  practice such as biopsies, gonadectomy, exposure
  of blood vessels, chronic catheter implantation,
  laparotomy or laparoscopy.
• Blood collection by more invasive routes such as
  intracardiac or periorbital collection from
  species without a true orbital sinus such as rats
  and guinea pigs.
• Administration of drugs, chemicals, toxins, or
  organisms that would be expected to produce pain
  or distress but which will be alleviated by
  analgesics.

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USDA classifications for pain-associated project

• Classification E
• Animals upon which teaching, experiments,
  research, surgery, or tests will be conducted
  involving accompanying pain or distress to the
  animals and for which the use of appropriate
  anesthetic, analgesic, or tranquilizing drugs
  will adversely affect the procedures, results, or
  interpretation of the teaching, research,
  experiments, surgery, or tests.

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Institutional Animal Care and Use Committee
Guidebook

• C.3. Other Protocol Review Considerations
• C.3.a. Agricultural Research
• C.3.b. Antibody Production
• C.3.c. Breeding Colonies
• C.3.d. Field Studies
• C.3.e. Hazardous Materials
• C.3.f. Instructional Use of Animals
• C.3.g. Surgery
• C.3.h. Transgenic Animals
• C.4. Monitoring of Approved Protocols

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Institutional Animal Care and Use Committee
Guidebook

• D. Evaluation of Animal Care and Use Concerns
• E. Recordkeeping and Communications
• E.1. Recordkeeping and Reporting
• E.2. Communications

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Institutional Animal Care and Use Committee
Guidebook

• Appendices
• Appendix A. Resources
• Appendix B. Office of Laboratory Animal Welfare
  Organizational Chart
• Appendix C. Mandatory IACUC Issues Identified
  During AAALAC International Site Visits
• Appendix D. Recommendations of the 2000 AVMA
  Panel on Euthanasia Appendix E. Federal and State
  Permits Required for Field Studies
• Appendix F. U.S. Government Principles for the
  Utilization and Care of Vertebrate Animals Used
  in Testing, Research and Training

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THE END