Animal Care and Use: What Researchers Need to Know

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Animal Care and Use What Researchers Need to Know
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Animal Research Statistics

• 2001 statistics (National Association for
  Biomedical Research)
• 30 Million lab animals used annually
• 1.2 million regulated species
• Slight trend toward annual reductions

• USDA Regulated Animals in Research (FY 2004)
  Species Numbers
• Dogs 64,932
• Cats 23,640
• Non-human primates 54,998
• Guinea pigs 244,104
• Hamsters 175,721
• Rabbits 261,573
• Sheep 19,218
• Pigs 54,504
• Other farm animals 31,956
• Other animals 171,312
• Total 1,101,958

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Legislation

• Animal Welfare Act (1966) and Health Research
  Extension Act (1985) stipulate animal welfare
  regulations
• Humane care
• Minimization of pain and distress
• Emphasizes minimal use of animals and appropriate
  justification
• The 3 rs

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U.S. Government Principles Used to Guide Animal
Research

• Justification of research
• Relevance to human or animal health, the
  advancement of knowledge, and good of society
• Justification of animal use and numbers
• Proper use of animals
• Minimization of pain, discomfort, and distress
• Humane euthanasia if pain cannot be relieved
• Appropriate care of research animals under
  veterinary supervision by trained personnel
• Experimentation only by trained personnel

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Standards for Animal Care

• Primary reference for animal care and use
• National Academy of Science publication
• Basis for Public Health Service standards on
  animal care

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Requirements of Research Institutions

• Assurance to follow federal guidelines - OLAW
• Describes program for animal care and use
  including facilities and training program for
  researchers
• Occupational health and safety program
• Numbers and types of animals used
• Submit to inspections
• Institutional Animal Care and Use Committee
  (IACUC)
• Assesses all research activities involving live
  vertebrate animals
• Keep records of all activities
• Provide annual report to OLAW

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IACUC Requirements

• Membership at least five members with four
  mandatory components
• Veterinarian
• Scientist
• Non-scientist
• Community member (not affiliated with
  institution)

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IACUC Functions

• Review all research proposals and monitor their
  activity to assess adherence to PHS government
  principles
• Semi annual facilities inspections
• Semi annual program reports and recommendations
  to Institutional Official
• Program review
• Suspend research activities if violations occur

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Importance of IACUC oversight for researchers

• Meet legal requirements significant penalties
  for non-compliance
• Training improves study design
• Research quality healthy animals yield better
  data
• Publication requirement IACUC approval is a
  publication prerequisite in most journals

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Requirements for Researchers Prerequisites for
Research

• Training
• Online Animal Care Module(s)
• Lab-specific Training
• Occupational Health Screening
• Protocol approval by IACUC

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Animal Care and Use Training
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Responsibilities of Researchers

• Obtain permission to conduct research on
  vertebrate animals
• Abide by all institutional and PHS policies
• Ensure that all personnel involved with approved
  projects are appropriately trained
• Comply with IACUC decisions
• Allow inspection of animal care and research
  areas
• Make no changes to approved protocols without
  IACUC consultation and approval

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The research protocol basic components

• Species and approximate numbers used
• Rationale for animal use, appropriateness of
  species, and benefits of research
• Complete description of animal use and care
• Descriptions of how injury and discomfort will be
  minimized to that which is unavoidable to conduct
  research and managed by anesthetics or analgesics
• Description of any euthanasia methods used

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MSU Protocol Cover Page

• Project Title
• Contact Information
• Principal investigator
• Project Characterization
• Status (new, renewal, amendment to existing
  protocol)
• Type
• Research category

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Protocol Section 1

• Personnel Information
• Identify everyone involved with project
• Describe all relevant training
• List online modules
• Lab specific training
• Previous experience

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Protocol Section 2 Project Description

• Non-technical summary lay audience
• Objectives
• Benefit of study (society, education, animals)
• Experimental design and methods
• Duration of project
• Justification
• Species used and numbers required
• Use as many relevant arguments as possible

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Protocol Section 2.3Required Keyword Search

• Evaluate literature for appropriate and/or
  alternative methods
• Important criteria
• Duplication of effort
• Use of animal model
• Must be current (lt 2 months old)
• Required information
• Date of search
• Keywords used
• Search resources
• Years covered by search results
• Written summary of results

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Section 3 Animal Use

• Animal Sources, species, and numbers used
• Sources must be approved for lab animals
• Wild animals must be collected with permission
• Animal facilities
• Where housed
• Location of any research activities
• Animal husbandry summary
• Housing, food, environmental or lab conditions,
  etc.

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Animal Use Procedures

• Animal procedures
• Check appropriate boxes
• Some require additional forms (surgery, field
  studies, etc.)
• Pain and distress
• Indicate number of each animal used in each pain
  category
• Category 5 pain must be carefully justified
• Pain alleviation
• Drug type and administration

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Investigator Assurances

• Signed list of statements that confirms adherence
  to rules
• Declaration that everything is correct and that
  you will follow the protocol as approved
• Signature for PI and Co-PI (graduate student)