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Animal Care and Use: What Researchers Need to Know 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

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animal research statistics
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) SpeciesNumbers
    • 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
legislation
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 r’s
u s government principles used to guide animal research
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
standards for animal care
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
requirements of research institutions
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
iacuc requirements
IACUC Requirements
  • Membership – at least five members with four mandatory components
    • Veterinarian
    • Scientist
    • Non-scientist
    • Community member (not affiliated with institution)
iacuc functions
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
importance of iacuc oversight for researchers
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
requirements for researchers prerequisites for research
Requirements for Researchers: Prerequisites for Research
  • Training
    • Online Animal Care Module(s)
    • Lab-specific Training
  • Occupational Health Screening
  • Protocol approval by IACUC
responsibilities of researchers
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
the research protocol basic components
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
msu protocol cover page
MSU Protocol Cover Page
  • Project Title
  • Contact Information
    • Principal investigator
  • Project Characterization
    • Status (new, renewal, amendment to existing protocol)
    • Type
    • Research category
protocol section 1
Protocol : Section 1
  • Personnel Information
    • Identify everyone involved with project
    • Describe all relevant training
      • List online modules
      • Lab –specific training
      • Previous experience
protocol section 2 project description
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
protocol section 2 3 required keyword search
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 (< 2 months old)
  • Required information:
    • Date of search
    • Keywords used
    • Search resources
    • Years covered by search results
  • Written summary of results
section 3 animal use
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.
animal use procedures
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
investigator assurances
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)