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What is the Purpose of the Animal Welfare Act (AWA)?
To provide ethical standards for animal research
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What animals are covered by the Animal Welfare Act?
- All warm blooded vertebrates except birds, purpose bred mice or rats, or animals used for food or fiber.
- Also covers horses and farm animals used in biomedical research
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Who administers the Animal Welfare Act?
United States Department of Agriculture
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Who inspects facilities for compliance with AWA?
Animal Plant and Health Inspection Service - Veterinary Medical Officer (APHIS - VMO)
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Institutional compliance with the Animal Welfare Act is dependent on what 5 components (committees, registration, inspections and guides that are used)?
- Registration with USDA
- Inspections by Animal Plant and Health Inspection Service - Veterinary Medical Officer (APHIS - VMO)
- The Guide for the Care and Use of Laboratory Animals
- AVMA Guidelines for Euthanasia
- Institutional animal care and use committee (IACUC)
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Who sets the guidelines for Euthanasia?
American Veterinary Medical Association (AVMA)
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The Institutional animal care and use committee is composed of what individuals?
Composed of veterinarian responsible for animal program, scientists that use animals & community member with no ties to institution other than being IACUC member. Requires minimum of 3 people.
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What 6 things that AWA reviews as part of the institutional components?
- Personnel qualifications
- Veterinary care
- Recordkeeping
- Annual Report submitted to USDA
- Access for inspector
- Individual identification of dogs & cats/Small animals can be ID'd in groups
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What are 3 specific requirements of the AWA?
- Housing and care requirements for each warm-blooded vertebrate species
- Transportation requirements
- Special provisions for exercise of doqs and (psychological) enrichment of monkeys
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What is the purpose of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals?
To provide ethical standards of care
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Who covers wild mice & rats; whales.
Who covers cattle used in heart research?
Animal Welfare Act for ALL
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What animals are covered under the PHS Policy on Humane Care and Use of Laboratory Animals?
- All warm blooded vertebrates
- Agricultural animals for biomedical research
- Cold blooded vertebrates like birds, fish
- Purpose bred mice and rats
- Agriculture animals used for food, fiber or agricultural research
- Invertebrates
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Who administers the Public Health Service Policy on Humane Care and Use of Laboratory Animals?
Office of Laboratory Animal Welfare (OLAW)
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Compliance of the Policy on Humane Care and Use of Laboratory Animals is based on what document?
Animal Welfare Assurance Statement
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What 5 types of information is included in the Animal Welfare Assurance Statement?
- Describes the lines of authority
- Defines role, responsibilities, and composition of the IACUC
- Assures compliance with National Institute of Health (NIH) standards
- Records and reporting requirements
- Training requirements
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Public Health Service Policy
Governed by:
Who reports non-compliance issues?
What happens in non-compliance situations?
- National Institute of Health (NIH) Office of Laboratory Animal Welfare (OLAW)
- Institutional Animal Care and Use Committee (IACUC)
- NIH funding can be taken away
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Institutional compliance with the Public Health Service (PHS) Policy is dependent on what 6 components?
- OLAW enforcement
- Submit Animal Welfare Assurance Statement
- IACUC compliance
- Follow The Guide for the Care and Use of Laboratory Animals
- Follow AVMA Guidelines on Euthanasia
- Follow the nine US Government Principles for the Utilization and Care of Vertebrate Animals, Used in Testing, Research and Training
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Who does the US Government Principals apply?
Anyone receiving federal money for research using vertebrate animals
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What are the 9 US Government Principals?
- I - Laws, Policies, Guidelines - Must follow the AWA guidelines for transportation, care and use of animals & other applicable laws, guidelines and policies
- II - Justification - Research must justify the purpose, model system is best to answer scientific question, and the research methods will provide valid results.
- III - Species Selection and Quantity - Animal selected must be appropriate species and use minimum number to obtain valid results
- IV - Proper Use of Animals - utilize methods that avoid or minimize discomfort, distress and pain
- V - Painful Procedures - should be performed with appropriate sedation, analgesia and/or anesthesia
- VI - Unrelieved Pain or Distress - if can't be relieved should be euthanized at end or during procedure
- VII - Environment and Well-being - provide appropriate living conditions for species
- VIII - Personnel - qualified and trained
- IX - Exceptions - require IACUC review
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What is the purpose of the Guide for the Care and Use of Laboratory Animals?
To provide guidelines for the ethical care and use for animals in research.
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What animals are covered under the Guide for the Care and Use of Laboratory Animals?
All live vertebrate animals
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What are the main components of The Guide?
- Institutional responsibilities
- Professional standards for Environment, Animal husbandry and Animal facilities (includes temperature, humidity, air exchange etc)
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What are the 3 levels of euthansia as defined by AVMA?
- Acceptable Ex CO2, barbituates, captive bolt
- Conditional acceptable (must be justified by IACUC) Ex: cervical dislocation w/o anes
- Unacceptable - Ex potassium chloride w/o anes
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What are the 4 IACUC Responsibilities/Authority?
- 1. Review and approval of protocols
- 2. Assess program and facilities semi-annually
- 3. Review of concerns regarding the care and use of animals
- 4. Authority to suspend activities
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Association for Assessment and Accreditation of Laboratory Animal Care - International
What is the purpose?
Standards according to
What is the process?
- Voluntary peer review group accreditation
- Federal policies and laws
- Site facility review with 1) accreditation 2) provisional accreditation 3) accreditation withdrawn. Every 3 years must have another site review.
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Who does the Good Laboratory Practice Regulations (GLPS) apply?
- Pharmacy and Biochemical Research
- Non-clinical Research trials
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Good Laboratory Practice Regulations (GLPS)
Purpose
Standards are according to what agencies?
- Purpose - More stringent guidelines than clinical research. To provide consistency, reproducibility and reliability.
- Standards - According to Food and Drug Administration (FDA) & Environmental Protection Agency (EPA) standards
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