Lab Animal; Regulations and Guidelines
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What is the Purpose of the Animal Welfare Act (AWA)?
To provide ethical standards for animal research
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
Who administers the Animal Welfare Act?
United States Department of Agriculture
Who inspects facilities for compliance with AWA?
Animal Plant and Health Inspection Service - Veterinary Medical Officer (APHIS - VMO)
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)
Who sets the guidelines for Euthanasia?
American Veterinary Medical Association (AVMA)
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.
What 6 things that AWA reviews as part of the institutional components?
- Personnel qualifications
- Veterinary care
- Annual Report submitted to USDA
- Access for inspector
- Individual identification of dogs & cats/Small animals can be ID'd in groups
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
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
Who covers wild mice & rats; whales.
Who covers cattle used in heart research?
Animal Welfare Act for ALL
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
Who administers the Public Health Service Policy on Humane Care and Use of Laboratory Animals?
Office of Laboratory Animal Welfare (OLAW)
Compliance of the Policy on Humane Care and Use of Laboratory Animals is based on what document?
Animal Welfare Assurance Statement
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
Public Health Service Policy
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
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
Who does the US Government Principals apply?
Anyone receiving federal money for research using vertebrate animals
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
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.
What animals are covered under the Guide for the Care and Use of Laboratory Animals?
All live vertebrate animals
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)
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
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
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.
Who does the Good Laboratory Practice Regulations (GLPS) apply?
- Pharmacy and Biochemical Research
- Non-clinical Research trials
Good Laboratory Practice Regulations (GLPS)
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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