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RATS Quiz 4
Lecture 6: Regulatory Agencies and Regulations
| Question | Answer |
|---|---|
| 1963 | The Guide for the Care and Use of Laboratory Animals |
| 1965 | AAALAC (accreditation of research institutions) |
| 1966 | Animal Welfare Act |
| 1979 | Public Health Service (PHS) Policy requiring IACUCs |
| Animal Welfare Act | enforced by the USDA, provides special provisions for certain species used in research, exhibition, and teaching |
| original purpose of AWA | protect the owners of dogs can cats from theft, prevent the sale or use of stolen animals, assure humane treatment in transport, prohibit the use of animals for fighting |
| species covered by AWA when used for specified purposes | dogs and cats, guinea pigs and hamsters, rabbits, nonhuman primates, warm-blooded animals other than the above |
| species excluded by AWA | birds, cold-blooded animals, rats and mice, horses not used for research purposes, livestock or poultry used for food, fiber, etc. |
| AWA provides specifications for | facilities and operating standards, animal health and husbandry standards, transportation standards, separation for species, veterinary care |
| dogs and cats purchased by research facilities or US government may only be purchased from | authorized operations of auction sales, licensed exhibitors, licensed dealers |
| how often by all registered facilities inspected unannounced by USDA veterinarians? | at least twice a year |
| The Guide for the Care and Use of Laboratory Animals | first published in 1963 by National Research Counsel; considered the primary reference on lab animal care and use |
| research facilities that receive funding from what agencies are required to adhere to the Guide? | government agencies (NIH, EPA, FDA) |
| The Guide -> animal environment and housing: | space recommendations, temperature/humidity, ventilation, illumination, noise |
| The Guide -> husbandry: | food, water, bedding, sanitation, waste disposal, pest control |
| The Guide -> population management: | animal identification, record-keeping, genetics |
| The Guide -> veterinary medical care: | animal procurement/transportation, preventative medicine, surveillance, diagnosis, treatment/control of disease, surgery, pain, analgesia, anesthesia, euthanasia |
| The Guide -> physical plant: | facility design and management |
| The Guide -> behavioral management: | structural environment, housing, social environment, single or shared habitats, activity, enrichment |
| what considerations does the Guide use in preparation and review of protocols? | relevance, alternatives, discomfort/pain/stress, sedation/analgesia/anesthesia, post procedure care, unnecessary duplication, euthanasia, safety, husbandry, experimental end points, qualification/training of personnel |
| AAALAC | Association for Assessment and Accreditation of Laboratory Animal Care; organization that accredits research labs |
| AAALAC mission | to enhance life sciences by promoting the responsible treatment of animals used in research, teaching, and testing through voluntary accreditation and assessment programs |
| how does the AAALAC make their decisions? | based on compliance with standards set forth by the AWA and The Guide |
| how does a research facility maintain their accreditation? | submit and annual program report, revisited/re-evaluated once every 3 years, major changes/deficiencies must be reported |
| IACUC | Institutional Animal Care and Use Committee; organization that approves the use of animals used in research or teaching |
| IACUC mission | to facilitate compliance with applicable laws, regulations, and policies consistent with the performance for appropriate and productive scientific endeavors |
| an IACUC board is composed of what persons? | community/non-affiliated member, veterinarian, scientist, non-scientist, chair |
| IACUC responsibilities | evaluate programs 2x a year, review/approve any live animal protocols, investigate animal care/use complaints, inspect facilities every 6 months, prepare/submit reports every 6 months, plan for correction of deficiencies, suspend noncompliant activities |
| IACUC protocols | detailed plan of proposed work submitted by principal investigator, justification for project, how project is carried out, species/# animals to be used, discomfort level, anesthesia/post-op care, alternatives available |
| if a procedure could cause pain, what must be provided? | a written description is required of methods and sources used to determine that alternatives are not available |
| the principal investigator must assure what? | that work does not unnecessarily duplicate previous experiments |
| important components of good lab practice regulations are: | quality assurance, adherence to standard operation procedures, extensive record-keeping |
| CHIMP Act | Chimpanzee Health Improvement, Maintenance, and Protection Act of 2000; created a sanctuary retirement system for chimpanzees previously used in medical research; applies to chimps used in studies supported by federal government |
| most animal laws address: | prevention of cruel treatment, provision of food and water, provision of shelter and protection from extreme weather |
| reduction | reduce the number of animals used, use enough to make data valid |
| refinement | refine techniques and procedures to reduce pain and distress |
| replacement | replace animals with non-animal techniques of a lower species |
| basic research | primarily concerned with advancing fundamental knowledge of physical, chemical, and functional mechanisms of life processes and diseases |
| applied research | involves that use of existing knowledge for solving a specific biomedical issue (new vaccines, surgical procedures, etc.) |
| clinical research | designed to build on the knowledge gained in basic and applied research (always live animals) |
Created by:
mkroon26
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