AALAS ALAT Chapter 2 Research Facility Environment


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AALAS ALAT Chapter 2 Research Facility Environment

  1. 1. AALAS ALAT Manual Chapter 2- The Research Facility Environment Tamara Goodman Kuhel RVT, RLATG, CPIA
  2. 2. Review of Chapter 2 <ul><li>The Research Program </li></ul><ul><li>Members of the Team </li></ul><ul><li>The Institutional Animal Care & Use Committee </li></ul><ul><li>The Protocol </li></ul><ul><li>Federal, State, & Local Legislation & Guidelines </li></ul><ul><li>Career Opportunities </li></ul>
  3. 3. The Research Program
  4. 4. The Research Program What are the specific aims & expected results? What methods will be used to accomplish aims?
  5. 5. The Research Program Why are animals needed? What procedures will be performed? How will the animals be housed & cared for?
  6. 6. The Research Program Is proposed research important & likely to produce significant results?
  7. 7. The Research Program If IACUC protocol approved & project funded, experiment can begin!
  8. 8. Members of the Team <ul><li>Principal Investigator </li></ul><ul><li>Co-Investigators & Research Technicians </li></ul><ul><li>What about Management Team & Business Office? </li></ul><ul><li>Laboratory Animal Technicians </li></ul><ul><li>Laboratory Animal Veterinarian </li></ul><ul><li>Commercial Animal Suppliers </li></ul><ul><li>& Equipment Manufacturers </li></ul>
  9. 9. Members of the Team… Principal Investigator <ul><li>PI is a scientist who plans &coordinates all phases of the research work. </li></ul><ul><li>Responsible for reporting the research findings to the scientific community. </li></ul><ul><li>Responsible for overall compliance with IACUC protocol. </li></ul>
  10. 10. Members of the Team… Co-Investigators & Research Technicians <ul><li>Perform the specific research tasks. </li></ul><ul><ul><li>Observing experimental animals. </li></ul></ul><ul><ul><li>Typically primary lab contact. </li></ul></ul><ul><ul><li>Performing laboratory tests. </li></ul></ul><ul><ul><li>Assisting with preparations. </li></ul></ul><ul><li>Collect, organize, & analyze the data. </li></ul>
  11. 11. Members of the Team… Laboratory Animal Technicians <ul><li>This includes Laboratory Animal Aides. </li></ul><ul><li>Perform animal care functions critical to maintenance of healthy animals. </li></ul><ul><li>Follow SOPs to control undesirable variables that adversely affect experimental data. </li></ul><ul><li>Willing to learn as much as possible about animals under their care & field of laboratory animal science. </li></ul><ul><li>Report all changes & errors. </li></ul><ul><li>Knowledgeable, confident, </li></ul><ul><li>mature, & honest. </li></ul>
  12. 12. Members of the Team… Laboratory Animal Veterinarian <ul><li>Coordinates animal care activities. </li></ul><ul><li>Advises on proper animal model selection & procedural use. </li></ul><ul><li>Overall maintenance of animal colony health & assurance of compliance. </li></ul>
  13. 13. Members of the Team… Commercial Animal Suppliers & Equipment Manufacturers <ul><li>Provide animals that meet specific research requirements (age, sex, strain/breed, etc.). </li></ul><ul><li>Supply products that meet/exceed minimum requirements (e.g. disease free). </li></ul><ul><li>Quality research depends on quality equipment, supplies, & animals. </li></ul>
  14. 14. The Institutional Animal Care & Use Committee <ul><li>AWARs & PHS Policy require IACUC. </li></ul><ul><li>IACUC members appointed by CEO. </li></ul><ul><li>CEO serves as Institutional Official (IO). </li></ul><ul><ul><li>IO at UC is Dr. Sandra Degen. </li></ul></ul><ul><ul><li>IACUC Chair is Dr. George Babcock. </li></ul></ul><ul><ul><li>LAMS DVMs are IACUC members. </li></ul></ul><ul><ul><li>Learn more about UC’s </li></ul></ul><ul><ul><li>IACUC & research program: </li></ul></ul><ul><ul><li>http://researchcompliance.uc.edu </li></ul></ul>
  15. 15. The IACUC <ul><li>Oversee animal research program. </li></ul><ul><li>Review all research protocols involving animals. </li></ul><ul><li>Inspect animal facilities at least every 6 months (misleading to say “twice a year”) & report findings/corrective actions to IO. </li></ul><ul><li>Membership must include: </li></ul><ul><ul><li>Laboratory animal veterinarian </li></ul></ul><ul><ul><li>Institutional scientist who uses animals </li></ul></ul><ul><ul><li>Non-scientist </li></ul></ul><ul><ul><li>Community member (unaffiliated with UC) </li></ul></ul>
  16. 16. The Protocol <ul><li>Provides detailed description of procedures involving animals for IACUC review: </li></ul><ul><ul><li>Scientific merit. </li></ul></ul><ul><ul><li>Appropriate use of animals. </li></ul></ul><ul><ul><li>Animal well-being. </li></ul></ul><ul><ul><li>Compliant with laws & regulations. </li></ul></ul><ul><li>Must be approved by IACUC before animals may be ordered or used. </li></ul>
  17. 17. Federal, State, & Local Legislation & Guidelines <ul><li>Animal Welfare Act </li></ul><ul><li>Public Health Service Policy on Humane Care & Use of Laboratory Animals </li></ul><ul><li>Guide for the Care & Use of Laboratory Animals </li></ul><ul><li>Good Laboratory Practices Regulations </li></ul><ul><li>State & Local Laws & Institutional Policies </li></ul>
  18. 18. Animal Welfare Act 28 Hour Law Pet Protection Act Animal Welfare Act AWA Amendment Improved Standards for Laboratory Animals Protection of Pets Farm Security & Rural Investment 1873 1966 1970 1976 1985 1990 2002 Set maximum length of time “farm animals” could be without food, water, & rest during transport. Intended to prevent cats & dogs from being stolen & sold to research labs. Set humane standards. Expanded animal coverage to include warm-blooded vertebrates used in research. Clarified animal transport & commerce. Addresses animal fighting for 1 st time. Addresses exercise of dogs & psychological well-being of NHP. Requires 5-day holding of dogs & cats in shelters before selling, etc. New recordkeeping requirements. Addresses bird fighting & ↑ $ for violations. Again, explicitly excludes birds, rats, & mice bred for research.
  19. 19. Animal Welfare Act <ul><li>Administered by USDA’s Animal & Plant Health Inspection Service (APHIS). </li></ul><ul><li>AWARs regulate all live or dead warm-blooded vertebrates in research except … </li></ul><ul><ul><li>Birds. </li></ul></ul><ul><ul><li>Purpose-bred rats ( Rattus ) & mice ( Mus ). </li></ul></ul><ul><ul><li>Farm animals used as food/fiber. </li></ul></ul><ul><ul><li>Farm animals used in agricultural studies. </li></ul></ul><ul><li>Covers all wild mammals. </li></ul>
  20. 20. USDA Regulated?
  21. 21. AWA Requirements <ul><li>USDA Registration </li></ul><ul><li>Maintain individual records on source/use of cats & dogs using tattoo or tag. </li></ul><ul><li>Annual report that includes number of animals used classified by species & pain category. </li></ul><ul><li>Bonus question- When is this annual report due? </li></ul><ul><li>House by species, providing space & environment according to AWARs . </li></ul><ul><li>Meet or exceed cage & facility sanitation. </li></ul><ul><li>Provide veterinary care. </li></ul><ul><li>Proper transportation. </li></ul>
  22. 22. AWA 1985 Amendment <ul><li>Personnel training. </li></ul><ul><li>Dog exercise. </li></ul><ul><li>Provide for psychological well-being of NHP. </li></ul><ul><li>Pain management. </li></ul><ul><li>Limiting major survival surgeries. </li></ul><ul><li>IACUC facility inspections. </li></ul><ul><ul><li>Unannounced & inspection report is public record. </li></ul></ul><ul><ul><li>What is FOIA? </li></ul></ul><ul><li>Animal alternatives. </li></ul><ul><li>Bonus question- Which “R” does this address? </li></ul><ul><li>IACUC. </li></ul>
  23. 23. Public Health Service Policy on Human Care & Use of Laboratory Animals <ul><li>Applies to studies funded by PHS/NIH. </li></ul><ul><li>PHS Policy enforced by the Office of Laboratory Animal Welfare (OLAW), a branch of NIH. </li></ul><ul><li>IO must submit Animal Welfare Assurance Statement to OLAW. </li></ul><ul><li>“ Promise” to conduct animal research in accordance with PHS Policy, the Guide, & other applicable laws/regulations (e.g. AWARs). </li></ul>
  24. 24. Animal Welfare Assurance Statement <ul><li>Major components of UC & lines of authority. </li></ul><ul><li>Description of veterinarians. </li></ul><ul><li>IACUC membership. </li></ul><ul><li>Protocol review process. </li></ul><ul><li>Description of OH&S program. </li></ul><ul><li>Outline of training program. </li></ul><ul><li>Description of facilities. </li></ul>
  25. 25. Guide for the Care & Use of Laboratory Animals <ul><li>1 st published in 1963 & most recently 1996. </li></ul><ul><li>Addresses humane care, use, & maintenance of laboratory animals. </li></ul><ul><li>Used by AAALAC as basis of evaluating quality of animal care & use program & ultimately accrediting. </li></ul><ul><li>Compliance with Guide required by many funding agencies. </li></ul>
  26. 26. Good Laboratory Practices Regulations <ul><ul><li>GLP Regulations apply to studies funded by FDA. </li></ul></ul><ul><ul><li>SOPs for all husbandry & scientific procedures. </li></ul></ul><ul><ul><li>Train personnel & maintain record. </li></ul></ul><ul><ul><li>Proper sanitation techniques. </li></ul></ul><ul><ul><li>Proper husbandry & records of such. </li></ul></ul><ul><ul><li>Separately house species & provide facilities to prevent interference in surrounding studies. </li></ul></ul><ul><ul><li>Keep records for at least 2 years after . </li></ul></ul>
  27. 27. Federal, State, & Local Legislation & Guidelines <ul><li>IACUC policies. </li></ul><ul><li>Any additional applicable internal policies (e.g. Radiation Safety, Institutional Biosafety Committee). </li></ul><ul><li>Completion of IACUC training every 3 years is example of internal policy/guideline. </li></ul>
  28. 28. Career Opportunities <ul><li>Starting & Advancing </li></ul><ul><ul><li>ALAT  LAT  LATG </li></ul></ul><ul><ul><li>Additional education through AALAS publications </li></ul></ul><ul><li>Seeking Employment in Laboratory Animal Science </li></ul><ul><ul><li>Seek positions that allow for professional growth. </li></ul></ul><ul><ul><li>Interview performance is critical . </li></ul></ul><ul><li>Performance Standards & Appraisal </li></ul><ul><ul><li>Must be specific, measurable, & attainable. </li></ul></ul><ul><ul><li>How well have you met the performance standards? </li></ul></ul>
  29. 29. Definitions <ul><li>Research Proposal </li></ul><ul><li>Animal Use Protocol </li></ul><ul><li>Grant </li></ul><ul><li>Principal Investigator (PI) </li></ul><ul><li>Institutional Animal Care & Use Committee (IACUC) </li></ul><ul><li>Institutional Official </li></ul><ul><li>Guide for the Care & Use of Laboratory Animals </li></ul>
  30. 30. Acronyms <ul><li>SOP </li></ul><ul><li>CEO </li></ul><ul><li>FOIA </li></ul><ul><li>PHS </li></ul><ul><li>NIH </li></ul><ul><li>OLAW </li></ul><ul><li>ILAR </li></ul><ul><li>AAALAC </li></ul><ul><li>GLP </li></ul><ul><li>FDA </li></ul><ul><li>EPA </li></ul><ul><li>ALAT </li></ul><ul><li>LAT </li></ul><ul><li>LATG </li></ul>
  31. 31. Acknowledgements <ul><li>AALAS 2005 ALAT Manual </li></ul><ul><li>Guide for the Care and Use of Laboratory Animals </li></ul><ul><li>Animal Welfare Act Regulations </li></ul><ul><li>Congressional Research Service “The Animal Welfare Act: Background & Selected Legislations”, 12/08/2009 </li></ul><ul><li>Numerous websites for images! </li></ul>