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Writing an Animal Protocol Advice from the IACUC

Writing an Animal Protocol Advice from the IACUC. December 2009. AALAS Publication: American Association for Laboratory Animal Science. Animal Activity Form FAQs. Animal Activity Form aka Animal Protocol Located on the IACUC website under Forms

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Writing an Animal Protocol Advice from the IACUC

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  1. Writing an Animal ProtocolAdvice from the IACUC December2009

  2. AALAS Publication: American Association for Laboratory Animal Science

  3. Animal Activity Form FAQs • Animal Activity Form aka Animal Protocol • Located on the IACUC websiteunder Forms http://iacuc.umc.edu/documents/IACUCprotocolform2009.doc • Download, complete, submit electronically to Ms Jean Garrett jgarrett@dor.umsmed.edu • Protocol of record submission date: 1st working date of the month • Protocol Approval runs on a 3 year cycle of review • 01 year submission of full Animal Activity Form • 02 year Annual Renewal Form • 03 year Annual Renewal Form • Clock resets and starts again • 01 year 3 year full submission include Progress Report (Appendix K)

  4. Form Questions #1 and #2 - Personnel • PI – must be Instructor rank or above • Indicate PI title – PhD, MD • Include all Technicians, Post Docs, Grad Students • ** Please Note • When individuals join your lab, submit a memo to the IACUC asking to add the individual to the protocol include information detailing his/her education/qualifications • When people leave the lab, draft a memo to the IACUC and ask that she/he be removed from the protocol

  5. Personnel Training • All persons who will work with the live animal must have documented participation in IACUC mandated Training • Information and forms are available on the IACUC website under Training http://iacuc.umc.edu/Training.html • Contact Ms Amanda Kinslow IACUC Training Coordinator amurray@animal.umsmed.edu

  6. Form Question #9 – Animal Requirements • Fill in table • Species • Strain/Stock • Gender: M, F, TP female*, pups* • *if using these, you must complete Appendix B • Source • Number – remember to calculate total of animals needed for 3 year period

  7. Form Question #11 – Potential Hazards • Chemical toxins in bedding/cages/carcasses? • Reviewed by Risk Mgmt? • Info at http://ehs.umc.edu/ • Radioisotopes in bedding/cages/carcasses? • Reviewed by Radiation Safety? • Info at http://dor.umc.edu/RSO/ • Infectious agents or recombinant DNA usage? • Reviewed by Biohazards Committee? • Info at http://ibc.umc.edu/ • All Environmental Health and Safety Concerns • Info at http://ehs.umc.edu • Fire/Chemical/Radiation/Laser/Biological

  8. Form Question #12 – Animal Husbandry Standard Nonstandard • Feeding • Watering • Caging/housing Examples of non-standard… • High/Low salt diet; high/low fat diet, etc • Drugs / Compounds (Sprite, alcohol) added to drinking water • Single housing, metabolic caging • For each non-standard situation… • Include description of what is added • Provide reason • Identify an individual responsible for overseeing the process • Develop lab book • Label appropriately • View and document “Non-standard feeding and watering” ppt on IACUC website

  9. Form Question #14 - Lay Summary • Describe the Proposed Use of Animals • Use non-scientific words • Define abbreviations • Provide brief description of the experimental design • Tie scope of work into possible human or animal health benefit

  10. Form Questions #15A and #15B –Justification for the Use of Animals • Justification of the selected species • Presence of a large body of scientific knowledge validates use of particular species or animal model • Existence of large body of lab data that would need to be repeated if another species was selected • Characteristics of the species make it uniquely suited for the study • Availability of research tools or reagents unique to the species • Provide rationale for using animal models versus non-animal models

  11. Form Question #16 –Description of Animal Procedures • This part of the protocol should stand alone, all necessary information needs to be included here • Flow charts, time lines and tables are very useful • If study utilizes several species, please identify experimental procedures for each species separately • Describe any non-surgical manipulations • Injections, scans (x-rays, MRI), sample collection • Route, volumes, frequency included • Be certain to complete Appendices D and F

  12. Form Question #16 –Description of Animal Procedures • Outline All Surgical manipulations • Be certain to complete Appendix C • Describe surgical manipulations including site preparation, surgical approach, and unique techniques for each surgical procedure • Provide information on Pre- and post operative care • Anesthesia and Analgesia • Intra-operative monitoring • Wound Closure and suture removal • Be certain to complete Appendix C • Identify all groups in the design • Include control and experimental groups • Number of animals per group • Number of iterations of testing/sampling/ injections • Describe behavioral testing • Be certain to complete Appendix L

  13. Form Question #17 – Justification of Animal Numbers • Consider power analysis and statistics • Center for Biostatistics http://research.umc.edu/Bio-Statistics/UMC_Biostatistics-summary.html is available to assist you • Define groups include controls • ***If personnel training is part of the study, include sufficient animals to ensure adequate training • Number of animals justified should equal the number of animals requested in Question #9

  14. Form Question #19 - Endpoints • Define appropriate humane time points • For early removal from study… • Include weigh loss range; morbidity assessment; impaired neurological status; ruffled fur/inability to groom; impaired ability to feed; excess tumor burden beyond specified size/diameter; pain and distress unrelieved by administration of analgesia • Consultation with the Vet staff (ext. 4-1385) should be considered

  15. Form Question #20 - Euthanasia • Provide both a Primary Method and a Secondary (adjunct) Method to ensure death of the animal • Consult with the LAF Vet staff and/or the AVMA Guidelines on Euthanasia, June 2007 available on the IACUC website • View/review “Euthanasia” ppt (IACUC website)

  16. Assurances • 1. Have all personnel received a medical evaluation from UMMC Student/Employee Health and updated Occupational Health Information annually? No Yes • 2. Have all personnel become familiar with the Training & Procedural Manual for Animal Use at UMMC? No Yes • 3. Review of the available resources and previous experiments have determined that the proposed activity is not unnecessarily duplicative of previously reported activities. No Yes • 4. USDA Policy #12, “Consideration of Alternative to Painful/Distressful Procedures”: states the following: The Animal Welfare Act (AWA) regulations require principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions, and replacements.

  17. 3Rs- Refinement, Reduction, Replacement • Replacement : consider use of computer models, cell culture, in vitro assays • Reduction: consider limiting group size to minimum; perform multiple experiments simultaneously; share tissue; animals serve as own control; newer instruments • Refinement: consider using new anesthetics; newer analgesics; newer bleeding/injection techniques; improved surgical technique

  18. Assurances and Written Narrative To comply with Policy #12 , the IACUC asks you to do the following two activities 1. Conduct a literature search using two different search engines (see next slide) 2. Describe and certify the results of the search in a narrative format

  19. Activity 1. Conduct a search of the literature To determine whether or not alternatives exist to procedures that may cause more than momentary pain and distress: This step requires the use of two different search engines. Search 1 and Search 2 The same search strategy can be used for both search engines. Sources utilized: Examples are listed below (please note: PubMed and Medline are the same and cannot both be used). Medline/PubMed (http://www.ncbi.nlm.nih.gov/pubmed) Toxnet (http://toxnet.nlm.nih.gov) AWIC (http://awic.nal.usda.gov) Agricola (http://agricola.nal.usda.gov) ISI Web of Science (http://apps.isiknowledge.com ) Other (     ) Key words: The IACUC recommends the inclusion of “in vitro” and “animal model” with search terms specific to your research. Search date: Covered years of search: Words Searched:       Search Results (list combinations of terms and number of hits for each):      

  20. Activity 2. Narrative Provide a brief summary of any articles that were identified in the search and how these studies relate to the current animal protocol. Certify in this section that no valid alternative was identified to any described procedures that may cause more than momentary pain or distress, whether relieved or not. Reduction, replacement and refinement (the 3 Rs) must be addressed, not just animal replacement. Additional assistance may be obtained by contacting the Rowland Medical Library reference desk at ext. 4-1231.

  21. Narrative – check format • Describe results of the search 2. Certification of alternatives 1. Methods that would REFINE, REDUCE, and/or REPLACE methods currently proposed for use are not available. 2. Are methods that refine existing tests by minimizing animal distress and/or distress available? Yes No if yes, explain why the method is not suitable   3. Are methods that reduce the number of animals necessary for an experiment available? Yes No if yes, explain why the method is not suitable       4. Are methods/techniques to replace whole-animal use with in vitro or other tests available? Yes No if yes, explain why the method is not suitable       When ascites production is used to produce antibodies, provide justification as to why in vitro systems cannot be used.

  22. Appendices • A Enrichment • B Breeding • C Surgical • D Collection of Biological Samples from the Live Animal • E Antibody Formation/Tumor Induction/ Hybridoma and Ascites • F Administration of Drugs/Test Compounds • G Prolonged Physical Restraint • H Multiple Major Survival Surgical Procedures • I Food and/or Fluid Restriction • J Animal Pain and/or Distress • K Progress Report • L Behavioral Training and Testing

  23. For additional assistance, contact the IACUC office, 5-5006

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