Writing an Animal Protocol Advice from the IACUC

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Writing an Animal ProtocolAdvice from the IACUC

• December 2009

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AALAS Publication American Association for
Laboratory Animal Science
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Animal Activity Form FAQs

• Animal Activity Form aka Animal Protocol
• Located on the IACUC website under Forms
• http//iacuc.umc.edu/documents/IACUCprotocolform2
  009.doc
• Download, complete, submit electronically to Ms
  Jean Garrett
• jgarrett_at_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)

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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

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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_at_animal.umsmed.edu

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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

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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

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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

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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

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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

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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

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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

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Form Question 17 Justification of Animal
Numbers

• Consider power analysis and statistics
• Center for Biostatistics http//research.umc.edu/B
  io-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

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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

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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)

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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.

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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

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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

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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)      

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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.

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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.

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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

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• For additional assistance,
• contact the IACUC office, 5-5006