Transcript Writing an Animal Protocol - IACUC Home

December 2009
AALAS Publication: American Association for Laboratory Animal Science
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Animal Activity Form aka Animal Protocol
Located on the IACUC website under Forms
http://iacuc.umc.edu/documents/IACUCprotocolform2009.doc
Download, complete, submit electronically to Ms Jean Garrett
[email protected]
Protocol of record submission date: 1st working date of the month
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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
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01 year
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3 year full submission include Progress Report
(Appendix K)
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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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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
[email protected]
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Fill in table
Species
Strain/Stock
Gender: M, F, TP female*, pups*
◦ *if using these, you must complete Appendix B
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Source
Number – remember to calculate total of animals
needed for 3 year period
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Chemical toxins in bedding/cages/carcasses?
◦ Reviewed by Risk Mgmt?
◦ Info at http://ehs.umc.edu/
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Radioisotopes in bedding/cages/carcasses?
◦ Reviewed by Radiation Safety?
◦ Info at http://dor.umc.edu/RSO/
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Infectious agents or recombinant DNA usage?
◦ Reviewed by Biohazards Committee?
◦ Info at http://ibc.umc.edu/
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All Environmental Health and Safety Concerns
◦ Info at http://ehs.umc.edu
◦ Fire/Chemical/Radiation/Laser/Biological
Standard
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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
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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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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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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
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Provide rationale for using animal models versus non-animal
models
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This part of the protocol should stand alone, all necessary information
needs to be included here
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Flow charts, time lines and tables are very useful
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If study utilizes several species, please identify experimental procedures for
each species separately
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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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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
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Identify all groups in the design
◦ Include control and experimental groups
◦ Number of animals per group
◦ Number of iterations of testing/sampling/ injections
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Describe behavioral testing
◦ Be certain to complete Appendix L
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Consider power analysis and statistics
Center for Biostatistics http://research.umc.edu/BioStatistics/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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Define appropriate humane time points
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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
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Consultation with the Vet staff (ext. 4-1385) should be
considered
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Provide both a Primary Method and a Secondary
(adjunct) Method to ensure death of the animal
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Consult with the LAF Vet staff and/or the AVMA
Guidelines on Euthanasia, June 2007 available on
the IACUC website
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View/review “Euthanasia” ppt (IACUC website)
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1. Have all personnel received a medical evaluation from UMMC Student/Employee
Health and updated Occupational Health Information annually?
No Yes
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2. Have all personnel become familiar with the Training & Procedural Manual for
Animal Use at UMMC?
No Yes
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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
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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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Replacement : consider use of computer models, cell
culture, in vitro assays
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Reduction: consider limiting group size to minimum;
perform multiple experiments simultaneously; share
tissue; animals serve as own control; newer instruments
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Refinement: consider using new anesthetics; newer
analgesics; newer bleeding/injection techniques;
improved surgical technique
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
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):
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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Describe results of the search
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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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A
B
C
D
E
F
G
H
I
J
K
L
Enrichment
Breeding
Surgical
Collection of Biological Samples from the Live Animal
Antibody Formation/Tumor Induction/ Hybridoma and Ascites
Administration of Drugs/Test Compounds
Prolonged Physical Restraint
Multiple Major Survival Surgical Procedures
Food and/or Fluid Restriction
Animal Pain and/or Distress
Progress Report
Behavioral Training and Testing
For additional assistance,
contact the IACUC office, 5-5006