December 2009

AALAS Publication: American Association for Laboratory Animal Science

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

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)

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

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 Traininghttp://iacuc.umc.edu/Training.html

Contact Ms Amanda Kinslow IACUC Training Coordinatoramurray@animal.umsmed.edu

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

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

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

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

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

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

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

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

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

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)

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.

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

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 2The 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.

1. 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.

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

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