PART II
Species____________________
Complete a separate copy for each species. If you have more than one species, complete additional copies
of Part II and attach to your RAM application.
15.
SCIENTIFIC JUSTIFICATIONS
Federal policy, as well as ethical principles, incorporates two goals: 1) live animal use should be
minimized, and 2) pain and distress should be reduced to the minimum necessary to obtain valid data.
Federal regulations direct the Institutional Animal Care and Use Committee to review proposals to
ensure that investigators incorporate these principles into their research. Potential sources for the
information needed to complete this section include the National Agricultural Library and the National
Library of Medicine.
A.
Justification for Live Animals
Describe the alternatives to the use of live animals that have been considered (e.g. in vitro systems,
mathematical or computer models, etc.) And why they cannot be used to obtain the desired data.
B. Justification for Choice of Species (Species chosen should be lowest possible phylogenetic
species)
____ The results will be directly applicable to the health, care or study of this species.
____ This is a new model. (Cite relevant information//literature describing how this
determination was made.)
____ This model has previously been used. Provide citation and an electronic copy of
article, if available.
C. Justification for Numbers. Check all that apply and answer subsequent questions.
____ Pilot study or preliminary project, group variances unknown at present. Explain
justification.
____ Group sizes based on quantity of harvested cells or amount of tissue required. Explain
how much tissue is need based on the number of experiments you will conduct and
how much tissue you expect to obtain from each animal. (NOTE: “The study requires
50 experiments” is not sufficient,)
____ Group sizes determined statistically. What statistical analysis was performed?
____ Other. Indicate criteria used to determine (NOTE: “This is the number used in
previous studies” is not sufficient.)
( ) IF ALL ANIMAL PROCEDURES ARE TO BE PERFORMED AFTER EUTHANASIA
ONLY, CHECK HERE AND PROCEED TO QUESTION 17.
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APPENDIX B
Species _____________
COMPLETE THE FOLLOWING SECTION FOR ALL ANIMALS IN PAIN CATEGORIES D OR E
(See PART A, Number 7)
COMPLETE A COPY OF THIS SECTION FOR EACH SPECIES
NOTE: If use of animals in Categories D or E is planned, PI MUST consult the University
Veterinarian or his/her designee prior to submitting the application: vet@oakland.edu
Date of consultation with the University Veterinarian? _____
A. Federal regulations and university policy require consideration of alternatives to procedures that
may cause more than momentary or slight pain or distress to animals. The intent of the
questions is to evaluate the consideration of procedures or parts of procedures that will produce
the least amount of pain or discomfort – the 3R’s: Replacement, Reduction, Refinement. Note:
Any procedure requiring anesthesia is a painful procedure.
1.
Explain why you cannot REPLACE your choice(s) of species with a lower species. (e.g., in
vitro models, computer models, less sentient animals).
2.
Explain why you cannot REFINE your experimental procedures further to minimize pain
and distress. (e.g., early endpoints; use of anesthetics and/or analgesics, techniques to
reduce stress).
3.
Explain why you cannot REDUCE the number of animals needed further than what you
have specified (e.g., appropriate statistical methods, reduction in experimental variability
by using defined genetic status, sharing tissue among investigators).
B. Methods used to search for alternatives. Indicate all that apply.
1. Literature search conducted.
Databases searched (more than one required). Suggestions: AAGRICOLA, Medline,
Pubmed, Altweb (http://altweb.jhsph.edu/databases/databases.htm), AWIC
(www.nal.usda.gov/awic).
Keywords used (specific to animal use involving pain/distress). Suggestions: assay,
techniques, method, culture, invertebrate, vitro, simulation, method, model, virtual.
Date search was completed:
Years searched:
2.
Consultation with colleagues, specific to alternatives to animal use, pain, distress.
Name and qualifications:
Date and Content of consult:
3.
Other: Provide a detailed explanation.
C. For any animals in Category E, provide a detailed explanation and justification for the
procedures and for not using appropriate alternatives. This information will be reported to the
USDA and is available under the Freedom of Information Act.
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PART II
16.
Species ________________
PROCEDURES
Note Regarding Use of Non-Pharmaceutical Grade Drugs: Investigators should use
pharmaceutical grade medications whenever they are available. Cost savings alone are not an
adequate justification for using non-pharmaceutical grade compounds in animals.
(http://www.aphis.usda.gov/ac/policy/policy3.pdf).
A. Breeding – If you are breeding animals as part of this project, you must complete APPENDIX C.
B. Describe each procedure in chronological order. Committee members should be able to follow the
progression of events from experimental initiation to completion.
C. Please specify the following information. This may be extracted from the description above.
1. Substances Administered.
Substance
2.
Dosage
Route
Volume
Site
Frequency
Methods of Restraint (e.g., physical, chemical) and duration.
NOTE: If prolonged, conscious physical restraint greater than thirty (30) minutes is required,
you must complete APPENDIX D. Physical restraint is defined in the Guide as "…the use of
manual or mechanical means to limit some or all of an animal's normal movement for the purpose
of examination, collection of samples, drug administration, therapy, or experimental manipulation.
Animals are restrained for brief periods, usually minutes, in most research applications. Animals
can be physically restrained briefly either manually or with restraint devices. Restraint devices
should be suitable in size, design, and operation to minimize discomfort or injury to the animal."
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3.
For Non-Surgical or Minor Surgical Procedures: (Minor Surgical Procedures may include
procedures that would be performed on humans in an outpatient clinical setting.)
Substance
Dosage
Route
Volume
Site
Frequency
a. Anesthetics and/or analgesics.
b. Potential study induced or phenotypic related issues the animal may experience. Consider:
changes in appearance (ocular discharge, swellings, tumors [cannot exceed 10% of body
weight]; changes in respiration, changes in appetite; changes in weight [cannot exceed
decreases greater than 10%]; other changes such as muscle atrophy, blindness, infection,
etc. Comment on any issues that may change the animal’s ability to behave or function
prior to the procedure, as well as how these will be monitored and addressed.
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IF PROCEDURES WILL INCLUDE MAJOR SURGERY (eg., entry into a body cavity), YOU
MUST COMPLETE APPENDIX E FOR EACH SPEICES.
APPENDIX E
Species ________________
COMPLETE A SEPARATE COPY OF THIS SECTION FOR EACH SPECIES
NOTE: Regarding Surgeries:
All surgeries must be performed using aseptic techniques.
All rodent survival surgeries must be performed in a designated area approved by the IACUC.
All non-rodent mammal surgeries must be performed in a dedicated surgical area.
1.
State name of the surgeon and experience with the species and surgical procedure.
2. Specify anesthetics and/or analgesics. (e.g. dosage, volume, sites, frequency, and how
anesthetic level will be monitored).
3. NOTE: If neuromuscular paralytics are to be used, provide detailed information as to which
physiological parameters will be minored, the variances which will be tolerated, and the steps
to be taken if any parameter varies outside of the expected range.
4. Describe specifics to the surgery such as approach, operative procedures, closure and
recovery.
5. Describe postoperative care, including analgesics, antibiotics and monitoring of fluids and
body temperature.
6. Describe potential surgery induced or phenotypic related issues the animal may experience.
Consider: changes in appearance (ocular discharge, swellings, tumors [cannot exceed 10%
of body weight]; changes in respiration, changes in appetite; changes in weight [cannot
exceed decreases greater than 10%]; other changes such as muscle atrophy, blindness,
infection, etc. Comment on any issues that may change the animal’s ability to behave or
function prior to the procedure, as well as how these will be monitored and addressed.
7. How long will animals be maintained after surgery?
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8. Multiple major survival surgeries are discouraged. If animals will undergo more than one
major survival surgery, provide an appropriate scientific justification.
PART II
Species _______________
17. EUTHANASIA: What method of euthanasia will be used?
Method: ___CO2 Overdose
___Drug Overdose
Other (Explain)
If drug overdose:
Name of drug:
Route:
Dosage:
Note: Proficiency at cervical dislocation for euthanasia must be verified by LAMS. If
intracardiac injection is used, animal must be sedated prior to injection.
18. METHOD OF ASSURANCE OF DEATH: Death must be assured by means other than an
overdose of drug or gas alone.
___ bilateral pneumothorax
___ transection of the aorta
___ cervical dislocation
___ Other, explain:
19. TRANSFER ARRANGEMENTS: At the conclusion of this project, if there are surviving
animals, indicate your preference as to the final disposition of these animals. NOTE: All animal
transfers/ donations to other approved projects must be approved by and coordinated through
LAMS.
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