The University of Texas at El Paso
Request for Use of Animals
National Institute of Health Assurance Number A3340-01
IACUC Office Use
Proposal #: ___________________________
Date Received: _____________________ ___
Approval Date: ________________________
Approval Period: ________________________
First Annual Review: ___________________
Second Annual Review: __________________
Triennial Renewal: _____________________
PLEASE TYPE (The original of this proposal signed by the principal investigator(s) and the unit
director/chairperson must be submitted to the IACUC Office, Burges Hall, Room 407.)
A.
ADMINISTRATIVE DATA
Principal Investigator (s):
Department(s):
Funding Source:
NSF
NIH/PHS
Other (specify)
Mailing Address:
Telephone:
Fax:
Email:
Project Title:
Initial Submission
Renewal
Modification
List any attachments here:
Pain/Distress Categories:
B. Experiments which involve no pain,
distress, or use of pain relieving drugs.
C. Experiments that involve momentary or
slight pain or distress.
D. Experiments involving accompanying pain
or distress to animals and for which
appropriate anesthetic, analgesic, or
tranquilizing drugs are used.
E. Experiments involving accompanying pain
or distress to the animals and for which the
use of appropriate anesthetic, analgesic, or
tranquilizing drugs would adversely affect the
procedures, results, or interpretation of the
experiments.
October 2006
Categories of Use:
Breeding.
Nutritional.
Field study.
Behavioral.
Learning
Developmental.
Teaching.
Display.
Tissue procurement after euthanasia.
Non-surgical procedure.
Survival surgery.
Non-survival surgery.
Multiple survival surgery in one animal.
Physical restraint.
Biological (human/animal pathogens, human
tissue, tumor cells, non-replicating
human/animal viruses) or recombinant DNA.
Toxicological.
Carcinogenic.
Radioactive isotopes or ionizing radiation.
Controlled substances.
Veterinary drugs.
Page 1 of 14
List the names of all individuals authorized to conduct procedures involving animals under this
proposal and identify key personnel (e.g., co-investigator(s), providing their department, and email):
All applicable training must be completed prior to handling of any animals.
Name/Status
Training Completed
(Faculty, Staff, Student,
Check all those that apply and have been completed.
Collaborator)
UTEP ID Number
Contact Information
(Department, e-mail address)
Yes N/A
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
Basic Laboratory Safety
Bloodborne Pathogens/Biosafety (including Zoonotic Disease)
AALAS Learning Library Courses
Surgical Certification
Occupational Health Screening
October 2006
Page 2 of 14
B. ANIMAL REQUIREMENTS
Genus:
Species:
[e.g., Mus]
Strain, subspecies, or breed: [e.g., C57BL]
[e.g., Mus musculus]
Common name:
[e.g., black laboratory mouse]
Approximate age, weight or size:
Sex:
(e.g., germfree (axenic), defined flora (gnotobiotic), specific pathogen free, conventional)
Microbiological status:
Source(s):
[e.g., name of vendor or breeder, bred in-house]
Primary housing location(s):
[Attending Veterinarian (Facility Manager) must certify that facility has the
resource capability to support the study. If animals will be housed in lab or
anywhere else outside central facility for more than 24 hours, provide building
and room number.]
Location(s) where manipulation will be conducted:
Number of Animals to be Used:
Year 1:
Total:
Year 2:
Year 3:
(if needed for granting agency)
C. TRANSPORTATION
No
Yes
If animals will be transported on public roads or out of state, describe efforts to comply with animal
welfare regulations. If animals will be transported between facilities, describe the methods and
containment to be utilized.
D. STUDY OBJECTIVES
Briefly explain in language understandable to a layperson the scientific or educational purpose of the
study. Limit explanations to no more than two paragraphs. Avoid technical jargon.
Briefly explain in language understandable to a layperson why the study is important to human or
animal health, the advancement of knowledge, or the benefit of society. Limit explanations to no
more than two paragraphs. Avoid technical jargon.
E. RATIONALE FOR ANIMAL USE
1) Explain your rationale for animal use (Check all that apply).
The complexity of the processes being studied cannot be duplicated or modeled in simpler
systems, e.g., insects.
There is not enough information about the processes being studied to design in vito or
non-living models.
Preclinical studies in living animals are necessary prior to human testing.
October 2006
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This is a behavioral, learning, or developmental study.
This is an ecological or field study.
This is a teaching/demonstration activity.
Other (briefly describe below):
2) Justify the appropriateness of the species selected (Check all that apply).
A large database exists for this species which will allow comparisons with previous data.
The anatomy, genetics, physiology, or behavior of the species to be used is uniquely suited
to the proposed study.
This is the phylogenetically lowest species that provides adequate size, tissue, or anatomy
for the proposed study.
The results will be directly applicable to the health or care of this species..
This is a teaching/demonstration activity.
Other (briefly describe below).
3) Justify the number of animals to be used. The number of animals should be the minimum number
required to obtain statistically valid results. When appropriate, statistical calculations should be
provided.
4) Does this proposed research duplicate any previous work?
Yes
No
5) If yes, provide justification for the duplication and indicate what procedures and sources were used
to determine that this protocol is not unnecessarily duplicative.
6) Specify the methods and sources used to search for duplication and alternatives. An alternative
consideration must be performed for Category D or E procedures. Alternatives include methods that
(a) refine existing procedures by minimizing animal stress; (b) reduce the number of animals
necessary for an experiment; and (c) replace whole animals with in vitro or other tests.
Keywords used for search:
Literature search. Date performed
. Years covered
to
.
(Check boxes for sources used.):
AGRICOLA Database <http://agricola.nal.usda.gov/>
ATLA (Alternatives to Laboratory Animals) <http://altweb.jhsph.edu/publications/journals/atla/atla-index.htm>
TOXLINE <http://toxnet.nlm.nih.gov/>
BIOSIS <www.biosis.org/>
MEDLINE < http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?DB=pubmed>
Laboratory Animal Journals
Biological Abstracts
Laboratory Animal Welfare Bibliography
Animal Welfare Information Center
<http://riley.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=1&tax_subject=183>
Benchmarks: Alternative Methods in Toxicology (ISBN 0-911131-91-1)
Alternatives to Animal Use in Research, Testing and Education (US Congress office of Technology
Assessment) <http://govinfo.library.unt.edu/ota/Ota_3/DATA/1986/8601.PDF>
Direct contact w/colleagues (must document source and substance of information below)
Other (must specify):
October 2006
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For category D and E procedures, describe your determination that alternatives were not available.
F. PAIN OR DISTRESS CLASSIFICATION
1. Pain or Distress Classification
Species
(common name)
USDA
Classification
*
B, C, D or E
Number of animals used each year
List amounts for years 4 and 5 if
requested by funding agency.
Year 1
Year 2
Year 4
Year 5
3 year total
number of
animals
Year 3
Total number of animals:
* USDA Classifications and Examples
Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery,
but not yet used for such purposes.
Examples:
 Breeding colonies of any animal species that are held in legal sized caging and handled in accordance with the
Guide and other applicable regulations. Breeding colony includes parents and offspring.
 Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations.
 Animals held under proper captive conditions or wild animals that are being observed.
Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain,
distress, or use of pain-relieving drugs.
Examples:
 Procedures performed correctly by trained personnel such as the administration of electrolytes/fluids,
administration of oral medication, blood collection from a common peripheral vein, catheterization, standard
radiography, parenteral injections of non-irritating substances, gavage, microchip and ear tag implants, tissue
collection after euthanasia, nutritional studies that do not lead to debilitation of the animal, behavioral testing,
procedures that cause only minor discomfort, live capture of wild animals.
 Euthanasia performed in accordance with the recommendations of the most recent AVMA Panel on Euthanasia,
utilizing procedures that produce rapid unconsciousness and subsequent humane death.
 Manual restraint that is no longer than would be required for a simple exam.
Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving
accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will
be used.
Examples:
 Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as
biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy.
 Blood collection by more invasive routes such as intracardiac or periorbital collection.
October 2006
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

Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but
which will be alleviated by analgesics.
Terminal tissue harvest, organ harvest, or exsanguinations under anesthesia.
Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving
accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing
drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or
tests.
Examples:
 Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence
testing, radiation sickness, and research on stress, shock, or pain.
 Surgical and postsurgical sequellae from invasion of body cavities, orthopedic procedures, dentistry or other hard
or soft tissue damage that produces unrelieved pain or distress.
 Negative conditioning that would be expected to cause pain in humans.
G. DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES
Briefly explain the experimental design and specify all animal procedures in the following three
sections. This description should allow the IACUC to understand the experimental course of an
animal from its entry into the experiment to the endpoint of the study. If you are proposing multiple
studies, clearly identify each individual study and describe it separately.
NON-SURGICAL PROCEDURES
Describe all non-surgical procedures to be carried out on live animals. If drugs or chemical agents are
administered, specify dose, frequency and route of administration. End points of procedures and time
frame must be clearly defined. For chronic, as well as acute experiments the length of time the
animals will be maintained prior to euthanasia must be estimated.
Specifically address the following:











Housing (list any special housing, equipment, animal care, e.g., special caging, water, feed, or waste
disposal, environmental enhancement, etc.).
Experimental injections or inoculations (substances, e.g., infectious agents, adjuvants, etc.; dose, sites,
volume, route, schedules, needle size and gauge).
Blood withdrawals (volume, frequency, withdrawal sites, and methodology).
Radiation (dosage and schedule).
Methods of restraint (e.g., collars, vests, harnesses, slings, etc.). Include how animals are restrained for
routine procedures like blood withdrawals. Prolonged restraint must be justified with appropriate oversight
to ensure it is minimally distressing. Describe any sedation, acclimation or training to be utilized.
Animal identification methods (e.g., ear tags, tattoos, collar, cage card, implant, etc.).
Personal Protective Equipment (e.g., general PPE that will be required of researchers conducting
procedures).
Other procedures (e.g., survival studies, tail biopsies, etc.).
Resultant effects, if any, that the animals are expected to experience (e.g., pain or distress, ascites
production, etc.).
Other potential stressors (e.g., food or water deprivation, noxious stimuli, environmental stress) and
procedures to monitor and minimize distress. If a study is USDA Classification E, indicate any nonpharmaceutical methods to minimize pain and distress.
Veterinary care (indicate desired plan of action in case of animal illness, e.g., initiate treatment, call
investigator prior to initiating treatment, euthanize).
October 2006
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


Euthanasia (indicate dose rate for anesthetic; carbon dioxide under anesthesia, dose and rate;
decapitation under anesthesia, justification).
Experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or
drink, behavioral abnormalities, clinical symptomatology, or signs of toxicity) must be specified when the
administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals are expected to
cause significant symptomatology or are potentially lethal. List the criteria to be used to determine when
euthanasia is to be performed. Death as an endpoint must always be scientifically justified.
Experience (list personal experience and familiarity with procedure(s) and species).
HUMANE ENDPOINTS TO PREVENT CHRONIC PAIN AND DISTRESS
Extreme moribund or death should not be used as an endpoint.
Not eating > 24 hours
Weight loss > 15% of normal weight
Depression > 24-36 hours
Non-weight bearing > 48 hours
Tumor size >10% of the baseline body weight (mice) or > 5% of the baseline body weight (rats).
Moderate to severe clinical signs of pain and distress unalleviated by appropriate analgesics
Other, specify
Where will observational records be kept? (specify building and room number):
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
NON-SURVIVAL SURGICAL PROCEDURES
In non-survival surgery, the animal is euthanatized while still anesthetized. Describe all non-survival
surgical procedures to be carried out on live animals. If drugs or chemical agents are administered,
specify dose, frequency and route of administration.
Pre-operative care:
Care Provider(s)
Medication(s) - List name of drug, route, dose, frequency and duration for each drug used preoperatively. Indicate if no drugs will be used pre-operatively.
Drug
Dose/Frequency
Route
Duration
Intraoperative care:
Care Provider(s)
Anesthetic(s):
Drug
Route
Dose/Frequency
Duration
Drug
Route
Dose/Frequency
Duration
Will a neuromuscular blocking agent (paralytic) be used?
No
Yes
If yes, describe below the procedure to be used to determine adequate anesthetic
depth throughout the procedure.
October 2006
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Indicate the indices and methods to be used to monitor the level of anesthesia and conditions during
surgery.
Respiratory rate
Reflexes (list which ones)
Heart rate
Capillary refill time
Mucous membrane color
Blood pressure
Body temperature
Oxygen saturation
EKG
Other (list)
Where will observational records be kept? (specify building and room number):
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
SURVIVAL SURGICAL PROCEDURES
Provide the following information:
A brief description of the survival surgical procedure(s). Include preoperative procedures (e.g.,
fasting).
A statement describing aseptic surgical techniques should be included.
If this procedure involves multiple survival surgery on one animal, provide scientific justification.
Current regulations do not allow multiple survival surgery on one animal unless scientifically justified
by the PI and approved by the IACUC.
Who will perform surgery and what are their qualifications and/or experience?
Where will surgery be performed and postoperative care provided (building and rooms)?
Has major survival surgery been performed on any animal prior to being placed on this study?
[Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of
physical or physiologic functions (such as laparotomy, thoracotomy, crainotomy, joint replacement, or
limb amputation).] If yes, explain:
Pre-operative care:
Care Provider(s)
Medication(s) - List name of drug, route, dose, frequency and duration for each drug used preoperatively. Indicate if no drugs will be used pre-operatively.
Drug
Dose/Frequency
Route
Duration
October 2006
Page 8 of 14
Intraoperative care:
Care Provider(s)
Anesthetic(s):
Drug
Route
Dose/Frequency
Duration
Drug
Route
Dose/Frequency
Duration
Will a neuromuscular blocking agent (paralytic) be used?
No
Yes
If yes, describe below the procedure to be used to determine adequate anesthetic
depth throughout the procedure.
Indicate the indices and methods to be used to monitor the level of anesthesia and conditions during
surgery.
Respiratory rate
Reflexes (list which ones)
Heart rate
Capillary refill time
Mucous membrane color
Blood pressure
Body temperature
Oxygen saturation
EKG
Other (list)
Post-operative recovery:
Care Provider(s)
Will an analgesic be administered?
Yes
, list the drug(s), route, dose, frequency and duration.
Drug
Dose/Frequency
Route
Duration
No
not providing analgesia.
Will other drugs be administered? No
Yes
If yes, list the drug(s), route, dose, frequency and duration:
Drug
Dose/Frequency
Route
Duration
Drug
Route
What specifically will be monitored
post-operatively?
Dose/Frequency
Duration
How often?
Post-anesthetic observations should be recorded until
sternal recumbancy can be maintained.
Body temperature
Weight
Behavior
October 2006
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Posture
Other, specify
After recovery and during experimental
study, what criteria will be used to assess
pain, distress and discomfort?
Not eating
Weight
Behavior
Posture
Other, specify
How often?
Post-surgical observations should be recorded until
wounds have healed (7-10 days)
HUMANE ENDPOINTS TO PREVENT CHRONIC PAIN AND DISTRESS
Extreme moribund or death should not be used as an endpoint.
Not eating > 24 hours
Weight loss > 15% of normal weight
Mutilation of operative site
Depression > 24-36 hours (hunched posture, lack of movement, rough coat)
Non-weight bearing > 48 hours
Infection not resolved with antimicrobial therapy
Moderate to severe clinical signs of pain and distress unalleviated by appropriate analgesics
Other, specify
Where will observational records be kept? (specify building and room number):
H. CONTROLLED SUBSTANCES
DEA Registration Number:
List name and estimated amount of controlled substance needed:
Describe the use, tracking, and security of controlled substances:
I. HAZARDOUS AGENTS
Attach documentation of Biosafety Committee approval for the use of recombinant DNA or potential
human pathogens.
Hazardous Agent
Radionuclides
Biological Agents (field research also)
Hazardous Chemicals or Drugs
Recombinant DNA
Yes
Study Conducted at Animal Biosafety Level:
No
1
Agent
2
3
Describe the practices and procedures required for the safe handling and disposal of contaminated
animals and material associated with this study. Also describe methods for removal of radioactive
waste and, if applicable, the monitoring of radioactivity.
Additional safety considerations:
October 2006
Page 10 of 14
J. METHOD OF EUTHANASIA AND DISPOSITION OF ANIMALS AT END OF STUDIES.
Indicate the proposed method of euthanasia. If a chemical agent is used specify the dosage and route of administration.
If the method(s) of euthanasia include those not recommended by the AVMA Panel Report on Euthanasia (e.g.,
decapitation or cervical dislocation without anesthesia), provide scientific justification why such methods must be used.
Indicate the method of carcass disposal.
Check all that apply.
Procedure:
Anesthetic overdose
Needle size
Gauge
Exsanguinations under
anesthesia
Describe specific conditions:
Drug name:
Dose per body weight:
(mg/kg)
I.M.
I.P.
I.V.
S.C.
Other:
Drug name:
Dose per body weight:
(mg/kg)
I.M.
I.P.
I.V.
S.C.
Other:
Inhalation of carbon dioxide
from a compressed gas
cylinder
Cervical dislocation without Justification:
anesthesia
Cervical dislocation with
anesthesia
Decapitation without
Justification:
anesthesia *
Decapitation with
anesthesia *
Other
Specify:
* Describe the equipment maintenance program to ensure the sharpness of blades (or other
instruments):
Describe how death will be verified:
Thoracotomy under anesthesia
Cervical dislocation under anesthesia
Exsanguinations under anesthesia
Prolonged exposure (>5 minutes) to carbon dioxide
Observation of vital signs for 5 minutes
Other, describe:
Final disposition of animals at completion of study/procedures:
Euthanize as described above
Return to housing/breeding colony
Return to field site
Transfer to protocol number
, principal investigator
Carcasses to be incinerated by Veterinary Services staff
Other, describe:
K. BIOLOGICAL MATERIAL/ANIMAL PRODUCTS FOR USE IN ANIMALS
(e.g., cell lines, antiserum, etc.)
October 2006
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1. Specify Material:
2. Source:
Material Sterile or Attenuated:
Yes
No
If derived from rodents, has the material been MAP/RAP/HAP tested? [MAP - Mouse Antibody
Production; RAP - Rat Antibody Production; HAP - Hamster Antibody Production]
Yes (Attach copy of results)
No
L. TRANSGENIC AND KNOCKOUT ANIMALS
Describe any phenotypic consequences of the genetic manipulations to the animals. Describe any
special care or monitoring that the animals will require.
M. FIELD STUDIES
If animals in the wild will be used, describe how they will be observed, any interactions with the
animals, whether the animals will be disturbed or affected, and any special procedures anticipated.
If animals will be maintained in captivity, describe details of housing and care to be provided.
Are federal/state collecting permit required?
Yes
Federal Permit Number
Date issued
State Permit Number
Date issued
No
N. SPECIAL CONCERNS OR REQUIREMENTS OF THE STUDY
List any special housing, equipment, animal care (e.g., special caging, water, feed, or waste disposal,
environmental enhancement, etc.).
October 2006
Page 12 of 14
O. PRINCIPAL INVESTIGATOR CERTIFICATIONS
1. I certify that the individuals listed in Section A. are authorized to conduct procedures involving
animals under this proposal, have completed the Institutionally-required training, and received training
in: the biology, handling, and care of this species; aseptic surgical methods and techniques (if
necessary); the concept, availability, and use of research or testing methods that limit the use of
animals or minimize distress; the proper use of anesthetics, analgesics, and tranquilizers (if
necessary); and procedures for reporting animal welfare concerns. The ultimate responsibility for the
well-being of the animals used in this project is mine.
2. I certify that I have determined that the research proposed herein is not unnecessarily duplicative
of previously reported research.
3. I certify that all individuals working on this proposal are participating in the Institution's
Occupational Health and Safety Program.
4. For all USDA Classification D and E proposals): I certify that I have reviewed the pertinent
scientific literature and the sources and/or databases as noted and have found no valid alternative to
any procedures described herein which may cause more than momentary pain or distress, whether it
is relieved or not.
5. I certify that I will notify the IACUC regarding any unexpected study results that impact the
animals. Any unanticipated pain or distress, morbidity or mortality will be reported to the attending
veterinarian and the IACUC.
6. I certify that I will notify the IACUC of any changes in objectives of the study; proposals to switch
from nonsurvival to survival surgery; change in degree of invasiveness of a procedure or discomfort
to an animal; change in species or in the approximate number of animals used; change in personnel
involved in animal procedures; change in anesthetic agent(s) or in the use or withholding of
analgesics; change in methods of euthanasia; or change in duration, frequency, or number of
procedures performed on an animal.
8. I certify that I am familiar with and will comply with all pertinent institutional, state, and federal rules
and policies.
Principal Investigator:
Name:
P. CONCURRENCE
Signature:
Date:
PROPOSAL NUMBER
Supervisory concurrence (Department Chair, Dean):
Name:
October 2006
Signature:
Date:
Page 13 of 14
IACUC ACTION:
Full Committee Review
Designated Review
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
Approved
Disapproved
Explanation: __
____________________________________________________
_________________________________________________________________
Modifications required to secure approval (Protocol with modification incorporated must
be resubmitted for subsequent IACUC consideration.)
Explanation: __
____________________________________________________
_________________________________________________________________
Review tabled or deferred.
Explanation: __
___________________________________________________
_________________________________________________________________
DATE __
_
FINAL APPROVAL:
Attending Veterinarian certification of oversight review, and consultation on proper use of anesthetics and pain
relieving medications for any painful procedures:
Name:
Signature:
Date:
Certification of review and approval by the Institutional Animal Care and Use Committee:
Name:
October 2006
Signature:
Date:
Page 14 of 14