Oklahoma State University
Institutional Animal Care and Use Committee
University Research Compliance
223 Scott Hall, Stillwater, OK 74078-2016
405-744-3592
ANIMAL CARE AND USE PROTOCOL
READ ALL SECTIONS FOR INSTRUCTIONS.
Answer all questions. Answer NA if the question does not apply. Complete electronically. No
hand-written versions accepted. Submit one fully signed original to 223 Scott Hall AND submit the electronic version to:
iacuc@okstate.edu.
SECTION 1
1.1.
Protocol Identification
Protocol Title:
Protocol Number:
Protocol Action:
New
Renewal
Amendment
Principal Investigator/Instructor Name:
Office Phone:
Alternate Point of Contact:
1.2.
Department/College:
Protocol Type:
Protocol Class:
Research
Teaching
Testing
Agricultural
Biomedical
Field Study
Office Address:
Lab Phone:
Emergency Phone:
Office Phone:
Revised
Lab Phone:
E-mail:
Emergency Phone:
E-mail:
Investigator/Instructor Assurance Statements
Pursuant to applicable Federal laws and regulations, Oklahoma Statutes, and Oklahoma State University Policies and
Procedures:
I affirm that all use of vertebrate animals in Oklahoma State University sponsored research, teaching, and/or testing programs shall be covered by
an Animal Care and Use Protocol (ACUP) that has been reviewed and approved by the Oklahoma State University Institutional Animal Care and Use
Committee (IACUC) and that IACUC approval shall be obtained prior to ordering animals and/or performing any animal procedures described
therein.
I affirm that any proposed changes in personnel, species, usage, animal procedures, anesthesia, post-operative care, or biohazard procedures that
will significantly impact upon the animal portion of the study will be reported in writing to the IACUC in the prescribed format and that IACUC
approval shall be obtained prior to performing the revised animal procedures described therein.
I affirm that unauthorized deviation from an approved ACUP is grounds for suspending/terminating the protocol and may result in disciplinary
action.
I affirm that the OSU Attending Veterinarian may perform unannounced inspections and observations of animal quarters and/or experimental
procedures and that the OSU Attending Veterinarian is authorized to humanely euthanize animals that are found to be experiencing severe pain
and/or distress that cannot be relieved and/or unilaterally suspend an approved protocol pending full IACUC review. (NOTE: The OSU Attending
Veterinarian will make a concerted effort to contact the PI and/or his/her designated staff prior to initiating such action.)
I affirm that all use of biohazardous materials and/or radiological materials must be reviewed and approved by the applicable Oklahoma State
University Institutional safety officials/committee. Failure to follow those approved protocols may result in withdrawal of authorization to conduct
research/teaching/testing at Oklahoma State University.
I affirm that I have considered alternatives to the use of live animals in research, teaching, or testing.
I affirm that the activities/methods/procedures described herein do not unnecessarily duplicate previous experiments.
I affirm that all animal procedures described herein that may cause more than momentary or slight pain or distress will be performed with
appropriate sedatives, analgesics, or anesthetics unless scientifically justified and approved by the IACUC; that paralytics will not be used without
anesthesia; and that I have consulted the OSU Attending Veterinarian or other veterinarian in planning/developing the regimen to alleviate
pain/distress.
I affirm that personnel performing animal manipulation, experimental techniques, surgery, etc. are or have been adequately trained and proficient
prior to performing those procedures.
I affirm that the ACUP contains sensitive information and is not to be released to unauthorized individuals.
I affirm that the information contained herein does not materially conflict with and/or deviate from information contained in related grant proposal
documents submitted to extramural funding agencies listed in the protocol.
I affirm that the IACUC will be notified to close out the protocol when all live animal work has been completed.
By signing this protocol the principal investigator/instructor certifies that he/she has read and agrees to abide by the assurance statements listed above
and the Oklahoma State University Institutional Policies governing the use of animals in research, teaching, and/or testing programs.
Signature:
Date:
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1.3.
Departmental Approval
By signing this protocol the department head certifies that the proposed animal use protocol has either been reviewed for scientific merit, is part of an
approved course of instruction, or is an essential validated diagnostic/safety/efficacy test method.
Department Head:
Department:
Signature:
Date:
1.4.
Coordination
Coordination with Animal Resources (AR)/OSU Attending Veterinarian is required prior to submission if AR facilities/equipment/personnel are required or
if the proposed animal procedures will cause more than momentary pain or distress. If the protocol involves the use of facilities, equipment, and/or
resources that are not under the PI’s control, the PI should list the applicable person/office/institution/and secure their signatures prior to submission.
Animal Resources/OSU Attending Veterinarian
Signature:
Date:
Signature:
Date:
Signature:
Date:
Signature:
Date:
The IACUC protocol coordinator will coordinate those protocols that involve the use of human pathogens, CDC select agents and/or toxins, USDA
restricted animal pathogens, recombinant DNA, mutagens, known carcinogens, hazardous/toxic chemicals, radioactive materials, ionizing radiation,
lasers, or other known hazardous materials/agents with the applicable OSU safety committee/office to insure that the procedures/practices described
are in accordance with the PI’s general OSU Institutional permit/license to work with these materials/agents. COMPLETE APPENDIX H, I, J, K
or T AS APPLICABLE.
SECTION 2 – Administrative/Management Data
2.1.
Non-Technical Summary/Abstract: (Briefly summarize in clear and simple terms that a NON-SCIENTIST can understand
2.2.
Funding Source(s):
the protocol objectives, animal species used, and potential benefits. This information may be used for press releases and/or responses to
Freedom of Information Act (FOIA) requests.)
Source(s)
Type
Select
Select
Select
2.3.
Personnel Performing Animal Procedures: (List research team members {including PI}, laboratory personnel, and/or
instructional staff. Do not list students being trained or instructed on how to perform animal procedures.)
For each person listed, the experience/training column should be relevant to the species and procedures being
used/performed and should include years of experience with that species. If you choose, a brief (2-page
maximum) biographical sketch may be attached to provide more information.
Name
Position
Degrees
Experience/Training
General
Procedures
Surgery/
Anesthesia
Euthanasia
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2.3.1. List/describe any additional specialized training needs and who will conduct the training:
2.4.
2.5.
Hazardous Agents/Materials Summary: (Check all of the boxes that apply and attach the applicable Appendixes)
Animal Pathogens (Appendix H)
Radioactive Materials/Isotopes (Appendix I)
CDC Select Agents (Appendix H)
Lasers (Appendix J)
Human Pathogens (Appendix H)
Hazardous/Toxic Chemicals (Appendix K)
Recombinant DNA/RNA (Appendix H)
Mutagens/Carcinogens (Appendix K)
USDA Restricted Animal Pathogens (Appendix H)
Ionizing Radiation (Appendix I)
Volatile Anesthetic Gases (Appendix K)
Transgenic Animals (Appendix T)
Required Biosafety Level: (Select the applicable laboratory and animal facility biosafety level from the drop-down menu.)
Laboratory Biosafety Level (BSL): NA
2.6.
2.7.
Animal Biosafety Level (ABSL): NA
Animal Procedures: (Check all boxes that apply.)
Blood Sampling/Collection
Unalleviated Pain/Distress (USDA Cat. E studies)
Death as an Endpoint
Trapping/Capture of Wild Animals (Appendix B)
Euthanasia
In-house Breeding Colony (Appendix C)
Food Restriction
Long-Term Restraint (Appendix D)
Non-standard Housing/Caging
Multiple Major Survival Surgeries (Appendix E)
Non-standard Husbandry
Non-Survival Surgery (Appendix E)
Noxious stimuli
Survival Surgery (Appendix E)
Other Non-Surgical Procedures
Anesthetics/Analgesics/Tranquilizers/Sedatives (Appendix F)
Special Diets
Paralytics (Appendix F)
Water Restriction
Antibody/Ascites Production (Appendix G)
Animal Source(s): (Check all that apply. You must attach Appendix L if privately-owned/client animals will be used.)
Municipal pound/shelter
USDA Licensed Dealer (See questions 2.10)
OSU Herd/Flock/Group
Wild Caught/Trapped (Appendix B)
Other Approved Protocol:
In-house Breeding Colony (Appendix C)
Other Commercial Vendor (See question 2.10)
Privately-Owned/Client Animals (Appendix L)
Private Farm/Ranch (See question 2.10)
Other – Explain:
Sale Barn/Livestock Auction (See question 2.10)
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2.8.
Requested Animal Species and USDA Pain Category Information: (For help selecting the correct USDA pain
category, see the definitions below. Put the total number needed for three years, stating the maximum number that could be used.)
Criteria
1st Species
2nd Species
3rd Species
4th Species
5th Species
6th Species
Common Name
Scientific Name (Genus species)
Strain/Stock/Breed
Age
Weight Range
Sex
Special Requirements
Number Purchased/Donated
Number Produced In-House
Number from Other Protocols
Number Trapped/Wild Caught
Number Client-Owned
Number Other
SPECIES TOTAL
Number in USDA Category C
Number in USDA Category D
Number in USDA Category E
Criteria
Common Name
Scientific Name (Genus species)
Strain/Stock/Breed
Age
Weight Range
Sex
Special Requirements
Number Purchased/Donated
Number Produced In-House
Number from Other Protocols
Number Trapped/Wild Caught
Number Client-Owned
Number Other
SPECIES TOTAL
Number in USDA Category C
Number in USDA Category D
Number in USDA Category E
USDA Pain Category Definitions:
Category C:
Are procedures that cause minimal, transient, and/or no pain/distress when performed by competent persons using recognized methods.
(i.e. NO PAIN)
Category D: Are procedures that cause more than minimal/transient pain/distress where the pain/distress is alleviated by the use of anesthetics,
analgesics, or tranquilizers. (i.e. PAIN ALLEVIATED)
Category E:
Are procedures that cause more than minimal/transient pain/distress WITHOUT the use of anesthetics, analgesics, or tranquilizers to
alleviate the pain/distress (i.e. UNALLEVIATED PAIN). MUST BE SCIENTIFICALLY JUSTIFIED – SEE 3.15.3.
General Note: Each animal species is categorized by the most painful procedure that it will be subjected to.
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2.9.
Animal Facilities: (Enter the IACUC approved buildings and room numbers where animals will be housed/used as applicable.)
Species
2.10.
Housing/Holding Areas
Bldg(s).
Room(s)
Non-Surgical Procedures
Bldg(s).
Room(s)
Survival Surgery
Bldg(s).
Room(s)
Non-Survival Surgery
Bldg(s).
Room(s)
Name(s) of Preferred Animal Source(s): (List “Class A Dealer” if a commercial vendor of research animals will be used,
leaving address and phone number blank. Otherwise, specify a preferred source or sources listing the address and phone number.)
Species
Name of Source
Address
Phone No.
SECTION 3 – Protocol Narrative Description
3.1.
Background: (Briefly summarize the scientific literature and/or previous research results, the curriculum/course, and/or the testing
3.2.
Goal(s)/Objective(s)/Hypothesis(es):
3.3.
Experimental Design/Teaching Plan/Test Method(s): (Briefly describe the experimental design/teaching plan/test
3.4.
Literature Searches:
standards/regulations/guidelines that are the basis for this animal use protocol.)
method(s) for each goal/objective/hypothesis listed in 3.2. to include: 1) the number of experimental/control groups; 2) the number of
animals per experimental/control group {or number of students per animal}; 3) the number of times the experiments {or instruction} will be
repeated/replicated; 4) what data will be collected and how will they be analyzed. A flow sheet, experimental design table, course syllabus,
and/or standard operating procedure (SOP) may be attached as Appendix A if extensive description is required.)
3.4.1. Search for Non-Animal Alternative Methods: (Search results summary should include what non-animal
alternative methods were found [if any] and why they were not suitable for use in this protocol. A minimum of two databases
are required to be searched.)
Database(s) Searched:
Search Date:
Years Covered:
Keywords:
Search Results Summary:
3.4.2. Search to Avoid Unnecessary Duplication: (A minimum of two databases are required to be searched.
RESEARCH PROTOCOLS: The search summary field should include what was found & why this study does not duplicate previous
work &/or why it is necessary to repeat previously published work. TEACHING/TESTING PROTOCOL: The “Database(s)
Searched” field should be marked NA & the rest of the fields left blank.)
Database(s) Searched:
Search Date:
Years Covered:
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Keywords:
Search Results Summary:
3.4.3. Search for Alternative Methods to Pain/Distressful Procedures: (Complete if any animal use is in USDA
Category D or E. The “Database(s) Searched” field should be marked NA and the rest of the fields left blank if all animals use is in
USDA Category C. A minimum of two databases are required to be searched.)
Database(s) Searched:
Search Date:
Years Covered:
Keywords:
Search Results Summary:
3.5.
Animal Model Justification:
3.5.1
Justification/Rationale for Using the Species/Strains/Stocks/Breeds Listed in 2.8.: (Briefly
describe why each species/strain/stock/breed listed in 2.8. was chosen for use in this protocol.)
3.5.2. Justification/Rationale for Using the Number of Animals Listed in 2.8.: (Briefly describe how the
number of animals per experimental/control group or the number of students per animal was arrived at [e.g., statistical sample size
calculation, basis for determining the student: animal ratio for each block of instruction, etc.] and clearly show how the total
number of animals listed was arrived at.)
3.6.
Animal Husbandry:
This section is not applicable for the following reason(s):
3.6.1. Housing/Caging: (Check all boxes that apply. Describe any nonstandard caging/housing systems and provide scientific
justification for requesting individual housing of social animals.)
NA for the following reason(s):
Facility:
Conventional
ABSL-2
ABLS-3
Housing:
Aseptic caging
Indoor run/pen/stall
Metabolism
Wire Bottom
Outdoor run/pen
Pasture
Shoebox
Static microisolator
Ventilated microisolator
Ventilated microisolator with HEPA-filtered exhaust
Tank
Other:
Bedding:
Contact
Non-contact
Density:
Group housed
Individually housed
None
Special Requirements/Explanation/Justification (for multiple species):
3.6.2. Feeding: (Check all boxes that apply. Describe all semi-purified/purified diets, medicated/treated diets, controlled feeding
regimens, food restriction, and any other special feeding requirements or practices. Nutritional studies/feeding trials should also be
briefly described here.)
NA for the following reason(s):
Type:
Method:
Autoclaved
Irradiated
Medicated/Treated
Purified/chemically defined diet
Semi-purified diet
Standard commercial diet
Ad libitum
Controlled feeding regimen
Food restriction
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Special Requirements/Explanation/Justification (for multiple species):
3.6.3
Watering: (Check all boxes that apply. Describe all use of medicated/treated water, controlled watering regimens, water
restriction, and any other special watering requirements or practices.)
NA for the following reason(s):
System:
Automatic waterer
Bowl/tank/trough
Type:
Autoclaved
Medicated/Treated
R/O
Other (Tap/Well/Pond/etc.)
Ad libitum
Controlled watering regimen
Method:
Water bottle
Municipal tap water
Water restriction
Special Requirements/Explanation/Justification (for multiple species):
3.6.4. Non-Standard Environmental Parameters: (Describe any special temperature, humidity, noise, or lighting
requirements.)
3.7.
General Animal Procedures/Manipulations/Restraint: (List and briefly describe all non-surgical animal
3.8.
Blood Sampling/Collection: (Briefly describe the method of restraint [physical or chemical], route, volume and frequency of
3.9.
Trapping/Capture of Wild Animals:
Yes (Complete Appendix B)
Not Applicable
3.10.
In-house Breeding Colony:
Yes (Complete Appendix C)
Not Applicable
3.11.
Long-Term Restraint (>4 hours):
Yes (Complete Appendix D)
Not Applicable
3.12.
Surgical Procedures:
Yes (Complete Appendix E)
Not Applicable
3.13.
Anesthesia/Analgesia:
Yes (Complete Appendix F)
Not Applicable
3.14.
Antibody Production:
Yes (Complete Appendix G)
Not Applicable
3.15.
Humane Endpoints:
procedures/manipulations [e.g., weighing, sexing, dosing, injections, etc.] and the restraint methods [physical or chemical] that will be used
for each of the listed procedures/manipulations that are not addressed in 3.8.-3.14. below.)
sampling.)
3.15.1. Expected Morbidity: (Describe what type and level of pain or distress the animals are expected to experience as a result of
this study.)
3.15.2. Intervention: (If sickness, illness, or injury is expected, describe what criteria will be used to assess the animals, how often
they will be assessed, and at what criteria will intervention such as euthanasia or other treatment(s) be performed.)
3.15.3 Justification for Not Alleviating Pain/Distress: (Required for all USDA Pain Category E Procedures.)
3.15.4. Justification for Using Death as an Endpoint: (Some studies may require a determination of whether a certain
dose of a drug or toxin is lethal [e.g., LD50 studies]. Most studies will allow euthanasia when an animal is moribund. If your study
will not, it is a death endpoint study and justification is required.)
3.16.
Animal Disposition: (Check all that apply. If more than one box is checked, use the “Other” box to clarify which animals fall into
each category.)
Euthanasia
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Drug/Agent/Method
Concentration
Dose
Route of
Administration
Brief description of each euthanasia method listed including the method(s) used to confirm death:
External Transfer to Non-OSU Entity (e.g., sale, adoption, etc.) (Transfer must be processed through AR.)
Internal Transfer to Another OSU Protocol/AR Holding Colony-ACUP #
Release Back to Wild
Return to OSU Herd/Flock/Group-ACUP #
Return to Owner/Client
Other:
3.17.
Post-Mortem Procedures: (Briefly describe what post-mortem procedures [necropsy, histology, etc.] will be performed.)
3.18.
Disposal of Animal Carcasses/Body Parts:
3.19.
Appendices:
(Briefly describe how carcasses/body parts/tissues/body fluids will be disposed of.)
(Check and attach all appendixes that apply.)
Appendix A –Flow Sheet/Experimental Design Table/ Syllabus/ SOP
Appendix B – Trapping/Capture of Wild Animals
Appendix C – In-house Breeding Colony
Appendix D – Long-Term Restraint
Appendix E – Surgery
Appendix F – Anesthesia/Analgesia
Appendix G – Antibody Production
Appendix H – Biological Hazards Summary
Appendix I – Radiation Hazards Summary
Appendix J – Laser Hazards Summary
Appendix K – Chemical Hazards Summary
Appendix L – Owner Informed Consent Form
Appendix M – Other:
Appendix T – Transgenic Animals
3.20.
References/Bibliography: (List all references that are cited in this protocol and/or are the primary scientific basis for this study. A
comprehensive listing of all relevant scientific literature is not required.)
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