IACUC Application/Narrative - Office of Research

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IACUC Protocol Application
IACUC #:
e-App #:
University of California, Irvine
Institutional Animal Care and Use Committee
Mod #:
For Office Use Only
Review the protocol submission instructions to ensure application requirements are understood. Provide your
responses in the blank white sections. Additional requirements that must be completed are indicated in yellow.
Select one:
New Application
3-year Renewal
Submit online via Web Portal
Modification of Approved Protocol
Protocol #:
Protocol #:
Complete Appendix A
Submit online via Web Portal
Before revising this application,
turn on Track Changes
Email to IACUC@uci.edu
Application Section
A. Title of Study
B. Lead Researcher
Name:
Home Dept:
Phone #:
After-hours Phone #:
UCI Email:
C. Faculty Sponsor (if required)
Name:
Home Dept:
Phone #:
UCI Email:
Describe the responsibilities of the Faculty Sponsor below
D. Alternative Emergency Contact Person
Emergency contact must be someone other than the Lead Researcher with the authority to make decisions about
animal care. Contact listed here will be CC’ed on all email correspondence with the Lead Researcher.
Name:
Home Dept:
Phone #:
After-hours Phone #:
UCI Email:
E. Administrative Contact Person
Contact(s) listed here will be CC’ed on all email correspondences to the Lead Researcher.
Name
UCI Institutional Animal Care and Use Committee
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F. Study Team Members
List the Lead Researcher and all personnel with live animal contact. Only individuals listed below will be authorized
to handle animals when IACUC approval is granted. To check your training status, go to the UCI Tutorial Check.
All study team members listed here and the LR need to be listed in Section 9.
Additional training and orientation is required for staff to gain access to campus vivarium areas. For more
information, please review the Training Policy.
(To add more rows, place cursor in the last cell on lower right and press the key “Tab”)
Name
UCI Email
CITI Training
Completed?
LAOHP
Current?
Refresher
training required
every 3 years
Must be updated
annually
Yes
No
Yes
No
Lead Researcher:
Faculty Sponsor:
(if applicable)
Study Team Members:
G. Study Funding and Scientific Merit Review
Place an X in the checkboxes that apply to indicate how the study costs will be supported. This includes any
pending funding sources. For pending funding sources, list “Pending” in the Award/Proposal # column.
Grant/Sub-award
List specific details below*
Contract/Sub-contract
Department or campus funds
(e.g., department support, unrestricted funds, start-up funds,
personal funds, campus program awards, etc.)
Non-cash support from manufacturer/sponsor
(e.g., free drug, device, research materials)
1. *List all extramural proposals or awards that will support this study:
Agency/Sponsor
Award or
Proposal #
PI of Award
Have the experiments described in this
protocol application undergone peer
review by the funding agency/sponsor?
Yes
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H. Animal Numbers
Based on the experimental design in this study, provide the following information about the animals in this project:
Genus-Species
or Common
Name
Condition Code
List the genus-species or common name of all vertebrate animals involved in the experimental
design.
Preg
Animals purchased while pregnant
DWL
Dams with a litter
N/A
Not Applicable: This includes all other animals, regardless of age, under this code.
Animals held only for breeding and not used for any research
Breeder animal
purpose. This includes founder/current breeder animals,
numbers must
replacement breeders, and animals produced but not used.
match Appendix B
Momentary or no pain, distress or discomfort (e.g., needle
C
stick)
Procedures reasonably considered painful or likely to cause
Experimental animal
D
discomfort or distress, but alleviated with analgesics,
numbers must
anesthesia or timely euthanasia.
match Section 3
Unrelieved pain, distress or discomfort
*E
(requires strong scientific justification)
Indicate the total number of animals involved in the project for the duration of the project or 3
years, whichever is less
B
USDA Pain
Categories
Total # Required
 Each animal should be counted only once in this table. The most invasive or potentially painful procedure
determines the USDA pain category.
 DO NOT list Individual strains or subspecies here. Please include complete information about strains,
genetically modified animals, etc., in Section 3.
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Species
Condition Code
(N/A, Preg, or DWL)
USDA Pain Category
(B, C, D, or E*)
Total # Required
(for 3 years)
*Animals in Category E: Unrelieved pain, distress or discomfort requires strong scientific justification with
particular attention to the significance, necessity, and potential benefits of the research.
 Investigators must perform euthanasia on all moribund experimental animals unless there is scientific
justification that euthanasia would invalidate experimental data collection.
 If euthanizing a moribund animal would seriously harm the study, the scientific justification for using death
as an endpoint must be provided below.
For additional information about euthanasia policy and alternative endpoints, click here.
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I.
Procedures to be Performed in Live Animals
List all species that will be used in this study and indicate which procedures will be performed in those species.
Species
Procedures
Place an X below to indicate the procedures that will be
performed. Complete any additional appendices as required.
1. Administration of experimental agents
2. Antibody production/collection
(monoclonal & polyclonal)
Complete
Appendix G
3. Breeding
Complete
Appendix B
4. Blood/tissue collection in live animals
5. Behavioral tests
6. Cardiac perfusion
(Terminal procedure involving replacement of blood
with fixative while animal’s heart is still beating.)
7. Euthanasia followed by tissue harvest
8. Invasive field study
(Study of animals in their natural habitat involving an
invasive procedure or one that harms or materially
alters the animals’ normal behavior.)
9. Any variations in standard housing
or husbandry
(e.g., food/water restriction, special
diet/water, alteration of cage
environment, withholding of standard
environmental enrichment, etc.)
Complete
Appendix K
10. Use of Human Adult or Embryonic Stem Cells
(including iPS cells)
HSCRO protocol #:
11. Minor survival surgery
12. Major survival surgery
(Surgical procedures which either penetrate a body
cavity or result in permanent impairment of normal
functions)
13. Multiple major survival surgeries
Complete
Appendix F
14. Terminal surgery
(Animal is not recovered from anesthesia.)
15. Use of neuromuscular blocking
agents (Agents causing paralysis of
skeletal muscles i.e., pancuronium,
suxamethonium)
Complete
Appendix E
16. Use of prolonged restraint
(Greater than momentary manual or
mechanical limitation of animal’s normal
movement.)
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Appendix D
IACUC Protocol Application & Narrative
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J. Hazardous Agents
Indicate which categories of hazards will be used in the study.
1. Anesthetic Gases
Agent
(e.g. isoflurane, urethane)
Method of Administration
(e.g., vaporizer, bell jar, etc.)
Method used to capture waste gasses
(e.g., active scavenging, passive scavenging with F/Air
canister, chemical fume hood, etc.)
2. Chemical & Biohazardous Agents:
Additional requirements are required for the use of chemical and biohazardous agents:
1) Schedule a safety considerations meeting to discuss cage labeling, door signs, and holding periods.
To schedule a meeting, contact EH&S at (949) 824-2041
2) Submit a completed Animal Room Hazard Communication Form (door sign) for the hazardous
agent(s) used in live animals. This needs to be posted at the animal room where the agent is used.
3) Submit an SOP for safe handling and disposal of contaminated materials. (Pre-approved SOPs for
commonly-used substances are available online)
(Refer to EH&S website for more information)
Place an X in the checkboxes that apply and specify the agent used in live animals.
Carcinogens, toxins, nanomaterials, investigational new drugs and other
potentially hazardous chemicals or agents
(e.g., formaldehyde,
urethane, tamoxifen,
BrdU, STZ, etc.)
Specify:
Institutional Biosafety Committee review and approval is required for the following biohazardous agents.
*Provide the associated IBC protocol number. If an application is pending, list as “Pending”.
Infectious Agents
(e.g., bacteria, viruses, fungi, etc.)
*IBC #:
(e.g., established cell lines,
primary cells, tissue, fluids, blood)
*IBC #:
(e.g., lentiviral vectors, AAV,
plasmids, etc.)
*IBC #:
Specify:
Human or Primate Materials
Specify:
Recombinant DNA
Specify:
Select Agents/Toxins
(as defined by the CDC Select Agent Rule)
*IBC #:
Specify:
3. Radioactive Hazardous Agents
Radiation Safety Committee review and approval is required for the use of the following hazardous agents.
For more information, consult with EH&S.
*Provide the associated RUA number. If an application is pending, list as “Pending”.
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Place an X in the checkboxes that apply and specify the agent used in live animals.
Radioactive Substances
(e.g., iodinated proteins, etc.)
*RUA #:
Specify:
Radiation-producing instruments
(e.g., irradiator, X-rays)
*RUA #:
Specify:
Lasers
*RUA #:
Specify:
4. Other Hazardous Agents
a. List the specific agent(s):
(e.g., infrasound, etc.)
b. Describe the potential hazards the listed agents may pose to animals and or humans.
K. Controlled Substances
Refer to the U.S. Drug Enforcement Agency’s list of Controlled Substances
A Controlled Substance Use Authorization (CSUA) must be in place before any drugs can be ordered. For more
information, contact EH&S at (949) 824-1616
Place an X in the checkboxes that apply to indicate which controlled substances will be used in the study. Provide
the associated CSUA #. If a number is not available, please state “Pending”.
Ketamine
Telazol
Sodium Pentobarbital (including any prepared solutions that contain it)
(e.g., Euthasol®, Nembutal®)
Buprenorphine
Butorphanol
Other:
CSUA #:
L. Animal Housing and Procedure Locations
1. Will any non-UCI site(s) and offsite locations be used?
Place an X in the checkbox to indicate Yes/No.
No
Complete Appendix H
Yes
2. Building and Room Information
a. Vivarium
For areas inside ULAR vivaria where live animals will be used, list the specific building
NOTE: (Room numbers of vivaria do not need to be listed)
(To add more rows, place cursor in the last cell on lower right and press the key “Tab”)
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Location will be used for:
Place an X in the checkboxes below to
indicate what the location will be used for.
Building
Animal
Housing
Non-surgical
Procedures
Surgery
b. Laboratory Areas
For areas outside of the vivarium where live animals will be used, list the specific building and provide the
room number.
(To add more rows, place cursor in the last cell on lower right and press the key “Tab”)
Location will be used for:
Building
Room Number(s)
Place an X in the checkboxes below to
indicate what the location will be used for.
Animal
Housing
Non-surgical
Procedures
Surgery
3. Indicate husbandry and housing responsibilities:
Place an X in the checkboxes that apply.
Animals housed in vivarium space with routine animal care and husbandry provided by ULAR staff
Specify agent(s):
Animals held outside of vivarium housing room for more than 12 hours
(e.g., in lab or
procedure space)
Complete
Appendix J
(e.g., lab space,
PI-maintained
animals)
Complete
Appendix I
Specify agent(s):
Laboratory staff to provide routine animal husbandry and care in
vivarium or other location
Specify agent(s):
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Departmental or Organized Research Unit (ORU) Approval
University of California, Irvine
Institutional Animal Care and Use Committee
The Department Chair’s signature is required if the study will be performed under the auspices of a Department
(includes campus centers and school-based research units). The ORU Director’s signature is required if the study
will be performed under the auspices of an ORU. (Refer to the Signature Requirements).
If the Department Chair is a member of the research team on this application (including Faculty Sponsor),
approval must be obtained from the next highest level of administrative authority (e.g., School Dean).
Department or ORU Assurance Statement:
By signing below, I hereby confirm that I have read the IACUC Application and Protocol Narrative and I certify
that:
 The research is appropriate in design.
(i.e., the research uses procedures consistent with sound research design, the study design can be
reasonable expected to answer the proposed question, and the importance of the knowledge expected to
result from the research is known)

The Lead Researcher and Faculty Sponsor (if applicable) are competent to perform or supervise the study.

There are adequate resources and funds available to support performance of this research, including costs
associated with animal husbandry and care.
Protocol #:
Lead Researcher:
Title of Study:
Printed Name of UCI Department
Chair/ORU Director
UCI Institutional Animal Care and Use Committee
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Signature of UCI Department
Chair/ORU Director
Date
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Investigator Assurance Statement
University of California, Irvine
Institutional Animal Care and Use Committee
As Lead Researcher, I have ultimate responsibility of the performance of this study, the ethical and humane care and use of the animals,
and strict adherence by all study team members to IACUC requirements, all federal, state and local laws, and regulations and policies of
the University of California governing the use of animals in research, teaching and testing. I hereby assure the following:
1.
2.
The information provided in this application is accurate to the best of my knowledge.
I have performed the required alternatives searches and to the best of my knowledge, the experiments and procedures
described in this protocol do not unnecessarily duplicate previous experiments, unnecessarily use animals, or unjustifiably
expose animals to potentially painful, uncomfortable or distressful procedures.
3. All experiments and procedures involving animals will be performed under my supervision or that of another qualified
professional listed on this protocol.
4. I will ensure that all study team members are qualified and authorized to conduct procedures involving animals under this
protocol. This includes ensuring that all study team members, including myself have:

Been (or will be) trained in handling and care of the involved species and approved procedures in this protocol, including
the proper use of anesthetics, analgesics and experimental agents, and euthanasia.

Read and understand the procedures outlined in the approved protocol.

Completed the CITI Training on animal care and use and other required ULAR training courses (as applicable).
5. Personnel will be allowed adequate time to obtain necessary training for this project and will not begin any procedures with live
animals until they have been successfully trained.
6. All animal acquisition will be coordinated through University Laboratory Animal Resources (ULAR) and all animals will be
housed in ULAR facilities, unless otherwise approved by the IACUC.
7. Emergency veterinary care is permitted for animals showing evidence of pain or illness not addressed specifically in the
approved protocol, in addition to routine veterinary care as prescribed for individual species.
8. All study team members with direct animal contact are registered in the UCI Lab Animal Occupational Health Program. All study
team members are aware of the potential hazards associated with the use of live animals and animal tissues. In addition, I
understand I am responsible for notifying EH&S if an individual’s level of animal contact changes, due to changes in the protocol
or job description.
9. I understand that, should I use the project described in this application as a basis for a proposal for funding (either intramural or
extramural), it is my responsibility to assure that the description of animal use in the funding proposal(s) is identical in principle
to that contained in this application. I will submit modifications and/or changes to the IACUC as necessary to assure these are
identical.
10. I and all of the co-investigators and research personnel agree to comply with all applicable requirements for the use of animal in
research, testing and teaching including, but not limited to, the following:

Making no changes to the approved protocol without first having submitted those changes for review and approval by the UCI
Institutional Animal Care and Use Committee; and

Promptly providing the IACUC with any information requested relative to the project; and promptly and completely complying
with an IACUC decision to suspend or withdraw its approval for the project; and

Obtaining continuing review prior to the date approval for this study expires (I understand if I fail to apply for continuing review,
approval for the study will automatically expire, and study activity must cease until IACUC current approval is obtained); and
filing a final report with UCI IACUC at the conclusion of this project.
Protocol #:
Lead Researcher:
Title of Study:
Printed Name of Lead Researcher
Signature of Lead Researcher
Date
Printed Name of Faculty Sponsor
Signature of Faculty Sponsor
Date
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IACUC Protocol Narrative
University of California, Irvine
Institutional Animal Care and Use Committee
Section 1: Project Overview
Provide a non-technical, lay language summary of the proposed project. Discuss the potential relevance (e.g., benefits)
of research findings to human or animal health, advancement of knowledge, and/or for the good of society.




Lay language is defined as language that can be understood by a non-scientific audience.
Avoid using scientific terminology, jargon or unexplained abbreviations – where use of such language is
unavoidable, define the term where it is first used.
DO NOT cut and paste from a grant application, journal article or abstract.
This summary should not exceed 250 words.
Section 2: Justification for the Use of Animals
Federal regulations require that investigators provide a narrative describing the rationale for using animals, the
appropriateness of the species, and the methods and specific sources used to determine that alternatives (e.g.,
replacement, reduction, refinement) to the use of animals and to the procedures have been considered.
A. Rationale for the Use of Animals
1. Explain why animals are required for these studies, and why non-animal model replacements, such as cell
culture or computer modeling, cannot fully replace animals:
2. Explain why the proposed species are the most appropriate:
B. Consideration of Alternatives to Live Animal Use, Painful Procedures and Unnecessary Duplication
The Animal Welfare Act regulations require researchers to consider alternatives to procedures that may cause
more than momentary or slight pain or distress to the animals and to provide a written narrative of the methods
used and sources consulted to determine the availability of alternatives, including refinements, reductions and
replacements. (Refer to Alternatives Search Guidelines)
Alternatives should be considered during the planning phase of all animal use proposals. Federal regulatory
agencies recommend a database search as the most effective and efficient method for demonstrating compliance
with the requirement to consider alternatives to painful/distressful procedures. (Refer to USDA Animal Care Policy
#12)
Perform at least 2 database searches
1. Database Searches
Place an X in the checkboxes that apply to indicate which databases were used:
Altweb
CRIS
PsycINFO
TBASE
National Agricultural Library (AGRICOLA)
TOXLINE
NORINA
CORDIS
MEDLINE via PubMed
CRISP
BIOSIS Previews
Web of Science
Other:
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2. Date(s) the database search was performed:
(Must be within the last 3 months)
3. Time period covered by the search:
(e.g., 1985 to present)
4. Keywords used in the search
The more keywords you use the more specific your search will be; however, being too specific may lead to
no results being found. In that case, reduce the number of terms used. Click here for search tips.
5. In some circumstances, conferences, colloquia, subject expert consultants or other sources may provide
relevant and up-to-date information regarding alternatives in lieu of or in addition to a database search. If a
consultant was used for considering alternatives, provide the following information to document the source of
information/consultation.
Expert Consultant’s Name:
Consultant’s Qualifications/Expertise:
Content of Consultation:
Date(s) of Consultation:
6. Database Search Narrative Description
Complete the following sections, providing adequate information for the IACUC to assess that a reasonable
and good faith effort was made to determine the availability of alternatives or alternative methods.
a. Discussion of Search Results
Summarize the results of the database search. If similar experiments are found, describe the aspects of
your research project that are novel and are not unnecessarily duplicative of other published work. If
alternative methods or procedures representing refinements to your procedures were found, discuss
why those alternatives cannot be used.
b. Replacement
Discuss efforts to partially or fully replace animals with in vitro models, computer simulation, or use of a
less sentient species (e.g. insects). If available replacements exist but are not acceptable, explain why.
c. Reduction
Describe the steps you have taken to reduce the number of animals to the minimum required to obtain
scientifically valid data.
d. Refinement
Explain how the experimental design and procedural techniques for this study are refined to minimize
pain and distress in the animals that will be used. Describe methods that refine animal use by lessening
or eliminating pain or distress and, thereby, enhancing animal well-being (e.g. use of appropriate
anesthetic and analgesic agents).
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Section 3: Experimental Design
Provide a concise description of the experimental design, describing all experiments to be performed.
For each experiment:
1. Provide the rationale behind the experiment or the hypothesis being tested.
2. Define the groups and number of animals per group needed for the experiment(s), including both
experimental and control animals and list the procedures to be performed on each group. A table may be an
effective way to present this information.
3. Explain how the number of animals for the experiment was determined to be adequate for the generation
of statistically significant data (i.e., power analysis, previous publications).
4. Describe the sequence and timing of all live animal procedures to be performed, according to the groups
defined above. Provide a timeline, diagram or flowchart if appropriate.
5. Define the procedural endpoints for each group of animals defined in above (i.e., what determines when the
live animal portion of the experiment is complete and animals are euthanized.)



DO NOT cut and paste from a grant application, journal article or abstract.
DO NOT provide a detailed description of the procedures here. These details should be in Sections 4 and 5.
DO NOT provide detailed descriptions of analytical methods or procedures that do not involve the use of animals.
PROVIDE EXPERIMENTAL DESIGN BELOW
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Section 4: Non-Surgical Procedures
Describe in detail all non-surgical procedures to be performed on live animals.
 Procedures described here must be referenced in Section 3.
 Animal monitoring and management (as applicable) must be addressed in Section 6.
 Each subsection below should be completed as it applies to the protocol.
 If a subsection does not apply, state “N/A” (Not Applicable).
N/A - Non-surgical procedures will not be performed on live animals (skip this section).
A. Terminal Procedures
1. Euthanasia followed by Tissue Harvest:
2. Cardiac Perfusion:
B. Blood and Tissue Collection in Live Animals
C. Behavioral Studies
D. Methods for Administering Experimental Agents in Live Animals

Describe all non-surgical methods that will be used to administer experimental agents in animals (e.g., tailvein injection, retro-orbital injection, oral gavage; etc).
 Provide details such as total volume (agent + vehicle) in any one injection; location of repeated injections
(e.g. rotating IP injection sites to minimize soreness); size of gavage needle, etc.
DO NOT list surgical methods (e.g., implantation of cannulae, stereotaxic injections) – this should be described in
Section 5
E. Induction of Anesthesia/Sedation for Non-surgical Procedures in Live Animals
1. Indicate how anesthesia/sedation is induced for non-surgical procedures:
2. Describe how the level of anesthesia/sedation is assessed to be adequate to begin the non-surgical procedure:
3. Describe how animals are monitored throughout the
non-surgical procedure:
(e.g., respiration pattern, response to noxious stimulation
(paw pinch, etc.), heart rate/pattern, EKG, blood pressure,
temperature, etc.)
4. Discuss any supplemental anesthesia dosing that may be required:
5. If animals will be placed on artificial ventilation, describe the range of respiration rates and tidal volumes.
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6. For survival non-surgical procedures, describe how animals are monitored for recovery from
anesthesia/sedation and when animals are returned to their home cages. Estimate how long it will take for the
animal to recover from anesthesia/sedation (i.e., ambulatory and feeding, etc.).
F. Non-invasive Imaging Procedures in Live Animals
(e.g., MRI, CT scan, ultrasound)
G. Other Non-surgical Procedures in Live Animals
H. Post-procedural Care for Non-Surgical Procedures in Live Animals (if applicable)
Section 5: Surgical Procedures
Describe in detail all surgical procedures to be performed.
 Procedures described here must be referenced in Section 3.
 Animal monitoring and management (as applicable) must be addressed in Section 6.
 Each subsection below should be addressed as it applies to the surgical procedure, for each type of surgical
procedure that will be performed.
 If a subsection does not apply, state “N/A” (Not Applicable).
N/A - Surgical procedures will not be performed on live animals (skip this section).
A. Pre-operative Care
Describe any care given to the animals prior to the surgery:
(e.g., fasting, sedation, pre-operative physical
exam or blood work, etc.)
B. Induction of Anesthesia for Surgical Procedures in Live Animals
1. Indicate how anesthesia is induced:
2. Describe how the level of anesthesia is assessed to be adequate to begin the procedure:
3. Describe how animals are monitored throughout the procedure (e.g., respiration pattern, response to noxious
stimulation such as a paw pinch, heart rate/pattern, EKG, blood pressure, body temperature, etc.). Discuss any
supplemental anesthesia dosing that may be required.
4. If animals will be placed on artificial ventilation, describe the range of respiration rates and tidal volumes:
C. Aseptic Techniques
1. Preparation of the surgical space:
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2. Preparation of the surgeon:
(e.g., surgical scrub of hands, donning surgical attire,
sterile gloves, etc.)
3. Preparation of the animal:
(e.g., clip fur, clean surgical site with antiseptics, use of
sterile drapes, application of eye ointment, etc.)
4. Sterilization of instruments
a. Describe how instruments will be sterilized:
(e.g., autoclave, glass bead sterilizer, chemical sterilant,
etc.)
b. Will instruments be used in multiple animals? If so, describe how sterility will be maintained.
D. Description of Surgical Procedures
Place an X in the checkboxes that apply to indicate if terminal and/or survival surgery will be performed in live
animals.
1. Terminal Surgery
Animal will not recover from anesthesia after completion of the surgery.
Provide details of the surgical procedures that will be performed during the terminal surgery. State the
surgical endpoints.
2. Survival Surgery
Animal will recover from anesthesia after completion of surgery.
Provide details of the surgical procedures that will be performed during the survival surgery. State the
surgical endpoints.
E. Methods to Prevent Dehydration & Hypothermia
F. Post-Operative Care and Analgesic Usage
For survival surgeries, provide details of the post-operative care that will be provided to the animals following
surgery. Describe how animals are monitored for recovery from anesthesia and when animals are returned to
their home cages. Estimate how long it will take for the animal to recover from anesthesia (i.e., ambulatory and
feeding).
Section 6: Adverse Effects & Animal Monitoring and Management
Describe the possible adverse effects that may arise during the course of this study.
 If a subsection is does not apply, state “N/A”
 NOTE: “N/A” only applies to experiments in which naive animals will undergo a terminal surgical
procedure or be euthanized for tissue harvest without any prior experimental manipulation.
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A. Clinical Signs & Symptoms of Pain/Distress and other Adverse Effects
Briefly summarize all possible adverse effects or phenotypic abnormalities that may present in the animals as a
result of study procedures, agents, disease processes, genetic alterations, etc. (i.e., tumor formation, ascites,
neurologic deficits, infection, diabetes, etc.). Describe the clinical signs and symptoms that may appear in the
animals, including any associated pain, distress or discomfort.
B. Monitoring and Managing Pain & Distress
a. Describe the monitoring parameters that will be used to assess pain, distress and
discomfort in animals (i.e., signs, symptoms and species-specific behaviors):
b. Provide details of the management plan that will be used to assess and treat pain,
distress and discomfort in the animals, including any special procedures that will be
used (e.g., periodic weighing of animals) and any interventions that will be performed
to relieve pain, distress and discomfort in the animals:
c.
(e.g., decreased
activity and appetite,
abnormal posture, etc.)
(e.g., analgesics,
antibiotics, special
housing/bedding, etc.)
Describe the frequency in which laboratory staff will be monitoring the animals, in addition to the daily general
observations made by ULAR vivarium staff.
d. Monitoring of animals (e.g., daily observations, treatments performed by research staff)
must be documented. Monitoring records must be made available to ULAR veterinary
staff and IACUC members upon request. Describe how monitoring will be documented:
(e.g., lab notebook, log
placed in animal room,
electronic records,
etc.)
C. Euthanasia Criteria
Describe the criteria that will be used to determine that an animal must be removed from the study and euthanized.
(Refer to the Euthanasia Policy for recommended criteria)
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Section 7: Table of Drugs and Agents Used in Live Animals
List all drugs or agents that will be administered to live animals, along with the details of their use in the applicable sections below.
Drug/Agent
Dose Range
*Route


Do not list euthanasia drugs here (euthanasia drugs should be in Section 8)
NOTE: Rodent biological materials, including cell lines, may require testing for pathogens prior to use.
Express dosages as a range and as mg/kg of body mass, wherever possible.
Indicate the routes of administration using the following abbreviations:
SQ
Subcutaneous
IV
Intravenous
IM
Intramuscular
IP
Intraperitoneal
PO
Per Os (by mouth)
IH
Inhalation
Other
Frequency
Specify how often it will be administered in each animal (e.g., every 8 hours, once a week, etc.)
Duration
Specify how long the drug or agent will be administered (e.g., one time, 3 days, 2 weeks, etc.)
Other not listed
(To add more rows, place cursor in the last cell on lower right and press the key “Tab”)
A. Anesthetic, Analgesic, and Paralytic Agents
Species
Drug/Agent
Dose Range
*Route
Frequency
Duration
*Route
Frequency
Duration
B. Therapeutic Agents
Therapeutic drugs include antibiotics, fluids, antimicrobials, etc.
Species
Drug/Agent
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C. Experimental Agents
Experimental agents include investigational new drugs, placebos, tumor cells, stem cells, gene markers, tracers, radioisotopes, imaging contrast agents,
viruses and other biological agents, etc. Agents listed here should be listed in Section 4.D and referenced in Section 3.
Dose Range of
Vehicle
Total Volume
*Route
Species
Drug/Agent
Frequency
Duration
(including vehicle)
Specific Agent
Used
D. Other Agents
Any other agents that are not listed in the previous categories.
Species
Drug/Agent
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Frequency
Duration
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*Yes
E. Will non-pharmaceutical grade drugs be used?
No
1. *Provide justification for the use of non-pharmaceutical grade drugs in live animals
2. *Describe the procedure for how the drug will be prepared before being given to the animals.
Section 8: Euthanasia Methods
Indicate the primary method(s) that will be used to euthanize animals. (Refer to the Euthanasia Policy)
Place an X in ALL checkboxes that apply. (This includes methods used to euthanize excess breeding animals that are
produced)
A. *CO2 Overdose with Secondary Physical Method
NOTE: All rodents euthanized with CO2 need to undergo a secondary physical method of euthanasia to ensure
death.
*Indicate secondary physical method:
B. Anesthetic Overdose
(e.g. pentobarbital)
1. List the anesthetic agent(s) that will be used to euthanize animals. Indicate the dose and administration route.
(To add more rows, place cursor in the last cell on lower right and press the key “Tab”)
Species
Agent
Dose
(mg/kg)
Route of
Administration
2. Confirmation of Death in Animals
Open chest inspection of the heart
Exsanguination (cutting a major blood vessel)
Physical method (specify):
Other (describe below):
C. Physical Methods
1. For each physical method that will be used to euthanize animals, provide a description of the method in the
blank white section below.
Decapitation
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Cervical Dislocation
Other Physical Methods (describe below):
2. Provide information about the anesthetic agent that will be used before the physical method of euthanasia
(To add more rows, place cursor in the last cell on lower right and press the key “Tab”)
Species
Agent
Dose
(mg/kg)
Route of
Administration
3. *If animals WILL NOT be anesthetized before the physical method of euthanasia, provide strong scientific
justification and a reference.
D. Other Methods
Describe in Section 4.A.2
Cardiac Perfusion
Other (describe below):
Section 9: Roles, Responsibilities, and Experience of the Study Team
List below all study team members who will have contact with live animals.





Personnel listed here need to also be listed in Section F.
Describe each person’s specific role and responsibility on the project, including the procedures they will perform.
Indicate who will be responsible for the daily care and monitoring of the animals.
Provide a description of their qualifications, level of training and expertise.
If a study team member does not have relevant experience or training for a particular species or procedure
they will perform, describe how they will be trained.
(To add more rows, place cursor in the last cell on lower right of the section you want to add and press the key “Tab”)
Lead Researcher:
Name
Qualifications, Level of Training, and Research Responsibilities
Research Personnel:
Name
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