BROWN UNIVERSITY
Institutional Animal Care and Use Committee
Animal Use Form
Principal Investigator Name:
Project Title:
Emergency Contact Information:
Name:
Telephone Number:
 Please create a protocol in Coeus. The Protocol Submission Guide can be found on the Coeus IACUC Protocol
Submission page. Then complete all applicable sections of this form, save as a PDF and upload into the Attachments tab
in your Coeus Protocol record.
 Veterinary Consultation: Before submitting your protocol to the IACUC, please consult one of Brown’s Veterinary Staff
below for consultation to assist with the development of your protocol. I have consulted the following Veterinarian prior to
submitting this protocol:
☐ Lara Helwig, DVM (863-5471) ☐ Tiffany Borjeson, DVM (863-1158) ☐ James Harper, VMD (863-3223)
1. Detailed description of the proposed use of laboratory animals.
a.
Provide a clear and concise sequential description of the procedures involving the use of animals that is easily
understood by non-scientific members of the committee. Outline, timelines and flowcharts are encouraged.
b. Exceptions: ☐ None
☐ Food/Fluid Restriction
☐ Prolonged Restraint
☐ Rearing in total darkness
☐ Nonstandard housing
☐ Omission of pain relieving agents
☐ Multiple Survival Surgeries
☐ Single Housing
☐ Other
i. Describe and Justify any departures from the Guide
ii. Scientifically justify the need for this exception.
c.
If animals are to be moved through non-research areas, including between buildings, describe the mode of
transportation and measures taken to protect the animals and minimize public exposure.
d. If a member of the Animal Care staff finds that one of your animals has died, describe how the carcass should be
handled and whether a member of your staff be contacted immediately.
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2. Surgical Procedures ☐ None
a. Name and describe in detail each surgical procedure as listed in the Coeus surgical procedures.
Identify on which animal each procedure is being performed.
b. Pre-Operative Procedures
i. Identify and describe all pre-operative procedures, including all preparations of the animal(s) for
surgery.
ii. Describe how the surgical site(s) will be prepared prior to surgery.
iii. Aseptic Procedures
1. Indicate each method that will be used to ensure the sterility of materials, excluding
materials that have been sterilized by the manufacturer.
High-pressure/temperature (autoclave)
☐ Gas sterilization (ethylene oxide at BioMedical Center)
☐ Dry heat (hot bead sterilizer, between multiple rodent surgeries after initial sterilization)
☐ Plasma sterilization (Lifespan, by special arrangement)
☐ Chemical sterilant, (e.g., glutaraldehyde, peracetic acid):
☐ Other (Explain):
☐
2. Indicate which of the following procedures will be used to maintain a sterile field during
surgery.
Sterile instruments
☐ Sterile gloves
☐ Sterile drapes
☐ Face mask
Surgeon cap
☐ Surgeon scrub
☐ Sterile gown
☐ Other (Explain):
☐
☐
c. Intraoperative Procedures
i. Identify and describe all intraoperative procedures
ii. If you plan on using implanted materials (sutures, staples, wound clips, etc.) or
experimental devices (catheters, electrodes, pins, pumps, etc.), complete the following.
Material
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Describe size and
composition
What is the
tissue closure?
Duration
(e.g. days)
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iii. Physical Support - Indicate any physical methods used to support the animal(s) during
surgery (e.g. heating pads, blankets, etc.)
iv. Monitoring - Describe methods used to monitor the state of anesthesia and general wellbeing of the animal(s) during surgery.
d. Post-Operative Care (for survival surgery only)
i. How long will the animal(s) survive after surgery? (If multiple surgeries are planned,
answer for the last surgery before euthanasia.)
ii. Give the frequency of post-operative monitoring and how long the monitoring will
continue.
iii. Who will be responsible for post-operative care until the animal can ambulate without
danger to itself and thereafter (including after-hours, weekends, and holidays)?
iv. List any physical methods used to support the animals in the immediate post-operative
period (e.g., heating pads, blankets, fluids, etc.)
v. If you do not plan to use analgesics to provide post-operative pain relief to the animals
following surgery, please justify.
vi. Please describe wound management measures that will be used to prevent chronic
infections around any implanted medical device(s).
e. Post-Operative Complications
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i. Describe any possible or expected post-operative complications and what will be done if
these complications arise.
ii. Provide criteria by which a decision to euthanize a surgical patient post-operatively will
be made.
iii. In case there is an emergency medical situation and you or your staff cannot be
reached, identify drugs or classes of drugs that should not be used as part of the
treatment plan.
iv. Maintenance of Post-surgical Medical Records
1. Identify the individuals who will be responsible for maintaining accurate, daily,
post-surgical written medical records.
2. Describe where post-surgical records will be kept.
f.
Multiple Survival Surgeries ☐ N/A
i. Provide the interval(s) between the multiple surgeries and the rationale for choosing the
interval(s).
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3. Euthanasia/Humane Endpoints ☐ N/A
a. Provide a description and rationale for humane endpoints.
b. If physical method, please describe.
c. If chemical method, please describe.
d. Describe endpoint criteria.
e. Describe disposal methods.
f.
Describe contingency plan.
g. Unless a deviation is justified for scientific or medical reasons, methods should be consistent
with the current AVMA Guidelines on Euthanasia. Guidelines can be found at:
https://www.avma.org/KB/Policies/Pages/Euthanasia-Guidelines.aspx
Justify any method that is not consistent with current AVMA guidelines.
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4. Drugs ☐ None (Go to question 5)
a. List all drugs identified in the Coeus procedures section.
Dose
Drug
mg/kg
mL
Route
Frequency
(e.g. times/day)
Duration
(e.g. days)
b. If agents are not human or veterinary pharmaceutical-grade substances, provide a scientific
justification for their use and describe methods that will be used to ensure appropriate
preparation and administration.
c. Describe the record system and security measures to be employed for maintenance of each
drug.
5. Non-Hazardous Agents/Materials ☐ None
a. List all non-hazardous agents/materials used in the protocol.
Agent/material
Dose and/or
Volume
Route of admin.
6. Hazardous Agents ☐ None
a. Describe the use of hazardous materials and provision of a safe working environment.
7. Biological Materials ☐ None
a. List all biological materials identified in the Coeus procedures section to be used in animals.
b. Describe how these materials were screened for infectious agents.
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8. Infectious Agents
☐ None
a. List all infectious agents, identified in the Coeus procedures section, to be used in animals.
Agent and strain or
construct
CDC Biosafety Level of
agent
Route of admin.
b. Describe whether an antibiogram, anti-viral drug sensitivity screen, or other appropriate drug
sensitivity panel has been determined for the agent(s) listed to assist physicians in selecting
proper therapy if an inadvertent human infection occurs.
c. If any of these agents are on the CDC list of "Select Agents", describe whether they pose a
bioterrorism risk.
d. Describe whether any infectious agent contains recombinant nucleic acid.
9. Toxic Agents/Materials ☐ None
a. List all toxic agents/materials, identified in the Coeus procedures section, to be used in animals.
Agent/material
Nature of Hazard*
Route of admin.
b. If any of these agents are on the CDC list of "Select Agents", describe whether they pose a
bioterrorism risk.
10. Radioactive Agents ☐ None
a. List all radioactive agents, identified in the Coeus procedures section, to be used in animals.
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Radioactive Agent
(include isotope)
Agent dose
mg/kg
mL
Activity (e.g. mCi/kg)
Route of admin.
b. List which investigator has been given permission by the Radiation Safety Committee to utilize
the isotope(s) indicated.
11. Specimen Collection ☐ None
a. List any fluids or tissues that will be collected from animals postmortem.
b. If blood is to be collected ante mortem, complete the table below.
*
Site of blood
collection
Amount of blood collected
expressed as volume (mL)/
and % of body weight
(assume 1 ml = 1 gram)
mL
%
mL
%
mL
%
Number of blood
collections
Interval between
collections
weeks
weeks
weeks
c. List all tissue and fluid to be collected ante mortem.
Tissue or fluid
collected
Site & method of
collection
Amount
(G)
Volume
(mL)
Number of
collections
Interval between
collections
12. Breeding ☐ None
a. Justify the need for breeding.
b. Describe breeding scheme/plan.
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c. Anticipated total number of postembryonic animals that will be produced (For all but amphibian
and fish):
Estimated # Estimated #
# of
Estimated # of offspring
of
# of Male Female
Expected of Offspring transferred
Offspring
breeders breeders
# of
used for this
to another Euthanized
Species
Strain
needed
needed
Offspring
protocol
protocol
without use
d. Describe what will be done with surplus animals.
e. If purchasing pregnant females, explain whether the dams will be allowed to give birth to live
pups and will the pups be used for this project. If pups will not be used for this project, describe
what will be done with the surplus.
f.
Transgenic/Knockout Breeding Programs
The NIH Guidelines for Research Involving Recombinant DNA molecules requires that the
Institutional Biosafety Committee (IBC) review and approve experiments involving the
generation of rodents in which the animal’s genome has been altered by stable introduction of
recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic animal).
i. Are two transgenic (or knockout) rodent strains being bred to create a new rodent strain?
Yes
No
ii. Is a transgenic (or knockout) rodent strain being bred to a new background strain?
Yes
No
iii. If yes to either above, the following questions must be answered:
1. Does either parental rodent contain the following genetic modifications?
a. Incorporation of more than one-half of the genome of an exogenous
eukaryotic virus from a single family of viruses?
Yes
No
b. Incorporation of a transgene that is under the control of a gammaretroviral
long terminal repeat (LTR)?
Yes
No
2. Is the transgenic rodent resulting from this breeding expected to contain more than
one-half of an exogenous viral genome from a single family of viruses?
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Yes
No
3. If yes to either above, the following questions must be answered:
a. Describe the unique characteristics of the transgenic founder(s).
b. Describe the expected unique characteristics of viable offspring.
c. Indicate the type of confinement used to house these animals
ABSL1
ABSL2
ABSL3
d. Describe the precautions that will be taken (or procedures used) to minimize
the possibility that animals could escape confinement.
e. Assuming that offspring of the breeding pairs were to escape and mate with
wild-type animals, describe the potential consequences of this event upon the
wild population of animals.
iv. DNA/transgene or gene to be disrupted.
v. Anticipated consequences to the animal of genetic manipulation.
vi. Method of monitoring presence of transgene in the animals.
vii. Describe any special care or monitoring that may be required.
viii. Describe the disposition of the founders and for how long will they be maintained.
13. Antibody Production ☐ None
a. Monoclonal Antibody Production:
i.
If monoclonal antibodies will be produced in animals or harvested from hybridoma cell lines as part
of this project, is antibody harvest limited to existing hybridoma cell lines with no further
immunizations or lymphocyte fusions planned?
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Yes
No
If not, complete the following table regarding the immunization protocol for the animals prior to
lymphocyte harvest for hybridoma creation. For each antigen for which multiple immunization days
will be used, use a separate row in the table for each immunization day.
Injection
day (e.g. day
0, 7, 30, etc.)
ii.
Antigen
Adjuvant
Total
injection
volume
Amount
antigen
mg
mL
mg
mL
mg
mL
Number
of divided
injections
Injection route
and anatomical
location
(e.g., SC, dorsum)
If feeder cells for supporting hybridoma colony growth will be collected from animals, describe the
exact procedures that will be used to collect the feeder cells and the number of animals needed for
this purpose.
b. Alternatives: Consider alternate research methods that can replace the use of animals. lf any animals
will be used to expand hybridoma cell lines so that antibodies can be harvested from ascites fluid,
complete items i and ii below; then proceed to item iii.
i.
Explain why in vitro cell culture systems for harvesting monoclonal antibodies are not adequate to
meet the research objectives.
ii.
Complete the following table.
Hybridoma
cell line
designation
iii.
Number of
animals used
for ascites
production
Priming
agent and
volume(mL)
Number and
timing of
priming
injections
Volume of
injected
hybridoma
cells (mL)
mL
mL
mL
mL
mL
mL
Number of
abdominal
taps before
euthanasia
Euthanasia - Describe the criteria that will be used to determine the terminal abdominal tap:
c. Polyclonal Antibody Production: If polyclonal antibodies will be produced in this species of animal as a
part of this project, complete items i. and ii. then go to item d. If not, go to item d below.
i.
Complete the following table. For each antigen for which multiple immunization days will be used.
Use a separate row in the table for each day.
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Injection
day (e.g.
day 0, 7, 30,
etc.)
ii.
Antigen
Adjuvant
Amount
antigen
Total
injection
volume
mg
mL
mg
mL
mg
mL
mg
mL
mg
mL
mg
mL
Number of
divided
injections
Injection route and
anatomical
location
(e.g., SC, dorsum)
Possible adverse effects in animals that might be seen from the proposed antigen or adjuvant
injections and what measures will be taken should these adverse effects occur.
d. Terminal blood collection: If animals used for antibody production will be exsanguinated as a method of
euthanasia, complete items i. through iii. below, then go to item e. If not, go to item e.
i.
Describe the method of exsanguination.
ii.
If anesthetics, tranquilizers, or analgesics will be used prior to exsanguination, describe the
administration of pain-relieving agents including dose (mg/kg), volume (ml), route, and
frequency/duration here; then proceed to item 5. If not, justify the omission of pain-relieving agents
below; then proceed to item e.
iii.
Describe method for ensuring animals are dead following blood withdrawal.
e. Describe how the antigens or cell lines listed above will be screened to ensure they do not harbor
infectious agents that could infect other laboratory animals or people after injection.
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Principal Investigator/Study Personnel Information
 To add additional personnel, add a new row by clicking the bracket [ at the top right of the table and
hit enter. Then copy and paste the information from the table into the new row.
Personnel Info
Name:
Degree:
Job Title:
Brown Employee:☐
Non-Brown personnel:☐
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Qualifications/Relevant Experience
Click here and hit enter to add a new row 
Species:
Qualifications:
Years experience with each species:
Procedures to be performed: ☐Breeding ☐Specimen Collection ☐Euthanasia
☐Injections ☐Surgery ☐Restraint ☐Drug/agents administration
☐Hazardous Agents ☐Other: List and describe:
☐ This person has limited or no experience working with animals and will complete
all mandatory training prior to working with animals including: Animal Research
Orientation, all relevant AALAS modules, Occupational Health and Safety
requirements, and any in-person surgical training. In addition, this person will be
trained by appropriate lab staff before conducting any assigned procedures.
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Principal Investigator Certification
I certify to the following:

The information provided in this IACUC protocol is complete and accurate.

This project will be conducted in accordance with the policies and procedures of Brown University
regarding the care and use of laboratory animals, the USDA Animal Welfare Act and Regulations, the
Guide for the Care and Use of Laboratory Animals, 8th edition, and any applicable federal and state
laws and regulations.

Due consideration has been given to alternatives to animal models and alternatives to procedures that
may cause more than momentary or slight pain or distress to the animals.

The proposed experiments do not represent an unnecessary duplication of previous work.

Veterinary staff will be consulted before initiating experiments that include USDA pain category D or E
procedures, as required by the Animal Welfare Act and Regulations.

All personnel who work with animals under this protocol have received, or will receive, appropriate
training in protocol procedures and animal handling methods prior to working with animals. I will ensure
that individuals not listed in this protocol do not participate in the protocol experiments.

All listed personnel will read this protocol after it has been approved by the IACUC and before
undertaking any procedures on laboratory animals.

This protocol meets all animal use and care requirements of the funding agencies asked to support the
project.

Procedures on experimental animals described in this IACUC protocol accurately reflect those
described in the funding applications and awards, if externally supported. DHHS policy requires that the
institution certify to the government that the IACUC protocols are appropriately consistent with the
federal grant applications.

Approval from the IACUC will be obtained prior to making any change to the approved protocol.
Signature Requirements: If the protocol is being submitted through Coeus by the PI, no signature is needed.
If the protocol is being submitted by someone other than the PI, the PI must sign this form before it is uploaded
into Coeus.
_________________________________
Signature of Principal Investigator
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___________
Date
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