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FLORIDA ATLANTIC UNIVERSITY
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
Rev. 11/4/05
ANIMAL USE PROTOCOL FORM
WELCOME TO THE FAU PROTOCOL PROCESS FOR ANIMAL USE
1. PLEASE NOTE THE REVISION DATE. YOU SHOULD USE THE LATEST VERSION FROM THE
WEB.
2. PLEASE COMPLETE ALL SECTIONS
A. SOME SECTIONS MAY NOT PERTAIN TO YOUR PARTICULAR PROTOCOL BUT IT IS STILL
REQUIRED INFORMATION. JUST INDICATE “NO” IF APPLICABLE.
B. IF A MAJOR PARAGRAPH IS MARKED “NO”, THEN DO NOT FILL OUT THE
SUBPARAGRAPHS.
C. IF A MAJOR PARAGRAPH IS MARKED “YES” ANSWER, ALL SUBPARAGRAPHS MUST BE
FILLED IN. IF NOT APPLICABLE, THEN SO STATE, “NA”
3. AFTER A DRAFT IS COMPLETED, THE PI MUST TO MAKE AN APPOINTMENT TO MEET WITH
THE UNIVERSITY VETERINARIAN. (FEDERAL REQUIREMENT)
4. ALL PERSONNEL ON THE PROTOCOL HAVE TO BE TRAINED BY THE UNIVERSITY
VETERINARIAN BEFORE THE PROTOCOL WILL RECEIVE FINAL APPROVAL.
5. THERE ARE AT LEAST 3 SIGNATURES THAT ARE REQUIRED BEFORE SUBMISSION – PI,
UNIVERSITY VETERINARIAN, AND DEPARTMENT CHAIRPERSON. (SECTIONS F & G)
6. SUBMIT THE PROTOCOL
A. AFTER ALL SECTIONS ARE COMPLETED
B. AFTER ALL SIGNATURES ARE OBTAINED
C. AFTER ALL REQUIRED PERMITS OR LICENSES ARE OBTAINED
D. SUBMIT
a. ONE COMPLETE ORIGINAL COPY WITH ALL SIGNATURES. INCLUDE ATTACHMENTS
AND PERMITS (ATTACHMENTS INCLUDE GRANT IF APPLICABLE, SURGREY FORM, WILDLIFE FORM, ETC.)
b. SEND (EMAIL OR ON DISK) ONE ELECTRONIC COPY OF PROTOCOL AND ALL
ATTACHMENTS
c. SUBMIT TO COMPLIANCE OFFICE, ROOM
231, SECOND FLOOR ADMINISTRATION
BUILDING, BOCA CAMPUS.
7. LAST ITEM, PLEASE DELETE THIS PAGE BEFORE SUBMITTING.
A. PUT YOUR CURSOR ON THE FRAME AND CLICK, SHOULD BECOME A HASH LINE, THEN
HIT THE DELETE KEY UNTIL THE TOP LINE IS DELETED PLUS ONE MORE CLICK TO BRING
THE PROTOCOL TO THE TOP OF THIS PAGE.
QUESTIONS, CALL THE UNIVERSITY VETERINARIAN -JIM NICHOLS AT 7-4233 (JNICHOLS@FAU.EDU)
OR DIRECTOR OF COMPLIANCE - ELISA GAUCHER AT 7-2318 (EGAUCHER@FAU.EDU; 231 ADMIN BLDG)
FAU Protocol Page 1 of 17
FLORIDA ATLANTIC UNIVERSITY
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
Rev. 11/4/05
ANIMAL USE PROTOCOL FORM
A. ANIMAL USE PROTOCOL SUMMARY
IACUC DATE STAMP: Shaded Areas for IACUC use only.
PROTOCOL NUMBER:
APPROVAL DATES:
Original:
MODIFICATION DATE:
1st Renewal:
2nd Renewal:
A.1. PROTOCOL TITLE
A.2. PRINCIPAL INVESTIGATOR (PI) NAME AND ADDRESS
First Name
Department
Last Name
After Hours Phone
Email Address
Home Phone
A.3. PROJECT PERSONNEL
(Include names of all individuals involved with the animals and this project).
ROLE IN PROJECT (please answer all that apply)
(For additional rows of species, left click in left margin to highlight, right click, insert row. For additional names copy section and add at the end of a section.)
Date of On Line General Training Completed:
Name
Animal Contact: NONE (Not required to answer species and jobs below)  YES (Have to answer all below)
Enter dates for hands on or online training (If doing Anest. and Surg., it
requires Surg. Training) (Euthan. requires Euthan. Training.)
Work Phone
Email Address
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Discuss previous training and
background working with each
species and each procedure
marked including when trained
and how trained.
Name
Date of On Line General Training Completed:
Animal Contact: NONE (Not required to answer species and jobs below)  YES (Have to answer all below)
Enter dates for hands on or online training (If doing Anest. and Surg., it
requires Surg. Training) (Euthan. requires Euthan. Training.)
Work Phone
Email Address
Discuss previous training and
background working with each
species and each procedure
marked including when trained
and how trained.
FAU Protocol Page 2 of 17
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Date of On Line General Training Completed:
Name
Animal Contact: NONE (Not required to answer species and jobs below)  YES (Have to answer all below)
Enter dates for hands on or online training (If doing Anest. and Surg., it
requires Surg. Training) (Euthan. requires Euthan. Training.)
Work Phone
Email Address
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Discuss previous training and
background working with each
species and each procedure
marked including when trained
and how trained.
Date of On Line General Training Completed:
Name
Animal Contact: NONE (Not required to answer species and jobs below)  YES (Have to answer all below)
Enter dates for hands on or online training (If doing Anest. and Surg., it
requires Surg. Training) (Euthan. requires Euthan. Training.)
Work Phone
Email Address
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Species
Handling/monitoring Non-Surg Procedure General
Anest
Surgery
Euthanasia
OHP Enroll
Discuss previous training and
background working with each
species and each procedure
marked including when trained
and how trained.
To add more people, place your pointer at the top, left corner of the above group (just outside of the “N”), right click, copy and then paste
just below this line. Add as many as required.
EMERGENCY CONTACT AND ANIMAL DISPOSITION
A.4. Daily and weekend contact numbers for emergencies. (Please provide PI and an alternate’s emergency info.)
Personnel listed in this section must also be listed as project personnel in the above section
PI
Alternate Person
B.1. TYPE OF SUBMISSION (CHECK ONE)
New Protocol
Emergency Phone
Emergency Phone
PROVIDE RELATED IACUC NUMBERS
(Not applicable for new protocols)
Amendment of IACUC Protocol #
Year 3 Renewal of IACUC Protocol #
Identical to IACUC Protocol #
B.1.a. FUNDING SOURCE(S)
B.2. PROJECT START DATE
FAU Protocol Page 3 of 17
B.3. PROJECT END DATE
USDA Pain
Level
Other (Specify :)
Anesthesia without surgery (i.e. blood
collection, gavage, etc.)
Paralytic Agents
Diagnostic X-rays
(B,C,D,E)
Antibody Production
Drugs (Drugs as research components other
than anesthetics, etc.)
. Immunization Procedures
Burns or Trauma
Biohazard
Food / Water Deprivation
Aversive Conditioning
Prolonged Restraint
Multiple Survival Surgery
Collection of Cells, Tissues, Organs
Est.
Proj.
Tot.
Non-survival Surgery
Survival Surgery
(SPECIES Common Name
and Strain)
Special Diet
PROCEDURES
Check ALL that apply
C.1.
Pain level: BBreeding
only(No tail
nip); C-Only
momentary or
slight(needle
stick); D-More
than momentary
or slight but
relieved with
medication; EMore than
momentary or
slight and not
relieved
1
2
3
4
5
Other (Specify:)
D.1. Facility and Room # Where Procedures Will Take Place (If multiple, so indicate)
Non-Surgical Procedures
Surgery and/or Anesthesia
Euthanasia
D.2. ANIMALS BROUGHT INTO AND TAKEN OUTSIDE OF THE ANIMAL FACILITY
ANIMALS BROUGHT INTO THE FACILITY
Approved Vendors
Quarantine
Animals ordered from approved, conventional vendors will enter quarantine as described in
Veterinary Services SOP’s. During the quarantine period, animals are not generally available to
use for research without specific approval from the Veterinary Services.
Veterinary Services Choice
From: (Fill in)
Proposed Vendor Unknown
Non-Conventional
Animals ordered from other Universities or non-approved vendors can only be ordered after
completion of special animal request forms and receipt of animal health information from the
Vendor Quarantine
vendor or source. These animals will undergo an extended quarantine period and may be health
tested at the cost of the investigator. Contact Veterinary Services for more information
Animal Stabilization
To reduce the impact of stress-induced elevation of hormones on your research, all animals
require a period of stabilization after transport to the Florida Atlantic University. Stabilization
periods occur during the quarantine period. Literature suggests the following guidelines:
Rodents and Rabbits
3 days
Dogs, Pigs, Other Mammals
5-7 days
ANIMALS TO BE TAKEN OUTSIDE OF THE FACILITY.
YES
D.3. Will animals be used in a laboratory outside the animal facility for less than 12 hours? (If YES,
complete the following)
FAU Protocol Page 4 of 17
NO
If the animal will be transported from one building to another for short-term housing (less than 12 hours), complete this section. PLEASE
NOTE: If the animal goes anyplace outside the ANIMAL FACILITY (animal quarters, vivarium), the answer should be YES. Room: State the
room OUTSIDE the facility where the animal will be used. Duration: How long will the animal be outside the animal facility? For animals taken
to a lab for tests and then returned in an average of 2 hours, state "2 hours." For animals that are never to return, state "Will not return to the
animal facility". Frequency: How often will each animal go out of the animal facility? In some cases, some will go more than others. You might
say that the controls will go once a week and group A will go every day.
D.3.a.
D.3.b.
D.3.c.
Building
Approximate duration in laboratory
How many times will the animals be
transported to the laboratory?
Room
To ensure legal and safe transportation of animals, the following guidelines MUST be followed: This
is to ensure legal and safe transportation of the animals. It also will help to determine what arrangements are required to support your
transportation requirements.
If moved within the building, animals must be transported in a covered cage in designated elevators.
D.3.d.
If moved between buildings, animals must be transported in an insulated, (Coleman) Transport container.
Please describe transport.
“As described above” is suggested for a reply if applicable .
STUDY AREAS
YES
NO
D.4. Will animals be used or housed in an area outside the animal facility for more than 12 hours?
If YES then you are requesting that the area be designated as a STUDY AREA. A study area requires special
justification, requires special animal monitoring requirements, and is subject to additional inspection by the
IACUC and federal authorities. Additionally, the study area must be inspected and approved by the IACUC
prior to animal housing.
D.4.a.
D.4.b.
D.4.c.
D.4.d.
D.4.e.
Justification
Building
Approximate duration in laboratory
How many times will the animals be
transported to the laboratory?
Who will provide the husbandry?
Room
To ensure that the animals receive proper husbandry and veterinary care, state who will care for the animals while they are out of the animal facility. Federal law states
how often the animals have to be fed, watered, cleaned, etc. We have to ensure that this is done and that the proper food is used, stored, etc. the statement normally
would be "PI" or "Animal Facility."
To ensure legal and safe transportation of animals, the following guidelines MUST be followed:
This is to ensure legal and safe transportation of the animals. It also will help to determine what arrangements are required to support your transportation requirements
If moved within the building, animals must be transported in a covered cage in designated elevators.
D.4.f.
If moved between buildings, animals must be transported in an insulated, (Coleman) Transport container.
Please describe
transport.
FAU Protocol Page 5 of 17
PHARMACEUTICALS USED WITH ANIMALS
E.1. ANALGESIC/ANESTHETIC (Generic name)
SPECIES
DOSE MG/KG ROUTE FREQUENCY
SPECIES
DOSE MG/KG ROUTE
SPECIES
DOSE MG/KG ROUTE FREQUENCY
1
2
3
4
E.2. EUTHANASIA METHOD/DRUG (Generic name)
1
2
3
4
E.3. OTHER DRUGS(List all injected/given: i.e. antibiotics,
fluids, Freund Complete Adj. etc.)
1
2
3
4
5
6
FAU Protocol Page 6 of 17
F. INVESTIGATOR ASSURANCE
GENERAL INSTRUCTIONS READ CAREFULLY AND SIGN AND DATE BELOW
PRINCIPAL INVESTIGATOR'S ASSURANCE
I have provided an accurate description of the proposed animal care and use protocol and agree to the following
conditions:
All personnel will be informed of the requirement to report all animal bites and animal related accidents
All personnel will be informed that any concerns for inhumane care and treatment of animals or unlawful acts
involving animals should be reported to the IACUC or the Attending Veterinarian and that anyone reporting such
concerns cannot be discriminated against or be subject to any reprisal for reporting their concerns.
I agree to abide by governmental regulations and policies concerning the use of animals.
I will ensure that veterinary care is provided to animals showing evidence of pain or illness.
I agree to give consideration to tissue sharing and will do so whenever possible.
If the procedures concerning animal use in this research activity are to be revised or changed, I will so notify the
IACUC of these changes before the change is implemented. I understand that failure to request an amendment
for changes in animal use may place the University and myself in violation of Federal regulations and the Animal
Welfare Act.
As required by Federal regulations, I assure that the activities described do not unnecessarily duplicate previous
experiments and I assure the animal models proposed are the most appropriate for achieving the objectives of this
project and have provided justification for each model used in the protocol (Animal Research Plan, Rationale).
As required by Federal regulations, I assure that the activities described do not unnecessarily duplicate previous
experiments and I assure the animal models proposed are the most appropriate for achieving the objectives of this
project and have provided justification for each model used in the protocol (Animal Research Plan, Rationale).
Principal Investigator Signature
Date
Requires a review of the protocol in a meeting with the veterinarian prior to submittal.
Attending Veterinarian’s Initials
Indicating that the meeting occurred.
FAU Protocol Page 7 of 17
G. CONFIRMATION OF SCIENTIFIC/INSTRUCTIONAL MERIT REVIEW
Before any project that utilizes animals can be initiated, it must be reviewed and approved based for scientific or
instructional merit. The IACUC is responsible to ensure a scientific or instructional review is conducted, not
necessarily to conduct the review. The IACUC is responsible for the proper, legal and humane, use of animals.
To assure the IACUC that this review is in place, the following information is needed regarding the review
process which is applicable for this protocol.
(Check one of the boxes below).
This project will only be initiated after it has been peer-reviewed outside Florida Atlantic University (e.g. NIH,
NSF, AHA, etc.) or within the University by a formal interdepartmental review group. If so, identify which group,
agency or board has reviewed or will review this project for scientific or instructional merit.
Name of Review Agency, Committee, or Board
Date of Review
OR
This project is being reviewed within FAU by one of several methods.
Departmental Committee for review of scientific or instructional merit
Name of Committee
Date of Review
Name of Committee Chairperson or Official Designee of the committee indicating approval
OR
Other Review Process
Describe the review process such as the IACUC, Department Chair person, etc.
Note: While it does not necessarily require someone who is an “expert” in the field of study, it does
require someone with sufficient scientific knowledge who can review a paper to ensure the project will
have merit and not use animals unnecessarily. Until a review is completed and the protocol
approved, the project can not be started.
Additional note: If the IACUC is asked to complete the scientific review, the project may be delayed until
someone with the required expertise can be recruited.
Name of person or persons who conducted the Scientific or Instructional Merit review.
If this is to be reviewed by the IACUC, then nothing will be required in this block since the IACUC will
have records of who reviewed the project.
Signature of Person
Date
In addition to any review within FAU, an “administrative review” by the chair person to indicate his/her
knowledge of the project and approval is required.
Signature of Department
Chairperson
FAU Protocol Page 8 of 17
Date
H. PROTOCOL SYNOPSIS
Provide a brief,
overall, non-technical description of the research or teaching project, emphasizing the
use of animals.
all
Provide an outline of
procedures involving the use of animals.
Note: Scientific details are listed below in I section.
This section is primarily concerned with the animals and their use.
For teaching protocols, outline animal procedures in this section and attach SOP’s to the end of the document.
Include the follow if applicable: 1. Quarantine/stabilization, 2. Each procedures, 3. With their effects and what you and/or
the veterinarian will do/look for, 4. Euthanasia, 5. etc. (If you inject a substance, what signs do you expect to see and
when/what are you going to do about it.) Safety of personnel and other animals should be discuss when applicable.
This is a test to see if you read the above. If you did, delete this line.
ANIMAL RESEARCH and TEACHING PLAN
I. RATIONALE
The regulations of the Animal Welfare Act (9 CFR 2.31(3) (2)) and University policy requires that animals selected for a
procedure should be of an appropriate species. The minimum number required to obtain valid results should be used.
I.1. Very briefly state the objective(s) and potential significance of the activities involving animal use
Briefly discuss the role of animals in the proposed activity. Indicate why these experiments cannot be done without animals or, if applicable,
why less invasive procedures that cause less potential or actual animal pain or discomfort cannot be used. If appropriate, include a brief
discussion of the medical or other practical dimension of the problem you are studying. Keep in mind that we are only interested in live animal
use. Any other parts of your total project should only be stated if it affects the use of animals.
(If wildlife, state species selected by [Agency] to be studied.)
I.3. Discuss the appropriateness of the NUMBER of animals to be used as follows:
State the number of animals needed for the total project. If the animals will be used for research, provide a justification, either statistical, quantitative,
etc. Even pilot studies, when selecting a number of animals (i.e. 3 or 6) should have basis for its selection. (A suggested approach is to use a
statistical power calculation or a yield of tissue per organ).
Note: Wildlife studies. In wildlife studies it is often hard to scientifically justify the number. What should be stated is the desired number to be
“used” and how you came up with that number such as number requested by an agency or expected population available. Often a number is desirable
but circumstances do not allow control of number “caught” such as using a fish net and one may get no fish or 100 fish. In such circumstances, the
IACUC should expect a report of the actual number “used” (caught, touched, disturbed, etc.) as soon as practical to the IACUC for our reports.
I.4. Summarize the experimental design in a simple table or other form that graphically clarifies how the groups,
Example
Group A
Group B
Group C
Total
time frames, and totals of animal use are broken down.
Test 1
10
10
10
30
Test 2
10
10
10
30
Control
5
5
5
15
__________________________________________________
Total
25
25
25
75
J. JUDICIOUS USE OF ANIMALS
FAU Protocol Page 9 of 17
Respond to all items. For all YES responses, provide descriptions and additional information in the blanks provided.
Attach additional sheets as necessary.
According to federal regulation (9CFR 2.31(e)(2), a proposal to conduct research or teaching utilizing animals "must
contain... a rationale for involving animals."
YES
NO
J.1. Are "whole live animals" required for this project rather than alternatives, such as cultured
cells? The questions the public may ask are: "Why do you need animals? Why can't you use a computer, tissue culture, etc.?"
If YES, include a brief explanation of efforts that you have made to reduce the number of animals used in
research (as it pertains to the 3 R’s [Replacement, Reduction, Refinement])
K. ANIMAL USE PROCEDURES
Respond to all items. For all YES responses, provide descriptions and additional information in the blanks provided.
Attach additional sheets as needed.
COLLECTION OF CELLS, TISSUES AND ORGANS
YES
NO
K.1. Blood sampling (If YES, complete the following)
If blood collection is one of the procedures, please complete the following information. Cardiac puncture requires anesthesia. Tail snips in adult
animals requires anesthesia (cuts through cartilage of the tail). Nicking the blood vessel with a needle or scalpel does not require anesthesia.
Periorbital/periocular bleeding is discouraged and requires scientific justification of why an alternative method can’t be used. See this website
for a popular blood collection technique for rodents (http://www.uib.no/vivariet/mou_blood/Blood_coll_mice_.html)
K.1.a.
Technique
How do you plan to collect
blood (e.g., after death,
under anesthesia, etc.?
K.1.b.
Site
From where do you plan to
collect the blood (e.g.
jugular vein, femoral vein,
heart, carotid artery, tail
vein, etc.)?
K.1.c.
Volume (Max)
What is the maximum
volume in ml. you plan to
collect each time?
Generally, the blood volume
of an animal is about 6 – 8
% of body weight and only
about 10% of the blood
volume should be collected
at one time and then 1 to 2
K.1.d.
Frequency
How often will you draw
blood (e.g. once, once every
day, once a week, etc.)?
YES
K.2. Urine, feces or other body fluids sampling (If YES, complete the following)
K.2.a.
Material
This information is required
for the IACUC if the
samples are obtained from
the animal. If they are
collected from the waste left
in the cage, this is important
information for the facility
manager.
FAU Protocol Page 10 of 17
NO
K.2.b.
Method
What method will be used
(e.g. from the waste in the
cage, postmortem,
expressed, drawn with a (?)
size needle by (?)
K.2.c.
Frequency
How often? Obviously, if
postmortem, only once.
Otherwise, how often (e.g.
hourly, weekly, etc.)?
K.2.d.
Duration
This is especially important
if a restraint device has to be
used (such as a metabolic
cage) or if an indwelling
catheter is required
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
K.3. Collection of tissues (except blood) BEFORE euthanasia (If YES, complete the following)
This would be filled out if animal tissues are collected prior to euthanasia. In some cases, the animal might be under anesthesia and might not be
allowed to recover. Antibody collection might be another example.
All unused tissues should be double-bagged and returned to the animal facility for disposal
K.3.a.
Tissues used only on this protocol
If all the tissues will be used with this protocol, so state “This Protocol”. If, however, tissue will be shared, then state who else
will use tissue from animals on this protocol
K.3.b.
K.3.c.
If Tissues are used on
another protocol, List
protocol numbers
Tissues Collected
What tissues will you collect (e.g. liver,
spleen, kidney, blood, etc.)?
K.4. Collection of tissues (except blood) AFTER euthanasia (If YES, complete the following)
This is the same as above except it is after death, thus lowering the chance of pain or distress to the animal. In some cases, tissues will be
collected both before and after euthanasia. If so, fill out both sections. The headings are the same as above
All unused tissues should be double-bagged and returned to the animal facility for disposal
K.4.a.
K.4.b.
K.4.c.
Tissues used on this protocol
If Tissues are used on another protocol, List protocol numbers
Tissues Collected
PROCEDURES and IMPLANTS
K.5. In Vivo Administration of agents, other than anesthetics or analgesics, such as:
drugs/reagents/etc. (If YES, complete the following)
1
K.5.a.
Agent
State what you are exposing the
animal to. All chemicals,
drugs used in the animals with
the exception of anesthetics or
analgesics should be
individually listed here
K.5.b.
Route
What is the route of
administration (I.V., I.M.,
S.C.)?
FAU Protocol Page 11 of 17
2
3
K.5.c.
Frequency
How often will you
administer the agent
K.5.d.
Side Effects
What do you expect to happen
after the agent is placed into or
on the animal? State "None" if
no side effects are expected
K.5.e.
Treatment
If side effects are expected,
state how you plan to treat
them or explain why they will
not be treated.
K.5.f.
K.5.g.
Needle Size
Max Volume
Administered
YES
NO
YES
NO
YES
NO
K.6. Indwelling catheters or implants (If YES, complete the following)
Any catheters or implants that will be put into an animal at a non-terminal procedure should be listed here.
K.6.a.
K.6.b.
Size
Type
What is it (e.g. cerebral cannula,
intravenous catheter, urinary
catheter, infusion pump, drug
release capsule, rumen cannula,
etc.)?
K.6.c.
Maintenance
What care is required for the
item (e.g. does it have to be
flushed, do antibiotics have to be
applied where it exits through
the skin, will inflammation
occur, etc.)? If heparin or
heparinized saline is used as a
flushing agent, include this in
section G.14 and the Drug Use
Page, as well.
K.6.d.
Duration
How long will the catheter or
implant be in the animal? How
long will it need care?
K.7. Tumor Transplantation or Cell Inoculation (If YES, complete the following))
Tumors/cells derived from Humans may potentially carry disease that could infect caretakers/technicians. If so, this
becomes a biohazard issue and Section (O) should be completed.
Tumors/cells derived from rodents are potential sources of rodent viruses that could spread
throughout animal facilities. Have you had the tumor/cell line tested for infectious viruses?
(Contact the Veterinary Services for additional information.)
K.7.a.
Tumor or Cell Type State the size of a
catheter or implant.
K.7.b.
Route of Administration What is it
(e.g. cerebral cannula, intravenous catheter,
urinary catheter, infusion pump, drug release
capsule, rumen cannula, etc.)?
K.7.c.
Frequency of Administration What
care is required for the item (e.g. does it have to
be flushed, do antibiotics have to be applied
where it exits through the skin, will
inflammation occur, etc.)? If heparin or
heparinized saline is used as a flushing agent,
include this in section
FAU Protocol Page 12 of 17
K.7.d.
Anticipated functional deficit How
long will the catheter or implant be in the
animal? How long will it need care?
K.7.e.
Treatment How do you plan to
care for the animal with this deficit?
K.7.f.
Monitoring Animals with deficits have to
be monitored. Describe how you plan to
monitor the animals. Weighing the animal on a
weekly basis can be helpful to monitor how
rapidly a tumor may be growing or how well an
animal may be eating.
K.7.g.
End Point At what point will you stop
using the animal? In some cases, this is at the
earliest signs of an adverse effect. State the
signs. Sometimes it is required that the animal
be allowed to continue to a certain point despite
the onset of some adverse event. Please state
what that point is. Generally, if tumors surpass
15 to 20% of body weight (compared to
untreated controls) the animal should be
terminated. Remember, animals must be
observed for painful sequelae and appropriate
action must be taken as soon as possible.
POST-PROCEDURE CARE
YES
NO
K.8. Will post-procedure care for non-surgical procedures listed above be required? (If YES,
complete the following)
K.8.a.
Who will provide care?
K.8.b.
What post-procedure care is required?
K.8.c.
When will post-procedure care be given?
K.8.d.
What analgesics will be given? (If none,
explain)
K.8.e.
What will be the endpoint?
L. ESTIMATION OF PAIN, DISTRESS AND SUFFERING
The IACUC is required to review carefully any pain or distress involving animals. This section provides the required assurance that you will be as humane as possible.
Federal law requires that the Principal Investigator consider alternatives to procedures that may cause more than
momentary or slight pain or distress to animals (Level D or E).
A written narrative description of the methods and sources (e.g. The Animal Welfare Information Center) used to
determine that alternatives were not available is required (Federal Regulations, 9 CFR Ch. 1, Sec. 2.31(d)(1)(ii)).
YES
L.1. Does this project involve procedures that may cause more than momentary or slight pain or
distress to animals? (If YES, complete the following)
Database(s) searched -State the database(s)
L.1.a.
searched (e.g. MEDLINE, AGRICOLA).
L.1.b.
L.1.c.
L.1.d.
Date range of the Database Search
Date the Database Search was done
Key words - State the key words used to
determine that no alternative to procedures that may
cause more than momentary or slight pain or distress
to animals is available.
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NO
L.1.e.
Please provide a brief narrative description of
search results that led you to believe that there
are no alternatives to procedures that may cause
more than momentary or slight pain or distress to
animals (this section does not refer to
“alternatives” to animal use) A simple statement of what you
found from your literature search (e.g., "From my literature search, I
found no alternative for the use of procedures that may cause more than
momentary or slight pain or distress to animals.").
L.2. What pain or distress is anticipated? (Be explicit and
include potential for pain or distress (in the presence or
absence of anesthesia) Fully describe the pain or distress you expect to
occur or has the potential to occur during all procedures. In most cases, a simple
statement that “The animal will only perceive the momentary pain associated with
a needle stick” or Pain associated with the surgery will be alleviated by anesthetics
and analgesics”.
The PI, the project personnel and Veterinary Services observe for the following signs of pain or distress:
Loss of appetite
Loss of weight
Loss of mobility
Guarding (protecting the painful area)
Vocalizing
Licking, biting, scratching or shaking a particular area
Restlessness
Failure to groom, causing an unkempt appearance
Teeth grinding
Abnormal resting postures in which the animal appears to
be sleeping or is hunched up
Failure to show normal patterns of inquisitiveness
YES
NO
YES
NO
YES
NO
L.3. Are there other signs that will be used to assess pain and distress? (If YES, explain below)
L.4. For protocols that have procedures that are potentially more than momentarily painful or
distressful, special observation is generally necessary. Does this protocol include such
procedures? In many cases, the correct answer will be NO. If an animal is just euthanized for tissue collection, this should be marked NO.
Any time more than momentary pain or distress will be expected for the animals, the answer has to be YES
L.4.a.
Frequency of observation How often will the animal be observed? The frequency will
depend on the amount of pain or distress. If in doubt, check with the University Veterinarian.
Whatever you put in this box needs to be documented and submitted on request by the IACUC,
Veterinarian or External Reviewers; if you will observe the animal “daily” you need to have records
that include documented weekend checks.
L.4.b.
Beginning (date or condition) The period when the animal will be checked has to be
defined. It generally starts just before the time you expect to see signs of pain or distress.
L.4.c.
Ending (date or condition) This is to ensure the animal will be properly observed until the
pain or distress is ended
L.5. Will there be unalleviated pain or distress in this protocol?
(If YES, this protocol falls into the USDA pain level E. Please supply the scientific justification why animals on this
protocol will be subjected to unalleviated pain or distress and enter USDA code E in Section A-9. The law states that any
procedure that could cause more than momentary pain or distress requires relief, generally through analgesics. The University Veterinarian is not allowed to
diverge from the law. It is assumed that an animal that has undergone surgery has pain post-surgically. Other procedures may also cause pain. Such a procedure
is usually evaluated as to how painful or distressful it would be to a human, and appropriate analgesia has to be provided. If USDA level "E" is specified,
therefore, no drugs are to be used, a full justification is required.
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M. STUDY TERMINATION/ANIMAL DISPOSITION
There are three possible outcomes for an animal assigned to a protocol:
1. Absolutely no harm to the animal will occur, and the animal will be available for redistribution
2. The animal will be euthanized at the end of the research
3. The animal will be in the experiment until it dies (commonly referred to as “death is the endpoint”)
YES
NO
M.1. Will any animal(s) survive the research with no harm?
(Often yes for Agricultural Teaching and Wildlife protocols) Examples of "no harm" include only small amounts of blood drawn or animals which only ran a maze
Complete M.1.a. and M.1.b. if “Yes” only
M.1.a. Will any animal(s) be used in another protocol?
(If YES, indicate protocol # and PI)
Protocol #
PI
YES
NO
YES
NO
YES
NO
YES
NO
YES
NO
M.1.b. Will any animal(s) be adopted?
(Rarely done but if the answer is YES, contact the University Veterinarian to make
arrangements.)
M.2. Will any animal(s) be euthanized?
M.3. Will death be the endpoint for any animal(s) in this protocol? ( i.e. The animal’s death is a
required experimental data-point.)
(For example, heart failure is induced in a rabbit and it is allowed to survive until it dies of congestive heart
failure without being euthanized).
(If YES, complete the following)
M.3.a. Will euthanasia ever be considered or is there any other measurable endpoint at
which euthanasia will be performed? below.;
If YES, this may not be death as an endpoint;
ONLY COMPLETE THIS SECTION IF M.3. is “YES”
Please explain
M.3.b. If euthanasia will never be
considered, please justify why death is
the end point rather than euthanasia
M.3.c. What signs are the animals
expected to exhibit as they go through the
terminal stages?
M.3.d. What measures can be taken to
alleviate pain (e.g. analgesics)? (If NONE,
please justify)
M.3.e. Who will observe the animal during
the terminal stages?
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M.4. Instructions for disposition of sick or injured animals.
This section is used to indicate what is to be done with animals in case they become sick or injured and what is to be done with dead animals and
tissue. (Weekend, holidays and nights are times that animals need care too, e.g., without being able to contact the investigator, the animal
caretaker may not know whether or how to keep the carcass until it can be examined or utilized by the investigator). An alternate person should
always be designated. The alternate person cannot include routine VS animal caretakers and that person should also be listed under the project
personnel.
M.4.a.
YES
NO
YES
NO
YES
NO
Call investigator Immediately? (A “no” answer means the investigator will be called the next
working day.)Normally, the investigator should be called. The investigator may wish to be notified the next working day;
complete I.5.b.
M.4.b.
In case of emergency, should the Veterinarian treat the animals? In case of an emergency, the
veterinarian needs to know whether the animal should be treated. If the animal should not be treated, why not? Should the
animal just be euthanized? If the animal is to be treated, what restrictions, if any, should the veterinarian be aware of (i.e. no
steroids; no drugs; etc.)
If NO, include justification on why the animal will not
be treated.
If YES, explain any restrictions on treatment below.
M.4.c.
Comments
M.5. Instructions for disposition of dead animals.
M.5.a.
Call investigator Immediately? (A “no” answer means the investigator will be called the
next working day.)
M.5.b.
Do you specifically request the Veterinarian to do a necropsy? The veterinarian is required to be notified of
any unexpected death and will either perform or be present at the necropsy. When deaths occur that are expected, the
veterinarian does not need to be notified, but if the death occurs after normal hours, or if the investigator or his/her backup cannot
be reached, the veterinarian may be asked to try to save certain tissues. In such circumstances, what instructions would you have
for him/her?
Discuss any special instructions for the
Veterinarian. (i.e. look at lungs, save heart,
save implant)
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Special Procedures
Note: If any of the following are a “yes” answer,
you will have to complete additional information specific to what was checked “yes”.
ANITIBODIES
N. Antibody production (If YES, complete SECTION N)
YES
NO
HAZARDS
O. Infectious/potentially infectious agents (If YES, complete SECTION O)
O. Toxicity testing and toxic materials (If YES, complete SECTION O)
O. Radioisotopes/radiation (If YES, complete SECTION O)
O. Recombinant or non-Recombinant DNA/RNA (If YES, complete SECTION O)
YES
NO
BEHAVIORAL TESTING
P. Behavioral testing WITHOUT significant restraint or noxious stimuli. Explain
YES
NO
YES
NO
YES
NO
DIETARY MODIFICATION
R. Special Diets or Food/Water Restriction (If YES, complete SECTION R)
YES
NO
ANESTHESIA
S. Anesthesia (If YES, complete SECTION S)
YES
NO
SURGERY, POST OPERATIVE CARE
T. Non-survival surgery (If YES, complete SECTION S and SECTION T)
T. Single survival surgery (If YES, complete SECTION S and SECTION T)
T. Multiple major survival surgeries (If YES, complete SECTION S and SECTION T)
T. Other Non-Surgical Procedures (If YES, explain below) This space is provided to describe any procedures not
YES
NO
YES
NO
YES
NO
YES
NO
If animals’ behavior will be observed or animals will be used in trials not involving restraint or noxious stimuli, complete this section.
RESTRAINT
Q. Behavioral testing WITH significant restraint or noxious stimuli
(If YES, complete SECTION Q)
Q. Prolonged restraint (If YES, complete SECTION Q)
covered above.
BREEDING COLONY
A breeding colony is one that is used to produce offspring which will be used in research. It can be a protocol by itself or combined with the
research phase to be a part of the research protocol. Either way, if animals are used for breeding, then this form should be completed.
U. Breeding Colony (If YES, complete SECTION U)
TEACHING
Use of animals in a classroom, in a building or outside, where faculty and/or students of FAU are involved requires a protocol.
V. Teaching (If YES, complete SECTION V)
WILDLIFE STUDY
A wildlife study involves using animals outside the animal facility that are free ranging animals not raised for research.
W. Wildlife Study (If YES, complete SECTION W)
Once completed
A minimum of 3 signatures are required: PI’s, University Veterinarian’s, Dept. Chair’s
1 Original Copy with all attachments and licenses plus an electronic copy are required to be submitted to OSR.
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