INITIAL REVIEW FOR USE OF ANIMAL SUBJECTS
Application Enclosure Checklist for Form A
IACUC Checklist for Initial Submission:
Take the “Working with the FIU IACUC” Animal Care and Use online training (http://www.ori.fiu.edu/IACUC/training.html).
This is required for all individuals that are affiliated with the research project (e.g., investigators, co-investigators, etc).
Take the EH&S “Animal Care Safety” online training course on safety in animal use for research/teaching if your research will be
conducted in a facility/laboratory (http://www.ori.fiu.edu/IACUC/training.html). This is required for all individuals that are
affiliated with the research project (e.g., investigators, co-investigators, etc).
If any part of your research will utilize the Animal Care Facility, contact the Supervisor (Rene Fernandez; rfernan@fiu.edu) for
specific information and training. Proof of communication with the Supervisor is required before we will review a protocol.
Fill-out this Form A protocol application. Send an email copy of the protocol first to the IACUC Coordinator
(barbara.llaneras@fiu.edu). Please do not send a hardcopy anywhere until after the IACUC has approved the protocol. At that
point, send a signed copy to the IACUC Office (MARC 430).
If there are any medical or surgical procedures requiring training or consultation, contact the FIU Attending Veterinarian (Dr.
Joseph Wagner; wagnerjj@bellsouth.net) for specific information and training. Proof of communication and, possibly, training are
required for protocol review.
Complete a literature review by searching databases for key words to ensure that this project is not duplicating existing research.
Documentation of your database search results must be attached to your application.
Include the following only if applicable:
A Copy of the Funding Grant Research Proposal or the Graduate School 5 Page Research Proposal - This allows the IACUC
to review your proposal and to identify your project with the proper funding source, dissertation, or thesis.
Approval Documentation from additional sites or universities if the proposal has been submitted elsewhere or is being
transferred. Include IACUC approval number as well as PHS assurance number and/or USDA certification.
Verification Letters from collaborators or additional research sites.
Conflict of Interest Disclosure
Key to Pain /Distress Categories (VII.D.)
Category B - Animals are being "bred, conditioned, or held for use in teaching testing, experiments, research, or surgery but not yet used for such
purposes"
Category C - Procedures involving no pain or distress or requiring no use of pain relieving drugs. Euthanasia is performed in accordance with the
recommendations of the AVMA report on Euthanasia. These are routine procedures such as blood sampling, tattooing, and injections. Polyclonal
antibody production and procedures involving administration of an anesthetic, analgesic or tranquilizing drug to an animal for short term
restraint purposes to perform a procedure that involves no pain or distress may be considered level C. Almost any terminal procedure, regardless of its
degree of invasiveness or effect on the organism can be considered a level C if done under complete anesthesia and followed by accepted euthanasia.
Category D - Alleviated pain. Procedures involving pain or distress for which appropriate anesthetic, analgesic, or tranquilizing drugs were given.
Terminal and survival surgeries are included in category D.
Category E - Unalleviated pain. Procedures involving pain or distress but for which appropriate anesthetic, analgesics, or tranquilizing drugs would
have affected the procedures, results, or interpretation of the results. An explanation of these procedures and reasons why appropriate drugs were not
used must be justified in the Animal Care and Use Protocol.
Please note: When typing in form boxes pages may shift causing blank pages. You may type over italicized text.
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IACUC Form A
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INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
APPLICATION FOR APPROVAL OF RESEARCH INVOLVING ANIMAL SUBJECTS
FORM A – FOR INITIAL SUBMISSION
IACUC Approval #
I.
ADMINISTRATIVE DATA
A.
Project Title:
B.
Department:
C.
Principal Investigator Information:
IACUC USE ONLY
PI Name (must be faculty):
Email Address:
PI Department / Campus Address:
Zip:
Campus Phone #:
Fax #:
Other Phone:
Choose from drop down lists below
D. Co-Investigators / Project Personnel
Position
**Animal Care Training/Certification required for IACUC Approval. Please attach Training Certificates for all investigators. **
E.
Project Information
1.
Status Of Project Review:
Choose “Teaching” or “Research” from drop down list to the left
New Research Project
2. Funding Agency:
4. Project Start Date:
3. Funding Status:
Not Seeking Funding
5. Project Completion Date:
6. Project Summary:
[Briefly explain in language understandable to a layperson the aim of the study and why the study is important to human or
animal health, the advancement of knowledge, or the good of society. Attach an extra sheet if necessary. Note that this is not
experimental design or procedures].
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IACUC Form A
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II.
ANIMAL REQUIREMENTS
A.
General Information
Genus: [e.g., Mus] and Species: [e.g., musculus]
Strain, subspecies, or breed: [e.g., C57BL]
Common name: [e.g., black laboratory mouse]
Approximate age, weight or size:
Sex:
Bacteriological status [e.g., germfree (axenic), defined flora (gnotobiotic), specific pathogen free, conventional]:
Viral status [e.g., simian immunodeficency virus, simian retrovirus]:
Source(s) [e.g., name of vendor or breeder, bred in-house]:
B.
Housing
Primary housing location(s) [Facility manager must certify below that facility has the resource capability to support the study. If animals will
be housed in lab or anywhere else outside central facility for more than 12 hours, provide building and room number.]
Housed numbers: [What will be the average daily numbers of animals house at any given time? What is the expected peek census?]:
Location(s) where manipulation will be conducted [Indicate the time period animals will be outside the housing facility. Field research
should indicate the general location of the animal contact.]:
C.
Numbers
Number of animals to be used:
Year 1:
Year 2:
Year 3:
Total:
D.
Transportation
[Transportation of animals must conform to all institutional guidelines/policies and federal regulations. If animals will be transported on
public roads or out of state, describe efforts to comply with USDA regulations. If animals will be transported between facilities, describe the
methods and containment to be utilized. If animals will be transported within a facility, include the route and elevator(s) to be utilized.]
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IACUC Form A
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III.
A.
RATIONALE FOR ANIMAL USE
Justify the necessity to use this (these) species. Indicate why non-animal alternatives cannot be used by describing the methods
and sources that helped you determine that alternatives are not available.
[Describe your consideration of alternatives and your determination that alternatives are not available. Delineate the methods and sources
used in the search. Database references must include databases searched, the date of the search, period covered, and the keywords used.
Alternatives include methods that (1) refine existing tests by minimizing animal distress, (2) reduce the number of animals necessary for an
experiment, or (3) replace whole animal use with in vitro or other tests. When ascites production is used to produce antibodies, justification
needs to be given as to why in vitro systems cannot be used. Note that you must certify no valid alternative was identified to any described
procedures which may cause more than momentary pain or distress, whether relieved or not.]
B.
On what do you base your assurance that this study is not unnecessarily duplicative? Please attach documentation of database
searches performed as Attachment A.
C.
Justify the number of animals to be used. Note the statistical method(s) used. Define ALL experimental variables and identify
experimental endpoints. Any study which has the potential for causing more than momentary pain and suffering requires
thorough statistical analysis justifying numbers used and Veterinary approval is also required.
D.
Indicate the names and qualifications/training of the personnel having contact with animals. Years of experience and training
either directly or under the guidance of others is appropriate. Special circumstances (e.g. work with potentially dangerous/toxic
material or surgical procedures) may require further official training and certification. **Provide a copy of all certifications
where appropriate**.
E.
Provide the scientific objectives (aims) of the research.
F.
Provide the potential value of the study with respect to human or animal health, the advancement of knowledge, or the good of
society.
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IACUC Form A
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IV.
A.
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B.
DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES
Briefly explain the experimental design and specify all animal procedures. This description should allow the IACUC to
understand the experimental course of an animal from its entry into the experiment to the endpoint of the study. Specifically
address the following if applicable: (Use additional sheets if necessary):
Experimental injections or inoculations (substances, e.g., infectious agents, adjuvants, etc.; dose, sites, volume, route, and schedules).
Blood withdrawals (volume, frequency, withdrawal sites, and methodology).
Surgical procedures (provide details of survival and non-survival surgical procedures in Section VII.).
Radiation (dosage and schedule).
Methods of restraint (e.g., restraint chairs, collars, vests, harnesses, slings, etc.). Include how animals are restrained for routine
procedures like blood withdrawals. Prolonged restraint must be justified with appropriate oversight to ensure it is minimally
distressing. Describe any sedation, acclimation or training to be utilized.
Animal identification methods (e.g., ear tags, tattoos, collar, cage card, implant, etc.).
Other procedures (e.g., survival studies, tail biopsies, etc.).
Resultant effects, if any, that the animals are expected to experience (e.g., pain or distress, ascites production, etc.).
Other potential stressors (e.g., food or water deprivation, noxious stimuli, environmental stress) and procedures to monitor and
minimize distress. If a study is USDA Classification E, indicate any non-pharmaceutical methods to minimize pain and distress.
Experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavioral abnormalities,
clinical symptomatology, or signs of toxicity) must be specified when the administration of tumor cells, biologics, infectious agents,
radiation or toxic chemicals are expected to cause significant symptomatology or are potentially lethal. List the criteria to be used to
determine when euthanasia is to be performed. Death as an endpoint must always be scientifically justified.
Veterinary care (indicate desired plan of action in case of animal illness, e.g., initiate treatment, call investigator prior to initiating
treatment, euthanize).
Fully describe the method of euthanasia, indicating the agent, dose and route of administration and how dead animals will be
disposed of.
[NOTE: How is death determined? Decapitation or cervical dislocation without anesthesia is not acceptable without specific reasons for
their use. Nor is freezing or dropping in fixative]
C.
Pain or Distress Classification
Species
(Common name)
USDA
Classification*
B, C, D or E
Number of animals used each year
Year 1
Year 2
Year 3
3 year total
number of
animals
Total number of animals (should equal total from Section III. C.):
NOTE: Selection of D or E REQUIRES the approval of the FIU attending veterinarian
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IACUC Form A
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D.
Anesthesia, Analgesia, Tranquilization, Other Agents
[Specify the anesthetics, analgesics, sedatives or tranquilizers that are to be used. Include the name of the agent(s), the dosage, route and
schedule of administration. Describe tracking and security of controlled drugs (Drug Enforcement Agency requirements).]
E.
Hazardous Agents
[Use of hazardous agents requires the approval of Environmental Health & Safety (EH&S) and/or Institutional Biosecurity Committee (IBC).
Attach documentation of approval for the use of radionuclides, biological agents, hazardous chemicals or drugs, and/or recombinant DNA.]
1. Does this project involve the introduction or the involvement of recombinant DNA, or DNA or RNA molecule
derived therefrom, into animals as defined in the NIH Guidelines for Research Involving Recombinant DNA
Molecule (Section III-D-4)?
Yes
No
2. If yes, has either an IBC Exception Request Form or Recombinant DNA and Gene Transfer Application Form
been filed with the IBC?
Yes
No
F.
Procedures Checklist
Affirmative answer requires completion of:
1. Tissue collection (other than blood) from live animals
Yes
No
Section IV.D.
2. Immunization or bleeding
Yes
No
Section V
3. Ascites production and harvesting
Yes
No
Section V
4. Drug administration (other than anesthetics or analgesics)
Yes
No
Section VI
5. Surgical procedure
Yes
No
Section VI
a. Exposure of live vertebrates to hazardous agents (Infectious, radioactive or
carcinogenic agents)
Yes
No
Section VII
b. Prolonged post-operative restraint of animal
Yes
No
Section VII
c. Special diets, fasting or housing conditions
Yes
No
Section VII
d. Pain or distress experienced by subjects
Yes
No
Section VII
e. Production of blindness or paralysis
Yes
No
Section VII
f. Death as an endpoint in any procedure (this is NOT euthanasia)
Yes
No
Section VII
g. Animals will be fasted
Yes
No
Section VII
h. Special assistance from facility staff
Yes
No
Section VII
i. Special circumstances requiring additional documentation
Yes
No
Section VII
6. Special circumstances:
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IACUC Form A
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The following items must be completed only for items marked yes in IV.F.
V.
IMMUNIZATION AND BLEEDING:
A.
Immunization:
Antigen, vehicle and concentration used:
Volume injected:
Site of injection:
Frequency of injection:
B. Frequency of bleeding:
C.
Volume of blood withdrawn:
D.
Method of collection:
E.
Hybridoma or ascites:
Agents used:
Volume injected:
Site of injection:
Frequency of injection:
Frequency of fluid withdrawn:
Volume of fluid withdrawn:
Maximum number of collections:
Frequency of animal observation:
F. Complete Freund's adjuvant used?
Yes
No
Number of times?
G. Incomplete Freund's adjuvant used?
Yes
No
Number of times?
H. Name(s) and frequency of other adjuvant's used:
I.
Administration of drugs other than anesthetic and analgesics:
Indicate the name(s) of agent(s) to be utilized, the dose(s), route(s), frequency, and duration(s)
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IACUC Form A
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VI.
SURGICAL PROCEDURE:
Note:
Aseptic techniques are required for all warm-blooded animals. Surgery must be performed in a surgical area approved by the
IACUC.
A.
Where will the surgery be performed?
Building:
Room No.:
B.
Where will post operative care be provided?
Building:
Room No.:
C.
Are there multiple surgeries or has major survival surgery been performed on any animal prior to being placed on this study?
No
Yes
If Yes, provide a justification for multiple surgeries
D. Provide a description of what happens to the animal during the surgical procedure:
E. List names and training of those who will perform the surgery. Name the individual(s) responsible for post-operative care and indicate
where post-operative records will be maintained. **Note. A medical history chart must be maintained with no less than daily entries.
F. Identify the anesthetic agent(s), dosage(s) and route(s) of administration. Describe the method used to monitor level of anesthesia.
G. If a gas anesthetic is used, is a scavenging system in place?
H. Will paralytic drugs be used?
No
I. Will post-operative antibiotics be used?
Yes
No
Yes, indicate the agent(s), dosage(s) and frequency of administration and the method
of monitoring anesthesia.
Yes, name the antibiotic and how it will be administered.
No, explain / justify
J. What post-operative measures will be taken to minimize discomfort? If none, explain/justify.
K.
If analgesia is used post-operatively, indicate:
Type (name):
Dose:
Frequency and route of administration:
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IACUC Form A
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VII. Special conditions:
A.
Identify the isotope or hazardous material:
1. Exposure route:
2. Exposure dose:
3. Exposure duration:
4. Will the agent be excreted?
If yes:
In urine
Yes
In feces
No
Exhaled
5. Indicate where animal(s) will be housed during and after exposure.
6. Indicate the method of disposal for the material/animal.
B. How will animal activity be restricted (as a result of surgical procedures or by chairs, tethers, stanchions, metabolism cages, etc?)
1. Indicate type of restriction:
2. Duration:
3. Frequency:
4. How frequently will the animal be observed during restraint?
C. List any special housing requirements required for the project (lighting, feed, caging, etc.).
D. Indicate the Pain/Distress category to which the animal(s) can be assigned.
See Checklist page for key to categories
Describe measure(s) that will be taken to alleviate pain or distress. If no measures are taken, you must justify this decision.
E. Justify why death as an endpoint is necessary to this study.
F.
How long and how often will a single animal be fasted?
G.
Describe the special assistance / training required from the animal facility supervisor or staff.
H. Indicate any procedure or occurrence which might be questioned upon review of your study and provide additional explanation or
justification that will be helpful in reviewing this procedure. If describing behavioral conditioning, indicate the purpose of the
conditioning, reinforcement techniques and criteria used to monitor the animal's condition.
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IACUC Form A
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AFFIRMATION OF COMPLIANCE AND ACCEPTANCE OF RESPONSIBILITY
The policies and procedures of Florida International University and the USDA apply to all activities involving live vertebrate animals
performed by the personnel at this institution. No activities involving the use of these animals are to be initiated without prior written
approval of the FIU Institutional Animal Care and Use Committee (IACUC).
The undersigned is familiar with and agrees to adhere to the PHS Policy on Humane Care and Use of Laboratory Animals, the regulations
and policies of the USDA, the NIH Guide to the Care and Use of Laboratory Animals and FIU policies.
I assure that:

Any change in the care and use of animals involved in this protocol will be promptly forwarded to the IACUC for review and approval
prior to implementation of the change.

Only properly trained individuals will participate in this project.

Animals will not be transferred between investigators without prior written approval of the IACUC

I will notify the IACUC of any adverse events related to this project
Signature of Principal Investigator
Date
Printed Name of the Principal Investigator
Signature of Other Researcher
Date
Printed Name of Other Researcher (If Applicable)
Signature of the Authorized IACUC Member
Date
Printed Name of the Authorized IACUC Member
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IACUC Form A
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