UNIVERSITY OF FLORIDA ANIMAL USE APPROVAL FORM

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UNIVERSITY OF FLORIDA ANIMAL USE APPROVAL FORM Powered By Docstoc
					Please read each set of instructions before answering each question, and provide only the
details requested. This form should be used to request the use of LIVE animals for teaching
purposes. The use of cadavers or tissues for teaching purposes can be requested using the
“Tissues Only” form.
Other than deleting the instruction boxes, DO NOT change the formatting of this form – if the
form does not look like the one on the website, it will not be accepted for review. IACUC staff
members are available for assistance if you have any questions while completing this form.
ACS veterinary staff must be consulted during the development of all animal use protocols and
must approve the form before it is submitted to the IACUC. Send an electronic copy of your
form to VConsult@grove.ufl.edu. Review by the veterinary staff takes time – they have a
large volume of protocols to review in addition to clinical duties. Please plan accordingly!
After ACS veterinary approval has been obtained, you will be notified and an electronic copy of
the completed form will be given to the IACUC by the veterinarians. All necessary training,
permits, and/or registrations must be obtained prior to IACUC approval.
Original signatures are required on the final (IACUC approved) version of your request form
before an official letter of approval can be issued.
        Double-click to the left of this box and hit the DELETE key to Delete this box.
FOR OFFICE USE ONLY:
Date Received:_________                                                          IACUC #______
Date Approved:_________                                                  Review Type: _DR-___
                                                                  Vet Consult # ____________


               ANIMAL USE FOR TEACHING PURPOSES
                      Approval Request Form
INSTITUTIONAL ANIMAL CARE & USE COMMITTEE                                               392-9917
P.O. BOX 100142                                                              http://iacuc.ufl.edu
Gainesville, FL 32610-0142                                                 IACUC@grove.ufl.edu



Responsible Faculty (PI):
Phone:                                                 Emergency Contact Number:
Fax:
E-mail:                                                Emergency E-mail:
Campus PO Box #
Department:
Dept. Chair:                                           Phone:
Other Contact Person involved in the study (name, phone number and email):

Usually there is one person (lab manager, course director) who is responsible for the details of
the animal use in a course. If this is not the Responsible Faculty member listed above, please



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identify that person and provide their email address. Do not list all personnel involved in the
course.                               Delete this instruction box.


1. Title of Course:
Include Title and any associated Course Number(s)             Delete this instruction box.


2.     Semester(s) or Date(s) of course:
If this is a one-time seminar, please list date. If it will be held annually, something like “2 days
in January each year” will suffice. If it’s a regularly scheduled seminar or course, provide
semesters and years (i.e. Fall of 2003-06 or Summer C of 2004-2007) Remember, the IACUC
only approves for one year, with up to two one-year extensions, so up to three years of
classes can be described. After that, a new request form will be required. Delete this box.


3.   Source of Funding:
Is the course funded by a department or college? Is it sponsored by a private company?
                                   Delete this instruction box.


4.   Description of the animal aspect of the course in non-technical terms:
The request will be returned without action if you fail to describe what will happen to the live
animals and why in non-technical terms.
This should describe, in a manner that the general public can understand, what you will do to
the animals. Include a statement of your goal or reason for using animals in this course and
the general procedures involved (Instructing students in the use of laparoscopic devices?
Demonstrating hoof trimming?) Describe, in general, what conditions the animal will endure in
this course, how long will any individual animal be involved, and if they will experience any pain,
distress, or discomfort. Detailed descriptions are requested later in this form.
                              Delete this instruction box.


5.     Please list all instructors and staff contacting animals, their training and experience
       with this species:
Please only list those involved with this project who will be contacting animals. The PI and all
listed personnel must have completed at least the “Level 1” training which consists of the
online Working with the IACUC course and exam; species and procedure-specific (if available)
online LATA training module(s); and the 2002 Health Risk Assessment for the EH&S Animal
Contact Program prior to having any animal contact. For more information please see:
http://iacuc.ufl.edu/Training.htm. Please include a statement verifying that all of these
requirements have been met by each individual.
It is required that all personnel be properly trained in the animal procedures you have listed in
this project. Please include a statement describing each individual’s role on this protocol. It is
essential to include details of experience/training in the procedures each person will be
responsible for performing as part of this project. This includes animal handling, restraint,



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euthanasia methods, and any special techniques to be employed. To arrange for training or
assistance in any animal procedures, please contact the ACS veterinary staff.
It is not sufficient to simply state an individual’s academic credentials, “15 years of
experience,” or “on file.” Personnel must attend the ACS “Animal Awareness & Use at UF”
seminar if access to secure ACS housing facilities is desired.   Delete this box but leave
the following format alone.
       Name Phone #           Training and Experience pertinent to role in this course



6.    List the species of live animal(s) to be used, their USDA pain/distress/stress
      classification status, and the total number of animals being requested. If no live
      animals will be contacted, please state that.
Common names for the exotic species are helpful; please state terms such as transgenic or
SPF if applicable. The IACUC only approves animal projects for up to three years at a time.
You must justify the number of animals you plan to use in item #13. Please list all the animal
species involved with this project.
Category A – NO live animals are contacted – includes observational field studies or use of
cadavers not euthanized specifically for this purpose.
Category 1 (reported in column C of the USDA annual report) – No/minimal pain, discomfort,
or distress is associated with the protocol and No pain relieving drugs or treatments are
necessary
Category 2 (reported in column D of the USDA annual report) – Pain, discomfort, or distress is
associated with the protocol and pain relieving drugs or treatment are provided
Category 3 (reported in column E of the USDA annual report) – Pain, discomfort, or distress is
associated with the protocol but pain relieving drugs or treatment are withheld because their
use would interfere with the study objectives. (must be explicitly scientifically justified and
approved)               Delete this box but leave the following format alone
      SPECIES                CATEGORY                 TOTAL NUMBER REQUESTED




7.    Rationale and Alternatives to the Use of Animals and Relief of Pain and Distress.
This recent search must reflect your attempt to achieve the 3 R’s:
Refinement – alternative techniques or procedures to minimize potential pain, distress, or
discomfort to those animals which must be used,
Reduction – alternatives or methods which allow you to minimize the number of animals
used to obtain significant results,
Replacement – alternatives to the use of live animals for this research.

       Your narrative must address the following:

       1. Explain your search for alternatives to the use of animals for your studies --
       why replacements, such as cell culture, tissues or modeling, cannot fully replace
       animals.




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       Databases Searched          Date Searched        Years Search Covered          Keywords
       A.
       B.


       2. Explain your search for alternative methods to pain and distress (CATEGORY 2
       AND 3, ONLY).




       Databases Searched          Date Searched        Years Search Covered          Keywords
       A.
       B.


       Other Sources (meetings, papers, consultations) Date                     Topics

Federal regulations require that all investigators provide a narrative describing the rationale for
using animals and methods (including specific sources) used to determine that alternatives
(refinement, reduction and replacement) to the use of animals and to procedures that cause
more than momentary pain and distress have been considered. The USDA requires that you
specify two or more databases that have been used with appropriate keywords or search
strategy (www.nal.usda.gov/awic/alternatives/searches/searches.htm ). To meet these
requirements at UF, two databases must be searched for: (a) alternatives to the use of
animals and (b) alternatives to procedures that cause more than momentary pain or distress
(Category 2 and 3 studies, only). Examples of databases include: Biological Abstracts,
Medline/PubMed, CRIS, and the Animal Welfare Information Center (AWIC). Websites that
may be used but are not limited to these include: http://altweb.jhsph.edu,
www.nal.usda.gov/awic/, http://agricola.nal.usda.gov/, and http://gateway.nlm.nih.gov/ .

For keyword and search strategy assistance contact Peggy Hsu, a reference librarian, at
peggy@library.health.ufl.edu .

       Delete this instruction box.


8.   Principal Investigator’s Certification:
     “The information contained in this application for animal use approval is accurate to the
     best of my knowledge. This project does not unnecessarily duplicate previously
     performed experimental work. No change to the final approved protocol will be initiated
     without prior written approval of the IACUC. Every effort has been made to minimize the
     number of animals used and reduce the amount of pain, distress and/or discomfort these
     animals must experience. Appropriate space has been arranged in the event that the
     project is approved. All involved personnel are listed, are properly trained and recognize
     their responsibility in strictly adhering to approved protocols. This project will be
     conducted in compliance with all University of Florida policies and applicable Federal,



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      State, and Local regulations.”
      “My supervisor/chairman has received a copy of this Animal Use Approval Request and I
      am prepared to vouch for the fact that the science is sound and that the use of animals is
      justified.” “The IACUC and the attending veterinarian or his/her designee will be allowed
      full access to all research animals and facilities in the protocol at all times.”




                              Signature                    (Date)
Only the completed e-copy is required for IACUC review. Please wait to submit your hard copy.
Your signature will be requested on the final approvable watermarked version which will be sent
to you by the IACUC. Do not sign the original electronic submission.
Please read and know what you are signing! This signature certifies that you and all
personnel listed in this form are aware of all applicable regulations and policies, have
completed all requirements, and will not deviate from the approved animal use protocol.
                                     Delete this instruction box.

9.    Justification for using this particular species:
Why are you requesting this species? The use of the lowest phylogenetic or least sentient
species possible is encouraged. Common statements have included: animal size; compatibility
with previous studies; known susceptibility; existing knowledge database; and the information is
intended for use in this species.   Delete this instruction box.


10.   Justification of your animal numbers:
      Class size and composition?
      Teacher to student ratio?
      Animal to student ratio?

11.   Where will you get your animals?
All animals entering the UF animal facilities must be ordered from an approved vendor through
the appropriate channels. Please indicate your vendor or supplier of animals here. If animals
are part of a stock UF herd or flock, please say so and indicate the unit in which they are
housed. Will animals be temporarily transferred from an off-study protocol for use in this class?
                                      Delete this instruction box


12. Where will the animals be housed?
Please indicate the building or housing unit where you intend to keep these live animals.
                                      Delete this instruction box


13.   Description of all non-surgical procedures to be used in this class:




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Describe in detail exactly what will be done to these animals and by whom. If animals are being
handled only by the instructor for demonstrations, please say so. If students will be handling
animals, please describe the animal contact and the supervision they will have.
                                       Delete this instruction box


14.    If surgery is being performed in this class, describe the instructor’s surgical
       training and experience with aseptic technique.
These personnel must be properly trained in aseptic techniques. Indicate their type and length
of training and experience below. How long they have been doing these specific procedures?
Completion of at least the LATA Aseptic Surgery and Anesthesia/Analgesia On-Line Modules,
as well as attending an ACS Hands-On Aseptic Techniques Workshop is required.
                        Delete this box but leave the following format alone
     Name               Training and Experience in Aseptic Surgical Techniques



15.  Location of any animal procedures or surgery. (The room must be visited and
     approved by EH&S and the IACUC prior to its use)
Please provide the location (building and room numbers) where the animal use for this class will
take place. Please verify inspections have been completed and room approved for animal use.
                                      Delete this instruction box.


16.   Description of sedation or anesthesia to be used for restraint, surgery, or
      euthanasia and method used to determine the animal’s level of anesthesia:
If you are sedating or anesthetizing your animals, provide details of the drugs (generic names),
dose range, and route of administration, along with details of how you will monitor the animal's
level of sedation or anesthesia.
Complete anesthesia details are needed for both survival and non-survival surgical procedures.
If you are using inhalant gases (isoflurane, halothane, etc.), list the agent and the method of
scavenging. Anesthetic waste gases are classified as environmental hazards. These gases
must be used in a fume hood or have a gas scavenging system in place. Consult the Division
of Environmental Health & Safety [(904) 392-1591] for information regarding this requirement.
The use of diethyl ether as an anesthetic agent is prohibited because of its flammability.
                                       Delete this instruction box.


17.   Description of all surgical procedures to be used in this course and all peri-
      operative care and physiological monitoring. (describe as “survival” or “non-
      survival” or multiple surgical events as appropriate)
Please provide a description of the pre-surgical preparation of the animals, all surgical
procedures and monitoring, the immediate recovery care and monitoring.
Include the surgical approach, organs involved, any implants, and method of skin closure. (The
use of silk to close the skin is not acceptable. Please identify a non-wicking material to use to
close the skin.) It is also necessary to describe the monitoring of body temperature, fluid
balance, and heart and respiratory rate during surgery and recovery.
Indicate what arrangements will be made for providing post-operative care after normal duty



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hours, weekends, and holidays.
Please read the Surgery Guidelines here at UF, posted on the IACUC website at
http://iacuc.ufl.edu/Guides.htm. If you cannot abide by any of these standards, you must
explain this deviation so that the Committee can review and approve it.
                                      Delete this instruction box


18.    Describe any signs of pain/distress/discomfort that might be observed, either as a
       result of any procedure(s) in this protocol or inherent to this particular model.
       Include any possible effects of treatments (both acutely and over time), any
       expected or potential post-operative and/or post-procedural signs, as well as your
       monitoring schedule, assessment criteria, and provisions for treatment.
Please provide details of what one might expect to see if one were to observe your animals on
a given day. Describe your monitoring schedule and parameters which will be evaluated. Even
if you do not expect to see any signs, please make a statement that describes how often
you will observe your animals – all animals must be observed at least once every 24
hours by a member of the research team; parameters you will monitor, and if signs do
occur, please describe what you will do.
If you expect any animals to develop any clinical conditions or abnormalities (including changing
tumor size, body weight gain or loss, inability to eat or drink, behavioral abnormalities, signs of
toxicity, hair loss, signs of discomfort, infirmity due to aging, etc.) please provide details here.
If you are providing analgesics supply their generic names, route of administration, dose
ranges, and dosing intervals.
In answering this section, be accurate regarding drugs and doses. The consultation with ACS
veterinarians will help you complete this section.       Delete this instruction box.


19.    Describe what will happen to the animals at the end of their roles in this course?
       (Euthanized - by what method? Returned to the herd, flock, or wild? Adopted or
       sold? Transferred to another approved project?)
Explain the AVMA-approved euthanasia method you intend to use. If you are using a drug(s),
you must indicate the generic name, dose and route of the drug. If your method is not
approved by the current AVMA Panel on Euthanasia, it must be scientifically justified. If you are
unsure about your method of euthanasia, consult with the ACS veterinarians. Cervical
dislocation or decapitation of animals requires prior sedation/anesthesia. If you cannot
anesthetize the animals prior to cervical dislocation or decapitation, you must provide scientific
reasons to justify withholding them. Also, if you cannot sedate animals prior to cervical
dislocation or decapitation, you are required to describe the training or experience acquired for
the person using this method. If you are using CO2 for euthanasia of rodents, the University
of Florida requires that you include either cervical dislocation, thoracic puncture, or some similar
procedure after the CO2 administration to ensure death. Please see:
http://iacuc.ufl.edu/Guides.htm
Options other than euthanasia must also be adequately described. If being transferred to an
approved project, provide the IACUC approval number and a description of the procedures
involved. If intended for adoption, UF’s established adoption policies and procedures must be
followed.
Please note: Federal Regulations require that any genetically altered animal, or any animal
treated with gene therapy, be disposed of in a manner that ensures it will not enter the food



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chain. At UF, that means the animals must be euthanized, and any tissue not being retained
for further study must be incinerated.           Delete this instruction box


20.        Departures or deviations from standard operating procedures, rules or regulations.
Type YES or NO for each. If “YES” for any item, explain the expected deviation from
standard operating procedures or guidelines and provide detailed scientific justification. READ
CAREFULLY, THE QUESTIONS HAVE CHANGED. The UF animal care websites provide
information concerning each of these items.       Delete this instruction box.
    a. Is this a Category 3 study? (If so, a description of the scientific justification for
       withholding anesthesia, analgesia, treatment, or timely intervening euthanasia is
       required.)

      b. Will animals be subjected to any non-standard housing, care, or treatment
         (including but not limited to: solitary rather than standard group housing, rodent
         caging with wire-mesh bottoms, metabolic cages, non-standard diet, bedding,
         light cycle, temperature, or method of sacrifice not approved by the AVMA Panel
         on Euthanasia)?

      c. Will animals be housed anywhere outside of ACS facility housing for periods of
         time >12 consecutive hours, or periods >24 hours for rats of the genus Rattus,
         mice of the genus Mus, and birds bred for research? (If so, this location must be
         inspected and approved by the IACUC, ACS, and EH&S to verify that it meets all
         animal housing facility regulations prior to its use. Please provide that location,
         justification for this housing, and date of most recent inspection.)

      d. As an investigator using animals, you are responsible for knowing and ensuring
         that all involved personnel adhere to all regulations, policies and guidelines. Do
         you have a copy of the NRC Guide for the Care and Use of Laboratory Animals?


      e. Have you read the NIH and UF Rodent Surgery Guidelines and do you agree to
         adhere to those guidelines? (If necessary, please describe and scientifically
         justify any planned deviations from those guidelines.)

      f.    Will multiple survival surgeries be performed? (If so, please provide the scientific
            justification for the multiple events.)

      g. Will protected species, exotic species or wildlife be used? (If so, please provide
         the permit #.)

      h. Will privately owned animals be used?
      i.    Will you be using dogs that will be exempted from the required exercise and
            enrichment program? (If so, please provide a brief description of the scientific
            justification for the exemption.)




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        j. Will you be using monkeys in a protocol that will require exemption or
              modification of the existing enrichment program or that prevents group housing?
              (If so, please provide a brief description of the scientific justification for the
              exemption.)

        k. Will animals be subjected to “excessive, unusual, or prolonged” restraint? (If so,
           please provide a brief description of the scientific justification.)

        l.    Will any paralyzing agents (vecuronium, gallamine, pancuronium, atracurium,
              etc.) be used without accompanying general anesthesia to restrain animals? (If
              so, please provide a brief description of the scientific justification for this form of
              conscious restraint.)

        m. Will you be using Freund’s Complete Adjuvant? (If so, please explain why an
           alternative cannot be used)

        n. Will animals undergo any food or water restrictions in excess of 24 hours?

        o. Will animals experience any electric shock? (If so, please provide a brief
           explanation of the circumstances and scientific justification)


  21.        Does this project involve any of the following items as they relate to the handling,
             housing or injecting of live animals? Check YES or NO for each item after the
             question “Using?” If YES all fields require a response. Please contact EH&S if you
             have questions (352-392-1591, bso@ehs.ufl.edu)


                              Known or suspected toxic compounds
1. Toxic Agents (toxic chemicals, toxic pharmacological agents,
suspected or known mutagens, carcinogens, teratogens, or similar
agents to be used in animals)
NOTE: PI must supply ACS with MSDS sheets (if applicable)
Using?
    NO (Proceed to #2)
    YES (Complete all fields)
                                                                                              Date of last
                                                   Frequency &                  Suspected
                       Route of                                    Route of                    Chemical
Chemical Name                         Dosage(s)     Duration of                  or known
                     administration               Administration   excretion                 Hygiene Plan
                                                                               carcinogen?
                                                                                                update




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2. Biological Materials (Will microorganisms, cell lines, tissue, nucleic acid, or
other biological material be administered? If radioactive, complete #4 also)
Using?
   NO (Proceed to #3)
   YES (Complete all fields in a, b, c, or d as appropriate)
a. Biological Toxins

                                                                                                     Acute toxin
                                       Dosage(s)        Frequency &                                     EH&S
                      Route of                                          Route of
  Toxin Name
                    administration
                                     (ml/kg, mg/kg)     Duration of
                                                                        excretion
                                                                                     Source       registration # (for
                                      and diluent      Administration                               LD50 of ≤ 100
                                                                                                         /kg bw)




b. Infectious Agents (bacteria, viruses, fungi, protozoa, prions or other agents. If this contains
recombinant nucleic acids, complete item d. also)
                                       Dosage(s)                                      CDC
                                      (CFU, PFU                                                   Biological
Agent, Strain or      Route of                        Route of     Frequency of     Biosafety
                                     and volume-                                                Agent EH&S
  Construct         administration        ml)         excretion    Administration     Level
                                                                                                registration #
                                     administered                                   ( 1,2, 3)




c. Human cells

                                                                                      OSHA
                                                                      Cells pre-
                                                                                      Blood
                                                                    screened for                Biological Agent
Cell type or cell                  Route of                                           Borne
  line name
                       Source    administration
                                                    Dosage(s)       which agent?
                                                                                    Pathogen
                                                                                                     EH&S
                                                                     (HIV, HCV,                  registration #
                                                                                     Training
                                                                        HBV)
                                                                                       date




d. Recombinant DNA, Recombinant Nucleic Acids, Recombinant Infectious Agents (Follow the NIH Guidance
for Research Involving Recombinant DNA molecules. Consult UF Biosafety Office and the University
Veterinarian for compliance issues)
                                                Route,
                     Gene (or
 Vector / Method                    Gene     frequency, &                   Route of    rDNA EH&S
                    construct)                               Dosage(s)
 of gene transfer                 Targeted    duration of                   excretion   registration #
                    delivered
                                            administration




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3. Transgenic Animals
Using?
    NO (Proceed to #4)
    YES (Complete all fields)
                                                                                                          Transgenic
                        Source                                                                            Animal EH&S
                                           Knock-out
 Species & Strain       (vendor,                                    Immune           Gene product         registration #
                                           or Knock-    Gene(s)
      name              colleague, or                              deficient?         excreted?           (purchased
                                           in?
                        other)                                                                            transgenics
                                                                                                          exempt)




4. Radioactive Agents or Irradiation (Will radioactive compounds be administered
or will animals be irradiated?)
Using?
   NO (Proceed to #5)
   YES (Complete all appropriate fields)
a. Radioisotopes

                                        Agent Dose
                                                                                                                 Date of
   Radioactive          Route of        (mg/kg), vol.   Frequency and                           Radiation
                                                                                                                Radiation
 agent (include       administration      (ml), and       Duration of       Diluent              Office
                      and excretion                     Administration                                           Safety
 Isotope name)                             activity                                           Approval Date
                                                                                                                Training
                                          (mCi/kg)




b. Irradiation

                                                                                  Date of
                                                              Frequency
                             Location of        Radiation                       irradiator-          Radiation Office
    Irradiator type                                               of
                             Equipment            dose                            specific            Approval Date
                                                                 dose
                                                                                  training




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5. The principal investigator is responsible for ensuring that his/her project personnel
have been adequately trained prior to work with hazardous materials or equipment.
Please contact Environmental Health & Safety 352-392-1591 for assistance if needed.
Identify project personnel listed in question #5 (Name) that have received training (date)
regarding the hazards identified above:

Name:                             Date:          Name:                             Date:
Name:                             Date:          Name:                             Date:
Name:                             Date:          Name:                             Date:
Name:                             Date:          Name:                             Date:



AS YOU PREPARE THIS DOCUMENT:

Do not change the formatting of this form. All items should be numbered and formatted as
in the original form. The committee must review a large volume of these each week and a
consistent format makes the review process much easier.
Submitted requests that do not conform will be returned without action for revisions.

If you have used “tracking” for editing, please “accept” your changes and eliminate the tracked
changes before submission.
Spelling and grammar count! SPELL-CHECK and proof-read it before submission!
This is a public document and should reflect your professionalism.

Please DO NOT double space your text.
Please Preview and Correct any formatting that may have been changed during your
editing before you SAVE IT as a WORD document and SUBMIT IT.

But first - DELETE THIS AND ALL OTHER INSTRUCTION BOXES!




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