IACUC Application by 1AfH7A

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                            Institutional Animal Care and Use Committee
                      Application for the Use of Laboratory Animals in Research, Teaching and Training



    Protocol No.      Date Received       Date Approved        Date Closed        Status                 Reviewers




INSTRUCTIONS
    The application form must be typed and all questions must be completed or marked Not Applicable (NA)
    Please e-mail this Application to amartinez@ochsner.org and send the signed original to the IACUC Office, New
     Research Building Room 1N006 – Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, LA 70121
    IACUC meetings are held on the fourth Thursday of every month. The deadline for receipt of applications is the first
     Thursday of the month.
    Incomplete protocol applications may be returned without committee review.


1) GENERAL INFORMATION
     a) Protocol Title (Include Animal Species)


     b) Name of Funding Agency or Source (If your Grant is PHS funded please provide your Grant number)


     c) Funding Agency Mailing Address



2) PRINCIPAL INVESTIGATOR
     a) Last Name, First Name


     b) Position/ Title - Department


     c) Office Phone             d) Beeper or Cell phone                 e) e-mail address



3) CO-INVESTIGATOR
     a) Last Name, First Name


     b) Department


     c) Office Phone                    d) Beeper or Cell phone




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4) EMERGENCY LAB CONTACT

    a) Last Name, First Name


    b) Department


    c) Office Phone                    d) Beeper, Cell or Home Phone


5) PROTOCOL CATEGORY
       New               Teaching         Experiential
       Resubmission – Please provide previous Protocol Number
       Three Year Renewal - Please provide previous Protocol Number



6) NATURE OF THE PROTOCOL/STUDY Please check [X] all applicable boxes
       Acute Study                  Breeding                         Multiple Surgeries
       Chronic Study                Antibody Production              Other
    If “Other” Explain




7) NON TECHNICAL SUMMARY
   Briefly summarize the aim(s) of the study. Explain why the study is important to human or animal health, the
   advancement of knowledge or the good of society. This should be stated in such a way that a non-scientist can
   understand the purpose of your work.




8) TECHNICAL SUMMARY
   State the protocol's broad, long-term objectives and specific aims. Describe the research design and methods for
   achieving these goals. This abstract should serve as a succinct and accurate description of the proposed work when
   separated from the application.




9) HUMANE END POINTS IN AN ANIMAL STUDY PROPOSAL
   List the manifestations of animal pain and/or distress and the guidelines that may lead to early study termination. Note
   that the humane endpoints are generally different from the standard study endpoints.




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10) ANIMAL INFORMATION
   a) Indicate the number of animals to be used over the full duration of the project or the three years approval
      period, whichever is shorter.

                                                                                               Avg. No.    Three Years
             Species           Strain           Breed              Sex     Age      Weight
                                                                                               per day        Total




   b) Animal Housing
         Richard Freeman (Rodents Facility)                  Coolidge West (Large Animals Facility)
         Overnight housing                                               Average number of animals housed daily
           If “Overnight Housing” please provide location and justification



         Collaborating Institution
          Indicate the name of the Institution and provide a copy of the IACUC approved Protocol as well as a copy of
          the approval notification from the Institution covering those animals.



         Other


   c) Animal Source
         Commercial Vendor               In-house Breeding
           If “In-house Breeding” please provide the reasons for establishing and maintaining a breeding colony, the
           scheme and methods of breeding, and monitoring



         Transfer form another Institution
          Provide the name of the Institution and justification.



   d) Special Requirements
         Caging – Please explain


         Housing – Please explain


         Medication – Please explain


         Physical Restraint – Please explain




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           Diet – Please explain


           Other



   e) Rationale for the use of animals
      Include the reasons why non-animal models cannot be used.



   f)   Rationale for the choice of species
        Justify the appropriateness of the species selected.



   g) Justification for the number of animals
     Describe statistical and non-statistical factors used in determining sample size. Attach tables showing experimental
     treatments and animal numbers where appropriate.




11) STUDY CLASSIFICATION
   Define the Classification of your study and include the total number of animals in each class.

                           Number of animals upon which teaching, research, experiments, or tests
          CLASS A          will be conducted involving no pain, distress, or use of pain-relieving
                           drugs.

                           Number of animals upon which experiments, teaching, research,
                           surgery, or tests will be conducted involving accompanying pain or
          CLASS B
                           distress to the animals and for which appropriate anesthetic, analgesic,
                           or tranquilizing drugs will be used.

                           Number of animals for which teaching, experiments, research, surgery
                           or tests will be conducted involving accompanying pain or distress to the
          CLASS C          animals and for which the use of appropriate anesthetic, analgesic, or
                           tranquilizing drugs would adversely affect the procedures, results, or
                           interpretation of the teaching, research, experiments, surgery, or tests.




   If “CLASS C” please explain the procedures producing pain or distress in these animals. The reasons such drugs
   were not used must be attached to this report.




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12) OCCUPATIONAL HEALTH AND SAFETY
         Please checks [X] all applicable boxes and provide a short description of the agent(s)

    a)       Infectious agent
    b)       Radioisotopes
    c)       Chemicals
    d)       Carcinogens
    e)       Recombinant DNA
    f)       Hazardous chemicals
    g)       Laser



    h) This agent / material is hazardous for
             Human only         Animals only           Human and Animals        Not applicable

    i)    This agent can be spread by          Blood              Feces/urine           Saliva/nasal droplets
                                               Does not leave animals           Other         Not applicable

    j)    Describe any human risk associated with agent.


    k) Please provide a plan for the protection of personnel and animals.


NOTE: A letter of approval from the Bio-Safety, Radiation, or Safety Committee(s) is required to order animals.


13) PERSONNEL QUALIFICATION AND TRAINING
    Provide a listing of all personnel involved with the proposed protocol. If Curriculum Vitae is not on file, please include
    a copy with this application.
                                                                                 Training Relevant to this      Curriculum
                                                          Specific Role on
             Name                     Title                                       Protocol and Years of           Vitae on
                                                              Project
                                                                                        experience                  File
                                                                                                                -
                                                                                                                -
                                                                                                                -
                                                                                                                -
                                                                                                                -



14) SURGICAL AND EXPERIMENTAL PROCEDURE DESCRIPTION
    a) Specific Aims


    b) Experimental Procedure Description
       Briefly describe the experimental procedure, estimated time of surgery, site and placement of catheters, device
       implantation, suture type, etc.




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   c) Will animals be allowed to recover from anesthesia?
           Yes                 No           Not applicable

   d) Will animals be allowed to recover from more than one surgical procedure?
           Yes                 No           Not applicable
        If “Yes”, please provide scientific justification for multiple major surgical procedures.



   e) Describe aseptic techniques for survival surgeries.


   f)   Describe any post-surgical monitoring and post-surgical care procedures.



15) ANALGESIA / ANESTHESIA

   a) Pre-anesthetic Agent(s)
                       Drug                                  Dose                                Route




   b) Induction Agent(s)
                       Drug                                  Dose                                Route




   c) Anesthetics
                        Drug                                 Dose                                Route




   d) Post Surgery Analgesia
                        Drug                                 Dose                               Route




16) OTHER INJECTIONS ADMINISTERED (Per Animal)

                 Material                         Purpose                 Number          Dose           Route




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17) ADVERSE EFFECTS
    Describe all significant adverse effects that may be encountered during the study (such as pain, discomfort, reduced
    growth, fever, anemia, neurological deficits, behavioral abnormalities or any other clinical symptoms of acute or
    chronic distress or nutritional deficiency). If genetically altered animals are used, please describe any potential effects
    that could be associated with the desired genotype, if known.




18) EUTHANASIA METHODS (Please check all applicable boxes)
         Pentobarbital 100 mg/kg + thoracotomy                  IM                         Thoracotomy
         CO2 OD - Bottled only                                  IV                         Decapitation
         Isoflurane 5%                                          IP                         Exsanguination
         Other                                                  IC                         Cervical Dislocation
                                                                Inhalation                 Other
      If “Other" explain




19) NON DUPLICATION ASSURANCE
    Regulatory agencies discourage duplication of research studies in animals. An appropriate literature search is
    required. – www.ochsner.org/body.cfm?id=660 access ANIMAL PROTOCOL and then AWIC FORM
    a) Briefly explain how you determined that this experiment is not a duplication of previous experiments.



    b) If this experiment is a replicate of previous experiments, describe the necessity to repeat the work.




20) DOES THE PRINCIPAL INVESTIGATOR, CO-INVESTIGATOR, OR ANY OTHER OF THEIR IMMEDIATE FAMILY
    MEMBERS
    a) Have any monetary interest (more than $5,000) in the device/product employed in this study?
         Yes       No

    b) Hold an ownership share (stocks, stock options or royalties) in the device/product employed in this study
       or in the company(s) which owns the device/product?
           Yes         No

    c) Stand to gain financially (other than as described in the study budget) whether directly or indirectly as the
       result of the conduct of this study?
           Yes         No




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As Principal Investigator, I will comply with the procedures and methods outlined in The Guide for the Care and
Use of Laboratory Animals, as well as the Public Service Policy on Humane Care and Use of Laboratory Animals,
the Animal Welfare Act, and the applicable OCF policies. The activities described herein do not unnecessarily
duplicate any previous experiments. I certify that the individuals listed in Section 13 are authorized to conduct
procedures involving animals under this protocol, and have received the necessary training in the handling and
care of laboratory animals. I also acknowledge that OCF is not a Good Laboratory Practice (GLP) facility for FDA
purposes.




                  PI’s Signature                                   Date




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