UNIVERSITY OF MIAMI ANIMAL CARE AND USE PROTOCOL FORM by 0DJvdO

VIEWS: 0 PAGES: 27

									UM Animal Care & Use Committee                     LONG FORM                                            version 03/03/2008
INSTRUCTIONS:

Complete the Animal Care and Use Protocol Form, save it to a disk and forward the printed and signed copy to the IACUC
office along with the file on diskette or email your protocol form to the IACUC (iacucsupport@med.miami.edu), FAX,
send or bring a signed copy of the signature pages to the IACUC office for the files. The IACUC Office FAX number is
305 243-2853. FOR ANSWERS TO YOUR QUESTIONS CALL THE IACUC OFFICE AT 305 243-2311 or visit our
website http://iacuc.med.miami.edu/x6.xml. INCOMPLETE OR IMPROPERLY COMPLETED FORMS MAY
DELAY THE REVIEW AND APPROVAL OF YOUR PROJECT. ALL PROTOCOLS MUST HAVE A
COMPLETED TABLE OF CONTENTS/CHECKLIST PAGE.

An Animal Care and Use Protocol Form (LongForm) must be completed and approved by the University of Miami
Animal Care and Use Committee (IACUC) before any research, teaching or demonstration activity involving the use of
live or dead vertebrate animals by any employee of the University of Miami, can be initiated. Please complete and submit
the TABLE OF CONTENTS and CHECKLIST page to indicate to the IACUC which sections of the protocol form are
applicable to your project.

Investigators are strongly encouraged to review the web-based IACUC Guidelines prior to completing the protocol form.
The Guidelines were drafted by the University of Miami Animal Care and Use Committee (IACUC) in order to clarify the
nominal position of the UM IACUC regarding commonly accepted procedures, and to provide investigators information to
aid them in completing the IACUC animal use protocol forms.
 1.     Please provide all information as concisely as possible, but with enough detail so that someone who is unfamiliar
with your work can appreciate the scope and depth of your project. You are encouraged to use diagrams and/or flow charts
to help describe complex experimental designs. Under QUALIFICATIONS OF PERSONNEL HAVING CONTACT
WITH THE ANIMAL SUBJECTS please indicate the experience of the research team with the procedures. A response
such as “20 yrs. working with rodents” is not acceptable.
2.       In several areas of the Form you will be asked to justify your study and/or the procedures to be used. Implicit in
the justification is adequate documentation. Such documentation is usually satisfied by a thorough search of the pertinent
literature. Statements such as "our experience in the area makes us confident that the work is not duplicative" will not be
accepted as an adequately documented justification by the IACUC. The motivation of the IACUC for justification and
documentation is only to insure that the University of Miami and its faculty are in full compliance with all USDA and NIH
regulations governing the use of vertebrate animals in teaching and research.
3.      Please pay close attention to PART 3E, Alternatives to Potentially Painful Procedures, of the FORM. This
item is often reviewed by the USDA and improper completion of this portion of the form will result in delays in the
approval process. If you need assistance in completing this portion of the FORM you can call the IACUC office for
assistance.
4.       Research projects, involving the use of vertebrate animals, which will not be externally peer reviewed (e.g.,
funded with departmental resources, or industrial funds) must be reviewed and approved for scientific merit by the
chairperson of your department. The signature of the departmental chairperson is required on Request Forms for such
projects. Many departments in the University have departmental research committees to aid the chairman in assessing the
scientific merit of the proposed research. Please indicate on the Review Form if a departmental research committee for
scientific merit has reviewed your project.
5.      A completed and approved Animal Use Form is necessary, but, may not in some cases, be sufficient to initiate
your project. Other Committees at the UM may need to approve your protocol and procedures. These other offices may
include the Office of Radiation Control (PART 11C), The Office of Environmental Health and Safety (PART 11C,
PART 11D), The Recombinant DNA Committee (PART 11 B or C). Questions regarding which other offices may need
to review your project can be addressed to the IACUC office.




UM Animal Care & Use Committee                 LONG FORM – version 03/03/2008                                         1/27
RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR
    The privilege of using animals in research and teaching at the University of Miami is extended to the faculty with the proviso that
         such activities will be conducted in accord with all applicable policies, regulations and procedures of the PHS, the USDA and
         University of Miami. Please review and check each of the following “Responsibilities of The PI”.
    The Principal investigator is:
         Required to have a current animal use protocol, approved by the University of Miami IACUC, before any activities involving live or dead
          vertebrate animals is begun.
         Required to comply with all applicable Federal regulations, laws and policies.
         Required to assure that all participants on this protocol will follow the policies set forth in the Guide for the Care and Use of Laboratory
          Animals (The Guide).
         Required to comply with all University of Miami Policies regarding the humane care and use of animals in research and teaching.
         Responsible for the conduct of the work and to assure that all co-investigators, technical staff, students and visiting fellows or collaborators
          comply with all federal regulations and Institutional policies.
         Responsible for assuring that all participants in animal research studies under their supervision are properly trained in the humane care and
          use of animals in research and in the procedures used in the current model system according to Institutional policy.
         Responsible for keeping the animal use protocol accurate and up to date. PI’s must inform the IACUC when there are changes in
          personnel and funding.
         Responsible to assure that the work follows the approved protocol. All changes in the protocol or procedures must be reviewed and
          approved before the procedure can be implemented.
         Responsible for maintaining animal records in a secure but accessible location. Records must be available at all time for review by the
          attending veterinarian, the IACUC, the USDA and/or PHS.
         Responsible for assuring that all pharmaceuticals, reagents and devices used in animal research are appropriate for the research and are
          within the manufacturer’s expiration date. The use of expired reagents or devices must be approved in advance by the IACUC. Under no
          circumstances can expired anesthetics, analgesics or antibiotics be used in either survival or non-survival surgery. All expired reagents
          should be clearly marked “expired - do not use” and returned to the DVR for disposal.
         Responsible for assuring that all controlled substances are stored in a safe and secure manner.
         Responsible for assuring that all animals in the protocol are properly identified and described according to the UM IACUC Guidelines.
         Responsible for obtaining approvals from Radiation Safety, Occupational Health and Safety and/or the Recombinant DNA Committee
          prior to beginning animal activities regulated by these campus agencies.



USDA Regulations, PHS Policies, Institutional Policies
  The policies and procedures of the University of Miami, the PHS and the USDA apply to all activities involving live vertebrate
  animals performed at or by the personnel at UM or performed elsewhere by UM personnel. No activities involving the use of these
  animals are to be initiated without the prior written approval by the University's Animal Care and Use Committee (IACUC).

  The undersigned is familiar with and agrees to adhere to the USDA regulations described in the Animal Welfare Act, the PHS Policy
  on Humane Care and Use of Laboratory Animals, the ILAR Guide for the Care and Use of Laboratory Animals and the University of
  Miami policies. I further assure that:
  1.   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.
  2.   Only properly trained and IACUC approved individuals will participate in this project.
  3.   Animals will not be transferred between investigators without prior written approval of the DVR.
  4.   As the PI on this protocol, I provide my assurance that all animal related procedures described in the referenced NIH grant
       application, have been submitted to the IACUC for approval.
  5.   As the PI, I agree to assume the responsibilities listed above. Further, as the PI, I agree to adhere to the PHS Policy on
       Humane Care and Use of Laboratory Animals, the ILAR Guide for the Care and Use of Laboratory Animals, USDA
       regulations as defined in the Animal Welfare Act and its amendments.



  Signature of Principal Investigator (P.I.)                                                                           Date

The Department Chair must indicate that the project has been reviewed for scientific or instructional merit and approved. If the P.I. is
a department chairperson, this form must be reviewed and signed by the Executive Dean for Research.


  Signature of Department Chair / Executive Dean for Research                                                          Date




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012          2/27
           UNIVERSITY OF MIAMI ANIMAL CARE AND USE PROTOCOL FORM
                       TABLE OF CONTENTS AND CHECKLIST
Completion and Submission of the CHECKLIST and PARTS 1-5 are REQUIRED for all new Animal Use
applications. PARTS 6-11 of this form pertain to specific applications of animal subjects in research. In
addition to the REQUIRED PARTS, submit only those additional PARTS (6-11) that apply specifically to your
project.

 Table of Contents                                                                                                     Completion
 CHECKLIST                                                                            REQUIRED
  PART 1. Introduction                                                                REQUIRED
            Investigators                                                             REQUIRED
            Project Title                                                             REQUIRED
            Qualifications of investigators                                           REQUIRED
            Animal models and Usage                                                   REQUIRED
  PART 2. Project Summary                                                             REQUIRED
  PART 3. Assurances and Justifications                                               REQUIRED
  PART 4. Euthanasia                                                                  REQUIRED
  PART 5. Certification of Compliance with Institutional Policies                     REQUIRED
 IS THIS A TISSUES ONLY PROJECT? (The removal of tissue from dead animals)
                                                                      Enter YES / NO:
 “Tissues only” protocols (do not complete PARTS 6 - 11.
                *TISSUES ONLY PROJECTS AND PROJECTS TO GENERATE TRANSGENIC MICE*
                                 FILL OUT THE TISSUE SHARING FORM ON PAGE 24.


 COMPLETE and SUBMIT ONLY PARTS 6-11 that apply to your project                                                     Enter YES / NO
    PART 6. Antibody Production
         6A Polyclonal /Monoclonal Ab. Production
         6B Collection of body fluids
    PART 7. Anesthetics, Tranquillizers, Sedatives, Analgesics
    PART 8. Drugs and chemical agents
             Non-surgical Procedures (e.g. Toxicity, Pharmacologic, Other Non-
             Surgical)
    PART 9. Non-Survival Surgery
   PART 10. Survival Surgeries
       10b. If yes, major survival surgery
             Is it multiple survival surgery
   PART 11. Special Considerations
       11.A Tumor Bearing Animals
       11.B Implantation of primary human tissues or products in laboratory animals.
       11.C Transgenic, Gene Knockout, Gene Therapy
       11.D Hazardous Materials in Animal Subjects
             If yes, Biological?
             If yes, Chemical?
             If yes, Radiation?
       11.E Restraint of Animal Movement
       11.F Behavioral Interventions, Conditioning, Non-invasive monitoring
       11.G Additional Procedures
       11.H Special Housing/Husbandry Requirements
             Will NHP be singly housed?
             Is food restricted?
        11.I Field Studies with Wild Animals
        11.J Tissue sharing questionnaire
*May require review by the Recombinant DNA Committee
**May require review by the Office of Environmental Health and Safety, the Recombinant DNA Committee and/or Radiation Control.


UM Animal Care & Use Committee   LONG FORM – version 2/7/2012    3/27
  UNIVERSITY OF MIAMI ANIMAL CARE AND USE PROTOCOL FORM
                                                          Animal Care and Use Committee only
                                                          Protocol No.
                                                          Date submitted
                                                          Date reviewed
                                                          Date approved
PART 1. INTRODUCTION
Protocol Title:



 Type of project                                                                       e.g., Research, Demonstration, Teaching
 Type of Application                                                                   e.g., New, Renewal, Continuation
 If a renewal, Old IACUC No.
 Principal Investigator                                                                UM Employee ID #
 Department/ Locator code
 Phone #
 Emergency Phone # 1
 Emergency Phone # 2
 FAX #
 Email address
 Funding Source (Do not abbreviate)
 Grants Administration #                                                         The number on the grant transmittal form
 Grant ID #
 Grant submission date
 Grant review date
 Grant project start date
 Duration of the project
 Enter key words
 Additional key words

Co-Investigators and Associated Personnel at UM
                     Name                                Role on Project               Department                     Phone




Co-Investigators and Associated Personnel at other Institutions
                     Name                              Role on Project                Institution                     Phone




 Has the project been approved by the IACUC of the institution(s) listed above?
                                                                         Enter YES, NO, PENDING, or N/A
 Please deliver documents to the IACUC office.
 Is any of the animal work related to this project being conducted at another institution/facility as a
 subcontract or on a fee for service basis?                                                   Enter YES / NO



UM Animal Care & Use Committee   LONG FORM – version 2/7/2012      4/27
QUALIFICATIONS OF PI AND PERSONNEL HAVING CONTACT WITH THE ANIMAL SUBJECTS

           Name                  Degree        Role On Project               Training/Years. experience With Procedures/Animal Model
                                           P.I.




 The PI and all personnel having contact with animal subjects must complete Core level instruction in the Use of Laboratory
 Animals in Research every 3 years. Have all personnel listed above completed Core level training from the IACUC in the
 past 3 years?                                                                                         Enter YES / NO:
 If you answer “No” you may register for the training at http://iacuc.med.miami.edu/x12.xml. Your protocol will not
 receive final approval until all participants have current training.
 OCCUPATIONAL HEALTH AND SAFETY FORM All personnel having contact with animal subjects must
 complete the Occupational Health and Safety Acknowledgement form, if they have not previously done so (form
 appended). Have all personnel listed above completed an OHS acknowledgement form?       Enter YES / NO:
 OCCUPATIONAL HEALTH AND SAFETY TRAINING Regardless of whether you and your staff participate in
 the OH&S program or not, you and all participants in this study must complete a web based instructional module entitled
 “Occupational Health and Safety When Working With Laboratory Animals”. Have all participants in this study completed
 this educational resource?                                                                            Enter YES / NO:
 This protocol cannot receive final approval until all participants have completed this instructional module. You and your
 staff may register for the OH&S module at: http://iacuc.med.miami.edu/x12.xml.


ANIMAL MODELS AND UTILIZATION                                                                                                             Yes / No
 Are live vertebrate animals used in the proposed project?
 Is this a “TISSUES ONLY” project involving only the removal of tissue from dead animals?

LIST THE NUMBER OF EACH SPECIES AND TISSUES REQUESTED ACCORDING TO THE
APPROPRIATE PAIN CATEGORIES (Please read the Pain Category descriptions carefully)
          Note: All pups used must be counted as an animal as of one day post-partum.

PAIN CATEGORY A: Animals that will be bred or purchased for breeding, but, not used for experiments. This includes breeders, young that
cannot be used because of improper genotype or gender, and any other animal that will not participate in the research studies.
 Species/Tissue                        Category A Procedure                              Year 01          Year 02         Year 03          Total




PAIN CATEGORY B: Animals that will undergo research procedures that involve ONLY BRIEF OR NO PAIN/DISTRESS. Examples
include observational studies, most intravenous and parenteral injections of nonirritating materials, most blood collections from peripheral vessels,
and the collection of fluids and tissues from animals AFTER euthanasia (Tissues only projects).
 Species/Tissue                        Category B Procedure                              Year 01          Year 02         Year 03          Total




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012         5/27
PAIN CATEGORY C: Animals that undergo research procedures involving the potential for pain and distress that is relieved by the
appropriate use of analgesics, anesthesia and/or sedatives. Examples include major and minor surgery performed under anesthesia (survival and
nonsurvival surgery), tissue or organ collections prior to euthanasia, painful procedures performed under anesthesia ( i.e., retro-orbital blood
collection in rodents), prolonged restraint accompanied by tranquilizers or sedatives and experiments involving infectious or otherwise hazardous
agents in animals that have provisions for immediate euthanasia if they become sick to effectively prevent pain and suffering. If an endpoint is used
that involves significant pain and distress, consideration should be given to listing the animals in Category D.
 Species/Tissue                        Category C Procedure                              Year 01         Year 02          Year 03          Total




PAIN CATEGORY D: Animals that undergo research procedures in which pain and distress is NOT relieved with the use of analgesia,
anesthesia, tranquilizers or by euthanasia. Examples include studies in which animals are allowed to die without intervention (e.g., LD50 studies),
studies which permit endpoints that are painful or stressful, addictive drug withdrawal experiments without relief, pain research and experiments with
noxious stimulation. Any experiment where the normal use of anesthesia or analgesia is precluded because the agents will have a detrimental impact
on the endpoint being studied.
 Species/Tissue                        Category D Procedure                              Year 01         Year 02          Year 03          Total




GRAND TOTALS: Bring all yearly and project totals down, by species/strain/mutant as appropriate
 Species/Tissue                        Procedure                                         Year 01         Year 02          Year 03          Total




ANIMAL CARE INFORMATION
                             Maximum number at             Preferred housing           Locations where procedures              Maximum time
        Species
                                any one time                    location                   will be performed                 outside the facility*




*If animals will be held outside the normal housing area for longer than twelve (12) hours, please provide an explanation
below and contact DVR at 305-243-2310.




 Will Special Husbandry Care be required for this project?                                                        Enter YES / NO:

If “Yes” provide a description of your requirements.


If the location where the procedures will be performed is not part of the centralized animal facility or under direct control of the
Principal Investigator, provide verification that the individual responsible for the space has approved your use of the facility.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012         6/27
PART 2. PROJECT SUMMARY. Provide a concise summary of the proposed project in lay terms so that someone who is
unfamiliar with your work will be able to appreciate what you want to do.
Note: If this is a renewal or a continuation, please describe how this protocol differs from your previous submission.
Please do not submit the abstract / summary from your grant application. PLEASE CONFINE YOUR SUMMARY TO THE SPACE
PROVIDED.


        1.   Purpose and Rationale




        2.   Experimental Approach




        3.   Procedures with Animals




        4.   Significance




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   7/27
PART 3. ASSURANCES AND JUSTIFICATION FOR THE USE OF ANIMAL SUBJECTS
Adequate justification of your responses to the following questions is required by NIH Animal Welfare Policy and USDA Animal
Welfare Regulations. Responses such as "not applicable" or "based on experience of the Principal Investigator" are not acceptable.
This form will be considered incomplete until adequate responses are provided. Justification can usually be provided by completing a
literature search. You are required to document the search, but do not provide copies of the literature searches with this form. Retain
any copies of the results from any searches conducted in response to these questions with your copy of this form for the duration of the
project plus 3 yrs. (Note: Federal guidelines state that a Medline literature search alone is not adequate.)

3A. On what do you base your assurance that the proposed studies are not unnecessarily duplicative?



3.A.1.
    Inclusive dates of the database search:                                 Date when Search was made:
 Databases used          MEDLINE                      BIOSIS PREVIEW        Other:
 Keywords searched
 Keywords searched
 Other methods used to base your assurance                                                                Enter YES / NO:
 If you answered YES, describe below:


3.A.2.                                                                                                                          YES / NO
 Is this a Demonstration/Teaching project?
 If you answered “YES”, answer i. and ii. below.
        i. New information or technique not previously available.
       ii. Others not previously exposed to information or technique.

3.B. What is the scientific justification for the use of animals in this project? You must indicate that you have considered
     non-animal alternatives (e.g., cell lines) and provide the scientific basis for rejecting the use of non-animal alternatives.


3.C. What is the scientific justification for using the species chosen for this project? Note lower financial cost is not an
     acceptable justification for the use of one species or another.


3.D. Study design and justification for the number of animals requested.
The Animal Welfare Act and PHS policy specifically state that investigators should provide a scientific
justification for the requested animal resources. This means that the investigator must assure that the proposed
sample size (‘n”) is neither too big nor too small to reach a valid conclusion. In most cases this will require a
statistical justification. Please keep in mind that all pups used must be counted toward animal numbers as of
one day post-partum. Please describe:

          1. The study groups, sample size and replicate groups. For complicated study designs a table or flow
             chart would be appropriate.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012    8/27
          2. The statistical methods used to arrive at the appropriate sample size (“n”). In most instances a power
             analysis will suffice to determine the appropriate sample size. A free calculator is available at
             http://www.math.uiowa.edu/~rlenth/Power/. Free software is available at http://www.psycho.uni-
             duesseldorf.de/aap/projects/gpower/. Include allowances for attrition (model failure). If such
             attrition is >20%, explain what you will be doing to REFINE the model so that the number of animal
             subjects may be REDUCED in the future.




          3. Molecular, Biochemical – Tissues only studies. It is recognized that in some studies where animal
             tissues are being used for genetic, molecular, biochemical or cellular analysis it may be difficult to
             justify the animal requirements in a statistical fashion. Nonetheless, your animal request must still
             be justified scientifically according to specific scientific endpoints and the resources needed to meet
             the goals of the study.

                o For example if you plan to do 20 experiments on various aspects of protein X and you need 10mg
                  of protein X for each study, you will need 200mg of protein / yr. If you can only extract 0.5mg
                  of protein X per rat liver you will need about 400 rats for the study.
                o It is not acceptable to base the animal request on how much work can be accomplished in a
                  specific period of time. (e.g., 1 experiment /week, 10 animals per experiment, 40 weeks =
                  400rats / yr) .

     Please justify your animal request for these types of studies in the space provided.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   9/27
3.E. The Animal Welfare Act (AWA) regulations require that the PI consider ALTERNATIVES (e.g., other approaches
    or methods, less invasive techniques, computer simulations, video tapes) to the POTENTIALLY painful or stressful
    procedures in the present studies. The AWIC and the USDA require that documentation of this consideration be
    provided to the IACUC. Examples of potentially painful or stressful procedures include antibody production with complete
     Freunds adjuvant, ascites production, prolonged restraint, caloric restriction, single housing of primates and any procedure
     performed under anesthesia such as survival and non- survival. (Note: Federal guidelines state that a Medline literature search
     alone is not adequate.)

 3.E.1. Does this protocol contain potentially painful procedures?                                      Enter YES / NO:

3.E.2. If “Yes”, you must provide a narrative listing the potentially painful procedures and less painful alternatives
    below. If less painful/stressful alternatives do exist, but are not used in the study, provide the scientific justification
    for not employing the alternative.


3.E.3. Describe how you determined that less painful alternatives Do or Do NOT exist (Literature search, Scientific
    meetings, Databases). The key words “Alternatives” and/or “Alternatives to Animal Testing” must be included and
    combined with the potentially painful procedure. Click Here to visit the UM Website for Searching Info.

      Inclusive dates of the database search:                                       Date Search was conducted:
      Databases used:         MEDLINE                       BIOSIS PREVIEW          Other:
   Keywords searched:
   Keywords searched:

Other methods (e.g., meetings, internet sites) to determine Alternatives:


3.F. Additional justification: 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.




PART 4. EUTHANASIA
4.A. Describe the methods of euthanasia for each species . Consult with the DVR for species-specific AVMA approved methods
        or review the 2000 AVMA panel on euthanasia for acceptable procedures.
           Species                        Agent and/or Method                  Dose of Agent                Route of administration




4.B. For any method of euthanasia that is not AVMA approved, provide scientific justification for using the method in
     this project.


4.C. Early termination of a study subject. Describe criteria for the early removal of an animal from the experiment if the animal
     becomes ill or impaired.


4.D. How will the dead animals be disposed?



UM Animal Care & Use Committee   LONG FORM – version 2/7/2012    10/27
4.E. Death as an endpoint:
 Is the time of spontaneous death of any animal subject an endpoint in any of the studies in your project?
                                                                                               Enter YES / NO:
 If “Yes”, use the space below to provide scientific justification why euthanizing the animal when it exhibits distress or becomes
 moribund will bias or compromise the experimental result:




PART 5. CERTIFICATION OF COMPLIANCE WITH INSTITUTIONAL POLICIES

5.A. COMPLIANCE WITH NIH GRANT REPORTING POLICY
  The NIH Office of Lab Animal Welfare (OLAW) requires that all animal activities described in NIH funded research grant
  applications be approved by the IACUC.

    5.A.i        Will the work described in this protocol be funded by the NIH?                         Enter YES/NO
          If NO, scroll down to PART 6.

    5.A.ii       If you answered YES to 5.A.i, are all animal related procedures described in the NIH grant
                 application referenced in Part 1, also described in THIS protocol?          Enter YES/NO
          If you answered YES to 5.A.ii, scroll down and sign the assurance below:

    5.A.iii      If you answered NO to 5.A.ii, Are any procedures described in this NIH grant application
                 described in another approved protocol?                                Enter YES/NO

    5.A.iv       If you answered YES to 5.A.iii, please provide the approved protocol number(s) below:


  If you answered NO to 5.A.iii, please describe those procedures in the NIH grant application that have not been submitted for
  approval by the IACUC. In addition, provide a written justification for not including these procedures in this protocol.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   11/27
PART 6. ANTIBODY PRODUCTION AND COLLECTION OF BODY FLUIDS
          NOTE: Body fluids include, but are not limited to blood, ascites, urine, cerebral spinal fluid, semen, gastric lavage
 Will Monoclonal or Polyclonal antibodies be prepared                                                     Enter YES / NO
If you answer “Yes” you must complete PART 6. If “ No” go on to PART 6B.

6A. Polyclonal/monoclonal antibody production
 How many antigens will you be using?                                                                   Enter Number
 Is the method to produce all antibodies the same?                                                      Enter YES / NO

If you marked “Yes” above, provide information for antibody #1 only. If you entered “No” provide information requested below for
each different procedure (see examples below this table)
                                            AB1                    AB2                AB3                      AB4
 Species
 Polyclonal /Monoclonal
 Antigen/cells
 Route of Administration
 Site of injection
 Volume/site
 Frequency
 Anesthesia (yes / no)
 Restraint method
 Adjuvant #1/primer
 Route of Administration
 Sites
 Volume/site
 Frequency
 Anesthesia (Yes / No)
 Restraint method
 Adjuvant #2/booster
 When given
 Route of Administration
 Site
 Volume
 Frequency
 Total number
 Anesthetic (yes / no)
 Restraint method
 Abdomen primed?
           If Yes then:
                             Agent
                            Volume
                    Number/schedule


EXAMPLES OF HOW PART 6 COULD BE COMPLETED:
                                            Example 1           Example 2            Example 3                       Example 4
 Species                                    Rabbit              Mouse                Mouse
 Polyclonal /monoclonal                     Polyclonal          Polyclonal           Monoclonal
 Antigen/cells                              Protein z           Protein z            Hybridoma x
 Route of Admin.                            Intradermal         IP                   IP
 Site of injection                          Lumbar region       Abdomen              Abdomen
 Volume/site                                0.05ml              0.05ml               1x106 cells
 Frequency                                  1x                  1x                   1x
 Anesthesia (yes/no)                        yes                 No                   No
 Restraint method                           chemical            Manual               Manual

UM Animal Care & Use Committee   LONG FORM – version 2/7/2012     12/27
 Adjuvant #1/primer                             Freund’s complete         Freund’s complete         N/A
 Route of Admin.                                Intradermal               IP                        IP
 Sites                                          Lumbar region             Abdomen                   Abdomen
 Volume/site                                    0.05ml                    0.05ml                    1x106 cells
 Frequency                                      1x                        1x                        1x
 Anesthesia (Yes/No)                            yes                       no                        No
 Restraint method                               chemical                  manual                    Manual
 Adjuvant #2/booster                            Freund’s incomplete       Freund’s incomplete       NA
 When given
 Route of Admin.                                SQ                        IP                        NA
 Site                                           Scapular region           Abdomen                   NA
 Volume                                         1ml                       1ml                       NA
 Frequency                                      Days 14,28,56             Days 14,28                NA
 Total number                                   3                         2                         NA
 Anesthetic (yes, no)                           yes                       No                        NA
 Restraint method                               Chemical/                 Manual                    NA
 Abdomen primed?                                NA                        NA                        Yes
    If Yes then:
                                  Agent                                                             Pristane
                                Volume                                                              0.2ml
                        Number/schedule                                                             1x, Day 0
Note these antibody production regimens are provided as examples of correct completion of the form. They do not constitute either
approval or recommendation of the techniques listed.


PART 6B.        COLLECTION OF BODY FLUIDS INCLUDING ASCITES.
 Will blood or other bodily fluid be harvested from animal subjects?                                                         Enter YES / NO
If “Yes”, complete Part 6B. See example provided. If “No” go on to PART 7.

                                 Collection 1             Collection 2               Collection 3                 Collection 4     Collection 5
 Species
 Fluid
 Volume
 Site
 Method
 How often
 Method of Restraint
 Anesthesia (Yes/No)

Examples of how you might complete PART 6B
                                 EXAMPLE 1                EXAMPLE 2                  EXAMPLE 3
 Species                         mouse                    Mouse                      Rat
 Fluid                           blood                    Blood                      Blood/
 Volume                          0.1                      exsanguinate               1.0ml
 Site                            Retro-orbital plexus     Brachial plexus            Tail vein
 Method                          Pasteur pipette          Cut with scalpel blade     Venapuncture
 How often                       1 x/month                1x                         2x/mo
 Method of Restraint             Manual                   Chemical                   Decapicone
 Anesthesia(Yes/No)              Yes (general)            Yes                        No

Note: These methods and techniques are provided as examples of correct completion of the form. They do not constitute either
approval or recommendation of the techniques listed.




UM Animal Care & Use Committee    LONG FORM – version 2/7/2012               13/27
 PART 7. Will ANESTHETICS, TRANQUILIZERS, SEDATIVES and/or ANALGESICS are used in
 these studies?                                                  Enter YES / NO
If YES complete PART 7, if NO go to PART 8.

ANESTHETICS, TRANQUILIZERS, SEDATIVES AND ANALGESICS
          Species                         Agent                 Dose and frequency of agent      Route of administration
         e.g., Rabbit                   e.g., ketamine                 e.g., 44mg/kg once               e.g., IM injection




Describe the methods (stimuli, responses, instrumentation, etc.) and criteria for determining depth of anesthesia. If a
paralytic drug (e.g., pancuronium) is indicated above, justify why the paralytic is necessary and describe the SPECIFIC
methods you will use to measuring the depth of anesthesia when a paralytic agent is employed:



  If gas anesthesia is used, is a scavenging system in place?                                        Enter YES / NO

 Will any procedure in this project cause more than momentary pain or distress to the animal subjects?
                                                                                                  Enter YES / NO
 If “Yes”, list in the above table the analgesic agents that will be used to alleviate pain and distress. If no
 measures are to be taken, use the space below to provide the scientific justification for withholding relief.



 Will any of the procedures to be conducted have the potential to result in infections in the animal?
                                                                                                 Enter YES / NO
 If You answer “Yes”, be sure to list the antibiotic agents in the table below (Part 8). If you answer “Yes” and do not plan to use
 antibiotics, provide the scientific justification for withholding treatment in the space below:




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012        14/27
PART 8. ADMINISTRATION OF DRUGS OR AGENTS OTHER THAN ANESTHETICS AND ANALGESICS

 Will drugs other than anesthetics and analgesics be used in the proposed studies?                Enter YES / NO
 If YES complete PART 8, If NO go to PART 9

 Will expired drugs or devices be used in the proposed studies?                             Enter YES / NO
 The use of expired antibiotics, analgesic and anesthetics is expressly prohibited by the Animal Welfare Act
 and PHS policy. Expired diagnostic reagents, drugs and devices may not be used at UM without prior
 approval by the IACUC. If you plan to use any outdated or expired reagents, materials or devices please
 provide a clear concise justification for their use. If YES provide justification below


LIST DRUGS OR AGENTS OTHER THAN ANESTHETICS AND ANALGESICS

                      Agent                       Species          Dosage          Route                   Schedule
 1
 2
 3
 4
 5
 6
 7

If drugs are considered hazardous (mutagenic, carcinogenic, teratogenic or toxic) to animal subjects or personnel, complete PART
11C and for highly detailed dosing regimens append a schedule for treatments and sample collection.

 A. Will any of these agents cause pain or distress to the animal subjects?                      Enter YES / NO
     If you answer “Yes” be sure to complete Parts 3.E. and 7.B.


PART 8B. NON-SURGICAL PROCEDURES (E.G. TOXICITY, PHARMACOLOGIC, OTHER NON-
SURGICAL)

If you are conducting pharmacokinetic studies or toxicity studies with chemical agents, radiation or some other
non surgical procedure in animal models, describe the procedures to be conducted in the space provided below.
Provide enough detail to ensure that the IACUC will be able to understand the study and it’s endpoints. For
example, if you are to determine a Maximum Tolerated Dose (MTD), describe the method to meet this goal. If
you will determine an LD10 or LD50, you must justify such experiments and provide references to previous
work with the toxic agent or insult.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   15/27
SURGICAL PROCEDURES IN LABORATORY ANIMALS

    Does this project involve SURGICAL PROCEDURES IN ANIMALS ?                                            Enter YES / NO
If you entered “YES”, complete SECTION 9 and/or as appropriate

TO BE COMPLETED FOR ALL SURGERY PROJECTS:

1. List the rooms and buildings where the surgical procedures will be conducted:
                                    Building                                                                   Room No.
     1
     2
     3
     4

2. List the names, training and yrs of experience of those who will perform the surgery:
                                                                           Training
                         Name                           Degree    Procedure        Species        Years of experience with procedure
                                                                  YES / NO        YES / NO
     1
     2
     3
     4
     5
     6

    Will food be withheld?                                                                              Enter YES / NO
    If “YES”, how long?
    How long will it take you to complete the surgical procedure?


PART 9. NONSURVIVAL SURGERY: Animals are euthanized at the end of the surgical procedure without recovery from
         anesthesia. This includes the collection of tissues from anesthetized animals and euthanasia via perfusion.
    Does this project involve non-survival surgery?                                                       Enter YES / NO
    If “Yes” complete PART 9A.

9.A. Provide a detailed account of what will happen to the animals during the nonsurvival surgical procedure. Please
     indicate the success rate for the procedure(s) and the reasons why animals might be excluded from the study after
     initiation of the procedure.




PART 10. SURVIVAL SURGERY. Survival surgery is defined as any surgical procedure where the animal is revived from
           anesthesia after the procedure.

    Will SURVIVAL SURGERIES be conducted?                                                                  Enter YES / NO
    If you entered “YES” complete Part 10A, If you enter “NO” go to PART 11.
        Minor procedures are those that do not enter a body cavity, may cause only momentary pain and distress, are not
         debilitating and have little or no risk for infection. Examples are tail clipping for genotyping, bleeding via the retro-
         orbital venous plexus, subcutaneous implants.
        Major survival surgery must be performed in an operating room or surgical suite designed for and used only for
         sterile surgery. Modified sterile technique may be used on rodents (i.e. sterile gloves, mask and instruments used in a
         room not dedicated to sterile operations).
UM Animal Care & Use Committee   LONG FORM – version 2/7/2012      16/27
10.A. DESCRIPTION OF SURVIVAL SURGERY: Explain in detail what will happen to the animals during each procedure.
        Please indicate the success rate for the procedure(s) and the reasons why animals might be excluded from the study after
        initiation of the procedure. Also describe how the site will be prepared and how the incision will be closed (e.g., sutures,
        staples, glue).




 10.B. Will MULTIPLE SURVIVAL SURGERIES requiring more than one period of anesthesia be
 performed on the same animal?                                              Enter YES / NO
 If “YES” enter species and justify the necessity for multiple survival surgeries in the space provided below:




10.C. PRE-SURGICAL CARE
                                                                        If “Yes”, how
 Will food be withheld?                            Yes / No
                                                                        long?
                                                                        If “Yes”, how
 Will water be withheld                            Yes / No
                                                                        long?
 Will antibiotics be used                          Yes / No             Note: If antibiotics are used be sure to complete Part 8
 .

10.D. POST-SURGICAL CARE AND SUPPORT

1. What is the post surgical frequency of observation of the animals?


2. Describe any special diet or other supportive care that might be required after the surgical procedure.


3. What fluids will be administered? (dosage and route)


4. What precautions will be taken to prevent hypothermia and/or dehydration after surgery?


5. Who will be responsible for the post-surgical care of the animals and where will the records of the procedure be kept?
 Name                                 Location of records


6. Experimental design. Describe what will happen to the animals after recovery from surgery. Provide a time line for the
subsequent studies. What are the endpoints of this study?



7. Early termination of the Study. Describe any physical or physiologic impairment to the animal due to the surgery. Include
criteria for early EXCLUSION AND EUTHANSIA if the animal becomes ill or impaired .




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   17/27
PART 11. SPECIAL CONSIDERATIONS

A. Tumor Bearing Animals. Complete this section if your studies involve the use or production of non-Hybridoma
   tumors in animals. Complete the requested information for each species used.

  Do the studies involve the use of tumor bearing animals?                                       Enter YES / NO
          If “Yes” complete PART 11A; If “No” go on to PART 11B.

Provide information on each different tumor model and animal host to be used.
                                            Model #1             Model #2             Model #3                 Model #4
  Tumor Model
  Host species
  Host strain
  Method of Induction
  e.g., tumor tissue, cells, virus, carcinogen, genetic manipulation.
  Route of inoculation
  e.g., intramuscular, subcutaneous, intradermal, intravenous
  Tumor site(s)

All cell lines to be implanted in laboratory animals must be tested for adventitious viruses and pathogens within
the past 12 months. This protocol cannot be approved until proof of cell testing is delivered to the IACUC. All
cell line testing must be approved by the DVR. Please see the DVR web site at http://www.miami.edu/research/
for more details and a link to the cell line testing policy.

  Have your cell lines been tested by the DVR?                                                   Enter YES / NO

  When were your cell lines last tested? Please provide a date.


 When will the tumor bearing animals be euthanized? Note: If the weight of the tumor will exceed 10% of the animal's
 body weight, you must provide scientific justification for the potential pain and suffering experienced by the animal. Further you
 must provide for the relief of this potential pain and suffering or provide the scientific justification for withholding relief.



  Is spontaneous death of a tumor bearing animal an endpoint in this study?                      Enter YES / NO
  If YES provide clear and concise scientific justification in the space below.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   18/27
Part 11.B. IMPLANTATION OF PRIMARY HUMAN TISSUES OR PRODUCTS IN LABORATORY
ANIMALS.


 Does your project involve the use of primary human tissue or materials in lab animals?
 If “Yes” complete PART 11B, If “No” go to PART 11C.                                 Enter YES / NO
 Your project may require review and approval by the UM IRB. Has this project been approved by the
 IRB?                                                                   Enter YES / NO / PENDING

 Please indicate the IRB protocol number
 Please provide the most recent IRB Approval date.


 Please describe the human primary tissue or product and your intended use of the material.




 Please describe how you intend to determine that the samples are free of known viruses and pathogens.




Part 11.C. MANIPULATIONS TO PRODUCE GENETICALLY ALTERED ANIMALS

 Does your project involve the use of genetically altered animals?                      Enter YES / NO
  If “Yes” complete PARTS 11C.1, 2, and 3. If “No” go to PART 11D.
 All projects involving the production of genetically altered animals and/or viral agents must be
 approved by the Institutional Biosafety Committee (IBC). Has this project been approved by the IBC?
 Enter YES / NO / PENDING
 If you are unsure about the need for IBC review, please call the IBC Office at 305 243-2311.


  11C.1. Do these animal strains already exist?                                       Enter YES / NO
If “Yes” complete PART 11C.2. If “No” go to PART 11C.3.

11C.2. Describe the derivation and source of these animals, with references.




11.C.3.
Describe the procedures to be used to derive new strains.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   19/27
2. Describe TRANSGENIC ANIMALS, GENE KNOCKOUT (induced or targeted mutation) and other procedures to
introduce DNA into animals. (Duplicate for each individual genetic manipulation)


3. Describe the species and strains to be used and the genes to be affected.


 4. Alternatives to creating new genetically altered animals: Are there alternatives (e.g., natural
 mutations) to using genetically manipulated animals?                                    Enter YES / NO

 5. Does this animal model currently exist?                                               Enter YES / NO
Identify below the sources you searched to answer #4 and #5 above.


If you answered YES to either #4 or #5 above, explain why it is necessary for you to create a new animal model.


What is the anticipated outcome of the genetic manipulation (e.g., tumorigenesis, tissue ablation, enzyme deficiency, other?)


 6. Procedures to select genetically altered animals                                              Enter YES / NO below
   1     Tail biopsy (describe in PART 9)
   2     Tissue biopsy (describe in PART 9)
   3     Collection of blood or other body fluid (describe in PART 7B)
   4     Other (specify below)


7. Animal Monitoring
   i. Describe the method and frequency of animal monitoring.


    ii. Describe any clinical signs that may be present in the animals:


    iii. Describe any distress that might be induced by these experiments:


    iv. How will animal suffering be reduced or prevented?


    v. What are the criteria for euthanasia?




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   20/27
8. Who will be producing the genetically manipulated animals?
                                                                                                 Enter YES / NO
  UM Transgenic/Targeted-Mutant Mouse Core Facility
  Principle Investigator or Staff
  Use procedures described in this protocol ?
  Use procedures described in another protocol ?
                                                   If Yes to above, enter protocol No:
  Subcontract or collaboration at another institution
  Company, if “Yes” then which Company”?
  OTHER UM INVESTIGATOR? If “Yes” then list below.
                Name
               Phone
               Email
  Active protocol No.

9. Gene therapy
   Are genes, genetic material, oligonucleotides or genetically altered cells being used to create or alter a
   pathologic state in animal subjects?                                                    Enter YES / NO

 a) Describe the genetic material and transfer vehicle to be used in these experiments.


  b) Describe the method of administration of the therapeutic gene. Include information regarding the use of:
      i) Helper viruses (specify)
      ii) Methods and site of direct injection
      iii) Transplantation of genetically altered cells
      iv) If you use cells, are they are free of adventitious virus (Yes / No)?
      v) Other approaches:


 c). Could the genetic material be pathogenic in humans?                                    Enter YES / NO
      If “Yes”, then please complete 11.D below.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   21/27
PART 11 D. Hazardous Materials:
 Will potential hazardous materials such as ionizing radiation, radioactive isotopes, chemical carcinogens,
 toxins, bacteria, viruses, recombinant DNA be used in this project?                       Enter YES / NO
If you enter “Yes”, complete PART 11D, starting with the table below, if “No”, go to PART 11E.

                                         Agent 1         Agent 2           Agent 3        Agent 4          Agent 5
   Chemical agents
           Species
           Agent
           Dose (mg/kg)
           Route
           Exposure Duration
   Radiation
           Species
           Type (x-ray, UV)
           Dose/fraction
           Exposure Field
   Biological agent
           Infectious agents
           Type (e.g., virus)
           Dose
   Radioisotopes
           Species
           Which isotope
           Dose
           Schedule
 Will the Agent be excreted?
        If “Yes” specify how?
 e.g., urine, feces, exhaled
                                         Explain here:
 Will the excreted agents or
 metabolites be present in
 sufficient amounts in cages
 or bedding to be a health
 risk for animal care
 technicians?

 Please describe the
 appropriate PPE and
 procedures

 Please provide the MSDS
 forms


2. If not already described in PART 3, Provide a schedule for dosing and sample collection


 3. Will any of these agents cause pain or discomfort to the animal subjects?                    Enter YES / NO
If “Yes” be sure to complete PART 3E and 7B.

  4. Indicate the method of disposal of contaminated materials.

Be advised that studies using chemical, biologic and/or radioactive agents may need to be reviewed and approved by OFFICE OF
RADIATION CONTROL and/or the OFFICE OF ENVIRONMENTAL HEALTH AND SAFETY


UM Animal Care & Use Committee   LONG FORM – version 2/7/2012      22/27
PART 11E. RESTRICTION OF ANIMAL MOVEMENT OR ACTIVITY

 Will the activity of animal subjects be physically restricted by more than manual restraint required to give
 an injection?                                                                          Enter YES / NO
Examples include use of chairs, slings, tethers, metabolism cages, etc.). If “Yes”, complete PART 11E, if “No”, go to PART 11F.

1.               Method of restraint                    Duration (hrs/days)   Rest intervals (hrs)       Frequency of rest




 How often will animals be observed during restraint?

  2. In studies requiring restraint of non-human primates, describe environmental enrichment procedures:



  3. Will any of these procedures cause more than momentary pain or distress to the animal subjects?
                                                                                         Enter YES / NO
If you entered “Yes” above, describe, IN THE SPACE BELOW, measures which will be taken to alleviate pain and
distress. If no measures are taken, what is the scientific justification?



PART 11F. BEHAVIORAL INTERVENTIONS, CONDITIONING AND NON-INVASIVE MONITORING

 Will interventions or conditioning be applied to elicit new behaviors?                            Enter YES / NO
 If “Yes”, complete PART 11F.1.

 Will noninvasive monitoring be conducted in animal subjects?                                      Enter YES / NO
 If “Yes”, complete PART 11F.2.

11F.1. Behavioral Interventions and Conditioning.
    For each species requested, in the box below:
        a. Describe the conditioned or desired behavior.
        b. Describe the purpose for behavior conditioning.
        c. Describe reinforcement techniques.
        d. Describe the criteria for measuring the animal’s condition.


 11F.2. Behavioral Non-Invasive Monitoring. Describe the methods of noninvasive monitoring and the circumstances during
          which non-invasive monitoring (e.g. EKG during exercise, locomotion testing after partial paralysis) will occur.


 Will procedures in 11F.1 or 11F.2 cause pain or discomfort to the animals?             Enter YES / NO
 If you entered “Yes” above, describe measures which will be taken to alleviate pain and distress.
 If no measures are taken provide the scientific justification below



Part 11G. Additional procedures. Procedures that are not described elsewhere in the protocol such as those involving imaging
(MRI, CT-scan, fluoroscopy etc) and examinations (Ultrasound, photography, etc).
 Will additional procedure(s) be performed?                                                        Enter YES / NO

UM Animal Care & Use Committee   LONG FORM – version 2/7/2012     23/27
Describe the procedure(s) and frequency in the space provided below:


Part 11H. Special housing conditions required for the project. Special housing conditions would include special lighting
conditions, special diets or feeding schedules, special caging requirements and/or special bedding .
  Will special housing conditions be required for this project?                                      Enter YES / NO
If special housing conditions are required describe in the space provided below (Be sure to contact DVR to assist you in
meeting the needs of your study).


Part 11I. Studies with wild animals:
Will studies be conducted using wild animals live or tissues?                                    Enter YES / NO
Wild animal subjects are those animals not specifically bred and sold for research, teaching or agricultural purposes.
If “YES” provide the information requested in PART 11G. PI's conducting observation, photography or recording
only are not required to complete this form.

1. Animal subjects
a    List Species: If species can not be exactly predicted,
        indicate range of species or families anticipated
b       List Common names
c       Where will the study be conducted?


2. Other than actual capture/collection of the animals, will the investigators interact with, manipulate or
alter the environment of animals in the wild?                                            Enter YES / NO
If the method or procedure is not specifically described in the SUMMARY (PART 2.), provide below a brief narrative
of how the investigators will interact with animals in the wild :



3. Will wild animals be collected for this project?                                              Enter YES / NO


4. If the PI or others listed in PART 1. are not personally collecting the wild animal subjects, who or what vendor will
be collecting the animal subjects for your studies?



5 A. If you answered "YES" to 3. above, INDICATE THE METHOD(S) OF CAPTURE OR FIELD COLLECTION.
      (check all that apply)
                 Aquatic/Marine Species                                              Terrestrial/Avian species
            Angling                                                     Manual Capture
          Fish traps                                                     Special Traps
Nets (indicate type)                                                              Nets
              Other                                                              Other

5 B. Why is the collection of wild animals necessary for this project?
    a This is a survey study                                                                     Enter YES / NO
    b Species are not commercially available                                                     Enter YES / NO
    c Commercially available animals are not of sufficient quality or condition                  Enter YES / NO
    d Other
      (explain)



UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   24/27
5.C. Briefly describe the following conditions of animal capture
    1 Describe the method of capture. Is this method an accepted method for the species?

     2     How often will traps/nets be monitored?


     3     How long will captured animals be held in captivity? If more than momentary capture and release, is there a SOP for the
           husbandry of the animals on file in the DVR? If no SOP for the species is on file, please submit one to the IACUC and to
           the DVR.


     4     Is accidental capture of other species anticipated and if “YES” how will such animals be dealt with?


     5     What is the expected injury/mortality rates, as a result of capture? (The total number of animals requested must include
           those that will be injured or killed during capture):


     6     What will be done with the injured animals? (Complete PART 4 on euthanasia if appropriate):


     7     What will be done with the captured animals at the end of the study?


     8     Do the cages, traps or other devices used in capturing wild animals provide protection from predators and
           other environmental hazards?                                                               Enter YES / NO

6. Describe any potential human health hazards (viruses, toxins, bites) associated with handling the wild animals and
   what will be done to minimize exposure of personnel to these hazards. If the species is known to carry rabies,
   indicate if personnel have been immunized against the rabies virus.



7. Do any of the species to be caught or used require state or federal permits/licenses?              Enter YES / NO
   If “Yes” which documents are required?


Have you obtained these Permits / Licensed           Enter YES / NO / Pending
PLEASE FURNISH THE IACUC WITH COPIES OF THESE PERMITS OR LICENSES AS THEY BECOME
AVAILABLE.




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012   25/27
Part 11. J. TISSUE SHARING/HARVESTING PROGRAM SURVEY
In order to fulfill the tenets of the 3Rs (replacement, refinement, reduction), the IACUC would like to pair investigators
needing tissues only with investigators having tissues available. Sources of available tissues would be training
surgeries, excess or retired breeding animals; unused rodent pups, etc. Please fill out the donor or request form, as
appropriate, and email it to iacucsupport@med.miami.edu.

ANIMAL DONOR SURVEY (Tissue Donor form)
                           Date
        Principal Investigator                                                             UM Employee ID #
             IACUC Number
                         Phone
                         E-mail
               Contact person
                         Phone
                         E-mail
Are you interested in tissue sharing                                                                     Enter YES / NO
Do you have animals available for tissue sharing?                                                         Enter YES / NO
Please choose: 1) Terminal surgeries, 2) Breeding colony, 3) Mother, 4) Tissue only, 5) Other :             Enter Number
                                Species
                                 Strain
                                    Sex
                            Age or size
                                Weight
             History Drugs/treatments
      Health status at time of donation
                           Tissues used
General condition of animal at time of euthanasia: (e.g.
anesthesia, low temperature, analgesics, paralytics, etc.)
  Location Bldg/Room
          Date available
Have tissues donated been exposed to radioisotopes or biohazards?                                          Enter YES / NO
   If yes, please specify
        Other comments
Animals/tissues available what basis?                                                           Enter Sporadic or Routine
 If regularly scheduled, indicate frequency:



ANIMAL RECIPIENT FORM (Tissue request form)
                           Date
         Principal Investigator
              IACUC Number
                          Phone
                         E-mail
                Contact person
                          Phone
                         E-mail
Are you interested in tissue sharing?                                                                  Enter YES / NO
Can you participate in tissue sharing?                                                                 Enter YES / NO
Are you interested in obtaining animal tissues?                                                        Enter YES / NO
Are you interested in obtaining live animals?                                                          Enter YES / NO
                                               Species
                                                Strain
                                                  Sex
                                           Age or size
                                               Weight
                    History Drugs/treatments excluded
                                       Tissues desired
                  Minimum number of animals feasible
                            Frequency of participation
                   Requirement for tissue preservation
          Approved method of anesthesia and euthanasia

UM Animal Care & Use Committee   LONG FORM – version 2/7/2012    26/27
                     Occupational Health Program for Animal Research Personnel
                                                Acknowledgement Form
                                       To be completed by ALL employees having animal contact at work

Section 1: To be completed by Employee
PLEASE PRINT
Last name _________________________First name _________________________SS#_______________________

Title_______________________ Date________ Wk phone#________________ Dept________________________

Building ___________________________Room number _______ Locator code __________ Campus____________

Supervisor/PI name_____________________________ Supervisor/PI phone#______________________________
Please initial appropriate area (Answer A or B)
A. ___________ I accept participation in the Occupational Health Program for Animal Research Personnel.
                     Accepting participation in the program REQUIRES the completion of the following
          forms:
                     1.     Consent Form for Program Participation
                     2.     Baseline Medical Surveillance Questionnaire
                      (To obtain these forms go to: www.miami.edu/health-safety , then “Employee Health Office”,
                     then “Workers Having Animal Contact”).
OR
B. ___________ I decline participation in the Occupational Health Program for Animal Research Personnel.
I understand that I have animal contact and this is a health risk. All the health risks have been explained to me as well as all the
components of the Occupational Health Program. I also understand that there are health risks in declining participation in this program. I
was offered the opportunity to be included in the Occupational Health Program for Animal Research Personnel and decline to do so. I
am given the opportunity to accept participation in this program in the future if I choose to do so.
Reason(s) for declining participation: _______________________________________
_____________________________________________________________________________________________
Suggestion(s) to improve the program: ____________________________________________
______________________________________________________________________________


Section 2:     To be completed by Supervisor/PI
A. Check the appropriate box
Yes  No       Individual works in an area identified to require participation in the Hearing
                Conservation Program
Yes  No       Individual authorized to wear a respirator (if yes, individual to complete
                Respirator Medical Evaluation Questionnaire and forward to EHS)
Yes  No       Individual has contact with animals

B. List the animal species and/or infectious agent(s) with which employee has occupational contact:
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________


_______________________________________                              ____________________________________
Signature of Employee                   Date                           Signature of Supervisor/PI              Date
Please return to: Environmental Health and Safety (R-23), Dominion Tower, Suite 405.Office: (305) 243-3400. Fax: (305) 243-3272




UM Animal Care & Use Committee   LONG FORM – version 2/7/2012        27/27

								
To top