UNIVERSITY OF MIAMI ANIMAL USE PROTOCOL FORM

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UNIVERSITY OF MIAMI ANIMAL USE PROTOCOL FORM Powered By Docstoc
					UM Animal Care & Use Committee                      SHORT FORM                                                     version 05/22/04

Instructions: This Short Form may be used to:
    1.       Submit a yearly renewal of a currently approved multi-year protocol (non-competing renewal).
    2.       Submit the same protocol for a different funding interval.
    3.       Resubmit an identical protocol to a different funding agency.
    4.       Submit the same protocol under a new title.
    5.       Change the Principal Investigator.
    6.       Add/delete investigators or staff from a protocol.
    7.       Make minor modifications to the protocol for the next year.

ALL PI's are strongly encouraged to review the ACUC Guidelines Document prior to completing the protocol form. The University of
  Miami Animal Care and Use Committee (ACUC) drafted the “Guidelines” in order to clarify the nominal position of the UM
  ACUC regarding commonly accepted procedure, and to provide investigators information to aid them in completing the ACUC
  animal use protocol forms. The Guidelines document is posted on the ACUC home page. Copies are also available at the ACUC
  Office.

ALL PI’s are required to read, sign and submit the PI responsibilities document appended to this Short Form.

LABORATORY ANIMAL WELFARE EDUCATION: It is the responsibility of the PI to arrange for all new personnel to obtain
  “Core” training in the use of laboratory animals in research, before beginning work on the project. Completion of the “Core”
  Course is now required every 3 yrs for all PI’s, Investigators and staff. If you or any of the research team has not taken the web
  based “Core” Animal Welfare Course in the past 3 yrs, contact the ACUC Office to arrange for a password to the course site.
  Protocols will not be approved until the educational requirement is fulfilled.

OCCUPATIONAL HEALTH AND SAFETY (OH&S) FORM: Please complete the Occupational OH&S Acknowledgement form
  appended to the end of the “short form”. The “Short form” will not be approved until all participants have submitted the OH&S
  questionnaire. Please also note that there are new requirements for Occupational Health and Safety instruction for PI’s, Co-
  investigators and Staff. Protocols will not be approved until the OH&S educational requirement is fulfilled.


                         Date                                                   Original ACUC #
      Principal Investigator                                                UM Employee ID #
                Department
      Original protocol title
           Original funding                                                              Phone #
                     agency

                             COMPLETE PARTS A and B as APPROPRIATE                                                     Checklist
   Part A.                                                  COMPLETE A1-A6
      Annual Animal Use Survey                              COMPLETE PART A7, A8, A9
      Annual Animal Use Survey ---field studies only.       COMPLETE PART A8
      Summary Progress Report                               COMPLETE PART A9
   Have there been any changes in the approved procedures since the last ACUC review? Enter
   YES/NO
    If YES, you must complete Part B.
    If NO, print, sign and submit this “Short Form” to the ACUC office by email

   Part B. MODIFICATIONS
     Change in animal number                                      COMPLETE PART B1
     Change in animal species                                     COMPLETE PART B2
     Minor change in procedures                                   COMPLETE PART B3
     Alternatives to a potentially painful procedure              COMPLETE PART B4

   Occupational Health and Safety Form                            All new Study Participants
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UM Animal Care & Use Committee   SHORT FORM version 05/22/04   page 2/7
PART A. Use Part A of this short form to: (Choose as many as apply)

A.1.      Submit a Non-competing Renewal (complete Part A7, A8 and A9 below)
          Enter Yes/No             If "Yes" enter start date                                    Enter new duration


A.2.      Resubmit an identical protocol with a different project Title
          Enter YES/NO                                   If "Yes" enter new project title below


A.3.     Submit the same protocol to a different funding agency
        Enter YES/NO                                  If "Yes" enter new funding agency below


A.4.      Submit the same protocol for a different funding interval
          Enter YES/NO            If "Yes" enter new start date                             Enter new funding interval


A.5.      Change in the Principal Investigator
          Enter YES/NO          If "Yes" enter Name of new PI                Experience with the procedures in the animal model

          Note: all new PI’s must complete the U of M Core and OHS training.

A.6.      Change in Co-Investigator(s) and/or Technical Staff
           Add/Delete               Enter Name(s) below                      Experience with the procedures in the animal model

          Note: all new Investigators and staff must complete the U of M Core and OHS training.

PARTS A.7, A.8, and A.9 must be completed for all Annual Renewal applications

A.7.     Animal Usage: Please provide the ACUC with a summary of your animal use for the past year.
        Species (common name)                        Number Approved         Number Used                        Inclusive Dates




A.8.     Field Investigation only. If you are conducting a field study that involves the collection of wild animals, please provide the
       ACUC with an update of your animal collection during the past year.
       Species (common name)                                Number Approved          Number Collected           Inclusive Dates




A.9.      Summary. Please provide a brief summary of the ANIMAL work conducted during the past year. What will be done in the
       next year? Include a short description of how you have practiced the 3 R’s of animal usage--- Replacement, Reduction and
       Refinement:




Part B. MODIFICATIONS TO THE APPROVED PROTOCOL
UM Animal Care & Use Committee                        SHORT FORM version 05/22/04                                                 page 3/7
       Have there been any changes in animal species, usage or procedures since the last ACUC review?
                                                                                                Enter YES/NO
         If there are no changes, the PI should sign, date and submit the form to the ACUC.
         If you answer “YES” above, complete the appropriate sections of Part B.

B.1.     Change the animal species on your approved protocol, with no change in the methods.
       Enter Yes/No          If "Yes" enter previous species                            new species

       Provide a scientific justification for the change in species:

       Have you consulted with a veterinarian regarding the change in species?

       Note: If the change in species requires a change in procedures (e.g., anesthesia, euthanasia, pain relief, drug doses, etc.), you
       must complete B3 and B4 below

B.2.        Change the number of animals on your approved protocol, with no change in the methods.
            Enter Yes/No              If "Yes" Enter Species               No. Approved                                Additional No.
                                                                                                                         requested



       Provide a scientific justification for the change in the number of animals:

       Provide a description of study groups and/or treatment schemes:


B.3.        Modify or add a procedure to an existing approved protocol
     This part of the form is to be used for minor modifications to an existing procedure. This form is           Enter YES/NO
     not to be used as a substitute for the New Projects Form (Long Form). If there are any questions
     regarding the use of this form, to avoid delays, contact the ACUC Office at 305 243 2311.
      Describe the modified procedure(s):

       How is it different from the approved procedure?


B.4.        Is the new procedure potentially painful / distressful to the animal?

     If you answer YES, provide a narrative describing Alternatives to the Potentially                            Enter YES/NO
     Painful Procedures. Include:
              A description of the potentially painful/distressful procedures:
       1.
              A literature search for alternatives to potentially painful/distressful procedures is required. Provide inclusive dates of the
              search, date the search was performed, keywords, and databases used. One of the databases used must be an
       2.     "Alternatives" Database" (See the ACUC guideline document or the training website for links to "Alternatives"
              Databases):

             If less painful procedures are identified by the search and you choose not to use them, provide the scientific justification
        3    for using a more painful/distressful procedure:




B.5.        Will expired drugs or other materials be used in the proposed studies?

UM Animal Care & Use Committee                           SHORT FORM version 05/22/04                                                     page 4/7
     The use of expired antibiotics, analgesic and anesthetics is expressly prohibited by the Animal Enter YES/NO
     Welfare Act and PHS policy. Expired diagnostic reagents, drugs and devices may not be used
     at the U of M without prior approval by the IACUC. If you plan to use any outdated or expired reagents, materials or devices
     please provide a justification for their use. If YES provide justification below:




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 ACUC, before any activities involving
        live or dead vertebrate animals is begun.
     Required to comply with all 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 ACUC, 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
        ACUC. 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 ACUC
        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.
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

Ver 05/22/04




UM Animal Care & Use Committee                       SHORT FORM version 05/22/04                                                  page 5/7
                        University of Miami Occupational Health and Safety Program

The Occupational Health Program at the University of Miami is offered to employees whose work duties involve contact
with research animals and is covered in the policy, Occupational Health Program for Animal Research Personnel
and Procedures Manual. The current components of this program are based on the recommendations of the National
Institutes of Health’s Office of Laboratory Animal Welfare (NIHOLAW) and are listed in the Summary of
Occupational Health Program for Animal Research Personnel. The occupational health services are provided
according to the employee’s animal exposure as well as any infectious agent(s) to which the employee may have contact.
These services consist primarily of a physical exam, laboratory tests, immunizations and medical follow-up after an
exposure incident.

Participation in the U of M Occupational Health and Safety (OH&S) Program is mandatory for all users (i.e., PI’s, Co-
Investigators, Staff and Students working on specific research projects) of laboratory animals in research and teaching,
unless you each specifically decline to participate. A written declaration must be filed with the UM OH&S Program
Office. It is the responsibility of the PI to provide co-investigators, staff and associated project students the opportunity
to participate. The level of surveillance and coverage under the program are risked based.

The Consent Form, the Acknowledgement Form (appended), and the Baseline Medical Surveillance Questionnaire
Form must be completed and originals forwarded to EHS. A copy of the Acknowledgement form should be submitted to
the ACUC office along with the short form protocol. In addition, those employees who are required to wear a respirator
at work must complete the Respirator Medical Evaluation Questionnaire. If an employee declines participation, only
the Acknowledgement Form is to be completed. However, if you or any of your staff or collaborators declines to
participate in the OH&S program, the individual will be required to complete a web based tutorial on
Occupational Health and Safety when Working With Laboratory Animals before the protocol will be approved.
You may register for the course at www.miami.edu/UMH/CDA/UMH_Main/1,1770,7432-3,00.html. If you have
questions, please contact Charles F. Gottlieb, Director EHS or Sandra Chen, Employee Health Manager, at (305) 243-
3400.


   Please indicate the names of new investigators and staff on this project.             Please indicate whether they are
   participating in the Occupational Health and Safety Program.
                                                                                        OH&S              Web-based OHS
                                  Employee
                 Name                               Department             Phone      participant       training completed?
                                    ID #
                                                                                       (Yes/No)               (Yes/No)




 Note: Please complete the Occupational Health and Safety Program participation listing and submit to the ACUC Office along with
 the short form protocol.




UM Animal Care & Use Committee                    SHORT FORM version 05/22/04                                             page 6/7
                     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                            SHORT FORM version 05/22/04                                               page 7/7

				
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