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ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY

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ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY
ALBERT EINSTEIN COLLEGE OF MEDICINE
OF YESHIVA UNIVERSITY
JACK AND PEARL RESNICK CAMPUS
MODIFICATION TO ANIMAL USE PROTOCOL FORM
TO ADD USE OF MicroPET CORE FACILITY
GENERAL INSTRUCTIONS
FORMS THAT ARE INCOMPLETE WILL BE RETURNED
1.
READ ALL INSTRUCTIONS BEFORE PREPARING YOUR MODIFICATION TO ANIMAL USE
PROTOCOL.
2.
DIFFERENT SPECIES CANNOT BE LISTED UNDER ONE PROTOCOL. IF YOU WISH TO ADD A
DIFFERENT SPECIES, PLEASE COMPLETE A SEPARATE ANIMAL USE PROTOCOL.
3.
YOU MUST RETAIN ONE ELECTRONIC VERSION OF THIS FORM, IN THE EVENT YOU ARE
ASKED TO REVISE SAME.
4.
THIS FORM MUST BE TYPED.
HANDWRITTEN FORMS WILL NOT BE ACCEPTED.
HANDWRITTEN FORMS WILL BE RETURNED BY INTEROFFICE MAIL.
5.
WRITTEN ANSWERS SHOULD BE AS LONG AS NECESSARY TO ADEQUATELY AND
COMPLETELY ANSWER THE ITEM. ADD PAGES, IF NEEDED.
6.
INCOMPLETE FORMS WILL BE RETURNED BY INTEROFFICE MAIL.
7.
YOU MAY SUBMIT THE INITIAL PROTOCOL BY E-MAIL TO: [email protected]
8.
DO NOT SUBMIT ANY ORIGINAL SIGNATURES UNTIL YOU HAVE BEEN REQUESTED TO
SUBMIT SAME BY E-MAIL. ORIGINAL SIGNATURES WILL BE REQUIRED ON THE FINAL
VERSION OF THE ANIMAL USE PROTOCOL IN ORDER FOR THE PROTOCOL BE APPROVED.
9.
IF THIS FORM NEEDS TO BE SIGNED BY EH&S YOU MUST SUBMIT AN ORIGINAL AND ONE
COPY TO EH&S WHEN YOU ARE ASKED TO OBTAIN THEIR SIGNATURE.
10.
IF YOU HAVE ANY QUESTIONS REGARDING HOW TO COMPLETE THIS MODIFICATION FORM,
PLEASE CONTACT DR. SUNDER SHRESTHA, ANIMAL WELFARE OFFICER, AT (718) 839-7145.
11.
PLEASE BE SURE TO MAINTAIN A FINAL VERSION OF THE MODIFICATION ON FILE AND/OR IN
YOUR LABORATORY AS YOU MAY BE ASKED TO PROVIDE SAME DURING THE INSPECTION
OF YOUR LABORATORY.
1|Page
ALBERT EINSTEIN COLLEGE OF MEDICINE
of Yeshiva University
Jack and Pearl Resnick Campus
ANIMAL USE PROTOCOL
Form 2
For use by Animal Institute Committee only
Date received:
____________________________________________
Protocol Number:
_____________________________________________
MODIFICATION TO REQUEST USE OF:
Delegated Review
MicroPET CORE FACILITY
Reviewer:
Date Approved: _______________________________
I. Protocol Information:
Protocol Number:
Protocol Title:
Principal Investigator’s
Name:
II. Explain below how the proposed modifications/experiments are related to the original APPROVED
protocol? Provide relationship to original APPROVED protocol below. If you are unable to provide the
relationship to the originally approved protocol, you MUST submit a separate animal use protocol.
Relationship:
III. Are you obtaining services from the MicroPET Core Facility at Albert Einstein College of Medicine?
No. STOP. You may not use this form.
Yes. Complete Appendices 1, 2, 6 and 8 (attached).
IV. Signature of Principal Investigator: You will receive the signature sheet from the IACUC office by e-mail
and be notified when to submit same after the modification has been reviewed. Please to not submit any
signatures until you are asked to provide same by the IACUC.
2|Page
1. BRIEF NARRATIVE WHEN ADDING NEW PROCEDURES. Please explain the procedures being
performed by the MicroPET Core Facility AND how they will be performed.
a.
The reason and justification for the MicroPET procedure is: (provide response below)
Reason for procedure:
b.
The procedures will be performed as follows (provide response below)
Procedures will be performed as follows under approved core protocol: MicroPET or PET/CT imaging will be
performed as described in the core protocol (20131203 for rats or 20131204 for mice). Animal preparation and
handling:
Mice are fasted overnight or for at least 2 hours. They are then anesthetized with 1.5% isoflurane-oxygen
mixture and are injected with 300-400 microCi [18F] fluoro-2-deoxyglucose (FDG) 0.1 ml normal saline via the
tail vein by Mr. Wade Koba, the MicroPET lab operations manager. They remain anesthetized during a 45
minute equilibration period and subsequent ten minute imaging session. During the imaging session the
mouse is positioned on the animal bed and anesthesia is delivered through a nose cone. Imaging is performed
using a Siemens Inveon Trimodal docked PET/SPECT/CT imaging system. After the imaging procedure the
mice are returned to their cages and are monitored until they are ambulatory. They are either kept in a hood in
Gruss 305 behind a lead shield for ten half-lives (typically overnight as the half life of 18F is 110 minutes) or
are transferred to a dedicated cubicle in the MicroPET animal facility in Gruss 309.
2. ADJUSTMENT IN TOTAL NUMBER OF ANIMALS ORIGINALLY APPROVED
a.
Please explain below how the original total number of animals approved will be adjusted below.
The original total number of animals approved will be adjusted as follows for MicroPET:
3. ANIMAL HOUSING
b. Where in the IAS would you like your animals housed?
Chanin
Kennedy Center
Ullmann Building
Price Center
c. What type of housing are you requesting? (check all that apply)
Quarantine
Conventional
d. Are you requesting housing outside the IAS for serial imaging?
No.
Yes. This is satellite housing. Complete table below.
e. Provide proposed satellite housing location outside animal facilities below:
Building: MRRC
Room No: 309
NOTE: Satellite housing outside IAS Animal Facility, must be inspected and approved by the IACUC.
Provide proposed satellite housing location outside animal facilities below:
Building: MRRC
Room No: 309
4. LOCATION OF ANIMAL PROCEDURES:
ATTENTION: “CLEAN” BARRIER RODENTS MAY NOT RETURN TO THEIR HOUSING AREAS AFTER
3|Page
TRAVELING TO LABORATORIES OR CORES LOCATED OUTSIDE THE BARRIER. IF ANIMALS NEED
TO RETURN TO IAS ANIMAL FACILITY, YOU MUST MAKE REQUEST ISOLATION SPACE. PLEASE
COMPLETE: REQUEST ISOLATION SPACE FROM
Building
Gruss Building
Room Number
Room Number: 305
Specific Procedure
MicroPET Imaging
4|Page
APPENDIX 1
SPECIAL HUSBANDRY PRACTICES FOR MICROPET CORE FACILITY
1. Special Husbandry: Check and describe all nonstandard practices or procedures (examples listed
below). Then go to 2.
Check
Duration of
special husbandry
Description of Procedure
Housing in “satellite animal facilities”
Biosafety in Animals – infected animals
(see also Appendix 8)
Approximate number of
animals requiring
specialized husbandry
at any given time
Duration of MicroPET study
Duration of MicroPET study
2. Justification. Describe below exactly what is being done and explain briefly the rationale for each
type of special husbandry requested in previous table. Provide response below then go to 3.
Response:
Animals are kept in lead shielded holding areas: either within Gruss 305 (the microPET
lab) or in Gruss 309 (the MicroPET satellite animal facility). Once the animal receives
the injection of radioactive material, the animal will remain radioactive for 10
effective half-lives of the isotope used (e.g. less than 18 hours for F-18 tracers). This
precaution is necessary due to radiation safety to decrease the potential exposure of
employees and other animals to radiation. Animals whose imaging has been completed
will be transferred from the imaging lab (Gruss 305) to Gruss 309. Bedding with any
significant residual radio-activity will be changed by the MicroPET staff before
transferring the animal to the animal facility. Radio-active bedding will be stored in a
lead shielded container in the utility space outside the Gruss 309 holding rooms
following the recommendation of the Einstein Radiation Safety Officer.
Husbandry during the MicroPET experiments is provided by MRRC MicroPET staff
unless other arrangements have been made.
3. Personnel performing special husbandry: Will you or your staff be performing the special
husbandry?
No. Go to 4.
Yes. Complete information below then go to 4.
Name of Individual(s) Performing Special Husbandry
Work Phone #
After Hours Phone,
Pager or Beeper #
4. Special Husbandry Cards: You are required to affix the appropriate “Special Husbandry Card” to
all cages. These cards are custom designed. Please consult with veterinary staff of the Institute for
Animal Studies (IAS) to make arrangements in advance of beginning a study that requires special
husbandry to prepare the “Special Husbandry Card” (X3220). By checking below, you acknowledge
5|Page
that you have read this statement and that you will contact the veterinary staff in order to obtain the
appropriate “Special Husbandry Card”. Check the box below.
I have read the above statement and will contact the veterinary staff to obtain the “Special
Husbandry Card” once I have received written notification from the IACUC that this
protocol has been approved.
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APPENDIX 2
TEST SUBSTANCES FOR MICROPET CORE FACILITY
1) Classes of test substances or other materials:
Class Description
A
Radioisotope
The letter of the Class identified above should be listed in column 2 in table below.
2) List the test substances or other material to be administered to the animals.
Substance Name
18F-Fluorodeoxyglucose
(FDG) is routinely used.
The use of other radiotracers must be
approved by microPET
staff and be included in
a separate protocol
modification.
Class
(See
above)
A
Is test substance
hazardous or
potentially infectious
to humans or
animals?
No
Yes
Dose
300-400 microCi
Dose Schedule (You must
include route, frequency
and maximum dose per
animal)
IV (tail vein); once per day,
maximum of 400 uCi
You must complete Appendix 4.
3) Will any cells or biologicals be injected?
No (go to next Appendix)
Yes (continue)
NOTE: Cells and biologicals to be injected into rodents should be free of contamination with adventitious infectious
agents. Otherwise, these materials could introduce infectious agents into our rodent populations. Please provide source
below:
Primary Human Tumor
Rodent Cell Line Propagated in Cell Culture
Human Cells Propagated in Tissue Culture
3A. Are any of the biologicals listed above derived from rodents (e.g. mouse hybridoma /monoclonal antibody) or
have rodent biologicals been used in the production or maintenance of these materials (e.g. human cells incubated with
media containing mouse serum), or have any of these biologicals been passaged in rodents (e.g cell lines that can only
be maintained in vivo)?
No. Proceed to item 4.
Yes. Answer 3B and 3C. You must download and
complete Appendix 8.
3B. Have these materials been tested and found to be free of exogenous infectious agents?
No
Yes. Please provide date and method of testing:
Unknown
. Proceed to item c.
3C. Have these materials been passaged ONLY in animals known to be free of exogenous infectious agents?
Yes. Proceed to 4.
N/A (not passaged.). Proceed to 4.
No. See note below.
Unknown. See note below.
YOU MUST CONTACT DR. L. HERBST, DIRECTOR OF THE INSTITUTE FOR ANIMAL STUDIES, AT EXTENTION:
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7100 OR 7135, FOR FURTHER INFORMATION ABOUT SPECIAL ISOLATION CONDITIONS OR TESTING
REQUIRED TO USE THESE MATERIALS PRIOR TO USING THEM IN RODENTS.
4) Will any the test substance(s) cause clinical signs, pain, or distress to the animal?
No
Yes. Answer 4A and 4B.
4A. Describe what signs are expected. Your answer below must be consistent with your response from items 16
and 17 from main protocol form.
Signs:
4B. Describe what measures will be taken to alleviate or minimize these affects. Your answer below must be
consistent with your response from items 16 and 17 from main protocol form.
Measures that will be taken:
8|Page
APPENDIX 3
FOR USE OF EINSTEIN MicroPET CORE FACILITIES
1) The MicroPET Facility will be used. Who will be responsible for animals during the time core services will be provided?
(Check one)
The Core Facility. Provide their protocol number then go to item 1B. CORE’S APPROVED ANIMAL USE PROTCOL
NUMBER: 20131203 (rats) 20131204 (mice)
The Principal Investigator and/or Laboratory Personnel. Read note below and go to item 3.
PLEASE NOTE THAT IF CORE FACILITY WILL NOT BE RESPONSIBLE FOR ANIMALS DURING THE TIME CORE
SERVICES ARE PROVIDED, THEN ALL THE PROCEDURES THAT WILL BE PERFORMED BY THE PRINCIPAL
INVESTIGATOR AND/OR THE LABORATORY PERSONNEL MUST BE DESCRIBED IN THE MAIN PROTOCOL FORM
AND THIS APPENDIX.
2) If Core will be responsible, please attach a copy of your agreement with Core Facility and/or documents from the Core
Facility regarding their standard operating procedures.
Are documents attached?
Yes.
No. If you have not attached documents, please provide
explanation below.
2B) Explanation why forms have not been attached.
Routine 18F-FDG microPET imaging of will be performed by the core as described in the
core protocols 20131203 (rats) and 20131204 (mice)
Explanation:
3) Describe the procedures to be performed in Core Facility not covered in other appendices. Check below
Non -noxious Testing
MicroPET
4) Indicate location where procedure will be performed.
Location: MRRC305
5) Provide frequency of test sessions.
Every day.
Every other day.
Every two days.
Other. Indicate frequency:
6) Provide duration of each test session.
Duration: 60
minutes (approx. 45 minutes equilibration with radiotracer and 15 minutes for imaging)
7) Indicate maximum number of test sessions on each animal.
Maximum number:
8) Total duration of other experimental procedures.
Hours:
Days:
Weeks:
Months:
Other:
9|Page
9) Describe the parameters of each procedure and expected outcome. (Test parameters include the stimulus, stimulus
intensity, stimulus duration). Include the “readouts”, the physical or behavior modifying characteristics of the stimulus or
material administered or withdrawn.
Parameters: Tissue
regions that take up FDG will appear hot (bright) in the images
10) Will any procedure cause more than momentary pain or discomfort?
No.
Yes. Complete items and b below.
10A) Describe below the procedures or methods used to minimize pain and discomfort or explain why such
methods cannot be used. You must include this search for alternatives in item 21 of main protocol form.
Mice are anesthetized with 1.5% - 2.5% isoflurane (in O2) throughout the procedures
(injection through imaging)
Description:
10B) Define specific humane criteria for removal of an animal from a potentially painful or stressful procedure
such as failure to succeed in a specified time, signs of exhaustion, inappropriate reactions, etc.
Define: If
tail vein injection is unsuccessful the animal will be removed from the study.
11) Describe the methods for monitoring the condition of the animal during and after the procedure.
Respiration is visually monitored before, during and after the imaging. A small camera is
used to visually monitor the mouse in the PET scanner.
Methods:
12) Provide the names and phone numbers of the person(s) who will perform these procedures and are responsible for
monitoring the condition of the animals.
Name
Wade Koba
Work Phone
718-430-8581
After hours phone, pager or beeper #
914-584-3395
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APPENDIX 4
RADIATION SAFETY PRECAUTIONS / MICROPET CORE FACILITY
This section of the protocol form refers to the use of: potentially hazardous chemicals, biological
materials (infectious agents, human tissues or cells), recombinant plasmid / viral vectors, and
radioisotopes in animals.

Standard Operating Procedure (SOP) for 18F is attached

YOU MUST contact the IAS Facilities Manager, [email protected], and inform IAS before
your initiate any studies using the Hazardous Agents listed below.

Hazard Sign for 18F will be laminated and will be affixed to the door by the MicroPET staff when
experiments start.
1. Summary Table: Please list all agents that are potentially hazardous below.
YOU SHOULD PROVIDE ALL INFORMATION IN EACH COLUMN
Problem Cause if Human
Animal Safety Protocol
Specific Holding time
Hazardous Agents
Exposed
(attached)
(IF ANY) for:
Check Appropriate
Boxes Below
No known biologic effects
For
For
18F Tracer (FDG)
RS-1B
Bedding
in tracer doses.
animals:
cages:
changed by:
IAS
18 hrs
18 hrs
Laboratory
2. Standard Operating Procedure (SOP): SOP for 18F Trader (FDG) is attached.
3. Hazardous Sign: Hazardous sign for 18F Tracer (FDG) is attached.
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ANIMAL STANDARD OPERATING PROCEDURE
Fluorine-18 (18F)
Animal Safety
Protocol
designation







Investigator
Responsibility


Entry
requirements






Cage Change


Decontamination
and Spill
Procedure



RS-1B
Animal bedding and cages must be held for 10 half lives (19 hours) and surveyed before
disposal.
See investigator responsibilities below
Research staff must inform Animal Care staff ahead of time of agent that will be used, and
arrangements will be made for isolation/quarantine housing of animals.
Fresh micro-isolator caging will be used for the animals at the time of administration.
Radiation Sign must be posted on the door of the room in which the animals will be housed
while experiments are in progress.
Cages will be labeled with a pink card with the following information:
1. Name of agent delivered to animal
2. Approximate dose
3. Date of administration
4. Date of bedding change
5. Contact Information
Animal husbandry performed by PI staff during period when isotope is present in animals until
10 half-lives.
Cards and door signs must be removed by the researcher once the hazard is no longer
present.
Consult with the Radiation Safety Officer concerning shielding requirements.
Access limited to PI staff and selected veterinary staff.
All Personal Protective Equipment (PPE) gown, gloves, face mask, shoe covers and cap
must be worn to enter animal room.
Hands must be washed upon exiting animal room.
Surgical mask, goggles, faceshield or use of a Biological Safety Cabinet (BSC) are required
when conducting research.
Animal waste and contaminated bedding shall be handled to minimize generation of dust and
aerosols.
Radioactive bedding and cages will be held in “red bags” and labeled with the isotope and
start date and anticipated decay date.
Once 10 half-lives is reached, survey the bag to verify that waste has decayed and dispose in
medical waste bin and transfer cages to IAS staff.
Once transferred to IAS, cages will be sanitized by standard IAS practices
In the event of a radioactive spill, the area will be immediately restricted and cleaned and
surveyed by laboratory personnel.
Equipment and work surfaces must be routinely cleaned with 10% freshly prepared bleach or
appropriate disinfectant. All equipment must be decontaminated prior to leaving the animal
room.
12 | P a g e
ADMITANCE TO AUTHORIZED
PERSONNEL ONLY
RADIATION SAFETY LEVEL RS-1B
Hazard Identity: Fluorine-18 (18F)
Personal Protective Equipment requirements: Gown, gloves,
face mask, shoe covers and cap. Surgical mask, goggles, face
shield or use of Biological Safety Cabinet when conducting research.
Responsible Investigator: Wade Koba
In case of Emergency call: 718-430-8581 or 914-584-3395
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