Animal Use Protocol Modification Form * Significant Change

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Institutional Animal Care and Use Committee
Keith J. O’Neill Center for Healthy Families, Room 208
2300 Adams Ave., Scranton, PA 18509
(570) 961-4778 email: research@marywood.edu
OFFICE USE ONLY:
MU IACUC Number: _________________
Date Received:
_________________
Final Approval Date: _________________
IRB Net Number: __________________
Review by Date: __________________
Expiration Date: __________________
ANIMAL USE PROTOCOL MODIFICATION FORM – SIGNIFICANT CHANGE
Please use this form to request an amendment to your currently approved animal use protocol. This form
is only to be used for SIGNIFICANT changes made to your currently approved protocol. Complete items
#1-5 on the form and any applicable items #6-11. Submit the completed amendment with the principal
investigator’s signature to the Office of Research, O’Neill Center for Healthy Families, Room 208.
STUDY INFORMATION
Date: _______
MU IACUC #: ____________
Principal Investigator Name: __ ______
Phone: _______
Study Title: __ ______
____
E mail: _____
____
Principal Investigator Signature: ______________________________________
TYPE OF MODIFICATION
Check all changes that apply and complete the corresponding sections below:
Strain – If phenotype could potentially affect the welfare of the animal
A. Describe the phenotype and list any conditions that are not normal in healthy animals.
B. Describe the course of action that will be taken to relieve pain/distress. How will the animals be
monitored and by whom?
Species – Addition and/or removal
Please describe what species you would like to add to this protocol and provide scientific justification
as to why this species is required.
Rev: 10/20/10
Increase in animal numbers from the total numbers approved in the original submission:
Complete A and B below if the increase in animal numbers is greater than 20% over initial approved
request. Please only describe the numbers needed beyond those animals approved in the original
submission.
A. Animal Number Chart:
Species
Number
Purchased
Number Transferred
(include originating MU
IACUC Protocol #)
Number
Produced
B. Animal Number Justification
Please justify why more animals are needed than those for which you were originally approved.
How will these additional animals be used on this protocol?
Animal Use Procedures (i.e. surgery, euthanasia, blood collection, special diets, etc)
Please complete A-C if applicable.
A. Description of the proposed procedures or change in procedures to be performed in addition to
those already approved on this protocol. Describe how this relates to the original goal of the
approved protocol. If the changes involve surgery, please completely describe the surgical
procedures, anesthesia/analgesia, post-procedure monitoring, etc. If these procedures involve
non-surgical procedures with the potential for pain/distress, please discuss how the pain will
be alleviated and how animals will be monitored.
B. Qualifications: Indicate the personnel that have the relevant qualifications for the specific
procedures proposed in this amendment.
C. Literature Search: For new proposed procedures that have the potential to cause pain and/or
distress, a literature search is required. Please refer to instructions in the original protocol form
to complete this section.
Rev: 10/20/10
Use of Additional Potentially Hazardous Substances
Biologics, radioisotopes, chemicals, drugs, infectious agents, recombinant DNA (including use or
generation of transgenics). Describe and justify any proposed changes in the use or the addition of
potentially hazardous substances, if applicable. State that approval has been obtained for the use of the
required controlled substances.
Principal Investigator: Please explain the reason for changing the PI and obtain the signature of
the New PI below.
New Principal Investigator Certification and Signature:
1.
2.
3.
4.
5.
6.
7.
8.
I certify that appropriate pain-relieving drugs have been or will be used throughout the entire study to relieve pain or
distress whenever it occurs, including postoperative or post-procedural care, unless specifically stated otherwise in this
protocol.
I further certify that the activities in this protocol do not unnecessarily duplicate previous experiments.
I certify that all personnel performing any procedures on animals will receive the proper training and will participate in
the training programs available. A description of this training and experience is provided in this protocol. Proof of
such training for all personnel and I will be provided to the IACUC upon request.
I understand that it is my responsibility as the Principal Investigator to ensure that all individuals listed on the protocol
have read and understand the procedures described for each species.
I am not using radioactive materials, infectious agents or other biologically or chemically hazardous materials in the
animal facility other than those included in this protocol.
I agree to abide by the provisions of the PHS policy and the NRC “Guide for the Care and Use of Laboratory
Animals”.
If I wish to change any of the procedures or personnel as shown on this protocol, I will request IACUC approval by
submitting the details of the changes(s) as an amendment to my approved protocol.
I understand that any failure to comply with the guidelines and requirements of the IACUC may result in suspension of
my studies and notification to the funding agency, OLAW, and AAALAC, if necessary.
SIGNATURE OF NEW PRINCIPAL INVESTIGATOR:________________________________ Date: ____________
Other Changes: Please describe and justify any additional changes you would like to make to this
protocol.
Rev: 10/20/10
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