Animal Use Protocol Modification Form Significant Change

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:

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.

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.

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:

B. Animal Number Justification

Pleasejustify 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.

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. 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.
2. I further certify that the activities in this protocol do not unnecessarily duplicate previous experiments.
3. 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.
4. 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.
5. 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.
6. I agree to abide by the provisions of the PHS policy and the NRC “Guide for the Care and Use of Laboratory Animals”.
7. 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.
8. 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