Protocol Amendment Form (6/2017)
The IACUC has developed this form to aid investigators with modifications to their approved animal use protocols. However, dependent upon the extent of the requested modification, the IACUC may request that the entire protocol be revised (rewritten) or that a stand-alone protocol be submitted. If an individual other than the Principal Investigator (PI) submits this amendment, the PI must be Cc’d with the submission email message. Personnel changes are made using a separate form located at
Easy to Use Template Instructions: Simply click in the gray blocks and type in your information. The box will expand as you type. To select a boxof your choice, simply click on it.
Date of Amendment Submission: / Click here to enter text. / Protocol Number: / Click here to enter text. /Principal Investigator: / Click here to enter text. / Phone: / Click here to enter text. / Email: / Click here to enter text. /
Department: / Click here to enter text. / Pain/Distress Category of Protocol: / Click here to enter text. /
Protocol Title: / Click here to enter text. /
Change(s) to be made:
☐ Project Title or ☐Funding source (make note of changes above in the Project Title or Funding Source entry boxes).
Provide new title or new funding source information here:
Click here to enter text.
☐ Number of animals or change/addition of animal genetic background or strain.
(The IACUC Chair is authorized to approve an increase in animal number up to but not exceeding 10% of the animal number approved in the protocol. A greater increase in animal number must be reviewed by the IACUC. [Complete Question 1]
☐ Change in animal source, animal housing unit, animal care facility or field site location. [Complete Question 2]
☐ Change in administration of experiment/treatment as it relates to timing, dose, volume, route of administration and/or specific chemical composition. [Complete item 3]. Also, revise the appropriate appendix of your approved protocol and paste it at the end of this form. For example, if you would like to increase or decrease the amount of blood collected, please modify Appendix C,using red ink, to identify the modification being requested and paste that revised appendix at the end of this document.
☐ Change in Disposition of Animals/Carcasses at End of Project. [Complete Question 4]
☐ Other change being requested.[Complete Question 5]
Provide information:Click here to enter text.
Approved 1/6/2009
Revised 3/4/2010
Revised 3/7/2011
Revised 5/1/2017Page 1 of 4
- Change in animal number or genetic background/strain:
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☐ / ☐ / Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. /
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☐ / ☐ / Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. /
Justification for additional animals(box will expand with entry)
Click here to enter text. /
Justification for additional strain/genetic background of the animals (box will expand with entry)
Click here to enter text. /
- Explain reasons for change in animal source, animal housing facility, housing unit or field site:(Please be as thorough as possible while providing information, if necessary, how this amendment alters the overall goal of the protocol).
- Explain reasons for change in experiment/treatment timing, dose, route of administration and/or specific chemical composition:(Please be as thorough as possible while providing information, if necessary, how this amendment alters the overall goal of the protocol).
- Explain reasons for change in disposition of animals/carcasses at end of project:(Please be as thorough as possible while providing information, if necessary, how this amendment alters the overall goal of the protocol).
- Other change(s) to be made:(Please be as thorough as possible with information of the change and how this requested change alters the overall goal of the protocol).
Click here to enter text. /
The addition of new procedures to a USDA regulated species that may cause pain or distress requires a new alternative search. A painful procedure in an animal is defined as any procedure that would be reasonably expected to cause more than slight or momentary pain and/or distress in a human. The UTK-IACUC is responsible for ensuring that investigators have appropriately considered alternatives.
Does this new procedure/activity result in a painful or distressful procedure? ☐Yes☐No
If yes, please list the painful procedure: Click here to enter text.
The Animal Welfare Act regulations require principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress in a human being to which that procedure is applied. Alternatives or alternative methods are generally regarded as those that incorporate some aspect of replacement, reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress consistent with the goals of the research. The UTK-IACUC believes that the performance of a database search remains the most effective and efficient method for demonstrating compliance with the requirements to consider alternatives.
A minimum of 2 databases must be searched. See the following site for more information: However, in some circumstances (as in highly specialized fields of study), conferences, colloquia, subject expert consultants, or other sources may provide relevant and up-to-date information regarding alternatives in addition to, a database search. In these cases, sufficient documentation, such as the consultant’s name and qualifications and date and content of the consult should be provided to demonstrate the expert’s knowledge of the availability of alternatives in the specific field of study.
Database 1 / Database 2Name of database searched / Click here to enter text. / Click here to enter text. /
Date of search (must be within 6 months of protocol submission) / Click here to enter text. / Click here to enter text. /
Years covered by search YY – YY / Click here to enter text. / Click here to enter text. /
Search strategy (must show how keywords were combined) / Click here to enter text. / Click here to enter text. /
Other sources consulted / Click here to enter text. /
When searching for alternatives the following should be addressed:
•Replacement of existing animal methods with non-animal methods whenever possible.
•Reduction of the number of animals needed.
•Refinement of research procedures to minimize pain and discomfort.
For each painful procedure, were alternatives identified (to replace, refine, reduce)?
Please address appropriate answer(s) below if yes or no. ☐ Yes☐No
If “Yes”, please describe:
Click here to enter text.
Will these alternatives be incorporated into your proposed work? ☐Yes☐No
If not, please explain?
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If “No”, Please provide a written narrative about your search results including references.
Click here to enter text.
Please submit this request electronically to .
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