Abilene Christian University

Institutional Animal Care and Use

Amendment Request

**Note: All revisions to initial protocol must be submitted as part of the Appendix with changes identified in Track Changes.

Title of Project: Protocol #: Date of Request:

Principal Investigator:

Faculty Advisor (If PI is a student): **Note: Faculty Advisor MUST read and sign the Investigator Assurances Form

Department / Affiliation: Degree/Credentials:

Phone: Email:

Address or ACU Box:

Point of Contact, if other than PI (Name, phone, email):

Are the requested changes:

Administrative (e.g., change in non-essential personnel, address or contact information, increase in number no more than 10% of original approved #)

Veterinary Verification and Consultation (e.g., minor changes to already approved procedures, such as the frequency, duration, or number of procedures performed; the type or dose of medication used; or the method of euthanasia; does NOT involve new procedures) *Please include a veterinary consultation form

Significant (e.g., new procedures, changes in pain/distress categories, change in primary personnel (e.g., PI), or changes in species)

Have the changes requested already been implemented? YesNo If yes, please consult with ORSP as to whether an Unanticipated Problems/Noncompliance Form is required.

Are the changes in response to an Unanticipated Problem? Yes No If yes and the problem was serious, please submit the Unanticipated Problems/Noncompliance Form with this amendment if one has not been submitted previously.Serious is defined as adversely affecting animal welfare.

Summarize the changes being requested (add more rows as needed):
Change / Explanation for the Change / Form being revised/New Form being submitted
[Change 1] / [Explain] / [e.g., initial application]
[Change 2] / [Explain] / [e.g., initial application]
[Change 3] / [Explain] / [e.g., initial application]
Number of animals used at the time of submission:
Category A
Category B
Category C
Category D
Category E

How will the proposed changes affect the risks:benefits to animals, humans, and/or society?

Will these procedures increase the pain or distress experienced by the animals?

If yes:

a)Describe any measures you will take to alleviate pain/distress and/or limit it to that which is unavoidable for the conduct of the research, including modifications to procedures and/or use of sedative, analgesics, and anesthetics (Refine):

b)Provide a summary of the recent literature as it relates to the 3 Rs (Replace, Reduce, Refine)?

(Describe your search strategy: a) Which databases were used and/or experts consulted; b) When was the search conducted and what was the date range covered; c) What key words/search strategies were used; d) summarize your search results addressing Replacement, Reduction, and Refinement)

**Note: Please be sure to revise ALL relevant sections of your animal use protocol, including descriptions of procedures, # of animals in each pain category, steps taken to minimize pain and distress, personnel training for the new procedures, risks/benefits, etc. All changes should be in identifiable text, such as Track Changes.

APPENDIX

Identify which items are included in the appendix

Signed Investigator assurance/signature form (required).

Training Certificates of Completion for any new research team members.

All revised forms identified in the table above with changes made in Track Changes.

All new forms identified in the table above.

Unanticipated Problems/Noncompliance Form

Other: ______

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