Submitting an Animal Protocol

How to get started

The type of animal research you are conducting will determine the type of Protocol Form and addenda you will need to complete.

If you have an approved protocol, you may be able to amend the protocol rather than submitting a new application. A protocol can be amended to include changes only if the addition or modification still fits into the scope of the original proposal. Acceptable types of amendments are listed here.

If the proposed work does not fall into the scope of the original proposal, you will need to submit a new Protocol Form.

Please submit all the completed forms and addenda as email attachments to the IACUC Office. All submissions are processed electronically and printed or faxed documents are not accepted. However, a completed Signature Page can be faxed to 621-3355. Please note the name of the protocol on the cover sheet and do not fax the entire Protocol Form.

Types of Animal Protocols

Please note the requirement for side-by-side comparison of the protocol with the grant for federally funded (e.g., NIH, NCI, NSF) projects and submit the title page and portion of the scientific description that relates to the animal work with the Protocol Form. Bear this review in mind when preparing the Protocol: differences between the Protocol and the grant must be reported to the relevant funding agency. If discrepancies occur (e.g., different compounds, mouse strains, surgical procedures, etc...), the reasons for the difference should be included on the Protocol Form.

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Addenda (that may need to be submitted with the Protocol Form)

Breeding Addendum

Complete the Rodent Breeding Addendum for protocols where rodents will be bred in-house.  Do not complete the addenda for protocols where pregnant animals will be purchased, but not bred.  

Client Owned Animal Consent Form

If privately owned animals are used by University investigators for research or teaching, the protocol submission must include a sample consent form for review by the IACUC.  The consent form must include the following elements at a minimum:

  • Principal Investigator's name and contact information
  • Title of the study
  • Purpose of the study
  • Description of the procedures performed on the client owned animals
  • Description of the risks, if any, to the animal or the client associated with the procedure(s)
  • Potential benefits to the client owned animal from the study
  • Costs (if any) incurred by the client for participation in the study
  • Information that participation in the study is voluntary and that the client may withdraw their pet/animal at any time
  • Information on who to contact if there are problems, including a phone number
  • Animal information (species, animal name, age of animal, number of animals enrolled for that client, animal identification, etc.)
  • Client consent statement.  For example:  "I am the owner of the animal(s) described in this document.  I permit my animal's participation in this study.  I understand that I am free to withdraw my animal from the study and discontinue participation in this project at any time.  I understand that my confidentiality will be protected to the extent provided by Law.  I have been fully informed of the use of my animals and the possible benefits and risks."
  • Lines for Investigator and client signatures and dates

Surgical Addendum

If you will be conducting surgery, you need to complete the Surgical Addendum. Surgery is defined as any procedure that "penetrates and exposes a body cavity and produces substantial impairment of physical or physiological function" (as per the Guide), and includes:

  • Any time a scalpel is used
  • Any procedure that requires wound suturing
  • Certain routine farm animal procedures
  • Catheter implantation or removal
  • Colonoscopy (as per the UA IACUC)
  • Corneal procedures
  • Device implantation and/or removal
  • Induction of stroke
  • Intracranial or intrathecal injection
  • Myocardial infarction
  • Perfusion (does not include post-mortem perfusion)
  • Peripheral vessel cannulation
  • Skin injury (does not include needle stick for injections)
  • Tumor implantation
  • Tumor resection

When completing the Surgical Addendum, pay particular attention to the following:

  • The type of anesthetic agent used should be approved for that animal species. A list of approved anesthetic agents is available here. If you cannot use an approved anesthetic, you must be able to justify use of another anesthetic on the basis of scientific needs, not on those of cost and/or convenience.
  • Indicate the type of palliative therapy that will be given. Consider giving pre-surgical analgesia and using long acting analgesics, where appropriate. Ensure the dosing schedule is appropriate for the analgesic agent. A list of approved analgesic agents is available here.
  • You must scientifically justify multiple survival surgical events. Multiple procedures conducted during a single anesthetization do not qualify as multiple surgical events. Survival surgery, followed by a non-survival surgery (e.g., survival device implantation followed 3 weeks later by terminal device removal) does not qualify as a multiple survival surgical event.

Non-survival surgery is defined as a surgical procedure in which the animal remains under anesthesia for the duration of the procedure(s) and is euthanized without regaining consciousness.  Non-survival surgery includes any procedure that is considered surgery (see above), as well as terminal perfusion (with or without additional procedures). The Surgical Addendum must be completed for non-survival surgical procedures.

Euthanasia prior to tissue harvest is not defined as surgery, and a Surgical Addendum does not need to be completed.

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GLP Addendum

For GLP studies, the Principal Investigator is responible for contacting University Animal Care and the Quality Assurance Office to assure that the work is in compliance with GLP regulations.

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Other resources

There are a number of other resources available to assist in completion of the Protocol Forms.

  • Contact the IACUC Office for assistance with completion of the forms, determining which forms and addenda are needed, and approximate timelines for approval
  • Call 626-1247 if you need any help downloading or using the forms
  • A UAC veterinarian
  • A detailed description of how to complete a Protocol Form is available here
  • A detailed description of the USDA Pain Categories is available here
  • A list of approved anesthesia and analgesia methods are available at here
  • A list of approved euthanasia methods are available here
  • A list of signs of pain and distress in lab animals is available here
  • A list of IACUC policies relating to certain procedures such as LD50 studies, footpad injections, ascites production, toe clipping, etc... are listed here