Amend your IACUC Protocol

This page contains information on how to submit an amendment to your IACUC protocol.

General Guidance About Amendments

  • You can only submit an amendment to a current, approved protocol (not to protocols that are in pending, expired or terminated status).
  • If you have a pending amendment, you cannot submit another one other than a separate personnel amendment concurrently.
  • It is always a good idea to check Section 13.1 to see if you need to change any of the "Yes/No" buttons on the species related activities. (When No is checked those sections will NOT open for you.) You may not need to open 13.1 if you know that the section that you want to amend is already open on your protocol.
  • Once the amendment is approved, the changes requested in the amendment become part of the protocol. You cannot see the changes separately in the protocol. It is a good idea to keep a PDF version of the proposed amendment for your records if you need it.
  • Amendments are reviewed on a schedule with two deadlines every month. Please refer to the schedule and deadlines listed on the page. An exception is made for personnel-only amendments, or those that require only minor administrative changes.

List of Common Amendments

Different types of amending actions may be combined in a single amendment submission. In these instances all sections related to each of the single actions must be completed.

When is this type of amendment required:

  • When a person will be working on the activities on the protocol in any capacity ( researcher, Vet, animal care staff etc.) is added to the protocol
  • When an individual already approved on your protocol, is no longer involved with the study. (Why is this important? To maintain accurate information on your protocol and to ensure that training, AUHSP requirements and contact information on this individual are not a requirement for your annual reviews and 3 year renewals.)
  • 15: Personnel list: Add person
  • 15.1: Personnel Information: Search for person using NetID
    • Note: if the person is not on the contacts list in eSirius, you must add them to the contact list first, by selecting as "Add a person not on the list"
    • To ask to remove an individual click on the remove radio button.
  • 15.2: Personnel information: Add contact information, role on protocol, training and experience of the person with respect to the activities that they will be involved in.

(b): Add activities to an approved person on the protocol: When the person will be working on activities not previously stated on the protocol.

Required e-Sirius sections:

  • 15.2.1: Personnel Protocol Related Activities: Select the activities the individual will be involved in pertaining to the protocol.

Note: No personnel are allowed to work with animals on a protocol, unless the amendment is approved by the IACUC, and the protocol reflects the addition of the personnel.

When this type of amendment is required:

  • If the protocol is already approved with animals in pain category C
  • The PI wants to get permission to purchase more animals in either category
  • The PI wants to move some animals to pain categories C from another pain category approved on the protocol.

Required e-Sirius sections:

  • 5: Scientific Design (usually 200 words or less): Modify the scientific design to reflect the new numbers, and/or incorporate any new design that is proposed. Provide an overview as to why the increase in animal numbers is necessary. Discuss how it affects any changes to previously described treatment and control groups, drug treatments, husbandry methods, housing conditions, etc.¬†Modify the total number of animals requested for all years of the protocol in each of the following sections. The total number requested must be the same in all sections.
  • 13.1: Species Information: Update the total number of animals requested.
  • 13.12: USDA Categories: Change the numbers in each category as appropriate, to correspond with the modified scientific design.
  • 13.13: Justification for numbers: Add specific justification for additional numbers of animals, or modify the existing justification(s) to reflect the numbers needed for the modified scientific design.
    • When possible, provide statistical power calculations to justify animal numbers. You must justify the number of groups in repeated studies in addition to justifying the number of animals per group. Examples not requiring power calculations include: pilot studies, tissue harvesting, breeding colony maintenance, etc. See Justification for numbers for examples and detailed guidance.

When this type of amendment is required:

  • If the protocol is already approved with animals in pain category D or E
  • The PI wants to get permission to purchase more animals in either category
  • The PI wants to move some animals to pain categories D or E from another pain category approved on the protocol.

Required e-Sirius sections:

  • 5: Scientific Design (usually 300 words or less): Modify the scientific design to reflect the new numbers, and/or incorporate any new design that is proposed. Provide an overview as to why the increase in animal numbers is necessary. Discuss how it affects any changes to previously described treatment and control groups, drug treatments, husbandry methods, housing conditions, etc.
  • 13.8: Discomfort, Distress, or Pain: Complete or modify this section to appropriately address pain and/or distress of the animals added (or moved) to category D or E. Contact a CARE Veterinarian if you need assistance. Be certain to address how you will determine the need for humane intervention based on quantitative measures as much as possible. (ACUP 402 - Humane intervention).
  • Modify the total number of animals requested for all years of the protocol in each of the following sections. The total number requested must be the same in all sections.
  • 13.1: Species Information: Update the total number of animals requested.
  • 13.12: USDA Categories: Change the numbers in each category as appropriate to correspond with the modified scientific design.
  • 13.13: Justification for numbers: Add specific justification for additional numbers of animals, or modify the existing justification(s) to reflect the numbers needed for the modified scientific design. When possible, provide statistical power calculations to justify animal numbers. You must justify the number of groups in repeated studies in addition to justifying the number of animals per group. Examples not requiring power calculations include: pilot studies, tissue harvest constraints, breeding colony purposes, etc. See Justification for numbers requested for details and examples.
  • 14: Search for Alternatives: Adjust your explanations for the 3-R's as appropriate

When this type of amendment is required:

  • If the protocol is NOT Approved for pain categories D or E and
    • the PI wants to get permission to purchase animals in either category, OR
    • The PI wants to move some animals to pain categories D or E from another pain category approved on the protocol.

In most instances adding pain category D and/or E will also mean changing or adding procedures in the protocol. See also Add non surgical procedures, Add surgical procedures, Add/modify Drugs as appropriate.

Required e-Sirius sections:

  • 5: Scientific Design (usually 500 words or less): Modify the scientific design to reflect the new numbers, and/or incorporate any new design that is proposed. Specifically describe why it is necessary to introduce pain and distress to your protocol, and its importance in achieving the goals of your research plan. Discuss any changes to previously described treatment and control groups, drug treatments, husbandry methods, housing conditions, etc.
  • 13.8: Discomfort, Distress, or Pain: Complete this section to address expected pain and/or distress experienced by animals added in category D or E, monitoring plans, and specific procedures designed to minimize pain and distress. Contact a CARE Veterinarian if you need assistance. Be certain to describe how you will determine humane intervention points based on quantitative data. (ACUP 402 - Humane intervention)
  • Modify the total number of animals requested for all years of the protocol in each of the following sections. The total number requested must be the same in all sections.
  • 13.1: Species Information: Update the total number of animals as needed
  • 13.12: USDA Categories: Change the numbers in each category to correspond with the modified scientific design.
  • 13.13: Justification for numbers: Add specific justification for additional numbers of animals, or modify the existing justification(s) to reflect the numbers needed for the modified scientific design. When possible, provide statistical power calculations to justify animal numbers. You must justify the number of groups in repeated studies in addition to justifying the number of animals per group. Examples not requiring power calculations include: pilot studies, tissue harvest constraints, breeding colony purposes, etc. See justification for numbers requested for details and examples.
  • 14: Search for Alternatives: Conduct and report on a literature and any other searches for alternatives. All changes adding pain categories D or E for the first time must include a new searches for alternatives. Describe these searches, and specifically discuss how you have addressed each of the 3-R's. See Alternatives for examples.

Additional sections that may need to be completed:

  • 13.7.1 Procedure location
  • 13.7.1.1 Procedure location information
  • 13.7.2 Non-surgical procedures
  • 13.7.2.1 Non-surgical procedure information
  • 13.7.3 Surgeries
  • 13.7.3.1 Surgical procedures
  • 13.7.4 Restraints
  • 13.7.4.1 Restraint types
  • 13.10 Drugs
  • 13.10.2 Drug information

When this type of amendment is required:

  • The PI is requesting permission to make a change to an already approved non-surgical procedure
  • The PI is requesting permission to add a new non-surgical procedure

Note: If the added or changed non-surgical procedure causes more than momentary pain or distress, this will require changing the numbers of animals in pain category D and/or E. See also Adding/moving animals to categories D & E or Add pain category D or E.

Required e-Sirius sections:

  • 5: Scientific Design (usually 200 words or less): Modify the scientific design to reflect the new and/or changed non-surgical procedures. Discuss changes to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.1: Species Information: If you do not already have an approved non-surgical procedure you will need to change the status of the Yes/No radio button for non-surgical procedures in the Species Activities section of page 13.1 first!
  • 13.7: Sequential List of Procedures: Add to or modify this section to reflect the changes in non-surgical procedures made to the scientific design. Describe how this additional procedure will be incorporated into the timeline of your existing procedures.
  • 13.7.2: Non-surgical procedures: Check the box that applies to the procedure(s) that you are adding.
  • 13.7.2.1: Non-surgical procedure information: Provide detailed information on each new non-surgical procedure, and/or modify existing detailed information to reflect the changes in non-surgical procedures made to the scientific design.
  • 15.2.1 and 15.2.2: Personnel: Indicate who in your research team will be performing the procedures and their training

Additional sections that may need to be completed:

  • 13.7.1 Procedures location: If a new location for the new or changed non-surgical procedure(s) is being used, complete this section.
  • 13.7.1.1. Procedure location information
  • 13.7.4 Restraints: If the new and/or changed non-surgical procedure involves the use of a restraint, this section will need to be completed or modified as appropriate. If you do not already have an approved restraint you must first change the Yes/No radio button in section 13.1 to enable adding restraints!
  • 13.7.4.1 Restraint types
  • 13.8 Discomfort, Distress, or Pain
  • 13.10 Drugs
  • 13.10.2 Drug Information

When this type of amendment is required:

  • The PI is requesting permission to make a change to an already approved surgical procedure
  • The PI is requesting permission to add a new surgical procedure

Adding or changing a surgical procedure may require Add/move animals to categories D & E, Add pain category D or E, or Add / remove Drugs.

Required e-Sirius sections:

  • 5: Scientific Design (usually 300 words or less): Modify the scientific design to reflect the new and/or changed surgical procedures. Discuss changes to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.1: Species Information: If you do not already have an approved surgical procedure you will need to change the status of the Yes/No radio button for surgical procedures in the Species Activities section of page 13.1 first!
  • 13.7: Sequential List of Procedures: Add to or modify this section to reflect the changes in surgical procedures made to the scientific design. Describe how this additional procedure will be incorporated into the timeline of your existing procedures.
  • 13.7.3: Surgical procedures: Add the procedure or choose an existing procedure to modify.
  • 13.7.3.1: Surgical procedure: Provide detailed information on each new surgical procedure, and/or modify existing detailed information to reflect the changes in surgical procedures made to the scientific design. If a new location for the new or changed surgical procedure(s) is being used, complete this section.
  • 15.2.1 and 15.2.2: Personnel: Indicate who in your research team will be performing the procedures and their training

Additional sections that may need to be completed:

  • 13.7.1 Procedure location: If the intended location for the surgery is not on the list which shows up on 13.7.3.1 then you will need to add it here first.
  • 13.7.1.1 Procedure location information
  • 13.10 Drugs
  • 13.10.2 Drug Information

When this type of amendment is required:

  • If you are adding new drugs to be used with animals.
  • You want to change dosages or routes of administration for a drug that you were previously approved to use on your protocol.

Required e-Sirius sections:

  • 13.1: Species Information: If you do not already have an approved drug you will need to change the status of the Yes/No radio button for drug use in the Species Activities section of page 13.1 first!
  • 13.10: Drugs
  • 13.10.1: Drug information
  • 15.2.1 and 15.2.2: Personnel: Indicate who in your research team will be administering the drugs and their training

If the drug is identified as a potential hazard to animal and/or human health, sections related to Adding/modifying hazardous agents will also need to be completed.

Additional sections that may need to be completed:

  • 5. Scientific Design (usually 200 words or less): If necessary, modify the scientific design to reflect the new and/or changed drug usage. Discuss changes, if any, to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.9 Hazardous Agents
  • 13.9.2 Hazardous Agents Information

When this type of amendment is required:

  • If you are adding new restraints to your protocol to be used with animals.
  • If a restraint that you were previously using on your protocol is no longer being used

Required e-Sirius sections:

  • 13.1: Species Information: If you do not already have an approved restraint you will need to change the status of the Yes/No radio button for restraint use in the Species Activities section of page 13.1 first!
  • 13.7.4: Restraints
  • 13.7.4.1: Restraint details
  • 15.2.1 and 15.2.2: Personnel: Indicate who in your research team will be administering the restraints and their training.

Additional sections that may need to be completed:

  • 5. Scientific Design (usually 200 words or less): : If necessary, modify the scientific design to reflect the new and/or changed restraint. Discuss changes, if any, to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.7.1 Procedure Location: If the new, or modified restraint, is being done in a location that does not show up in the list shown on 13.7.4.1, then the location needs to be added here first.
  • 13.8 Discomfort, Distress, or Pain: If the change in restraint is expected to impact the pain or distress to the animal.

When this type of amendment is required:

  • When a new hazardous agent needs to be added to the protocol
  • When additional information is made available on an existing hazardous agent that requires changes to SOPs, PPE, safety precautions etc.

Required e-Sirius sections:

  • 5: Scientific design (usually 200 words or less): Modify the scientific design to reflect the new and/or changes in hazardous materials. Discuss changes to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.1: Species Information: If you do not already have an approved hazardous agent you will need to change the status of the Yes/No radio button for hazardous agent use in the Species Activities section of page 13.1 first!
  • 13.9 Hazardous agents (as they relate to each species that you will be using) Add or remove hazardous agents as appropriate.
  • 13.9.2 Hazardous agent information For each new hazardous agent complete all the sections. If there is updated information for a listed hazardous agent add or change information as appropriate. Provide enough detail so that the AUHSP (Animal Users Health & Program) group can adequate evaluate the risks.
  • 15.2.1 and 15.2.2: Personnel: Indicate who in your research team will be using the hazardous agents and their training.

The following sections will also need to be completed if you previously had NO hazardous agents associated with your protocol:

  • 9: Use of Hazardous agents
  • 9.1 Hazardous agent use information

When this type of amendment is required:

  • When there are changes to the current method of euthanasia approved on your protocol
  • When a new method of euthanasia is requested

Required e-Sirius sections:

  • 13.1: Species Information: If you do not already have an approved euthanasia method you will need to change the status of the Yes/No radio button for euthanasia in the Species Activities section of page 13.1 first!
  • 13.11 Euthanasia
  • 13.11.1 Euthanasia information
  • 15.2.1 and 15.2.2: Personnel: Indicate who in your research team will be performing euthanasia (if this has changed) and their training

Additional sections that may need to be completed:

  • 5. Scientific Design (usually 200 words or less): If necessary, modify the scientific design to reflect the new and/or changed euthanasia approach. Discuss changes, if any, to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.8 Discomfort, Distress, or Pain if the change in euthanasia method is expected to impact the pain or distress to the animal.
  • 13.10 Drugs Be sure to add any new drugs being used for euthanasia to this section.
  • 13.10.2 Drug Information

When this type of amendment is required:

  • Whenever you will deviate from established standards of care as specified in The Guide for this species. Most often this is because of housing (caging) or husbandry practices required by the research or teaching.

Required e-Sirius sections:

  • 13.14 Exemptions from Standards of Care: Complete all sections in detail to describe the deviation(s). (NB: This section replaces the previous paper forms for Exemptions from Standards of Care that were being used before September 2009.)

Additional sections that may need to be completed:

  • 5. Scientific Design (usually 300 words or less): If necessary, modify the scientific design to reflect the new exemption from standards of care. Discuss changes, if any, to treatment and control groups, and any impact upon previously described drug treatments, husbandry procedures, housing conditions, etc.
  • 13.8 Discomfort, Distress, or Pain if the exemption from standards of care is expected to impact the pain or distress to the animal.

When this type of amendment is required:

  • Whenever you need to add, or to change a housing location. (Note: when whole facilities close/open the changes may be made administratively.)

Required e-Sirius sections:

  • 13.4: Housing location
  • 13.4.1: Housing location information
  • 13.6: Clinical care, quarantine, acclimatization & Daily care: specify if there are any changes to these as a result of change of housing locations.

May also need:

  • 12: Transportation of animals: if there will be changes to the way in animals will be transported due to a change in housing location.

Please note: Housing locations must be approved by the IACUC before animals are housed.

When this type of amendment is required:

  • Whenever you want add or change a location to carry out a procedure on animals.

Required e-Sirius sections:

  • 13.7.1 Procedure location
  • 13.7.1.1 Procedure location information
  • Please note: Procedure rooms must be approved by the IACUC before work can be performed in them.

Additional sections that may need to be completed:

  • 13.7.3 and 13.7.3.1 Surgery: If the new procedure room is to be used for surgery.
  • 13.7.4 and 13.7.4.1 Restraints: If the new procedure room is to be used for restraint.

Note that the guidance provided for each amendment type is based on the assumption that the PI is requesting ONLY that particular change in the approved protocol. For example, if you are requesting permission to add animals to pain category C as well as use new drugs or perform new procedures, you must follow the guidance provided in (2), (4) and (7). However, if you are adding animals to pain category C and do not propose to make any other changes to your protocol, you only need to follow the guidance provided in (2).