Changing an Approved Animal Use Protocol

Amendments

Approved AUPs may be modified with the submission of an amendment to the AUP through the iRIS program.

The PI may change any section of the AUP, exclusive of personnel, using the amendment process. Multiple changes may be combined into one amendment to reduce the total number of amendments submitted. Note: iRIS will only accept the processing of one amendment at a time, though an amendment and a Personnel Change Request may be submitted concurrently.

Examples of potential amendments include, but are not limited to:

  • changes in animal procedures, such as anesthesia, surgical procedures, feeding, or sampling;
  • need for additional animals or new species;
  • changes to animal housing sites or procedure areas;
  • change in ultimate disposition of animals; or
  • change in funding source, or project title.

The amendment is a two-part process with general information provided about the type of modification requested followed by modification of the AUP itself. Since the AUP is considered a “living document”, all modifications are incorporated directly into the approved AUP during the amendment process.

Significant changes in procedures or experimental objectives may result in a request for a new AUP.

See the applicable iRIS Manual for additional help with this process (Texas A&M NetID authentication required), or contact the Animal Welfare Office staff at (979) 845-1828 or animalcompliance@tamu.edu for assistance.

Veterinary Verification and Consultation

Veterinarian Verification and Consultation (VVC) is an expedited process the PI can utilize to make minor modifications to previously approved AUP activities without having to submit an Amendment. Modifications must not result in a change in study objective, or increase pain, distress or degree of invasiveness beyond what is currently approved in the AUP.

Examples of modifications eligible for VVC include, but are not limited to:

  • Modify the dose, route, concentration, volume, and/or duration of an approved anesthetic, analgesic, antimicrobial, sedative or experimental drug
  • Changes related to blood collection (e.g.: frequency, volume, vessel of access)
  • Altering the duration or interval between procedures (e.g.: lengthening an imaging episode or the time between episodes)
  • Changing an identification means (e.g.: ear tag vs microchip)
  • Adding or altering behavioral testing methods providing they do not involve greater pain and distress or degree of invasiveness
  • A change in the final disposition of the animal including change from euthanasia to adoption, or transfer to another protocol. Transfer to invasive protocols such as terminal surgery or infectious disease studies require IACUC review
  • A change in AUP-approved euthanasia to any method approved in the current AVMA Guidelines for the Euthanasia of Animals (same species)

To utilize the VVC process:

  1. Contact a veterinarian with CMP (College Station and Galveston) at (979) 845-3800, or ARU (Dallas) at (214) 828-8149. (Note: VVC is not currently available for PIs at IBT or Kingsville)
  2. Describe the modification you wish to make to your AUP
  3. The veterinarian will review the modification for congruency with the AUP and IACUC approved SOPs and other documents such as drug formularies and the AVMA Guidelines for the Euthanasia of Animals
  4. If the request is congruent with the IACUC approved VVC materials:
    1. The PI will be authorized to implement the modification immediately
    2. The veterinarian will notify the AWO of the VVC modification. AWO staff will incorporate the modification into the AUP in iRIS on the PIs behalf.
    3. If the request is not congruent with the IACUC approved VVC materials:
      1. The PI will be notified that the modification is not eligible for VVC and an amendment must be submitted for IACUC review and approval before the change can be implemented

See the VVC Explained document for more information on this process.

Contact the Animal Welfare Office staff at (979) 845-1828 or animalcompliance@tamu.edu for more information on the VVC process.

Personnel Change Requests

The Personnel Change Request (PCR) process in iRIS may be used to modify the personnel on an approved AUP. See the applicable iRIS Manual for additional help with this process (Texas A&M NetID authentication required), or contact the Animal Welfare Office staff at (979) 845-1828 or animalcompliance@tamu.edu for assistance.

Examples of potential personnel modifications include:

  • addition or removal of personnel;
  • change in existing AUP personnel duties or roles; or
  • change in principal investigator.

It is strongly recommended that personnel complete all training and enrollment requirements for participation on the AUP prior to submission of the PCR. Please see IACUC Guidance TAMU-G-029 Guidelines for Animal Protocol Participation and Handling for more information on participation requirements, or contact the Animal Welfare Office staff at (979) 845-1828 or animalcompliance@tamu.edu for assistance in determining training requirements.