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Research and Innovation

Research Compliance

IACUC Approval Process and Forms

Who Needs Approval

  • All faculty, staff, and students using animals, regardless of location or funding, must obtain approval from the Institutional Animal Care and Use Committee (IACUC) before activities begin.
  • The use of animals is defined as any activity involving vertebrate animals in which the natural life style or movements of the animals is materially altered. Use of animal carcasses, tissues, and fluids obtained specifically for research, testing, or teaching purposes are subject to review according to applicable regulations and may be determined to be “use of animals.”
  • If you are unsure if your project involves use of animals, contact Research Compliance at researchcompliance@tamuk.edu and or the IACUC at TAMUK.IACUC@tamuk.edu.

Required Documentation

Administrative Review

  • Research Compliance staff receives all new animal use protocols (AUPs) and assign an AUP tracking number. All future correspondence between the IACUC and the investigator should reference the assigned AUP number.
  • Research Compliance staff will perform an administrative review of the AUP for completeness, request needed modifications, and make suggestions for improvement before the submission is routed for IACUC review. The PI is encouraged to contact the Research Compliance at 361-593-2677 or TAMUK.IACUC@tamuk.edu for clarification or assistance in addressing the administrative review comments.
  • As part of the IACUC AUP approval process, principal investigators must document the training and experience of their personnel. The IACUC requires all personnel to complete their CITI training. In addition, personnel who work with animals or are at risk from animal exposure must complete the  Occupational Health Program form and informed of the risks associated with the animal exposure.

Committee Review Process for Committee Review

  • The IACUC utilizes two methods of protocol review: Designated Member Review (DMR) and Full Committee Review (FCR)
    •  FCR:
      • All members of the IACUC are notified when an Animal Use Protocol (AUP) is received and are given the opportunity to call the submission to FCR at a convened meeting of a quorum of the voting members of the IACUC. Additionally, the IACUC may require protocols with certain activities to automatically be reviewed by FCR.
      • An IACUC member performs a pre-review of the submission, clarifications and modifications are requested from the PI using the Request for Modification (RFM) process, and the member presents the results of the review and clarification/revision process to the IACUC for its consideration.
      • The PI is notified when an AUP is scheduled for review by FCR and invited to attend the IACUC meeting, if so desired
      • The IACUC may approve the AUP, request additional modifications to secure approval or withhold approval
      • The PI is notified of the outcome of the committee’s review.
    •  DMR:
      • In absence of a call or requirement for FCR, the IACUC chair assigns at least one member of the IACUC to perform DMR.
      • The member performing DMR may also request that the submission be reviewed by FCR.
      • The IACUC member performs a review of the submission and requests modifications to secure approval using the RFM process if the AUP is not ready for approval.
      • The PI is notified when the AUP is approved.
    • Additional review comments from the Attending Veterinarian (or veterinary designee) and individuals performing a review of the hazardous activities proposed in the AUP are also routed to the PI through the RFM process.
    • The PI is encouraged to promptly and completely respond to all review comments to reduce delays in approval. Research Compliance staff are available to assist the PI by providing clarification or assistance in addressing review comments. Contact the Research Compliance at 361-593-2677 or TAMUK.IACUC@tamuk.edu.

Communicate Outcome

  • Once approved, Research Compliance staff will prepare an approval letter which is routed to the investigator. The relevant compliance section in Maestro is updated for sponsored funds.

Conduct Research

  • The following is information about maintaining an approved Animal Use Protocol (AUP) required for research or instructional use of live vertebrate animals at Texas A&M.
    • Amending Approved Animal Use Protocols (AUPs) including Updates to Personnel
      • Approved AUPs may be modified with the submission of an amendment to the AUP through submission of an IACUC Amendment Form.
      • 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. 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.
    • Triennial Expiration
      • AUPs are approved for three years. Note that all activities described in the protocol must halt on or before the expiration date. The IACUC is not allowed under federal regulation to extend the approval period beyond the original expiration date.
      • The PI must take action in a timely manner to address the expiring protocol and may choose to close the AUP, or continue the work by combining the project with another AUP or submitting a New AUP. 
      • If the project is  complete:
        • Notify Research compliance by email that the AUP work is completed and it can be closed out.
        • The PI must ensure there are no animals remaining on the AUP prior to closure.
      • If the project is  continuing:
        • The PI is required to submit a new AUP as soon as possible to replace the expiring AUP.
        • The New AUP must be approved before the old AUP expires for continuing activities. This is critical if animals remain on the expiring AUP. Working with the Research Compliance staff on your draft before submission may help speed the IACUC review and approval process, though prompt submission is still advised.