Approval Process for Research/Teaching with Animals
An animal use protocol must be submitted to the IACUC for approval of any research, testing, and/or teaching involving animals.
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 the IACUC office.
1. Documentation Needed
Submitting an Animal Use Protocol for Research and/or Teaching
An animal use protocol (AUP) must be submitted to the IACUC for approval of any research, testing, and/or teaching involving live vertebrate animals. Please contact the Animal Welfare Office (AWO) staff for assistance in determining if the submission of an AUP is required, if the proposed work can be added by amendment to an existing AUP for investigators with an already approved AUP, or if IACUC review and approval is not required. Submissions are accepted at any time.
Various attachments may be required as a part of the AUP submission. Instructions are included in iRIS when an attachment, such as a wildlife collection permit, is needed.
To submit an AUP for review, log in to the iRIS submission program. For instructions on how to log in and use iRIS, visit our informational portal.
Submission of External Protocols
The following must be submitted for IACUC review when activities with vertebrate animals are performed at a location under the oversight of an external IACUC on behalf of a Texas A&M investigator (e.g.: subaward, subcontract, unfunded collaboration, etc.), or by Texas A&M faculty, staff or students as a function employment or completion of a degree:
- A brief description of the scope of work including species to be performed at the external institution
- a copy of the external institution’s approval letter; and
- the contact information for the external IACUC office (if requested by AWO staff).
Once received and reviewed, if acceptable, the AWO will initiate a memorandum of understanding (MOU) between the TAMU and collaborating IACUC. Upon completion of the MOU, the IACUC will issue a letter of acceptance of the external institution’s oversight. The expiration date will coincide with the participating institution’s protocol expiration date. Continuing review of the applicability of the collaboration will be performed upon expiration of the external protocol for continuing projects.
2. Administrative Review
The Animal Welfare Office (AWO) staff receives all new animal use protocols (AUPs) in iRIS and the system assigns an AUP number. All future correspondence between the IACUC and the investigator should reference the assigned AUP number.
The AWO 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 AWO at (979) 845-1828 or animalcompliance@tamu.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 expects all personnel to participate in Texas A&M animal care and use training opportunities to satisfy their training requirements. In addition, personnel who work with animals or are at risk from animal exposure must be enrolled in a Biosafety Occupational Health Program and informed of the risks associated with the animal exposure. AWO staff will notify the PI during the administrative pre-review process if protocol participants are lacking IACUC required training, certification or BOHP enrollment so that this may be addressed while IACUC review is underway.
3. Committee Review
The IACUC utilizes two methods of protocol review: Designated Member Review (DMR) and Full Committee Review (FCR)
Full Committee Review (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 within iRIS, 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 through iRIS
Designated Member 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 in iRIS if the AUP is not ready for approval.
- The PI is notified when the AUP is approved through iRIS.
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 in iRIS.
The PI is encouraged to promptly and completely respond to all review comments to reduce delays in approval. AWO staff are available to assist the PI by providing clarification or assistance in addressing review comments. Contact the AWO at (979) 845-1828 or animalcompliance@tamu.edu. See the applicable iRIS Manual for additional assistance in addressing review comments in iRIS (NetID authentication required).
4. Communicate Outcome
Once approved, the Animal Welfare Office staff will prepare an approval letter which is routed to the investigator electronically and posted in iRIS. Protocol participants and the housing facility staff may also be informed when the animal use protocol is approved. The relevant compliance section in Maestro is updated for sponsored funds.
5. 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
- Triennial Expiration
- Animal Transfers
- Preparing for an AAALAC Accreditation Site Visit
- Post-Approval Monitoring of the Approved Animal Use Protocol
- Reporting Unanticipated Adverse Events and Self-Identified Noncompliance
- Investigation of Alleged Noncompliance and Animal Concerns
Principal Investigators are encouraged to view the AWO-P-039 video training on IACUC expectations and resources for success. This video will provide information about the IACUC, the responsibilities of the Principal Investigator, hints & tips for success, reporting unanticipated adverse events, and avoidance of noncompliance.