Obtaining an Animal Use Protocol
Any research or instructional use of live vertebrate animals by Texas A&M faculty, staff, or students requires the approval of an animal use protocol (AUP) by the appropriate Institutional Animal Care and Use Committee (IACUC). The AUP must be approved before any animal user may acquire, house, or use animals.
Submission of AUPs
An animal use protocol must be submitted to the IACUC for approval of any research, testing, and/or teaching involving animals.
To submit an AUP for IACUC review, log in to the iRIS system.
Submission of External Protocols
When animal work outlined in your protocol is being conducted at another institution the following information must be provided for IACUC review and acceptance:
- a copy of the participating institution’s approved protocol;
- a copy of the institution’s approval letter; and
- a copy of the institution’s Public Health Service (PHS) assurance number, if PHS funded.
Once received and reviewed, if acceptable, 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’s expiration date.
Approval of Animal Use Protocol
The Office of Research Compliance and Biosafety, Animal Welfare Assurance Program staff receives all new AUPs and assigns an AUP number. The investigator is notified of the receipt of the protocol and the assigned protocol’s number. All future correspondence between the IACUC and the investigator should reference the assigned AUP number.
As required by law, the protocol is distributed to the committee for their consideration. The committee is given a designated time period to consider the protocol. The designated reviewer (DR) will consider all of the comments or concerns raised by the committee. If further clarification is required, the DR will prepare a pending approval memo to the investigator requesting a response and revision to the protocol. The investigator has 30 days to respond with a revised protocol. If the revised protocol satisfactorily addresses the concerns iterated in the pending approval memo, the chair has the authority to approve the protocol.
At any time during the review period, a committee member may call for full committee review (FCR) of the AUP. This occurs when there are serious concerns. The DR will assign a primary and secondary reviewer whose responsibility is to conduct a thorough review of the protocol, grant and all committee comments. The investigator may be contacted and interviewed by at least one of the reviewers. The protocol will be brought before the next fully convened meeting of the IACUC for discussion and consideration. There is no requirement for the investigator to attend the meeting. If further clarification is deemed necessary by the committee, a pending approval memo will be generated and forwarded to the investigator, requesting revisions to be made and resubmitted within 30 days of receipt of the memo.
Once approved, the animal program staff will prepare an approval letter and forward a copy of the approved animal use protocol to the investigator electronically and via campus mail. A copy of the approved AUP will be sent to the funding agency, routing agency, housing facility, and the attending veterinarian.
An AUP is approved for a three year period. To submit an AUP for IACUC review, log in to the iRIS system.
Generating Antibodies
If you plan to produce polyclonal or monoclonal antibodies in vivo, you must submit an AUP for antibody production. Please note in-vivo acites production is highly discouraged and must be justified with evidence an in vitro alternative is not adequate for your antibody production.
Important Information for Investigators About Polyclonal Antibody Production
Polyclonal antibody production services are available through the Comparative Medicine Program (CMP). CMP’s service provides standardized antibody production procedures with technical support by skilled personnel who perform these tasks on a daily basis. You may provide your antigen to CMP personnel and they will generate your antibody for you for a reasonable cost, without the need for new AUP approval. CMP personnel can also provide copies of approvals to be submitted to NIH.
The CMP AUP is approved for rabbits, chickens, goats, and sheep, and has the ability to use a number of adjuvants. CMP’s standard immunization protocol uses Titermax® or Titermax/Gold® as the adjuvant. However, if an animal does not respond as expected, or if the Titermax® protocol is known to be a poor adjuvant choice for a specific antigen, an alternative adjuvant selection can be made following consultation with, and approval from the veterinary immunologist working with the CMP Service. Alternate adjuvants that are approved on the CMP AUP include Freund’s (Complete and Incomplete), RIBI®, Saponin and Aldydrogel®.
For information, contact CMP at (979) 845-3800 and inquire about the CMP Polyclonal Antibody Production Service.
Genetically Modified Animals
Use of genetically modified animals (e.g. transgenic) or inducing genetic changes in animals require review and approval by the Institutional Biosafety Committee (IBC) before IACUC approval is granted. The IACUC has established guidelines on the use of genetically modified animals.
Genetically Modified (Transgenic) Animals and the Use of Recombinant or Synthetic Nucleic Acid Molecules in Animals
Please contact the Office of Research Compliance and Biosafety if you have any questions regarding the proposed use of transgenic animals.
Use of rDNA, Pathogens, Biological Toxins in Animals
Any proposed use of recombinant DNA, zoonotic pathogens, or biological toxins in live animals require review and approval by the Institutional Biosafety Committee (IBC) prior to review and approval by the IACUC.
Use of Hazardous Materials in Animals
Use of hazardous chemicals in animals includes, but not limited to carcinogens and mutagens, radioactive, and toxic materials in live animals require the completion of Part VI of the AUP form before IACUC approval can be granted.
If you have any questions regarding hazardous materials, contact the Environmental Health and Safety Division at (979) 845-2132.