Laboratory Animal Resources Center
As a prospective/new investigator at TTUHSC, there are certain actions that must be taken prior to protocol review and approval. To help you acquaint yourselves with the TTUHSC protocol review system, please review the information listed below.
- TTUHSC Office of Sponsored Programs -- IACUC Resources
- Developing a New Protocol
- Resources for Writing Protocols
- Required Training Prior to Protocol/Amendment Approval
TTUHSC's Institutional Animal Care and Use Committee is a key resource in developing your animal resource protocol. According to the 1966 Animal Welfare Act (AWA), any institution that uses laboratory animals for research and/or instruction purposes must create and maintain an Institutional Animal Care and Use committee to oversee and evaluate the program.
Per the AWA, the IACUC should include, at a minimum, a designated chairman, a veterinarian trained and experienced in laboratory animal science and medicine, as well as a member not affiliated with the institution. Of course, many IACUC committees include more than three members; the only stipulation restricting this states that not more than three members can be from the same administrative unit.
At least once every six months, the IACUC must conduct a thorough review of the institution's program for human care and use of animals. Facility inspections must also be completed biannually to determine if the welfare of the animals is truly upheld. Furthermore, any protocols (new or renewing), protocol amendments, addition/change/deletion of personnel, etc. must receive IACUC approval prior to authorization and activity.
For more general information about the AWA, please visit the Animal Welfare Act and Regulations website.
For more information about the TTUHSC Institutional Animal Care and Use Committee, please visit the TTUHSC IACUC website.
A TTUHSC investigator who seeks to use animals in research must complete the Protocol Application Form appropriate for the type of research to be conducted (research/training or breeding) along with the appropriate supporting documents, including relevant appendices for special provisions. These documents should be submitted to the TTUHSC Office of Sponsored Programs well in advance of the desired research start date. Protocol Application Forms may be obtained online at the IACUC website given above.
The completed, submitted protocol application/amendment/document will be reviewed during a subsequent IACUC meeting, which occurs regularly on a monthly basis. As stated on the IACUC webpage:
The primary considerations for approval are that animals are cared for and treated according to applicable Federal and TTUHSC guidelines. While peer-review is NOT a primary function of the IACUC, all animal research must have a sound scientific basis. Therefore, investigators must provide an explanation of scientific significance where requested in the application, since this information is essential for the final approval of a protocol.
Each protocol/amendment to be reviewed is assigned a primary reviewer, who serves as liaison between the committee and the investigator for the duration of the protocol. Any errors, problematic issues, or questions that members of the committee may have are sent to the primary reviewer, who works with the investigator to either correct the errors/issues or develop an alternative approach to the aspect in question, prior to full IACUC review.
Once approved, a specific revision of a protocol is valid and active for three years before it warrants complete renewal. The investigator may, however, request permission to make some adjustments and/or changes to the protocol in the following areas with a complete, submitted protocol amendment:
- Addition/deletion of a title
- Addition/deletion/change of a procedure location
- Addition/deletion/change of personnel or PI
- Addition/deletion of an animal species
- Request for additional animals
- Addition/deletion/change of a procedure
Furthermore, an annual progress report must be submitted in order to maintain active status for a protocol. This is submitted to the IACUC committee in a similar fashion to amendments and protocols.
If desired, you may print: What to Expect in the IACUC Protocol Review Process
Gordon Brackee, DVM, MS, DACLAM is the Institutional Veterinarian and a helpful advisor for investigators who are preparing protocols. The IACUC strongly recommends contacting him early in the process of preparing applications, renewals, or amendments to provide advice on the appropriate and optimal species-specific uses of procedures, anesthesia, analgesia, and euthanasia.
Dr. Brackee may be contacted via office phone at (806) 743-2565, cell phone at (806) 787-1603, or via e-mail.
The IACUC will not approve an item (i.e., application, amendment, or renewal) until the PI and all personnel have enrolled in the Employee Health Program and completed the required training.
All personnel listed on a protocol are required to enroll in the TTUHSC Employee Health Program. However, enrollment in the program does not require participation in the program. Upon receipt of an application for a new protocol or a protocol renewal/amendment adding new personnel, the LARC will send an e-mail notice to each (new) person listed on the protocol. This e-mail notice will provide all necessary attachments to be completed and submitted to your local campus health or risk assessment nurse. The nurse then provides the enrollment form for signature, and submits verification to the LARC that your enrollment in the Employee Health Program is complete.
In addition to EHP enrollment, all personnel listed on a protocol are required to complete LATA training modules pertaining to their particular study. The link to the modules will also be provided in your e-mail notice from the LARC. All protocol personnel are required to complete the basic "Laboratory Animals" module as well as any module available pertaining to the species to be used in the protocol. Upon completion of each training module, the LARC will receive verification from the LATA webmaster listing the modules completed.