General Questions
Who can be a Principal Investigator (PI)?
Please see the IACUC's policy for Who can be a Principal Investigator (PI)? Note the IACUC’s definition of a PI may differ from other departments or committees, such as OSP, IBC, IRB, etc.
Is UT accredited by AAALAC?
Yes. The University of Texas at Austin is fully accredited by AAALAC International, a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. It is made up of more than 1,000 institutions in 44 countries. UT Austin has been fully and continuously accredited since 2001.
Why must we have an IACUC?
The Institutional Animal Care and Use Committee (IACUC) is a federally mandated committee that oversees its institution’s animal program, facilities and procedures. It provides a framework for compliance with federal policies, guidelines and principles related to the use of animals in research, teaching and testing. The IACUC is a self-regulating body, which derives its existence from two sources:
- The Animal Welfare Act and its amendments, which are administered by the USDA through the Animal and Plant Health Inspection Service (APHIS)
- The Health Research Extension Act and its amendments, which are administered by the National Institutes of Health (NIH) through the Office of Laboratory Animal Welfare (OLAW)
Who sits on the IACUC?
According to PHS Policy, the IACUC must be comprised of a minimum of five members, including:
- A veterinarian with program responsibilities
- A scientist experienced in laboratory animal procedures
- A non-scientific member
- A non-affiliate/ community representative (a person who has no other affiliation with the organization other than sitting on the IACUC committee)
What are the responsibilities of the IACUC?
Some of the most important IACUC functions are to:
- Review and approve proposed activities that will involve animals as well as any significant changes in IACUC-approved proposals that may arise later
- Inspect all animal facilities (including satellite facilities) at least every six months
- Monitor the institution’s program for humane care and use of animals; evaluate compliance with the AWA, PHS Policy and other requirements and report to the responsible institutional official and federal agencies as described in their respective rules
- Investigate legitimate concerns or complaints received from facility personnel or the public
- Suspend an activity involving animals if the activity is not conducted in accordance with the AWA and PHS Policy as approved by the IACUC
What is the Animal Resources Center (ARC)?
The Animal Resources Center oversees the care and use of vertebrate animals utilized as part of the research and teaching activities of the University, and serves as a source of expertise and support for investigators and the administration on all issues related to laboratory animals.
The ARC is dedicated to advancing scientific knowledge and improving human and animal health through the highest standards of care and ethical treatment of laboratory animals. We support the academic community by providing exceptional animal husbandry, veterinary care, and compliance with regulatory standards, ensuring that all research conducted is humane, responsible, and of the highest quality. Our commitment to education and collaboration fosters an environment of respect and compassion for animals, while promoting innovative research that contributes to the global understanding of biology and medicine.
I am a new animal researcher/ student at UT Austin. How do I get started?
As a new animal researcher or student, you must complete a series of steps with the IACUC and ARC in order to be able to work with animals.
- Gain access to eProtocol and complete mandatory training for working with animals. If you cannot login to eProtocol IACUC with your UT EID, then email IACUC@austin.utexas.edu to get access. Once you can login to eProtocol IACUC, begin the required training. Mandatory training includes enrollment in the HealthPoint Occupational Health Program (OHP) and online modules depending on the species and procedures in the protocol. See the Mandatory Training for Working with Animals for more information. You cannot be added to an IACUC protocol until all required training is completed.
- Gain access to ARC facilities once your animal use protocol has been approved. Complete the ARC Access Form and obtain a PROXIMITY card. See the question, “How can I (or my lab members) gain access to the ARC?” below for more information.
- Request specialized training from ARC staff (optional) and/or receive protocol specific training from experienced lab members. Reference the Training page for information on classes offered.
- Familiarize yourself with UT Austin Animal Care and Use Policies, Procedures and Guidelines.
What are the types of IACUC review and how long will it take for my protocol to be reviewed?
The IACUC utilizes three methods of protocol review:
1. Full Committee Review (FCR)
Requires a convened meeting of a quorum of the IACUC. Protocols must be submitted and accepted by the deadline date to ensure they are reviewed at the upcoming IACUC meeting. All new or third-year resubmission animal use protocols must be reviewed at a convened meeting of the IACUC.
This review’s turnaround time is generally about a month. All review processes are largely dependent upon how quickly a PI and/or their staff responds to reviewer comments and requests for additional information. The RSC staff makes every effort to maintain an expeditious review process and promptly review submissions.
2. Designated Member Review (DMR)
Allows for each IACUC member to be given a seven-day member consideration period to review the protocol document and respond either allowing the DMR to review the protocol or hold the protocol for the next FCR. If no members request FCR, then at least one member of the IACUC designated by the Chair will review the activities and may provide reviewer comments. The DMR has the authority to approve, require modifications in (to secure approval) or request FCR of any of the activities.
AURF, amendment and continuing review applications that are sent to a DMR generally receive approval within two or three weeks from submission to the IACUC.
3. Administrative Review (AR)
Utilized to review non-significant protocol changes, which are interpreted by the IACUC as changes that do not have the potential to impact health and well-being of the experimental animals. The Office of Research Support and Compliance staff review and approve these non-significant changes.
These protocol changes generally receive approval within three days of submission.
For more information, see IACUC's policies on Protocol Review Procedures and Modifications to Approved Protocols.
What should I do if I have a disagreement with a committee decision?
Investigators have the right to appeal a decision of the IACUC within two weeks of receiving notification of the IACUC’s decision. Contact the Office of Research Support and Compliance by email at orsc@uts.cc.utexas.edu with any questions, comments and/or concerns.
What is Post-Approval Monitoring (PAM)?
UT’s Post Approval Monitoring program encompasses protocol reviews, semiannual facility evaluations, designated monitoring based on IACUC recommendation, veterinary oversight, records review and quality assurance visits. The IACUC may also at any time require that a protocol receive a quality assurance visit to help a research group improve compliance with IACUC policies and procedures.
Please refer to the IACUC’s policy on Post-Approval Monitoring (PAM).
Protocol-Related Questions
Where can I go for eProtocol and eAnimal Ordering help?
Please see the eProtocol IACUC and eAnimal Ordering pages. If the answer you are looking for is not on this page, then please contact the IACUC office for eProtocol help and the ARC for eAnimal Ordering help.
How long is my protocol approved for?
Protocols are approved for up to three years. The three-year period begins on the actual date of IACUC approval; the IACUC may not administratively extend approval beyond the three years. Third-year resubmissions must be received, reviewed and approved prior to the expiration date of the original protocol.
When do I need to do to make changes to my approved IACUC protocol?
An amendment is required whenever you need to change your protocol. Examples include, but are not limited to:
- Adding or removing personnel
- Adding additional experiments or animals
- A change in funding
- A protocol title change
- A change in room location
- Any changes in any of the current procedures
Remember: Any change requires approval by the IACUC prior to implementation.
What is considered a significant/non-significant change to a protocol?
Significant changes to an IACUC-approved protocol must be reviewed and approved by the IACUC before they occur (PHS Policy IV.C.1. and AWR §2.31[d][1]). UT interprets significant changes to mean those that have the potential to impact substantially and directly on the health and well-being of the experimental animals. Examples of significant changes include, but are not limited to, changes:
- From non-survival to survival surgery
- Resulting in greater pain, distress or degree of invasiveness
- In housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC
- In species
- In study objectives
- In Principal Investigator (PI)
- That impact personnel safety
The University interprets non-significant changes to mean those that do not have the potential to impact substantially and directly on the health and well-being of the experimental animals. Examples of non-significant changes include, but are not limited to, changes:
- Correction of typographical errors and/or grammar
- In the funding source
- Contact information updates
- In personnel (other than the PI)
- In the use of a new vivarium housing location
Do temporary research personnel have to be added prior to working on a study?
The IACUC is unable to extend any blanket exemptions for this requirement, but there are ways that student participation can be managed. For example, undergraduates that have classroom contact with research animals as part of a wet lab session are under close supervision by the instructor and/or experienced TAs at all times.
Individual course participants do not need to be listed by name if an IACUC protocol is submitted in a way that:
- Makes it clear that this is a teaching situation
- Explains how students will be closely supervised
- Describes how the students will be given targeted training in ethical use of research animals at UT
- Lists the instructors and TAs that will be responsible for training and supervision. These personnel must fulfill the IACUC training requirements
The situation with rotating graduate students is somewhat different because as they become active in a lab, they will be expected to work independently and perform more complicated procedures than those included in undergraduate education. However, streamlining the process of adding graduate students is still possible, especially if those responsible for designing and coordinating graduate programs consider animal use training requirements. If it is likely that some or all of the graduate students in a particular training program will eventually rotate through a lab that uses animals, then those individuals should be instructed to take the online training modules in advance of their rotation. Graduate program coordinators can also educate students on the need to be added to protocols when they rotate to a new lab and might even be able to provide the PI with some administrative assistance to expedite the process.
Can I add non-UT personnel to my protocol?
Yes, you may. Please see IACUC's policy on "Non-UT Personnel" for more information on how to add non-UT personnel to your protocol.
For information about minors working in the lab: Environmental Health and Safety’s Laboratory Safety Manual III.12 "Minors in Laboratories."
Now that my animal use protocol has been approved, how do I order animals?
Please see the eAnimal Ordering page.
How can I (or my lab members) gain access to the ARC?
Step 1 - Fill out the online access form completely. If the form has missing information it will not be processed.
Step 2 - Go to the Flawn Academic Center ID center and obtain a PROXIMITY card.
Step 3 - Once your PI has signed the electronic Docu-sign access form, you may bring your activated proximity card to the ARC lobby on the second floor. The ARC is located at 2701 Speedway.
View the ARC Access Policy for more information.
How can I learn more about the ARC’s rate and billing information?
For the most current rate and billing information, visit the ARC Rates page.
I had an animal colony at another institution. Can I import it while waiting for IACUC approval?
New work cannot begin until an IACUC protocol is approved at UT Austin. New PIs may contact the Animal Resources Center to discuss using the ARC holding protocol to cover the transfer if there are urgent extenuating circumstances that require animal shipment before protocol approval.
What is an Animal Use Registration Form and why do I need one?
Animal Use Registration Forms (AURF) are to be used to register collaborative projects and contracted studies with UT Austin IACUC where no housing of live animals or activities with live animals take place at the University of Texas at Austin. AURF’s are needed when the research project funding is sponsored by T]he University of Texas or UT Austin affiliated personnel will be working with animals at another institution.
Researchers wishing to engage in animal use projects meeting these criteria where no activities with live animals will be performed at the UT should identify appropriate performance sites which are qualified as to the following standards:
- The performance site must provide facilities that are appropriate to the selected species. The performance site must meet specifications outlined in the Guide for Care and Use of Laboratory Animals (“the Guide”).
- The collaborating institution must maintain or be willing to file an animal welfare assurance statement with the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH).
- For USDA covered species: The collaborating institution must maintain an active registration with the United States Department of Agriculture (USDA).
You DO NOT need to register with the IACUC via AURF if the research activities fall under the following categories:
- Researcher receiving residual tissue samples that are an excess product of a live animal activity.
- Researcher receiving deceased animals or animal products that are generated regularly at an animal production facility and not specifically designed or tailored to the researcher’s need. Additionally, the researcher must have no ownership of the animals (e.g. antibodies ordered from a catalog, in stock animal research models not specifically bred for PI’s research).
If you have questions about if your work needs to be registered, please email IACUC@austin.utexas.edu.
When submitting a new AURF in eProtocol, you must attach copies of the host institution’s IACUC approval letter and approved protocol, as well as any grant application information for federally funded projects. Prior to submission of an annual review for an AURF, the PI should attach the latest approved copy of the host institution’s IACUC protocol along with the most recent approval letter from the collaborating performance site.
What are the Personal Protective Equipment (PPE) requirements for working with my animals?
PPE requirements differ based on what species or drugs and chemicals you are using. In centralized facilities, PPE requirements are posted on the animal room doors. It is the responsibility of the PI to post PPE requirements on satellite laboratory doors. Please check with EHS to see if extra precautions should be taken in addition to the standard requirements.
Refer to the IACUC Guidelines for the Use of Appropriate Personal Protective Equipment in Animal Research and Guidelines for the Use of Appropriate Personal Protective Equipment for Personnel Working with Non-Human Primates at UT-Austin, for more information.
Funding Questions
When is a congruency review needed and what are my responsibilities?
NIH Grants Policy states, “It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.” If you have new federal funding, then the IACUC will need to perform a congruency review.
The extent of the verification of consistency between grant proposals and IACUC protocols will be limited to a confirmation that the species, number of animals requested and procedures relating to use of animals described in the proposal are included in the protocol. This will be a unidirectional comparison of the procedures described in the grants. In conducting the verification, the IACUC focuses on the following three questions:
- Are the species used in the grant proposal included in the IACUC protocol?
- Are the number of animals requested in the grant proposal consistent with the number of animals in the protocol?
- Are animal care and use procedures described in the grant proposal included in the IACUC protocol?
Verification of grant and protocol congruence concentrates on animal care and use and will not include a judgment of scientific merit. Differences noted between the two documents will be assessed as to if they represent a change in scope of the research.
Grant congruence verification can take place at any time prior to grant award. It is strongly recommended that investigators do not seek IACUC approval for a grant proposal until they have at least received a fundable grant score.
For new IACUC protocols, the investigator should attach a full copy of the grant proposal that was submitted to the NIH to the eProtocol submission. The IACUC will validate grant congruence as part of the protocol approval process.
To add new funding to already approved protocols, a full copy of the grant proposal should be attached as part of a funding amendment request and submitted in eProtocol.
As part of the review process, the investigator may be asked additional questions, to add clarifying comments and add additional information in relation to congruence. Additionally, further amendment of the protocol may be necessary if contradictions exist.
The protocol approval letter is not a verification of grant congruence and should not be used to indicate to granting agencies that grant congruence verification was performed. Please email the IACUC at IACUC@austin.utexas.edu to request a memo confirming grant congruence.
What should I do when I receive a “Just-in-Time” request?
In order to reduce the administrative burden of requiring various certifications as part of initial grant applications, the NIH has instituted a request process whereby only those proposals with the possibility of being funded will be asked to submit these documents. Within 15 days of receiving a fundable proposal score a Just-in-Time (JIT) request will be sent to the investigator and institution.
The NIH understands that it may not be possible to receive IACUC approval in the timeframe that a response is due for Just-in-Time requests. Therefore, IACUC approval is not required as part of the response. However, grant funds will not be released until IACUC approval has been filed. It is suggested that investigators begin the IACUC approval process as soon as funding appears probable.
Note: Various non-federal funding groups also use variances of a Just-In-Time submission process. You should note any differences you need to be aware of including deadlines for submission.
How do DOD reporting requirements differ from other funding agencies?
Unlike NIH funding, the first step in receiving funding from the Department of Defense (DOD) will be to receive IACUC approval for the proposal from The University of Texas at Austin. Once approval is received, the researcher will submit the approved IACUC protocol and other required documentation to the appropriate Department of Defense compliance office (ACURO, BUMC, etc.). The DOD office will perform a secondary review of the IACUC protocol at this time.
Refer to IACUC Department of Defense Funding and IACUC Procedures for more information.