Animal Research FAQ

General Questions

The physiological systems of humans and other species of animals are very similar and as a result, research studies involving animals have led to critical contributions to the treatment of a wide variety of diseases. Vaccinations for polio, tuberculosis and diphtheria as well as pacemakers and cochlear implants have all been developed through research on animals. In fact, 180 of the 216 Nobel Prize award recipients in the Physiology or Medicine category used animal models in their research (Foundation for Biomedical Research, Nobel Prizes in Medicine, 2018)!

Animal research not only benefits humans. It also plays a key role in the development of veterinary medicine for our pets. These discoveries include the feline leukemia vaccine and flea control methods. These advances would not have been possible without the use of laboratory animals.

UT Austin researchers and animal caregivers understand that good science is dependent on proper animal care. Highly trained, licensed veterinarians and veterinary technicians with specialized training in laboratory animal medicine provide medical care for all animals at the University. Animal care technicians receive training through the American Association for Laboratory Animal Science (AALAS).

It is expected and mandated at UT Austin that the best possible care be given to ALL animals used for research, teaching and testing. Our animal care and use program takes accusationsof animal mistreatment very seriously and the IACUC is obligated to investigate all concerns regarding the care and treatment of animals. Any and all observed mistreatment of animals or failures to follow procedures and regulations should be reported to the Attending Veterinarian and/or IACUC.

UT Austin is committed to the principles of the “3Rs:” Reduction, Refinement and Replacement for animals used in research. Each time a UT Austin researcher requests approval for animal research, they must consider alternatives first.

  1. Reduction – Methods which minimize the number of animals used per experiment
  2. Refinement – Methods which improve animal welfare by refining practices
  3. Replacement – Methods which replace the use of animals with less sentient or non-animal models

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 the USDA and OLAW. Please see the New to Animal Research at UT Austin page for more information on IACUC functions.

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.

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 five business 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 3 days of submission.

For more information, see IACUC's policies on "Protocol Review Procedures" and "Modifications to Approved Protocols".

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 with any questions, comments and/or concerns.

Please refer to the IACUC’s policy on Post-Approval Monitoring (PAM).

Protocol Related Questions

Please see the eProtocol IACUC & eAnimal Ordering page. 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.

Protocols are approved for up to three years with a requirement of an annual continuing review application. 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.

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,
  • or any changes in any of the current procedures.

Remember: Any change requires approval by the IACUC prior to implementation.

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]). The Institution 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); and
  • 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); and
  • in the use of a new vivarium housing location.

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 and
  • 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.

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"

Although protocols are approved for up to three years, the IACUC requires an annual continuing review. The continuing review application must be submitted with enough time prior to the required deadline to allow for processing and Committee review (typically 30 days before the protocol’s anniversary).

The continuing review is used to ensure continued compliance by providing current information regarding all ongoing activities. The submission is also an opportunity for investigators to update study personnel, contact information, etc.

If a continuing review has not been processed and approved by the expiration date, the protocol will expire. Should IACUC approval expire, all activities involving the care and use of animals must cease immediately. Any activities conducted under the protocol after expiration will be in a serious and reportable violation of Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and may also be reportable to the United States Department of Agriculture (USDA) or applicable funding agencies.

If this is the first time you are submitting a continuing review, count the number of animals used since the IACUC approval date of the protocol. If this is the second continuing review for the protocol, count the number of animals used since the first continuing review. The number used is protocol specific and should not include the number of animals used under other protocol numbers.

AURF’s 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 the 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 University of Texas at Austin 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 bread for PI’s research).

If you have questions about if your work needs to be registered, please contact 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.

Funding Questions

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 (3) questions:

  1. Are the species used in the grant proposal included in the IACUC protocol?
  2. Are the number of animals requested in the grant proposal consistent with the number of animals in the protocol?
  3. Are animal care and use procedures described in the grant proposal included in the IACUC protocol?

Verificationof grant and protocol congruence concentrates on animal care and use and will not include a judgment of scientific merit. Differences noted between the two document 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 contact the IACUC (iacuc@austin.utexas.edu) to request a memo confirming grant congruence.

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 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.

iacuc_timeline_example

Agencies of the Department of Defense (DOD) use a two-step/dual approval process for work involving animals. All DOD funded work approved by the University of Texas IACUC must receive secondary approval from the DOD prior to initiation. Unlike NIH funding, the first step in receiving funding from the 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 along with their grant proposal to the appropriate Department of Defense office (ACURO, BUMC, etc.). When approving the grant, the DOD office will do a secondary review and approval of the IACUC protocol.

DOD Protocol Amendments: Once a grant proposal has been funded by the DOD, the PI should submit an amendment to the IACUC to add the funding to their protocol.

The Office of Research Support and Compliance(RSC) has implemented the following procedures to support Principal Investigators in the management of their DOD funded work (funding must be listed on the protocol in order for RSC to be able to assist in reporting):

When a researcher amends their DOD funded UT protocol, in addition to the UT approval letter, they will receive a notification from the RSC office that they are not allowed to implement the change until the DOD has issued a secondary approval. The RSC will submit the amended protocol to the DOD on behalf of the Principal Investigator. The DOD will review the change and issue their own approval letter. The time to receive notification of secondary approval depends upon the complexity of the amendment. CAUTION: Implementing any change prior to receiving the secondary DOD approval notice is considered non-compliance with grant stipulations.

DOD Funding and Project Collaborations: Collaborative investigators at other institutions must submit their own protocol and proposal to the appropriate DOD office. Therefore they should work with their own institution’s IACUC to maintain compliance with DOD grant expectations.