IACUC Frequently Asked Questions

The Institutional Animal Care and Use Committee (IACUC) is required by federal mandate at institutions that use live, vertebrate animals for research, teaching, or testing and oversees the 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 (AWA) and its amendments, which are administered by the USDA through the Animal and Plant Health Inspection Service (APHIS).
• The Health Research Extension Act (HREA) and its amendments, which are administered by the National Institutes of Health (NIH) through the Office of Laboratory Animal Welfare (OLAW). The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (the Policy) is a key component of this act and applies specifically to all research funded by the Public Health Service. The Policy mandates that institutions follow the standards set forth in the Guide for the Care and Use of Laboratory Animals (the Guide), which provides detailed guidelines for the proper housing, care, and humane treatment of laboratory animals in research settings.

As a new animal researcher or Principal Investigator (PI), you must complete a series of steps with the IACUC and Animal Resources Center (ARC) in order to be able to work with animals.

• Gain access to InfoEd, by working with your Trusted Requestor to submit a Tivoli request for “Investigator Access to the InfoEd Lab Animal Module”. To find your Trusted Requestor go to ITIM.utmb.edu and click on FIND TRs link. 
• New PIs please email the IACUC Office, iacuc.emp@utmb.edu to schedule a New PI Orientation to the animal care and use program and the InfoEd system prior to submission of an initial animal protocol.
• Researchers requiring ABSL2 or higher training need to register for biosafety training with the Department of Biosafety (DOB) at https://utmb.us/5zk.
• Complete mandatory requirements for working with animals. See the Guidelines on Training Requirements for Research Personnel for complete information. Animal researchers need to go to Section E in the Guidelines and email the completed table to IACUC.emp@utmb.edu for assignment of required training. Personnel cannot be added to an IACUC protocol until all required training and Occ Health clearance is completed.
• PI will then submit an amendment to add new animal researchers to the protocol. The IACUC Office with send an approval letter once requirement completions are confirmed and the amendment is approved.
• Access to Animal Resources Center (ARC) vivarium is granted by ARC after researchers are added to the protocol by submitting a Facility Access Request to schedule a Facility Orientation with ARC.
• Practical (hands-on) training may be done by ARC, DOB, or the laboratory. One or more of the following needs to be completed:
• Contact ARCTraining@utmb.edu to schedule hands-on training with ARC Trainers.
• DOB training is requested when registering for the theoretical courses.
• Laboratories are required to document any training.
• UTMB IACUC Policies can be found at https://www.utmb.edu/provost/resources/research-regulations-and-compliance/iacuc/utmb-iacuc-policies. All researchers need to be familiar with the policies applicable to their research.

The animal protocol describes, in detail, how an investigator will utilize animals in their proposed research. This animal protocol is submitted through InfoEd. Investigators can refer to the resources provided in the User Guides  for detailed information and support on submission processes.

The AWA defines a covered animal as:
…any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds*, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes.

*Birds (other than those bred for research) are covered under the AWA. New regulatory standards were published on February 21, 2023 (https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/new-bird-rule/awa-standards-for-birds)

The UTMB IACUC utilizes the following four methods of review. Please also check out IACUC Protocol Review Process Flowchart:

1. Full Committee Review (FCR):
   Requires a convened meeting of a quorum of the IACUC. Protocols must be submitted and accepted by the deadline to ensure they are reviewed at the upcoming IACUC meeting. All new protocols and triennial resubmission with any component of unrelieved pain/distress must be reviewed at a convened meeting of the IACUC.
2. Designated Member Review (DMR):
   IACUC members to be given a five (5) business days period (for new/triennial protocols) or one (1) business day for amendments to protocols to review the submission and respond either by allowing the DMR to review the submission or call it for an FCR. If no members request FCR, then the submission will be reviewed by DMR. The DMR may result in approval, require modifications to secure approval (RMTSA), or referral to FCR. 
3. Administrative Review:
   Utilized to review non-significant/minor protocol changes, which are interpreted by the IACUC as changes that do not have the potential to impact health or well-being of the experimental animals. The IACUC Office staff review and approve these changes.
4. Veterinarian Verification Consult (VVC):
   Certain significant changes to a protocol may be processed administratively according to IACUC-approved policy/guidance document in consultation with the veterinarian authorized by the IACUC. The veterinarian is not conducting DMR but is serving as a subject matter expert to verify that compliance with the IACUC–approved policy/guidance document is appropriate for the animals in this circumstance. Consultation with the veterinarian must be documented.
   

Additional notes and resources

• The review process (and approval time) is largely dependent upon how quickly a PI and/or his/her research staff respond to reviewers’ comments and requests for additional information. The IACUC Office makes every effort to maintain an expeditious review process and promptly review of submissions.
• For information regarding the significant/VVC and minor changes to an approved animal protocol, please see the IACUC Policy #6: Requesting Changes to an Approved Animal Use Protocol.
• Check out the User Guides for instructions on how to submit a protocol/amendment/VVC and/or how to respond to an IACUC Requires Modification to Secure Approval (RMTSA) letter. 

For Training Requirements please see: Guidelines on Training Requirements for Research Personnel.

Principal Investigators and all research personnel working with live vertebrate animals must be listed in Section 1 (do not list personnel who will not be working with live vertebrate animals) and Section 20B (if performing a surgery).  A secondary contact may be listed, as needed.

To add or remove research personnel, you will need to submit an amendment to your protocol. Before submitting an amendment to add personnel please read the Guidelines on Training Requirements for Research Personnel.

If proposed animal protocol includes the use biological agents, recombinant material, Human and Non-Human Primate Products, an NOU is required before the animal protocol can be approved. For NOU instructions or any questions regarding NOU requirements, please contact the  Department of Biosafety.

If the proposed animal protocol includes the use of  certain hazardous chemicals a High Risk Hazardous Chemical Safety Plan is required before the animal protocol can be approved. If the proposed animal protocols include the use of radiation hazards (radioactive material, x-ray producing devices, or lasers), a Radiation Permit is required before the animal protocol can be approved.  For more information and specific requirements please contact EHS at 409-747-0515 or email: ehs@utmb.edu

Power calculations are statistical analyses usually used in prospective studies. Power analysis is typically used to estimate the sample size needed to achieve power (probability of correctly finding statistical significance). Power analysis can be used to determine the approximate minimum number of animals required so that an effect can be detected within the given sample size. Power calculations can also be used to calculate the minimum effect size that is likely to be detected in an experiment with a given sample size. There is software that is specifically design for power analyses (free software click here) but most statistical packages have power analysis functions. For more information regarding power analysis please contact UTMB Office of Biostatistics.

No.

Animal work cannot begin until IACUC approval is granted. All animal protocol applications are required to undergo IACUC review before a decision is rendered.

Three  years from the date it was approved.  Federal regulations indicate that approval can only be granted for a three-year period. The Principal Investigator is responsible for ensuring that his/her approval does not lapse. A triennial renewal must be submitted prior to the three-year expiration date to keep the study active. InfoEd is sending the Investigators a 90-, 60- and 30-days reminder of protocol expiration.

• 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. Applicants with a potentially fundable score will receive a JIT request from an NIH system generated e-mail or directly from an agency contact via e-mail or telephone.  When a JIT request is received immediate submission of the Animal Protocol is strongly encouraged to assure IACUC review and approval is granted within the time frame requested by NIH.  Animal Protocols may be submitted and reviewed by the IACUC prior to receipt of the JIT request.
• If a "Just-in-Time" (JIT) request is received for an already approved protocol, the PI may need to amend the existing protocol to ensure the grant application fully aligns with the animal protocol. This means updating the protocol as needed to match the new information requested in the JIT, ensuring it is "congruent" with the grant.

The first step in receiving funding from the Department of Defense (DOD) will be to receive IACUC approval for the proposed animal work from our institution. Once approval is received, the PI will submit the approved IACUC protocol and other required documentation to the appropriate Department of Defense compliance office (ex. ACURO, etc.). The DOD office will perform a secondary review of the IACUC protocol at this time and inform the PI of the review outcome/approval.

During a congruency review, all animal work proposed in the grant application must be approved by the IACUC in the corresponding animal protocol(s). The review typically ensures that the following areas are aligned between the grant application and the IACUC protocol(s):

• Species involved in the study.
• Number of animals to be used.
• Description of proposed procedures to be performed on the animals.
•  Procedures to alleviate discomfort, distress, pain or injury
• Drugs (including agents, dosages, and routes of administration) that will be used.
• If survival surgeries are proposed, plans for post-surgical care.
• Experimental/human endpoints;
• Method(s) of euthanasia, as applicable.

After ensuring that all elements of the protocol are congruent with the grant application, a memo confirming the grant congruence is uploaded in InfoEd for the respective protocol.

The Animal Welfare Act (AWA) regulations require principal investigators (PIs) to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals.

The PI must provide a written narrative that describes the methods and sources used to determine that alternatives were not available.  Alternatives to be considered include those that would:

1. Replace animals with non-animal alternatives
2. Refine the procedures to minimize discomfort that the animal(s) may experience
3. Reduce the number of animals used overall

This approach ensures compliance with ethical standards and regulatory requirements regarding the humane treatment of animals in research.

• The IACUC is charged with ongoing review and oversight of the animal care and use program as mandated by the PHS Policy, Animal Welfare Act and Guide. The IACUC is also committed to serving the public by ensuring compliance with all legal and ethical standards regarding the use of animals in research.  One of the IACUC’s responsibilities is to conduct semiannual facility inspections and program reviews. The Facility Inspections are conducted to ensure labs are complying with the regulations relating to animal research. 
• The IACUC conducts inspections, at least once every six months, of all of animal housing facilities and areas outside the housing facilities, which include satellite housing, and all surgical sites within research laboratories.
• The IACUC inspects on a yearly basis all non-surgical spaces/laboratories where live vertebrate animals are used for research (ex. euthanasia procedures, behavioral…etc).

A satellite facility is a location outside of the vivarium where animals are housed or held for more than 12 hours for USDA species or more than 24 hours for non-USDA species.

Grant applications often ask for a “PHS Animal Welfare Assurance Number”. The UTMB Assurance Number is: A3314-01.

You can find this and other regulatory information for applications on our Institutional Information website.

The UTMB USDA Registration number is: 74-R-0073.

You can find this and other regulation information for applications on our Institutional Information website.

The UTMB Animal Care and Use Program is Accredited by AAALAC International. Our AAALAC number is 000870. We have been accredited since 1995 and our most recent accreditation letter date is: November 27, 2023.

You can find this and other regulation information for applications on our Institutional Information website.

Yes.

Only PIs who have an approved protocol can place animal orders and/or house animals at these facilities.

You can let the protocol naturally expire or to close the protocol before expiration date you need to contact the IACUC office at iacuc.emp@utmb.edu and the IACUC office staff will close the protocol after verifying that no live animals remaining on the protocol.