What is the Institutional Animal Care and Use Committee?
Any institution utilizing animals for the purpose of research, teaching, or testing is required by federal regulations to establish an Institutional Animal Care and Use Committee (IACUC). The Institutional Animal Care and Use Committee (IACUC) provides oversight of all animal use and activities including the review of Animal Use Protocols and the University of Houston’s animal care and use program. The IACUC is responsible for ensuring the university’s research and animal facilities (including satellite facilities) comply with Federal, State, Local, and Institutional regulations regarding research involving live, vertebrate animals.
What regulations and guidelines are there to dictate the committee's policies?
- The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training,
- The U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals
- The USDA Animal Welfare Act and Regulations
- The Guide for the Care and Use of Laboratory Animals.
The University of Houston is also accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), which helps to ensure that the program continually maintains the highest standards of animal care.
What is the difference between the IACUC and ACO?
Institutional Animal Care and Use Committee (IACUC): The IACUC is a standing committee of the university whose primary responsibilities include the review of animal research protocols (no animal work may begin until final approval is secured), oversight of the University of Houston’s Animal Care and Use Program (primarily through semi-annual program reviews and facility inspections), post-approval monitoring of ongoing research, and conducting compliance investigations as necessary. These and other defined responsibilities ensure that all aspects of the University’s Animal Care and Use program maintain compliance with all federal, state, local and institutional regulations. The IACUC is not involved in the day-to-day business operations of ACO (below), with respect to billing, per diem charges, and/or housing assignments.
Animal Care Operations (ACO): ACO provides professional veterinary and husbandry services to support animals used in biomedical and behavioral research, including the maintenance of standards for animals, facilities, equipment, and procedures defined by the governing regulations and accreditation organizations. This is attained by providing such services to the Investigative staff as: animal procurement, training, veterinary consultation in research design, transportation of animals, and veterinary care. ACO is not involved in the administrative aspects of the IACUC office (e.g. receipt, routing and processing of IACUC protocols), although the Attending Veterinarian is a voting member of the IACUC.
What is an Animal Care and Use Protocol?
The Animal Care and Use Protocol is a document that describes, in detail, how an investigator will utilize animals in their proposed research. The protocol application asks questions directly related to animal use requirements set forth by the regulatory agencies defined above. Once the form is completed by the investigator, it should then be submitted via email to the Institutional Animal Care and Use Committee (IACUC) office at email@example.com. The application will then go through both an administrative and veterinary pre-review process prior to being assigned to a fully convened IACUC meeting for review. If administrative details or required sections are left blank, the IACUC coordinator may contact you to request this information prior to placing the protocol on an agenda. Once feedback from the meeting is sent, all requested modifications must be addressed prior to final protocol approval. No animals may be ordered or research procedures conducted prior to the receipt of IACUC approval.
When should an Animal Care and Use protocol be submitted to the IACUC?
An Animal Care and Use protocol should be submitted to the IACUC for all research that involves the use of live vertebrate animals for testing, instructional and research purposes. Please review the submission deadlines, and also allow time for the IACUC determination to be released (usually 5-7 business days following a meeting). Most protocols will require at least minimal modifications prior to approval; more substantial modifications will require additional time for IACUC reviewers to verify that responses are adequate to address regulatory approval criteria. As many funding agencies require documentation of IACUC approval prior to making an award, we strongly suggest submitting a protocol as soon as you receive an indication that the work will be funded. Finally, research funds cannot be released by the Division of Research until the Office of Research Policies, Compliance, and Committees (ORPCC) verifies that an approved protocol is in place that is congruent with the research described in the grant application. Bottom line – the sooner, the better!
Where can the Animal care and Use protocol be found?
The current version of the Animal Care and Use form, as well as the corresponding appendices, can be found on the IACUC website.
Where should a completed Animal Care and Use form be sent?
Please send all Animal Care and Use forms, along with any corresponding appendices, to firstname.lastname@example.org.
Who should be contacted for assistance with writing an Animal Care and Use form?
The IACUC’s policies and guidance are located here to assist you in writing your protocol:
For veterinary assistance, (e.g., proper model selection, anesthetic/ analgesic recommendations, consultation on drug doses, routes of administration, surgical procedures, etc.), contact the IACUC Veterinarian. ACO veterinarians are also available for consultation.
For general assistance with the protocol submission and review process, clarifications on required modifications, inspection findings, technical assistance in completing the application, IACUC training opportunities and general information on IACUC policies and procedures, contact the IACUC Coordinator.
Can animal work continue past the protocol’s expiration date?
No. Federal regulations do not permit the IACUC to extend approval periods. If a renewal protocol has not been processed and approved by the IACUC prior to the expiration date, the protocol will expire. If expiration of approval occurs, all activities involving the use of animals must cease immediately, and animals will go on a holding protocol for routine husbandry only (no research manipulations or maintenance of special research conditions).
Per diem charges still accrue for these animals, however federal funding may not be used for these charges and a different account must be identified upon protocol expiration. The research will not be allowed to commence until a new protocol has been submitted, reviewed, and approved by the IACUC. If a protocol has expired and the use of animals continues, this is considered to be a violation of federal regulations that govern the use of animals in research, and may jeopardize both individual and university funding.
If the Investigator is confident that all animal research related to the Animal Care and Use protocol in question is completed, then the protocol may be closed. When closing an animal protocol, the Investigator is asked to confirm that no animals remain in the UH ACO facility under the protocol in question. If animals do remain, then the Investigator must either transfer the animals to another protocol, or make other human arrangements for the remaining animals prior to the submission of the protocol closure form. Please be aware that once a protocol is closed, it cannot be re-opened, and a new protocol will need to be submitted to the IACUC for additional research.
In order to close a protocol, the PI should submit an IACUC Protocol Closure Form to the IACUC Office. The form must be completed in its entirety. Once completed, the form should be submitted to email@example.com.
Any modification or change to responses provided within an IACUC-approved protocol application must be reviewed and approved by the IACUC prior to implementing the change. Research procedures are specific to individual protocols, meaning that even if the requested procedures are approved in a different or previous research protocol, they must also be listed in the protocol applicable to the animals the investigator is working with. Please note that references to other protocols are not accepted, and that as regulations continue to evolve, additional information may be requested on a procedure that was approved in the past.
Protocol revisions (submitted as an addendum (DOC)) may include, but are not limited to, the following:
- Changes in personnel (either adding or removing personnel from a project)
- Addition of a different species, strain, stock, or breed
- Changes in anesthetics, analgesics, antibiotics, paralytics, tranquilizers, or any other substance administered (this includes doses and routes of administration).
- Addition of a surgical procedure (survival or non-survival).
- Changing or adding an animal manipulation
- Addition of animal breeding
- Addition of a behavioral study
- Change in the location of a procedure room or animal housing if it is located outside of the animal facility. (Please note if the animal will be kept outside of the animal facility for greater than 12 hours, it is considered a satellite facility and the area will need to be reviewed and approved by the IACUC prior to use).
- Increasing the number of animals needed for the study.
Please review all associated IACUC policies for guidance prior to the submission of a protocol addendum.
Which revisions qualify for an Administrative Review?
Addenda that involve a change in personnel (adding or removing), change in protocol title, or a change in room number if the room is already on the IACUC inspection schedule, qualify for an Administrative Review. When adding personnel, the administrative reviewer will verify that the personnel have completed the appropriate CITI training modules. Training requirements can be found here. Administrative reviews generally take about 24-48 hours to approve, although under certain circumstances (i.e. adding untrained personnel), the review may take longer.
Which revisions qualify for Designated Member Review?
Many changes to Animal Care and Use protocols can be reviewed and approved via the Designated Member Review (DMR) process, by which all IACUC members are informed of the addendum via email and given 48 hours to call for a full committee review. If none of the reviewers call for discussion at a fully convened meeting, the addendum is assigned to an IACUC member. The IACUC Member performing the DMR has the authority to approve or require modifications to the addendum prior to approval. A DMR reviewer may not disapprove an addendum, but may request a full committee review if he/she has significant concerns about its contents.
Examples of revisions that may be reviewed via the DMR process include, but are not limited to, the following:
- Change of PI
- Significant change in age of animals (ex: adults to neonates)
- Increasing dosage levels or administration frequency
- Increasing blood sampling times or volumes
- Modification of the conventional environmental or husbandry practices
- Minor increase in number of animals
- Replacing or adding another standard anesthesia/analgesia or euthanasia method
- Adding or replacing a strain of animal
- Decreased invasiveness of procedure leading to decreased pain or discomfort
- Adjusting experimental endpoint for earlier termination of the study
- Decreased dose levels or decreased dosing frequency of animals
- Reduced blood sampling quantities or frequency
- Changing a survival surgery to a non-survival surgery
- Minor modifications in surgical techniques that do not lead to an increase in clinical consequences
- Adding a subgroup for an additional time point, with no additional clinical consequences
All change requests approved in this manner will be presented for informational purposes at the next fully convened IACUC meeting.
Some addenda, due to their complexity or potential increase in clinical consequences, require assignment to a full IACUC meeting. If you have questions regarding whether your revision qualifies as administrative, DMR, or full board, please contact the IACUC Coordinator.
How long does it take for a protocol or addenda to receive full approval?
Protocols/addenda that require review by the full committee are reviewed on a monthly basis. The submission deadlines and meeting dates are here. Once a protocol is reviewed, a memo from the IACUC office will be sent within 5-7 business days. Protocol outcomes and approval memos are sent to the investigator electronically (via email). If you have not received a response within 7 business days post-meeting, please feel free to contact the IACUC office at (713) 743-9252.
What are the possible outcomes of an IACUC protocol review?
Once the IACUC has reviewed an Animal Care and Use protocol or addenda, one of the following outcomes will occur, depending on the deliberations of the committee:
Approved – If the IACUC has determined that the proposal meets all regulatory requirements and that no additional changes or clarifications are needed, then the IACUC may approve the protocol. Once the Animal Care and Use protocol has been approved, the investigator may proceed with ordering animals and implementing study procedures.
Modifications Needed to Secure the Approval (MNSA) – The IACUC may request that modifications be made to the Animal Care and Use protocol prior to granting final approval. When a protocol receives this outcome, the investigator is provided a memo that details the modifications requested by the committee. Once the investigator responds to the IACUC’s request for additional details, the original protocol reviewer and any other reviewers designated at the full meeting will be provided the response. The reviewers will determine if the response meets the committee’s expectations. The available options are to 1)approve it, 2) that there needs to be further clarification from the investigator in order to secure an approval, or 3) that the response should be returned to the committee for a Full Committee Review at the next meeting. In some cases, the IACUC may determine that the modifications requested are minor, and that the response may be reviewed via Administrative Review procedures.
Withhold Approval – The IACUC may determine that the information provided in the Animal Care and Use application does not adequately address all of the requirements of the PHS Policy the Guide for the Care and use of Laboratory Animals, and/or the AWA. In these cases, the IACUC must withhold the approval of the application. When this occurs, the committee provides a detailed list of the findings that substantiate the determination. With further clarification provided by the Investigator, the protocol may come back to the committee for a full committee review. Designated Reviewers cannot withhold approvals, only a fully convened IACUC meeting may withhold the approval of a protocol. Higher institutional authority may not overrule an IACUC decision to withhold approval of a proposal.
When does a Memorandum of Understanding (MOU) need to be in place?
When UH is the primary institution responsible for the research project and enters into an agreement for some or all of the animal research to be conducted at another institution, a Memorandum of Understanding (MOU) (DOC) must be in place between the institutions. This agreement defines the collaborative activity involving animals and addresses each institution’s responsibility for animal use, animal ownership, and IACUC review and oversight. The document also establishes that the collaborating institution is PHS-assured, and whenever possible, AAALAC accredited. Prior to approving the collaborative research at UH, the IACUC must receive the collaborating institution’s IACUC approval letter specific to the project. If the collaborating institution is not AAALAC-accredited, a copy of the complete IACUC protocol is also required.
What submissions are required following protocol approval?
Revisions: See “When is it necessary to modify the Animal Care and Use protocol” section, above.
Annual Reports: In addition, all protocols require an annual report to the committee. This report (DOC) will request up-to-date numbers of animals used and a statement of progress. All publications resulting from the research should be cited.
De novo Resubmisisons: Protocols are approved for a maximum of 36 months. That is, all protocols expire at the three-year anniversary of the initial IACUC approval and must be submitted de novo (as a new protocol). This 3-year resubmission is submitted using a new application (DOC), and must include all previously approved addenda, new literature searches, and the most recent regulatory requirements within the completed application. De novo protocols require review by the fully convened IACUC. At this time, the protocol will receive a new number; all work moving forward (including animal ordering and cage cards) must reflect the new protocol number.
All submissions should be emailed to the IACUC office: firstname.lastname@example.org.