FAQs:

What is the Animal Utilization Protocol/ IACUC Application?

Answer: The Animal Utilization Protocol (AUP) is a document that describes in detail how an investigator will experiment on animals. This document must be completed by all investigators wanting to use animals in research. After filling out the AUP form, the investigator should submit it to the Institutional Animal Care and Use Committee (IACUC) for review. Protocols must be given full approval prior to the use of animals.

Where can I find the AUP or IACUC Protocol?

Answer: The current version of protocol forms (both eProtocols and Legacy
Protocols) can be found on the Forms page of the IACUC website.

Where do I send my AUP or IACUC Protocol?

Answer: Please send your AUP to the IACUC Program Coordinator at the Office of Research Support (ORS), Mail Code A3200. You can also deliver it in person to Suite 5.200, North Office Building A.

I have missed the deadline for turning in my protocol, but the IACUC meeting has not yet convened. Can I have the IACUC review my protocol on a last minute basis?

Answer: No, the IACUC members are sent the packet at least one week in advance of the meeting in order to have sufficient time to prepare and review each protocol. Therefore, submit your proposal as soon as possible. Based on the type of experimentation, it may be expedited.

Who do I contact for a status report on my proposal?

Answer: Please contact the IACUC Program Coordinator at the Office of Research Support (ORS). The email address is iacuc@austin.utexas.edu and the phone number is (512) 475-8650.

When is it necessary for me to modify, amend, or make changes to my protocol?

Answer: A Protocol Personnel Modification Form (PPMF) should be filled out whenever a new employee is added to your protocol or a Protocol Modification Form (PMF) should be completed when you wish to add additional experiments or animals. It is also necessary if you would like to change any current procedures listed on your protocol. Again the changes will need final approval prior to them being implemented.

Where can I find the Protocol Modification Form (PMF)?

Answer: The Protocol Modification Form (PMF) is available on the Documents, Materials, and Forms page of the IACUC website.

If I want to increase the number of animals used in my protocol, how do I request this change?

Answer: Complete the Protocol Modification Form (PMF) outlining the increase in animal numbers and explaining what will be done with these additional animals. The PMF should be emailed to the IACUC Program Coordinator at iacuc@austin.utexas.edu (PREFERRED), sent via campus mail (to mailcode A3200) or faxed to 512.471.8873.

I would like to change the type of anesthesia and a procedure that I am using under my current protocol. What should I do?

Answer: Complete the Protocol Modification Form (PMF) with the requested changes and forward it on to the IACUC Program Coordinator. The PMF should be emailed to the IACUC Program Coordinator at iacuc@austin.utexas.edu (PREFERRED), sent via campus mail (to mailcode A3200) or faxed to 512.471.8873.

Is it necessary for the IACUC protocol to list EVERY person that will be involved with the proposed research project?

Yes. The names of anyone who is actively handling, manipulating, or performing procedures on live vertebrate animals must be provided to the IACUC either in the original protocol submission or in a formal modification sent to the committee.

Is there a legal requirement for this, or is it just a campus policy?

It is a specific regulatory requirement for all institutions that receive federal funding from NIH. As a part of the evaluation of proposed research projects during the protocol review process, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals requires the IACUC to assess whether personnel conducting procedures are appropriately qualified and trained in those procedures¹. Similar requirement are found in the regulations promulgated under the federal Animal Welfare Act, and in the NIH Guide for the Care and Use of Laboratory Animals². As shown in the model IACUC protocol template provided by NIH Office of Laboratory Animal Welfare (OLAW), there is a requirement for the protocol to list the names of "all individuals authorized to conduct procedures involving animals” under the protocol³.

Is it a serious issue if personnel are performing studies with animals and they aren't on the protocol?

Yes it is. OLAW requires that significant instances of noncompliance be promptly reported to federal agencies, and unlisted participants is one of the examples of a “significant” deficiency. The guidance states that "participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained" is a reportable offense⁴. If such a situation is identified, the IACUC must perform a review of the situation and issue a report to the Vice President for Research, who then is required to formally report the findings to NIH, along with the name of the PI and a listing of any NIH funded studies that were involved.

Can't transient personnel such as students be excused from this requirement?

There is no ability for the IACUC 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. If an IACUC protocol is submitted which a) makes it clear that this is a teaching situation, b) explains how students will be closely supervised, c) describes how the students will be given targeted training in ethical use of research animal at UT, and d) lists the instructors and TAs that will be responsible and shows that they have fulfilled IACUC training requirements, then the individual course participants do not need to be individually listed.

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 also to perform more complicated procedures than would be included in undergraduate education. However, streamlining of the process is still possible, especially if those responsible for designing and coordinating graduate programs take animal use into consideration. If it is likely that some or all of the graduate students in a particular training program will eventually rotate through a lab which uses animals, then it is suggested that these individuals 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 some administrative assistance to expedite the process. Finally, if a large proportion of the students in a particular program will be predictably be rotating through animal labs, there would be an opportunity to create a specific teaching protocol structured so that it would cross-reference the IACUC approved protocols of a number of potential rotation projects, which would minimize the number of protocol modifications needed to cover the rotation students over time.

Doesn't adding personnel take a long time for the IACUC to approve?

No, it is accomplished by filling out the short Protocol Personnel Modification Form (PPMF)⁵. NOTE: for eProtocol REVISIONS, the process may be delayed if there is a pending action (e.g., REVISION or RENEWAL). In order to help make this as simple as possible, the OLAW guidance was revised in 2003 to allow changes in personnel (other than the PI) to be considered a "minor" change which can be approved administratively rather than requiring a full IACUC protocol review. The IACUC is still required to assure that all such personnel are a) appropriately identified, b) adequately trained and qualified, and c) enrolled in applicable occupational health and safety programs⁶. The basic training requirements for being added to a protocol can be fulfilled by turning in a short occupational health questionnaire form and completing a few online training modules. A complete description of how to fulfill training requirements can be found on the IACUC website⁷.

What training is required to add personnel to a protocol?

Please visit our Training page for more information.

Who can I contact to discuss training issues and the process of adding persons to a protocol?

Answer: Please call the IACUC Program Coordinator at 475-8650 with any questions.

How do I add a new employee/laboratory member to my protocol?

Answer: Effective March 8, 2010, a Protocol Personnel Modification Form
(PPMF) must be completed for EACH personnel addition or removal for Legacy Protocols (i.e., paper protocols) or by completing a protocol REVISION for eProtocols. The PPMF should be emailed to the IACUC Program Coordinator at iacuc@austin.utexas.edu (PREFERRED), sent via campus mail (to mailcode A3200) or faxed to 512.471.8873. NOTE: Individuals cannot add themself to a protocol. The PPMF should be submitted by the PI or lab manager. If the request comes from a lab manager, the PI should be copied on the message.

What is an Annual Protocol Update Form (APUF)?

Answer: All animal protocols must be reviewed annually. At least two weeks prior to the expiration of your protocol, an Annual Protocol Update Form (APUF) should be submitted. The APUF is very short: check the appropriate boxes, list the current active personnel, and list the species and number of animals used in the last year. The APUF should be emailed to the IACUC Program Coordinator at iacuc@austin.utexas.edu (PREFERRED), sent via campus mail (to mailcode A3200) or faxed to 512.471.8873. If there are changes to your protocol, a Protocol Modification Form (PMF) should also be submitted outlining the changes.

When my Animal Utilization Proposal (AUP) goes to the IACUC for a third year renewal, will my protocol number change?

Answer: Yes. It is treated as an entirely new protocol.

Where can I find out about IACUC Policies and Procedures?

Answer: The IACUC Policies and Procedures Manual is available as PDF by visiting http://www.utexas.edu/research/rsc/animalsubjects/policies_index.html.

Who do I contact about other IACUC questions?

Answer: Please call the IACUC Program Coordinator at 475-8650 with any questions.

(1) See section IV.C.1.f in the Public Health Service Policy on Humane Care and Use of Laboratory Animals
http://grants.nih.gov/grants/olaw/references/phspol.htm

(2) As summarized in section C.2.e. (Personnel Qualifications) in the ARENA/OLAW Institutional Animal Care and Use Committee Guidebook
http://grants1.nih.gov/grants/olaw/GuideBook.pdf

(3) See section A, “Administrative Data” of the Sample Animal Study Proposal
http://grants.nih.gov/grants/olaw/sampledoc/animal_study_prop.htm

(4) Communicated in the OLAW notice "Office Of Extramural Research Revised Guidance Regarding IACUC Approval Of Changes In Personnel Involved In Animal Activities"
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-046.html

(5) A copy of the current Protocol Personnel Modification Form (PPMF) can be downloaded here:
http://www.utexas.edu/research/rsc/iacuc/forms.html

(6) Communicated in the OLAW notice "Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals"
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html

(7) A training checklist can be found on the IACUC website at:
http://www.utexas.edu/research/rsc/animalresearch/training.php

FAQs:

Animal Utilization Proposal Questions

Protocol Modification Questions

Protocol Personnel

Annual Renewal Questions

General IACUC Questions