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The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011* or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

*If you have questions concerning the other policy, HOP policy 5-2011, “Conflicts of Interest, Conflicts of Commitment, & Outside Activities,” you should contact the Provost’s Office evpp_coi@austin.utexas.edu.

Frequently Asked Questions (FAQs)

Last updated February 20, 2014



A. General Questions

1. Where can I find out about IACUC Policies, Procedures, and Guidelines?

The IACUC website contains all policies, procedures, and guidelines.

2. Who can be a Principal Investigator (PI)?

All use of animals in research, teaching, and/or testing at The University of Texas at Austin must be under the direct supervision tenured, tenure track, or research faculty with assigned research space at The University of Texas at Austin.

For more information, please see the IACUC/HOPP Section 3.4: Who can be a Principal Investigator?

3. Why is my lab always being visited by the IACUC?

Federal regulations governing the use of animals in research require that the IACUC review and evaluate the care and treatment of animals in all animal study areas at least once every six months. The IACUC must have reasonable access to these areas for the purpose of verifying that activities involving animals are being conducted in accordance with the proposal approved by the IACUC.

4. What type of protocol records may be requested during the semiannual evaluations?

The IACUC may request to review animal identification and health records, staff training logs, sanitation and calibration records, Standard Operating Procedures (SOPs), controlled substance logs, environmental control, and/or husbandry records, etc. Essentially, the IACUC may request to see any documents or documentation that relates to the use of animals in research, teaching, and/or testing.

5. What if I have a disagreement with the committee’s decision?

Investigators have the right to appeal a decision of the IACUC within two weeks of receiving notification of the IACUC decision.

Please contact the Office of Research Support with any questions, comments, and/or concerns.

6. Who do I contact about other IACUC questions?

Please contact the Office of Research Support with any questions, comments, and/or concerns.

7. I have missed the submission deadline for the next IACUC meeting and it has not yet occurred. Can I have the IACUC review my protocol on a last minute basis?

No. IACUC members are provided access to protocols as they are accepted for review. Sufficient time to prepare and review each protocol is essential in ensuring a thorough review and allows for PI correspondence opportunities.

8. What is a pilot study?

Pilot studies may be appropriate to determine the technical feasibility of larger studies, to make initial assessments of the effect of procedures on animals, and/or assessing the skills of the research team. When novel studies are proposed or information for an alternative endpoint is lacking, pilot studies may be an effective method for identifying and defining humane endpoints and reaching consensus among the PI, IACUC, and veterinarians. Pilot studies require review and approval by the IACUC prior to any work beginning.

B. eProtocol

1. Who can log in to eProtocol?

Access to eProtocol IACUC is restricted to current faculty, staff, and students. A University of Texas Electronic ID (UT EID) is required to log on to eProtocol IACUC. A UT EID and password provides access to The University of Texas at Austin UT Direct and its services, and identifies authorized users of these services. See the UT EID website for more information.

2. How do I get access to eProtocol?

If you have a UT EID and are unable to log on to eProtocol IACUC, your sponsoring Principal Investigator must complete the eProtocol IACUC Access Form, available on the Documents, Materials, and Forms page of the IACUC website

3. I have an UT EID and password, but can’t log in. What do I do?

If you are a new faculty member, student, or staff member, your paperwork may not have cycled through the various campus systems yet. If after attempting to log in to eProtocol IACUC you are still unable to access the system, please submit an eProtocol IACUC Access form to the Office of Research Support. The access form is available on the Documents, Materials, and Forms page of the IACUC website.

See FAQ.B.2. for more information.

4. I tried entering information into eProtocol and received an error message. What do I do?

While you are entering information in eProtocol, the system will often notify you that you have entered information incorrectly or are missing required information. These kinds of messages will appear in red text towards the top of the protocol application page. Sometimes, however, you might attempt to navigate within the system or perform another type of action and you receive a message alerting you to contact the system administrator. If you receive this kind of message, close ALL browser windows and then re-open one window and try logging in again.

5. What computer/browser do I need?

To access eProtocol IACUC, you will need a computer with an Internet connection. If on a Windows machine, use Internet Explorer (IE) as your browser. If on an Apple machine, use Safari or Firefox as your browser. Pop-up blocking software must be disabled (pop-ups must be allowed) while using eProtocol.

6. How can I see certain protocols?

Once logged in to eProtocol, you will have access to see all those (and only those) protocols on which you have been listed in the Personnel Information section. You will only have access to edit those protocols on which you are listed as either: Principal Investigator, Co-Principal Investigator, Administrative Contact, or Other Submitter. You must have edit access for a particular protocol in order to start an Amendment (revision) or Continuing Review (annual renewal) application for that protocol. PLEASE NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read access to that protocol.

7. How can I edit a protocol?

You will only have access to edit those protocols on which you are listed as either: Principal Investigator, Co-Principal Investigator, Administrative Contact, or Other Submitter. You must have edit access for a particular protocol in order to start an Amendment (revision) or Continuing Review (annual renewal) application for that protocol. PLEASE NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read access to that protocol.

For more information, please see FAQ.E "Protocol Modifications."

8. Can you explain my HOME page?

The first page you encounter after logging in to eProtocol is your HOME page. This is also called your eProtocol Investigator dashboard. The protocols created by you and the protocols in which you are a member are automatically displayed on the HOME page after their creation. Protocols are sorted under their appropriate headers according to their status.

eProtocol Home Page

9. How do I print a protocol?

An Adobe PDF file of your protocol application form can be printed or saved to your computer. Once you have opened your protocol, navigate to the left-hand menu of the protocol application form, click on PRINT VIEW. A window will appear to allow you to customize your file/print out. The Adobe .PDF file will be generated; you may then save it to your computer or print it. Alternatively, you may download a PDF of the protocol by clicking on the version you want to download from the Event History page.

10. Why isn’t my protocol opening?

You most likely have pop-up blocking software turned on in your browser. Even if you believe you have allowed pop-ups, there may be additional toolbars, etc. that are blocking your pop-ups. Disable your pop-up blocking software. If you are still having problems, please contact the Office of Research Support.

11. Why can’t I see my approved protocols?

Your approved protocols appear on your eProtocol HOME page (the page you see when you first log in) in the section labeled "Approved Protocols."

For more information, please see FAQ B.6 "How can I see certain protocols?"

12. Why can’t I start my amendment/continuing review application?

If the option to Start Continuing Review or Start Amendment is not available:

  1. You may not have EDIT access to this protocol. Select "Open in View Mode" and click on the left-hand menu option "Personnel Info". Only those folks listed in the first four roles (PI, Co-PI Admin Contact, Other Submitter) have access to EDIT the protocol and start continuing review applications. For more information, please see FAQ B.6 "How can I see certain protocols?"
  2. A continuing review or amendment may have already been started or is in-process for this protocol. Check on your HOME page, under PROTOCOL EVENT in the AMENDMENT or CONTINUING REVIEW section to see if an application has already been created.

13. Why can’t I see the reviewer comments?

You might be confusing the Return Notes button in the left-hand side of the protocol application form with the IACUC Comments page.

Return Notes are used when Office of Research Support staff request additional information or clarification prior to accepting the protocol for review. You do not need to provide a response to the individual comments, but you do need to update your protocol as requested.

IACUC comments are used during the official review cycle after the protocol has been accepted for review. Each IACUC comment needs to be addressed and the protocol needs to be modified as applicable.

If you are attempting to access comments from the IACUC for a protocol that has already been assigned to a meeting date, please see the instructions on how to respond to IACUC comments (FAQ C.6.). If your protocol was returned, please see instructions for returned protocols (FAQ C.5.).

14. I received an email saying the IACUC has questions, but I can’t find the comments, where are they?

For more information, please see FAQ C.6. "How do I respond to IACUC comments?"

C. Protocol Review Process

1. Where can I find the status of my submitted IACUC protocol?

Please visit eProtocol IACUC to view the status of your submitted protocol. The column titled "Protocol Event" will describe the status of your submitted protocol.

  1. Yet to Submit to IACUC. The protocol is in the creation phase, but has not been submitted to the IACUC.
  2. Submitted to Committee. The protocol has been submitted to the IACUC for review.
  3. Moved. The protocol has been moved from the assigned meeting date to some other meeting date
  4. Tabled. The protocol has moved to a future IACUC Full Committee Review for further discussion.
  5. Comments Received (Cycle X). The protocol has received comments from the IACUC reviewer(s).
  6. Responses Sent (Cycle #). The PI has responded to the IACUC reviewer comments and has sent the protocol and comments back to the IACUC for review.
  7. Resubmit the Protocol.The protocol application has been returned to the PI asking for changes to be made.
  8. Resubmitted to Committee. The protocol application that was previously returned to the PI, has been resubmitted to the IACUC for review.

2. Who do I contact for a status report on my submitted documents?

Please visit eProtocol to view the status of your submitted documents. The column titled "Protocol Event" will describe the status of your submitted documents. Please see FAQ C.1. for a description of what the protocol event means. You may contact the Office of Research Support if you still have questions.

3. What are the different kinds of IACUC reviews?

The IACUC utilizes three methods of protocol review; Full Committee Review (FCR), Designated Member Review (DMR), and Administrative Review (AR).

Full Committee Review (FCR) of a protocol requires a convened meeting of a quorum of the IACUC. Protocols must be submitted by the deadline date to ensure they are reviewed at the upcoming IACUC meeting. All new or third-year resubmission protocols must be reviewed at a convened meeting of the IACUC.

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 to hold the protocol for the next FCR. If FCR is not requested, 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.

Administrative Review (AR) is utilized to review non-significant protocol changes which are interpreted by the IACUC as changes that do not have the potential to impact substantially and directly on the health and well-being of the experimental animals. The Office of Research Support staff review and approve non-significant changes.

For more information, please see the IACUC/HOPP section 3.6 Protocol Review Procedures and section 3.9 Review of Modifications to Approved Protocols.

4. How long will it take to get my protocol approved?

The review process is largely dependent upon how quickly Principal Investigators and/or their staff respond to reviewer comments and requests for additional information. Office of Research Support staff make every effort to maintain an expeditious review process and promptly review submissions.

5. My protocol was returned to me, how do I re-submit it?

After your protocol has been submitted, it will undergo an initial review by staff in the Office of Research Support. The protocol is reviewed to ensure the correct type of application form was used, that the application is complete, and that it includes all of the necessary attachments, etc. Sometimes it is necessary to Return a protocol. This releases the protocol back to the PI (with full EDIT capability) so that any necessary adjustments can be made. If a protocol is returned, an email notification is sent alerting the PI. The Protocol Event status on the Investigator dashboard will display "SUBMISSION RETURNED". The PI will need to open the protocol in EDIT mode and click the link in the left-hand menu labeled "RETURN NOTES" to determine what changes are needed.

A small window will open with information on the reason(s) for why the protocol was returned and instructions on how to proceed. Once any necessary adjustments have been made, and you are ready to resubmit the protocol, click the "SUBMIT PROTOCOL" button, just as was done for the initial submission.

A response does not need to be provided to the individual comments, but the protocol does need to be updated as requested.

6. How do I respond to IACUC comments?

Once your protocol has been accepted for review it will be assigned a meeting date and assigned one or more IACUC member(s) for review. Check your email regularly. You will receive an email for each major event in the review process, alerting you to when you need to log into the system and take a particular action. You can also see the status by looking at the protocol listing on your HOME page in the eProtocol application. Click on the link "Comments Received (Cycle #) in the Protocol Events column to access the comments page.

You will need to:

  1. Make the adjustments to the protocol itself (click the "GET PROTOCOL" button to open up a new window with the protocol)
  2. Enter a response for each comment (and "SAVE")
  3. Click the "SUBMIT TO IACUC" button to send your responses and revised protocol back to the IACUC.

PLEASE NOTE: Clicking SAVE will save your responses to the comments. However, these responses are not sent to IACUC until you click the SUBMIT TO IACUC button.

7. When will my protocol be reviewed?

If you are submitting a new or three-year resubmission protocol and it has been accepted for review within the established deadlines, your protocol will be reviewed at the meeting date that is displayed in your eProtocol Investigator dashborad. Only complete protocols will be reviewed by the IACUC. Simply submitting a protocol by the deadline does not mean that the protocol is ready for Committee review. If your protocol is returned for any reason, you must resubmit the revised protocol by the deadline date to be considered at that month’s FCR.

8. How soon can I expect to hear results from the IACUC meeting?

The ORS staff will communicate the review status within five business days of the IACUC meeting or receipt of review comment(s) from the Designated Member Reviewer(s).

9. For how long is a protocol approved?

The IACUC approves a protocol for three years with a requirement of annual continuing review submission and approval. 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 receive approval prior to the expiration date of the original protocol.

For more information on annual continuing reviews, please see FAQs G. Continuing Reviews.

D. Animal Utilization Proposals (AUP)/ Protocol Applications

1. What is the Animal Utilization Proposal (AUP)/IACUC application?

The Animal Utilization Proposal (AUP), or protocol, is a document that describes in detail how an investigator will use animal models in teaching, research, and/or testing.

2. Is the AUP the same as a protocol?

Yes.

3. Where can I find the AUP?

The AUP must be created and submitted via eProtocol. Refer to FAQ B.1. Who can log in to eProtocol? for further information on access requirements.

4. How do I create a new protocol?

To create a new protocol, log into eProtocol and from the Investigator dashboard page click on the CREATE PROTOCOL button in the upper right-hand corner of the page. You will need to enter basic information (such as Protocol Title, Personnel Information) before the application form is generated and a protocol number assigned. Once a protocol number has been assigned, you may continue to complete the application, or exit the system and return at a later time to complete. Once you have made all of the necessary modifications click on "SUBMIT FORM" located on the left hand column menu. A window will pop-up to confirm you want to submit, click on "YES."

5. How do I clone a protocol?

To create a new protocol from an existing protocol, log into eProtocol and click on the "CLONE PROTOCOL" button in the upper right-hand corner of the Investigator dashboard page. Select the protocol you would like to clone and then click on "CLONE PROTOCOL." Select "YES" to confirm you want to clone the selected protocol. Blue text at the top of your home screen will confirm that your cloned protocol was created. Once created, select the cloned protocol and open in "EDIT" mode to begin editing. You may continue to complete the application, or exit the system and return at a later time to complete.

Note on Cloned Protocols: Make sure to review all of the cloned data and ensure that all of the information is current and correct. Many times overlooked information on the protocol will include out of date literature searches, expired funding sources, new or old personnel that need modification on the personnel information page and under specific procedures, and incorrect locations or husbandry information.

6. How do I submit a protocol?

After completing your protocol application form, you can submit it to IACUC by clicking on the "SUBMIT FORM" button in the left-hand menu of the protocol application form as shown below. You will need to have the protocol application open in "EDIT" mode.

Please be patient after clicking submit. The application will automatically check to make sure that all parts of the application form are complete. If the application is complete, a small window will open thanking you for submitting your protocol. If the application is not complete, then a window will open indicating the portions of the application that remain to be completed. Navigate to those areas and complete the required information before attempting to submit again. You may also click directly on the link to be taken directly to the section that needs to be completed. PLEASE NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read/view access to that protocol

7. How do I transfer animals to my protocol?

The Animal Resource Center (ARC) has an Animal Transfer Form available to request the transfer of animals from one protocol to another.

8. I am new to the University. How can I have my animal colony imported while I am waiting for IACUC approval of my protocol?

If animals must be shipped before lab personnel are established on campus, the best option is often to identify an existing faculty member in the department that has a breeding protocol and technical assistance available. That protocol could be amended to include the new strain(s); the animals can be shipped and later transferred to the new PIs protocol.

New work cannot begin until an IACUC protocol is approved. If a suitable partnering lab is not available and if breeding can be suspended in the interim, new PIs may contact the Animal Resource Center to discuss using the ARC holding protocol to cover the transfer.

9. I closed my protocol before its 3-year expiration. Can I reactivate the protocol?

No. While you cannot "reactivate" a closed protocol, you may clone the closed protocol and submit for IACUC review. Before submission, ensure that all of the information is current and correct. Please see FAQ D.5. for more information.

E. Protocol Amendments, Changes, and Modifications

1. How do I make changes to or modify a protocol?

Log into eProtocol; from the HOME screen select the protocol you want to modify and a small window will open. Select the amendment option and click "OK." Include a brief description of the modifications being requested in the amendment summary section. Make the desired changes/additions to the protocol application form. Submit the revision by clicking the "SUBMIT FORM" option in the left-hand column menu.

2. When is it necessary for me to modify, amend, or make changes to my 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 changes require approval by the IACUC prior to implementation.

3. Do I always need to submit an amendment for changes in my protocol?

Yes. Any change requires approval by the IACUC prior to implementation.

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

Submit an amendment form via eProtocol. Once an amendment has been created, select the species tab from the left hand column and modify the species, animal numbers, etc. as appropriate. Ensure that the rationale section of the protocol has been updated to justify the additional animals as well as any other section, e.g., procedures, procedure relationships, attachments, etc.

See FAQ E.1. for more information on how to submit an amendment.

5. Is there anything that can help the review of my protocol when I request additional animals?

Yes! Ensure that you have accounted for the increase in animal numbers across your protocol, e.g., rationale, procedures, etc. Also include additional justification for the increase in the requested number of animals.

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

Submit an amendment via eProtocol. Select the "Protocol Information" tab from the left hand column and modify the procedure from the procedures tab. Select the appropriate procedure and begin your modifications. If you are also adding personnel, make sure to include a training plan and who will train them as well as including them as an anesthetist, surgeon, and under perioperative care as appropriate.

If the protocol contains more than one procedure, ensure that you have updated the "Procedure Relationships" section of the protocol. Once you have finished making your modifications, click "Save." A check for completeness will run in the background. Pay attention to any red font alerts as these indicate the actions you need to take prior to being able to submit your modifications. You must click "Submit Form" for the amendment to be submitted.

See FAQ E.1. for more information on how to submit an amendment.

7. How do I change the title of my existing IACUC protocol?

Submit an amendment form via eProtocol. Select the "Protocol Information" tab from the left hand column. Modify the "Official Project Title" section. Include the reason for the title change in the amendment summary section. Select "Save" and proceed with additional modifications and/or submit the amendment.

See FAQ E.1. for more information on how to submit an amendment.

8. I’m requesting a change in protocol for a procedure that I’ve done previously on a prior protocol. Can I just reference that protocol in my request?

No. Each protocol should be complete and be able to "stand alone." You are more than welcome to copy and paste the information into the amendment, but you will have to add your procedure to each protocol as applicable.

F. Personnel/Personnel Requirements

1. Can I make a change in the principal investigator (PI) for a protocol?

Yes. Submit an amendment via eProtocol. Select the "Personnel Information" tab from the left hand column. Under the Principal Investigator section click on "Search." A "Find User" window will appear. Enter the new PI’s name or EID and click on "Find." Select the user and click "OK." The new PI’s information will now be populated in the Principal Investigator section. Select "Save" and proceed with additional modifications and/or submit your amendment.

Notes for success: A PI cannot remove him/herself from a protocol. Have another person with edit privileges submit the amendment to change the PI.

See FAQ E.1. for more information on how to submit an amendment.

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

Submit a protocol amendment via eProtocol. If the added personnel will be performing anesthesia, surgery, or perioperative care procedures, please ensure they are listed under the appropriate procedures, including any relevant sub-tabs. Include a training plan or their prior experience with the specific models & procedures in the protocol. If personnel will not be involved in anesthetic procedures, please state this in the text box describing their experience/training on the personnel information section.

See FAQ E.1. for more information on how to submit an amendment.

3. Is there a legal requirement for requiring an amendment to add personnel, or is it just a campus policy?

This 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 procedures. Similar requirements are found in the regulations promulgated under the federal Animal Welfare Act, and in the NIH Guide for the Care and Use of Laboratory Animals. 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 protocol.

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

Yes. OLAW requires that significant instances of noncompliance be promptly reported to federal agencies, and unlisted participants are 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 offense. 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.

5. Can’t transient personnel such as students be excused from the need to be added by an amendment prior to working on the study?

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.

Individual course participants do not need to be individually listed if an IACUC protocol is submitted which:

  1. Makes it clear that this is a teaching situation.
  2. Explains how students will be closely supervised.
  3. Describes how the students will be given targeted training in ethical use of research animal at UT.
  4. Lists the instructors and TAs that will be responsible and shows that they have fulfilled 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 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 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.

6. Doesn’t adding personnel take a long time for the IACUC to approve?

No. Typical turnaround time is less than three business days for approval of adding personnel only; this does not include adding or replacing a PI (see FAQ E.8.). Personnel may NOT work on a study until the amendment to add them to the protocol has been approved by the IACUC.

The IACUC is required to assure that all personnel working on a study are:

  1. Appropriately identified.
  2. Trained and qualified.
  3. Enrolled in occupational health and safety programs.

The basic training requirement for being added to a protocol consists of turning in a short occupational health questionnaire form and completing online training modules. Training must be completed before personnel can be added to a protocol. A complete description of how to fulfill training requirements can be found on the IACUC website.

7. What training is required to add personnel to a protocol?

The IACUC requires that all personnel that conduct any research, teaching, or testing that involves handling, manipulation, or performing procedures on live vertebrate animals, whether in the laboratory or in the field, to complete minimum training items. Protocols will not be reviewed by the IACUC until all personnel listed on a protocol are up-to-date with the required training.

The basic training requirement for being added to a protocol consists of turning in a short occupational health questionnaire form and completing online training modules. Training must be completed before personnel can be added to a protocol. A complete description of how to fulfill training requirements can be found on the IACUC website.

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

Please contact the Office of Research Support.

G. Continuing Reviews

1. What is a continuing review?

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.

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

2. How do I submit a continuing review?

To create a continuing review, log into eProtocol. From your Investigator dashboard, click on the protocol and then select the option "Start Continuing Review." A pop-up window will appear asking, "Do you want to open IACUC Protocol AUP-0000-00000 (PI last name) for Editing?" Select "EDIT." Ensure you enter the correct number of animals used for the year and answer the questions provided. Once you have completed the form, click on "SUBMIT FORM" located on the left-hand column of the protocol screen. Once your continuing review has been successfully submitted the protocol event column will change to "SUBMITTED TO IACUC" and you will receive an email confirming the submission.

NOTE: You can make any protocol modifications/changes at time of continuing review.

3. On the Project Summary section, how do I find the number of animals used?

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; do not include the number of animals used under other protocol numbers.

4. Is there anything I can do to speed up the review process?

Yes. Review each page of the protocol to ensure it is up to date; review personnel listings, procedure relationships, attachments, etc.

5. I have submitted my continuing review form. When will I receive the notification of its renewal?

Once your continuing review form has been accepted for review it will be sent to the IACUC for review. The ORS staff will communicate the review status within five business days of the IACUC meeting or receipt of review comment(s) from the Designated Member Reviewer(s).

Please see FAQ C. "Protocol Review Process," for more information.

6. I am very busy and do not have time to submit my continuing review, is there any way to extend my approval period?

No. Federal regulations do not permit the IACUC to extend any approval periods. 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.

7. Do I submit a continuing review if I am done with the study?

No. If all work has been completed and there are no animals remaining on the protocol, then a Protocol Closure Report must be submitted to the IACUC.

Please see FAQ I. "Protocol Closure Report," for more information.

H. Third-Year Resubmissions

1. When my AUP goes to the IACUC for a third-year resubmission, will my protocol number change?

Yes. The IACUC considers the third-year resubmission an entirely new protocol.

2. How do I submit a third-year resubmission?

Follow the same steps to submit a protocol as covered in FAQ D.4 and FAQ D.5. If you are cloning a protocol, please ensure that all of the information is current and correct. The resubmission must be accepted for IACUC review by the Full Committee Review submission deadline date to be reviewed at the next scheduled meeting.

Please see FAQ C. "Protocol Review Process," for more information.

3. When should I clone a protocol?

If a majority of your procedures have stayed the same, then cloning your previous protocol may be a viable option in your resubmission process. Cloning your previous protocol, however, is not always the best option if a significant number of modifications are necessary in your three-year resubmission.

Please see FAQ D.5. "How do I clone a protocol?" for more information.

4. Should I always clone a protocol to save time?

No. If a majority of your procedures have stayed the same, then cloning your previous protocol may be a viable option in your resubmission process. Cloning your previous protocol, however, is not always the best option if a significant number of modifications are necessary in your three-year resubmission. If there are significant modifications then a new protocol is recommended.

Please see FAQ D.5. "How do I clone a protocol?" for more information.

5. For the three-year resubmission, if there are no major protocol changes over the previous approval period, can a short form be used that would only detail new or modified procedures instead of the full protocol form?

No. In accordance with PHS Policy IV.C.3.5., the IACUC must conduct a complete protocol review, also called the "de novo review" at least once every three years. Therefore, you must complete and submit the three-year resubmission to allow ample time for IACUC review.

6. I am very busy and do not have time to submit my three-year resubmission, is there any way to extend my approval period?

No. Federal regulations do not permit the IACUC to extend any approval periods. If a third-year submission has not been processed and approved by the expiration date of the original IACUC approval the work 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.

7. Why do I need to submit a Protocol Closure Report (PCR) if I am not renewing my protocol?

A PCR informs the IACUC that you would like to close or end the protocol approval, verifies the number of animals used for the study and gives the IACUC information about the project outcomes. In addition a PCR will turn off any automatic reminders from eProtocol. Please see FAQ H.2 "How do I submit a third-year resubmission?" for more information.

I. Protocol Closure Reports (PCR)

1. Why do I need to submit a PCR if I am not renewing my protocol?

A PCR informs the IACUC that you would like to close or end the protocol approval, verifies the number of animals used for the study and gives the IACUC information about the project outcomes. In addition a PCR will turn off any automatic reminders from eProtocol.

2. How do I submit a PCR?

To complete a PCR, please visit eProtocol. Once logged in, select the protocol you wish to close, and then select the option "Start Closure Report Form." The form will automatically include the total number of animals previously reported. Ensure that you add the number of animals used since the last report. Submit the revision by clicking the "SUBMIT FORM" option in the left-hand column menu.

J. Animal Utilization Registration Forms (AURFs)

1. What is an AURF?

This eProtocol form must be used to register a project involving vertebrate animals and utilizing funds or personnel that are affiliated with The University of Texas at Austin when it is performed wholly or in part at another institution.

Please see B. eProtocol for more information.

2. How do I submit an AURF?

Please visit eProtocol to fill out and submit an AURF. Click the blue "Create Protocol" button, enter a protocol title, and select the "Animal Utilization Registration Form" radio button.

Complete the Principal Investigator details and then click the blue "Create" button. The protocol form will be generated. Complete each section and ensure to upload PDF(s) of any related grant proposal as well as a copy of the current protocol(s), including approval letter(s), from any collaborating institution(s). Once complete, press "Submit Form".

3. Why am I being asked to submit a new AURF instead of an Annual Protocol Update Form (APUF)?

In an effort to streamline the process AURFs are now electronic; paper forms will no longer be accepted. This allows all Principal Investigators to use the same process and system for correspondence with the IACUC.

Please see J.2. How do I submit an AURF? for more information. On the "Rationale" page, please answer "Yes" for the question "Is this a third-year resubmission of an existing protocol?" and provide your 8 digit protocol number as this is your first AURF in eProtocol.

4. How do I make changes to an AURF?

All changes are made by logging into eProtocol.

Please see E. Protocol Amendments, Changes, and Modifications and F. Personnel/Personnel Requirements for more information.

5. Do I need to submit a third-year resubmission for an AURF?

Yes, unless the project has ended and you would like to retire your protocol. Please see FAQ I. "Protocol Closure Report," for more information.

Please visit eProtocol to fill out and submit an AURF. Click the blue "Create Protocol" button, enter a protocol title, and select the "Animal Utilization Registration Form" radio button.

Complete the Principal Investigator details and then click the blue "Create" button. The protocol form will be generated. Complete each section and ensure to upload PDF(s) of any related grant proposal as well as a copy of the current protocol(s), including approval letter(s), from any collaborating institution(s). Once complete, press "Submit Form".

On the "Rationale" page, please answer "Yes" for the question "Is this a third-year resubmission of an existing protocol?" and provide your 8 digit protocol number.

6. Where can I find these documents?

The forms are available by logging into eProtocol.

Please contact the Office of Research Support with any questions or concerns.

7. What is the review process for these documents?

Whenever a research project involving vertebrate animals and utilizing funds or personnel that are affiliated with The University of Texas at Austin is performed wholly or in part at another institution, the protocol approval process needs to be coordinated so that BOTH institutions have approved the work. To avoid full dual review, however, if the project is performed entirely at another institution that has its own animal care and use committee, the UT-Austin IACUC can accept a valid approval by the host institution if a completed AURF (along with the required supplementary documents) is submitted to the Office of Research Support.

Typically these documents will go through Designated Member Review unless Full Committee Review is called. Please see FAQ C.3. "Protocol Review Process" for more information.