IBC FAQs

All IBC Policies and Procedures are available online.

Contact the Office of Research Support and Compliance with any questions.

An rDNA protocol is a document that describes a research or teaching activity that involves recombinant or synthetic nucleic acid molecules. This document must be completed by any investigator wanting to use recombinant or synthetic nucleic acid molecules, including transgenic animals in research or teaching activities. After completing the rDNA protocol form, it must be saved and submitted to the Institutional Biosafety Committee for review. Biosafety protocols are required with rDNA protocols involving infectious agents, sequences or genes from infectious agents or toxins, and the generation of transgenic plants or animals. Protocols must be given full approval prior to the use of recombinant or synthetic nucleic acid molecules or transgenic animals.

A Biosafety protocol is a document that describes a research or teaching activity that involves biohazardous materials including: human fluids, tissue, or cells, recombinant or synthetic nucleic acid molecules, infectious agents, and toxins. This document must be completed by any investigator wanting to use biohazardous materials in research or teaching activities. Biosafety protocols are usually required with an rDNA protocol (see: What is an rDNA protocol? above). After completing the Biosafety protocol form, it must be saved and submitted to the Institutional Biosafety Committee for review. Protocols must be given full approval prior to the use or collection of biohazardous materials, infectious agents or toxins and recombinant or synthetic nucleic acid molecules.

The rDNA and Biosafety protocol forms can be found on the eProtocol IBC Information Center page.

The IBC accepts protocols only from tenured, tenure track, or research faculty with assigned research space. Exceptions to this policy will be considered by the IBC on a case-by-case basis.

Submission deadlines are found on the meeting dates page.

Protocols submitted after the meeting deadline are held for the next meeting.

Contact the Office of Research Support and Compliance (RSC).

Whenever you change the work described in your rDNA and/or Biosafety protocol, you need to update the protocol(s) to reflect the change(s). Protocol amendments are required with any change in host, vector or modified gene expression, any change in biohazardous materials, agents, or toxins used, and any change in procedures, location of your work, or to update IRB, IACUC, or IBC protocol numbers.

To change or add a new vector or host, your rDNA protocol will need to be returned to allow access for changes. Your Biosafety protocol may also need to be returned to include the change. Contact the IBC Program Coordinator to return your protocol(s).

To change or add a new transgenic animal, your rDNA protocol may need to be returned to allow access for changes. Contact the IBC Program Coordinator regarding the status of the proposed addition.

To change or add a type of sample from your study participant(s), you will need to update your Biosafety protocol. Your Biosafety protocol will need to be returned to allow access for changes. Contact the IBC Program Coordinator to return your protocol.

The IBC requires completion of all IBC required training by the PI and lab personnel, current lab Biosafety Manual, and current lab inspection certifying the lab for work at or above the biocontainment level determined by the IBC for approval of the protocol(s).

Most rDNA and Biosafety protocols are approved for one year. Some low risk rDNA protocols have up to a three year approval.

If there are no changes to your protocol, including locations or updates to IACUC or IRB protocol numbers simply save and submit your protocol for review.

If you have submitted your protocol for review but need to make a change, contact the IBC Program Coordinator to return your protocol for changes.

All research activities pertaining to the research described in the expired protocol must cease. Contact the IBC Program Coordinator immediately.

If you no longer need a rDNA protocol, contact the IBC Program Coordinator and your rDNA protocol will be removed from the active database.

If you no longer need a Biosafety protocol, contact the IBC Program Coordinator and your Biosafety protocol will be allowed to lapse approval.

Duplicate protocols need to be removed from the active database even if they have not been submitted. If the protocols have been submitted, contact the IBC Program Coordinator to delete one from the database. If the protocol is a Biosafety protocol that has not been submitted, simply go to the bottom of the Biosafety form and select the “Delete” button. If the duplicate rDNA or Biosafety protocol has been previously approved, contact the IBC Program Coordinator BEFORE you delete your protocol.

Access to eProtocol IBC is restricted to current faculty, staff, and students. A University of Texas Electronic ID (UT EID) is required to log on to eProtocol IBC. 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.

If you have a UT EID and are unable to log on to eProtocol IBC, your sponsoring Principal Investigator must complete the eProtocol IBC Access Form, available on the eProtocol IBC Information Center page of the IBC website

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 IBC you are still unable to access the system, submit an eProtocol IBC Access form to the Office of Research Support and Compliance. The access form is available on the eProtocol IBC Information Center page of the IBC website.

See FAQ C.2. "How do I get access to eProtocol?" for more information.

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.

To access eProtocol IBC, you will need a computer with an Internet connection. If you are on a Windows machine, use Internet Explorer 8 (or newer version) as your browser; if on an Apple machine, use Safari as your browser. You may experience difficulties when using other operating system/browser combinations. The pop-up blocking feature of the browser must be disabled (pop-ups must be allowed) while using eProtocol.

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. NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read access to that 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. NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read access to that protocol.

For more information, see FAQ F. "Protocol Amendments, Changes, and Modifications".

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.

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.

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, contact the Office of Research Support and Compliance.

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, see FAQ C.6. "How can I see certain protocols?".

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, see FAQ C.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. If an amendment or continuing review application is already in process, you must wait until the review process for the amendment or continuing review application has been completed before you can begin a new amendment or continuing review application for that protocol. This is a good reason to check your protocol carefully before submitting to the IBC.

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

Return Notes are used when Office of Research Support and Compliance 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.

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

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

For more information, see FAQ D.6. "How do I respond to IBC comments?".

Visit eProtocol IBC 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 IBC. The protocol is in the creation phase, but has not been submitted to the IBC.
2. Submitted to Committee. The protocol has been submitted to the IBC 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 IBC meeting for further discussion.
5. Comments Received (Cycle X). The protocol has received comments from the IBC reviewer(s).
6. Responses Sent (Cycle #). The PI has responded to the IBC reviewer comments and has sent the protocol and comments back to the IBC 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 IBC for review.

Visit eProtocol to view the status of your submitted documents. The column titled "Protocol Event" will describe the status of your submitted documents. See FAQ D.1. "Where can I find the status of my submitted IBC protocol?" for a description of what the protocol event means. You may contact the Office of Research Support and Compliance if you still have questions.

The conduct of official IBC business, such as protocol review, occurs at convened meetings that must include a quorum of members in order for the meeting to be held.

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 and Compliance staff make every effort to maintain an expeditious review process and promptly review submissions.

For new protocols or third-year resubmissions, the turnaround time is usually about a month. For more information, see FAQ E. "Protocol Application Forms" and IBC/HOP Section 3 "Protocol/Modification Submission and Review".

For amendments: see FAQ F.6. "How long will it take for my amendment to be approved?".

For continuing reviews: see FAQ H.3. "How long will it take for my continuing review to be approved?".

After your protocol has been submitted, it will undergo an initial review by staff in the Office of Research Support and Compliance. 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.

Once your protocol has been accepted for review it will be assigned a meeting date and assigned one or more IBC 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 IBC" button to send your responses and revised protocol back to the IBC.

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

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 dashboard. Only complete protocols will be reviewed by the IBC. 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 meeting.

The RSC staff will communicate the review status within five business days of the IBC meeting.

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 IBC approval; the IBC 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, see FAQ H. "Continuing Reviews".

The IBC protocol application form, or protocol, is a document that describes in detail how an investigator will use recombinant or synthetic nucleic acid molecules (rsNA) and biohazardous agents, materials, and toxins in teaching, research, and/or testing.

Yes.

The protocol application form must be created and submitted via eProtocol. Refer to FAQ C.1. "Who can log in to eProtocol?" for further information on access requirements.

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."

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.

After completing your protocol application form, you can submit it to IBC 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.

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. NOTE: If you are listed in the "Other Personnel" section of a protocol, you only have read/view access to that protocol

No. While you cannot "reactivate" a closed protocol, you may clone the closed protocol and submit for IBC review. Before submission, ensure that all of the information is current and correct. See FAQ E.5. "How do I clone a protocol?" for more information.

• Log in to eProtocol IBC with your UT EID and password.
• Click on the blue "DELETE PROTOCOL" button.
• Select the protocol you wish to delete by selecting the checkbox next to the protocol.
• Press the blue "DELETE" button. A pop-up window will appear asking, "Do you want to delete this protocol?" Select "YES".

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.

NOTE: if an amendment or continuing review is in‐process (that is created, submitted, and/or under review by the IBC) for the selected protocol, you must wait until the amendment has completed the review process before you can begin a new amendment for that protocol. This is a good reason to check your protocol carefully before submitting to the IBC.

An amendment is required whenever you need to change your protocol.

Remember: Any changes require approval by the IBC prior to implementation.

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

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 F.1. "How do I make changes to or modify a protocol?" for more information on how to submit an amendment.

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.

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 and Compliance staff make every effort to maintain an expeditious review process and promptly review submissions.

For amendments, the turnaround time is usually about a month.

• Log in to eProtocol IBC with your UT EID and password.
• Click on the blue "DELETE PROTOCOL" button.
• Select the protocol you wish to delete by selecting the checkbox next to the protocol.
• Press the blue "DELETE" button. A pop-up window will appear asking, "Do you want to delete this protocol?" Select "YES".

NOTE: Only the unsubmitted protocol amendment will be deleted and the existing approved protocol will remain.

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 F.1. "How do I make changes to or modify a protocol?" for more information on how to submit an amendment.

Submit a protocol amendment via eProtocol. Include a training plan or their prior experience with the specific models & procedures in the protocol.

See FAQ F.1. "How do I make changes to or modify a protocol?" for more information on how to submit an amendment.

Submit a protocol amendment via eProtocol. If the removed personnel was performing training for other personnel, ensure they are removed from the appropriate training sections.

NOTE: To ensure the removed personnel’s name is deleted from all areas of the protocol, you can download a PDF of the protocol and search the PDF for their name, which will indicate which sections of the protocol need to be updated.

See FAQ C.9. "How do I print a protocol?" for more information on how to download a PDF of the protocol.

See FAQ F.1. "How do I make changes to or modify a protocol?" for more information on how to submit an amendment.

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 F.5.). Personnel may NOT work on a study until the amendment to add them to the protocol has been approved by the IBC.

The IBC 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 IBC website.

Yes.

The IBC requires that all personnel that conduct any research, teaching, or testing that involves recombinant or synthetic nucleic acid molecules (rsNA) and biohazardous agents, materials, and toxins to complete minimum training items. Protocols will not be reviewed by the IBC 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 IBC website.

Contact the Office of Research Support and Compliance.

Although protocols are approved for up to three years, the IBC 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.

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 IBC Protocol IBC-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 IBC" and you will receive an email confirming the submission.

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

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 and Compliance staff make every effort to maintain an expeditious review process and promptly review submissions.

For continuing reviews, the turnaround time is usually about a month.

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

Once your continuing review form has been accepted for review it will be sent to the IBC for review. The RSC staff will communicate the review status within five business days of the IBC meeting.

See FAQ D. "Protocol Review Process" for more information.

No. If a continuing review has not been processed and approved by the expiration date, the protocol will expire. Should IBC approval expire, all activities involving recombinant or synthetic nucleic acid molecules (rsNA) and biohazardous agents, materials, and toxins must cease immediately.

No. If all work has been completed then a Protocol Closure Report must be submitted to the IBC.

See FAQ J. "Protocol Closure Report (PCR)" for more information.

• Log in to eProtocol IBC with your UT EID and password.
• Click on the blue "DELETE PROTOCOL" button.
• Select the protocol you wish to delete by selecting the checkbox next to the protocol.
• Press the blue "DELETE" button. A pop-up window will appear asking, "Do you want to delete this protocol?" Select "YES".

NOTE: Only the unsubmitted continuing review application will be deleted and the existing approved protocol will remain.

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

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

See FAQ D. "Protocol Review Process" for more information.

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.

See FAQ E.5. "How do I clone a protocol?" for more information.

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.

See FAQ E.5. "How do I clone a protocol?" for more information.

No. You must complete and submit the three-year resubmission to allow ample time for IBC review.

No. If a third-year submission has not been processed and approved by the expiration date of the original IBC approval the work will expire. Should IBC approval expire, all activities involving recombinant or synthetic nucleic acid molecules (rsNA) and biohazardous agents, materials, and toxins must cease immediately.

A PCR informs the IBC that you would like to close or end the protocol approval and gives the IBC information about the project outcomes. In addition a PCR will turn off any automatic reminders from eProtocol.

• Log in to eProtocol IBC with your UT EID and password.
• Click on the blue "DELETE PROTOCOL" button.
• Select the protocol you wish to delete by selecting the checkbox next to the protocol.
• Press the blue "DELETE" button. A pop-up window will appear asking, "Do you want to delete this protocol?" Select "YES".

A PCR informs the IBC that you would like to close or end the protocol approval and gives the IBC information about the project outcomes. In addition a PCR will turn off any automatic reminders from eProtocol.

To complete a PCR, 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.

• Log in to eProtocol IBC with your UT EID and password.
• Click on the blue "DELETE PROTOCOL" button.
• Select the protocol you wish to delete by selecting the checkbox next to the protocol.
• Press the blue "DELETE" button. A pop-up window will appear asking, "Do you want to delete this protocol?" Select "YES".

NOTE: Only the unsubmitted PCR will be deleted and the existing approved protocol will remain.