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The University of Texas at Austin
Institutional Biosafety Committee

Section 3: Protocol/Modification Submission and Review

3.0 Submissions

The IBC is responsible for overseeing and evaluating all aspects of research involving rDNA and biohazardous materials, agents and toxins, and is charged with reviewing proposals that involve rDNA and biohazardous materials, agents and toxins to ensure that the criteria established in the IBC Policy and the federal regulations and guidelines are implemented.  In its review of the proposals, the primary goal of the IBC is to facilitate research personnel compliance with applicable laws, regulations, guidelines and policies consistent with the performance of appropriate and productive scientific endeavors.

IBC protocol submissions, whether they are new IBC protocol submissions, modifications or renewals, must be submitted to ORS by the Principal Investigator for review and IBC approval.  No research involving rDNA and biohazardous materials, agents and toxins can be initiated until the Principal Investigator has received the approval of the IBC. 
Although federal regulations allow exemptions for some types of rDNA used, the Principal Investigator must submit an application for all projects using rDNA and biohazardous materials, agents and toxins so that the IBC is aware of the activities and can verify that they are exempt.  For more information on exemptions visit http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Experiments_that_are_
Exempt_from_the_NIH_Guidelines.pdf.

No one shall obtain or use rDNA and biohazardous materials, agents and toxins until the protocol has been approved by the IBC.  Modifications to approved protocols shall not be implemented until approved by the IBC. 

3.1 Experiments Requiring IBC Review

Experiments that required IBC review include, but are not limited to:

  • Recombinant studies that are exempt from the NIH Guidelines.
  • The deliberate transfer of a drug resistance trait to micro-organisms that are not known to acquire the trait naturally.
  • The deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants (human gene transfer).
  • The deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules.
  • The use of RG-2 or RG-3 agents as host-vector systems.
  • The use of human etiologic and animal viral etiologic agents.
  • The cloning of DNA from RG-2 or greater agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems.
  • The use of infectious or defective RG-2 or greater agents.
  • Whole animals in which the animal’s genome has been altered by stable introduction of rDNA or DNA derived into the germ-line (transgenic animal).
  • Viable rDNA-modified micro-organisms or cell lines tested on whole animals.
  • Genetically engineered plants by rDNA methods.
  • More than 10 liters of rDNA culture in a single vessel.
  • The formation of rDNA molecules containing one-half or more of the genome of a eukaryotic virus or from the same virus family.
  • Experiments using BSL-2 or BSL-3 containment.
  • Non-recombinant research using biohazardous materials, agents or toxins.
  • All research using biological toxins or bioactive derivatives or subunits of toxins.
  • Research collecting or analyzing human or non-human primate cell lines, tissues, fluids or other potentially infectious material.

3.2 New Submissions

The online applications for both Biosafety and rDNA must be accurately completed and submitted for review and IBC approval. 

For Biosafety Applications:

  • To facilitate the approval of the research all BSL-2 and BSL-3 laboratories are required to be inspected and develop a Lab Biosafety Manual.  The BSO, as agent for the IBC, will assist the Principal Investigator in completing this step of the application, for information on this process go to EHS website: http://www.utexas.edu/safety/ehs/biosafety/bsl_approval.html
  • The protocol will be reviewed by the IBC Program Coordinator and the BSO.  To ensure a complete submission, it may be necessary for the Principal Investigator to submit additional information if requested by the IBC Program Coordinator or BSO.
  • If the research is rDNA exempt a Biosafety application may still be required.
  • Approval/Non-approval will be determined by the IBC. 
  • The online application is available online at: https://utdirect.utexas.edu/vr/biosafety_list.WBX

For rDNA Applications: 

For non-exempt rDNA research a current approved Biosafety application number must be included in the application.

  • The protocol will be reviewed for completeness by the IBC Program Coordinator and it may be necessary for the Principal Investigator to submit additional information, to ensure a complete submission, if requested by the IBC Program Coordinator.
  • The application will be assign to a designated Subcommittee (see Section 2.2) for review prior to a convened IBC meeting.  It may be necessary for the Principal Investigator to submit additional information if required by the Subcommittee.
  • Approval/Non-approval will be determined by the IBC.
  • For submission deadlines and meeting dates visit: http://www.utexas.edu/research/rsc/ibc/meetings.html
  • The online application is available online at: https://utdirect.utexas.edu/vr/recom_dna.WBX

Once applications have been saved, a protocol number will be assigned that can be used to reference the study with ORS or Office of Sponsored Projects (OSP) for grant applications.  The Principal Investigator will be notified of the IBC decision.

3.3 Continuing Review / Renewal

The Principal Investigator is required to resubmit their protocol(s) annually.   The Principal Investigator will be notified of pending expiration of approval at 90, 60, 30 and 15 days prior to expiration of study approval.  These resubmissions are reviewed in the same manner as new protocol submissions.  Research cannot be continued if protocol renewal is not approved prior to the expiration date from the previous approval. 

3.4 Failure to Submit Renewal/Respond to IBC Requirements

If the Principal Investigator fails to provide a renewal form to the IBC by the anniversary date, a letter will be sent to the Principal Investigator, and copied to the Chair/Dean of the department. All research activities pertaining to the research described in the expired protocol must cease.  If the Principal Investigator does not provide a renewal by the next IBC meeting, this issue is added to the agenda and the IBC determines whether or not to terminate the IBC protocol.  Termination of the IBC protocol may require termination of any related IACUC or IRB protocols, and notification to OSP.

 3.5 Modification Process

Changes or modifications to approved protocols (i.e; change in or additional of research personnel, room changes, new procedures or agents) must be reviewed and approved by the IBC prior to initiation.  If the changes are extensive, or change the scope of the review, a new submission should be made.

3.6 Protocol Termination

The Principal Investigator will notify the IBC Program Coordinator when a research involving rDNA and biohazardous materials, agents and toxins is completed or no longer active.  The IBC shall contact the Principal Investigator if there area any questions or concerns regarding Termination of Approval.

As stated in Section 4.3 above. Failure to renew a previously approved IBC protocol may result in termination of the protocol(s).  In addition, non-compliance with institutional and federal regulations, policies and guidelines or requirements of the IBC that are either serious or ongoing will be evaluated and the IBC may determine that the incidents require protocol termination.

3.7 Relationships to IACUC and IRB

IBC protocols submission involving the use of live animals will require IACUC review and approval prior to initiation.

IBC protocol submissions involving the administration of biohazardous agents or rDNA to humans, or involves the collection of tissues or fluids from humans, requires IRB review and approval prior to initiation.

Current IACUC and IRB protocol numbers must be included on the IBC submission.

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