Section 3: Protocol/Modification Submission and Review
- 3.0 Submissions
- 3.1 Experiments Requiring IBC Review
- REVISED 3.2 New Submissions
- REVISED 3.3 Continuing Review / Annual Renewal
- REVISED 3.4 Failure to Submit Renewal or Continuing Review/Respond to IBC Requirements
- REVISED 3.5 Modification Process
- REVISED 3.6 Protocol Closure
- 3.7 Relationships to IACUC and IRB
The IBC is responsible for overseeing and evaluating all aspects of research involving recombinant or synthetic nucleic acid molecules and biohazardous materials, agents and toxins, and is charged with reviewing proposals that involve recombinant or synthetic nucleic acid molecules 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 recombinant or synthetic nucleic acid molecules 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 recombinant or synthetic nucleic acid molecules used, the Principal Investigator must submit an application for all projects using recombinant or synthetic nucleic acid molecules 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/rdna/rdna_faq_list.html
No one shall obtain or use recombinant or synthetic nucleic acid molecules and/or 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.
Principal Investigators (PI) can submit applications to the IBC to work with recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents, and toxins. In general, a PI is a tenured, tenure track, or research faculty with assigned research space. Should a PI not have assigned space to conduct the research, the PI must submit the below statement from the person who is responsible for the research space. Exceptions to this policy will be considered by the IBC on a case-by-case basis.
I, [insert name of person with assigned research space] am aware of the attached research of [insert name of PI without assigned space] that will be conducted in space assigned to me. I acknowledge my responsibility for ensuring that this research will be conducted in a safe manner and in accordance with institutional and federal regulations.
Experiments that required IBC review include, but are not limited to:
- Studies using recombinant or synthetic nucleic acid molecules 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 recombinant or synthetic nucleic acid molecules or DNA or RNA derived from recombinant or synthetic nucleic acid molecules into human research participants (human gene transfer).
- The deliberate formation of recombinant or synthetic nucleic acid molecules containing genes or sequences 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 recombinant or synthetic nucleic acid molecules or DNA derived into the germ-line (transgenic animal).
- Viable micro-organisms or cell lines with modified recombinant or synthetic nucleic acid molecules - tested on whole animals.
- Genetically engineered plants by recombinant or synthetic nucleic acid molecules methods.
- More than 10 liters culture of organisms or cells containing recombinant or synthetic nucleic acid molecules in a single vessel.
- The formation of recombinant or synthetic nucleic acid 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.
Protocol application forms for research, teaching, and testing activities involving recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents, or toxins must be accurately completed and submitted for review and IBC approval.
Requirements for Review and Approval:
- To facilitate the review of protocols, Principal Investigators submitting IBC protocols will have their labs inspected and they must 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 and Biosafety Manual Templates go to EHS website: http://www.utexas.edu/safety/ehs/biosafety/
- Upon submission, 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.
- Additional IBC protocols may be required based on the nature of the activities described in the protocol.
- The protocol will be assigned to designated reviewers (see Section 2.2) for review prior to a convened IBC meeting. It may be necessary for the Principal Investigator to submit additional information and/or clarifications if requested by the designated reviewers.
- Approval/Non-approval will be determined by the IBC, and the Principal Investigator will be notified of the decision.
- For submission deadlines and meeting dates visit:
- The protocol application form is available at: http://www.utexas.edu/research/rsc/ibc/forms.html
Principal Investigators 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, that can be used to reference the study with Office of Research Support (ORS) or Office of Sponsored Projects (OSP) for grant applications.
The Principal Investigator is required to resubmit their legacy rDNA or Biosafety protocols for renewal or a continuing review application for eProtocols annually. The Principal Investigator will be notified of pending expiration of approval at regular intervals prior to expiration of approval period. All annual renewals of legacy rDNA and Biosafety protocols and continuing review of eProtocol with significant changes are reviewed in the same manner as new protocol submissions (see Section 4.1.1). Continuing reviews of eProtocols without changes or with non-significant changes may be reviewed by designated reviewers and approved administratively (see Section 4.1.2). Research cannot be continued if protocol renewal or continuing review is not approved prior to the expiration date of the previous approval period.
If the Principal Investigator fails to renew rDNA or Biosafety protocols or submit a continuing review application by the anniversary date, a letter will be sent to the Principal Investigator, and copied to the Chair/Dean of the department. All activities pertaining to the project described in the expired protocol must cease. If the Principal Investigator does not provide a renewal or continuing review application within five business days, this issue is added to the agenda and the IBC determines whether or not to close the IBC protocol.
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.
Major changes are those that change the scope of the review or that are inconsistent with the focus of the approved protocol. For major changes the PI should submit a new protocol.
Significant changes are changes to approved protocols that are extensive and include but are not limited to the following: change in Principal Investigator, change of an infectious agent or toxin, a change of protocol components that are not exempt from the NIH Guidelines, and changes that affect the risk assessment of the protocol. Significant changes will be reviewed by designated review and require approval at a convened IBC meeting. Proposed significant changes require designated review and IBC approval prior to initiation.
Non-significant changes that may be approved administratively and not require full IBC review include but are not limited to the following: changes in research personnel other than Principal Investigator, protocol title, IACUC and IRB protocol numbers or OSP grant number, change of protocol components that are not recombinant and do not affect the risk assessment, and changes in BSL-1 agents, vectors, host and genes that are exempt from the NIH Guidelines and do not affect risk assessment. Non-significant changes may be approved by administrative approval outside a convened IBC meeting. Proposed non-significant changes require administrative review and approval.
The Principal Investigator will notify the IBC Program Coordinator when a protocol involving recombinant or synthetic nucleic acid molecules and/or biohazardous materials, agents and toxins is completed or no longer active. The IBC shall contact the Principal Investigator if there are any questions or concerns regarding closure of a protocol.
As stated in Section 3.4 failure to renew a previously approved IBC protocol may result in closure of the protocol. 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 closure.
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 recombinant or synthetic nucleic acid molecules or biohazardous materials, agents or toxins 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.