The University of Texas at Austin
Institutional Biosafety Committee
POLICIES AND PROCEDURES
SECTION 4.0 IBC Review
4.0 IBC Review
4.1 Protocol of Select Agents or Select Agent Toxins
4.2 Review of rDNA
4.3 Review of Incidents and Personnel Exposures
4.4 Notice of IBC Action
4.5 Length of Approval
4.5.1 rDNA and Infectious Agents (Excluding Select Agents and Toxins)
4.5.2 Select Agents and Select Agent Toxins
4.6 Modifications to Approved Protocols
4.7 Continuing Review of Approved Protocols and Notice of Termination
4.7.1 Continuing Review of Approved Protocols
4.7.2 Notice of Termination
4.7.2.1 Termination
4.0 IBC Review
Any researcher that desires to possess or use rDNA and/or biohazardous materials shall, (including those whose protocols are deemed exempt by the NIH Guidelines) submit an appropriate protocol document with the IBC. The IBC shall review and approve any activity involving a) recombinant DNA, b) infectious agents capable of infecting humans, animals or plants, c) select agents/toxins, and d) any other potentially biohazardous materials. Although federal regulations allow exemptions for some types of rDNA use, PI's must submit an application for all rDNA projects so that the IBC is aware of the activities and can verify that they are exempt.
No one shall obtain or use rDNA and/or biohazardous materials until the protocol has been approved by the IBC. Modifications of approved protocol shall not occur until approved by the IBC.
4.1 Protocol of Select Agents or Select Agent Toxins
The university is registered with the CDC for receipt of select agents. Any researcher that desires to receive, use, store, or transfer a select agent or toxin, whether or not exempt from federal protocol, and regardless of risk category or biosafety level, shall submit a Biosafety Form (Appendix B) to the IBC. Approval from the IBC must be received before obtaining, using, transferring, or destroying any select agent or toxin. Researchers approved to use or store select agent toxins must track its use using the Biosafety Form. The following information shall be included with the protocol as an attachment:
- Written protocol or biohazardous manual that describes the potential biohazards related to the use of the select agents/select agent toxins and the precautions that must be taken when working with the select agents/select agent toxins.
- An emergency plan for the handling of accidental spills and personnel contamination.
4.2 Review of rDNA
The researcher conducting any rDNA research shall submit an rDNA Form (Appendix A), to the IBC. IBC approval must be obtained before initiating any rDNA research. The following information shall be included with the application as an attachment:
- A copy of the grant describing the use of rDNA.
- Written protocol or biohazardous manual that describes the potential biohazards related to the use of the rDNA and the precautions that must be taken when working with the rDNA.
- An emergency plan for the handling of accidental spills and personnel contamination.
The following paragraphs summarize rDNA experiments covered by the NIH Guidelines; refer directly to the NIH Guidelines for a more detailed description of experiments and specific requirements. The IBC will review and approve all projects subject to sections III-A though III-E by a convened meeting of a quorum of the IBC:
- Experiments Requiring IBC Approval, RAC Review, and NIH Director Approval Before Initiation (Section III-A) – This includes experiments considered as Major Actions under the NIH Guidelines and experiments involving the deliberate transfer of a drug resistance trait to microorganisms that do not acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease in humans, veterinary medicine, or agriculture.
- Experiments Requiring NIH/OBA and IBC Approval before Initiation (Section III-B) – This covers experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram body weight. IBC approval is required prior to initiation of the experiments.
- Experiments Requiring IBC and IRB Approvals and RAC Review before Research Participant Enrollment (Section III-C) – These experiments involve the deliberate transfer of rDNA, or DNA or RNA derived from rDNA, into human subjects (human gene transfer).
- Experiments Requiring IBC Approval Before Initiation (Section III-D) – Full Board Review and Approval Required Before Commencing Research. This category covers the following subsections: (a) experiments using RG2, RG3, RG4 or restricted agents as host-vector systems; (b) experiments in which DNA from RG2, RG3, RG4, or restricted agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems; (c) experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems; (d) experiments involving whole animals and/or whole plants; and (e) experiments involving more than 10 liters of culture.
- Experiments Requiring IBC Notice Simultaneous with Initiation (Section III-E) – This includes experiments not included in Sections III-A, III-B, III-D, III-F, and their subsections. Under these IBC Policies, IBC approval is required prior to initiation of the research.
- Exempt Experiments (Section III-F) – Refer to Appendix D for a list of rDNA molecules that are exempt from the NIH Guidelines. Under these IBC Policies, protocol and approval of the exempt status by the IBC is required prior to initiation of the research. Note the Chair of the IBC may make this determination and provide information to IBC through agenda and minutes.
If an rDNA experiment falls into Section III-F (Exempt) and into either Sections III-D or III-E as well, the experiment is considered exempt from NIH Guidelines, but is still subject to IBC protocol and approval of exempt status prior to initiation of the research.
4.3 Review of Incidents and Personal Exposure
The PI’s Responsibility
Section IV-B-7-e-(2) Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the BSO/RRT, or Greenhouse/Animal Facility director as applicable, IBC, NIH/OBA and other appropriate authorities.
Section IV B-7-e-(3) Correct work errors and conditions that may result in the release of recombinant DNA materials; and
Section IV-B-7-e-(4) Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics)
Comply with any further requirements established by the IBC
The University’s Responsibility
Section IV B-1-j of OBA/NIH guidelines establishes the responsibility of the institution to report any significant problems, violations of the NIH Guidelines, or significant research related accidents within 30 days unless the PI has already done so (which the PI must report to the IBC.)
Pertinent to OBA Sections IV-B-7-e-(2), IV-B-3-c-(2), IV B-2-b-(8), and IV B-1-j respectively, the PI, the BSO, and the Rapid Response team are responsible for providing this information, in writing to the IBC for their review at the next convened meeting. The information submitted to the IBC should be sufficient to allow for an understanding of the nature and consequences of the incident as well as the cause. In addition, the IBC will be informed of any measures that have been taken to mitigate the problem and preclude its reoccurrence as of that date. It is the responsibility of the IBC to determine what additional actions if any are necessary. For example, the IBC may choose to change the frequency of lab inspections, or change the Biosafety Level of the protocol, based on results of the incident. The incident Report Form will be used to describe the incident for the IBC. The final copy of the Biological Incident Reporting form (Appendix E) will be signed and dated by the BSO, IBC Chair, and the IO.
4.4 Notice of IBC Action
The IBC Chair shall provide written notification of the Chair’s/IBC’s decision to the researcher on the electronic application form.
4.5 Length of Approval
4.5.1 rDNA and Infectious Agents
IBC approval of rDNA and biohazardous materials is valid for one year. All IBC approvals of rDNA and infectious agents are subject to continuing review (see Section 4.7), which will occur within the first 12 months after the initial approval date at the anniversary IBC meeting and every year thereafter at the anniversary IBC meeting unless the IBC determines a shorter period is required.
4.5.2 Select Agents and Select Agent Toxins
IBC approval of select agents and select agent toxins is valid for one year. IBC approval of select agents and select agent toxins is subject to continuing review (see Section 4.7), which will occur within the first 12 months after the initial approval date at the anniversary IBC meeting and every year thereafter at the anniversary IBC meeting unless the IBC determines a shorter period is required.
4.6 Modifications to Approved Protocols
The researcher shall not initiate or implement any changes or modifications of IBC approved protocols without the prior review and approval of the IBC. This includes, but is not limited to, modification of rDNA and/or biohazardous materials, procedure changes (including change of the researcher), changes in laboratory or personnel, or changes that increase the risk of the project and/or the biosafety level. An IBC Protocol Modification Form (Appendix C) shall be submitted to the IBC for review and approval.
4.7 Continuing Review of Approved Protocols and Notice of Termination
4.7.1 Continuing Review of Approved Protocols
Researchers who wish to continue their activity with rDNA and/or biohazardous materials must complete and submit IBC Continuing Review, Notice of Termination or Transfer Form (Appendix D) to the IBC Chair at least one month prior to the next scheduled annual IBC meeting. If there are modifications or revisions, a Modification Form must be submitted in addition for review. Continuing review is conducted by the full committee at its annual meeting. The IBC Chair shall notify the researcher in writing of the IBC’s decision.
4.7.2 Notice of Termination
4.7.2.1 Termination
The researcher will complete an IBC Continuing Review, Notice of Termination Form (Appendix D) and file it with the IBC Chair when a research project involving registered rDNA and/or biohazardous materials is completed or no longer active, or when the rDNA and/or biohazardous material is properly disposed of or is no longer in the possession of the researcher. The IBC Chair shall contact the researcher if there are any questions or concerns regarding Termination of Approval. The IBC Chair shall review and approve the request to terminate protocol.