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IBC Registration

Q: How can I obtain assistance regarding the process of submitting my registration form to the IBC?

A. Contact the Office of Research Compliance and Biosafety (RCB) at IBC@.tamu.edu or 979.458.3624.

Q: How can I obtain assistance regarding technical questions in my registration form?

A. Contact the RCB at biosafety@.tamu.edu or 979.862.4549 and ask to speak to a biosafety officer.

Q. What type of research must be registered with the IBC?

A. All research conducted by Texas A&M University employees or students, involving any of the agents/materials listed below, must be approved by the Texas A&M Institutional Biosafety Committee (IBC) prior to initiation:

  • Pathogens and potential pathogens of humans, animals, or plants;
  • Materials potentially containing human pathogens (including human blood, tissue, and cell lines; non-human primate blood, tissue, and cell lines);
  • Recombinant DNA (and RNA) including creation or use of transgenic plants and animals;
  • Select agents and toxins (see http://www.selectagents.gov), including strains and amounts exempted from the select agent regulations;
  • Any material requiring a CDC import license or a USDA permit.


Q: Who needs an IBC permit?

A. All principal investigators possessing or using biohazardous materials must have an IBC permit. Principal investigators (PIs) are defined in University Rule 15.01.01.M2 5.1:

“Eligibility to act as a University principal investigator or senior personnel on a sponsored research project is a privilege typically limited to University employees (generally faculty members). Non-faculty University principal investigators must hold a faculty-equivalent research position to serve as a principal investigator, project director, co-principal investigator, or other senior personnel on a sponsored research project. …”

If a PI has a grant in their name (involving biohazards), that PI must also have an IBC Permit. Multiple grants can be included on one IBC permit through the amendment process.

Q: How do I submit the IBC registration form?

A. All forms are available in the online system, iRIS at http://imedris.tamu.edu.

Q. I do not receive funding from the NIH. Am I required to register my protocol with the IBC?

A. Yes. ALL research subject to IBC oversight requires IBC approval. The source of the funding does not alter this requirement.

Q. My research is funded by internal or startup funds; am I required to register my protocol with the IBC?

A. Yes. ALL research subject to IBC oversight requires IBC approval. The source of the funding does not alter this requirement.

Q: How long is my approval for?

A. Your IBC permit is valid for three years from the approval date with annual renewals required.

Q: What is an annual renewal?

A. An annual renewal is required for IBC permits for all containment levels. Three months (90 days) prior to the second and third anniversaries of the approval date, the PI must submit an annual renewal form to the RCB. All forms are available in the online system, iRIS at http://imedris.tamu.edu.

Q: What is a three-year renewal?

A. The IBC permit is approved for a period of three years. Three months (90 days) prior to the expiration date of the IBC permit, you will need to submit a new IBC Registration Form for review and approval in order to continue the project. All forms are available in the online system, iRIS at http://imedris.tamu.edu.

Q: Do I need to tell the IBC that I am leaving the University? When and how do I do this?

A. Yes, you must inform the IBC that you will be departing the University and will need to terminate your IBC permit. As soon as you find out that you will be leaving the University please notify the IBC by sending an email to IBC@tamu.edu with the anticipated departure date with your IBC permit number. This will allow for the RCB to help assist you with any transporting issues if you plan to take agents with you and to perform a final walk through inspection of your laboratory.

Q: My research has changed; do I need to modify my IBC permit?

Alterations in research locations, agents used, and personnel will required you to amend your IBC permit prior to implementation of the changes. Changes in procedures may require you to amend your IBC permit. Please contact Research Compliance and Biosafety at biosafety@tamu.edu or 979.458.3624 to see if an amendment is required. Amendments can be submitted to the IBC via iRIS at http://imedris.tamu.edu.

Q.  Why is the technical description of my research important? It’s all in my grant(s).

A. The IBC relies on the technical description to review and assess all biohazard risk(s) associated with your proposed research. The technical description does not need to be too lengthy nor too detailed, but it should address all manipulations involving biohazardous/recombinant agents. It is important to address what actions will be taken (working in a biosafety cabinet, decontamination procedures, and personal protective equipment in place) to mitigate any potential risks associated with the proposed research. The technical description should not read like the materials and methods section of a publication; for example, details such as length or speed of centrifugation or incubation temperatures are not necessary. Rather, please include from start (e.g., source of agent) to finish (e.g., decontamination or storage of the agent) the processes involved in your research and used in your lab. If you have questions, please don’t hesitate to contact the RCB for assistance.

Q.  What if I am unsure of which section of the NIH Guidelines applies to my research?

A. If you are unsure which sections of the NIH Guidelines apply to your research, you may leave these sections blank. The Office of Research Compliance and Biosafety and the IBC will review your submission and ensure that the correct section of the NIH Guidelines (if one applies to your research) is selected.

Q.  Where can I find the risk group of the agent(s) I’m working with?

A. Appendix B of the NIH Guidelines:

http://oba.od.nih.gov/rdna/nih_guidelines_oba.html

If you remain unsure of the risk group, leave this space blank and we will work with you to find the best answer.

Q.  Where can I find information regarding disinfectants for decontamination in my lab?

A. Please use the EPA’s website for selected EPA-registered disinfectants:  http://www.epa.gov/oppad001/chemregindex.htm.

If you need additional help, please contact the Office of Research Compliance and Biosafety at biosafety@.tamu.edu or you may call 979.862.4549.

Q.  Are there any activities with risk group 2 agents that may be performed safely on the open bench?

A. Not without specific approval from the IBC. The BMBL states, in regard to biosafety level 2 laboratories:

  1. Properly maintained BSC's (preferably Class II), other appropriate personal protective equipment, or other physical containment devices must be used whenever:
    • Procedures with a potential for creating infectious aerosols or splashes are conducted. These may include pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, opening containers of infectious materials, inoculating animals intranasally, and harvesting infected tissues from animals or eggs.
    • High concentrations or large volumes of infectious agents are used. Such materials may be centrifuged in the open laboratory using sealed rotor heads or centrifuge safety cups.

In a research setting, almost all projects will involve activities with a potential for creating infectious aerosols or splashes or involve a high concentration of infectious agents. Therefore, unless specific IBC approval has been obtained, all work with biohazardous materials in BL2 laboratories must be performed within a certified BSC. Certain activities, such as the inoculation of solid media from an unconcentrated broth culture or the transfer of bacterial colonies from one solid medium to another, may be allowed by the IBC on a case-by-case basis. If so, this approval will be documented on the IBC approval letter. The inoculation of plates or tubes from frozen stocks would need to be conducted inside a BSC as this activity involves a high concentration (e.g., greater than normal growth concentrations) of agent.

Procedures with a potential for creating infectious aerosols or splashes or when high concentrations or large volumes of agents are used that cannot be performed in a BSC may also be conducted if the appropriate personal protective equipment or other physical containment devices are used and specific IBC approval has been granted by the IBC on a case-by-case basis. This approval will be documented on the IBC approval letter.

Q. Is there a University rule for working with infectious biohazards and/or recombinant DNA?

A. Yes. University Rule 24.01.01.M8: Infectious Biohazards and/or rDNA in Research can be found at: http://rules.tamu.edu/PDFs/24.01.01.M8.pdf.

Q: What are the requirements for people who enter biosafety laboratories?

A. See Information for People Who Enter Biosafety Laboratories.

Bloodborne Pathogens

Q. Where can I find the standard administrative procedure for working with bloodborne pathogens?

A. You can access the Bloodborne Pathogen Exposure Control Standard Administrative Procedure at: http://rules-saps.tamu.edu/PDFs/24.01.01.M4.01.pdf.

Inspections

Q. What if I do not agree with a finding on a biosafety laboratory inspection report?

A. First, please communicate your concern with the individual who inspected your laboratory so that everyone understands the finding. You may also discuss your concern with the campus biological safety officer (Dr. Christine McFarland). It may be possible that once you have communicated your concerns, a solution can be developed that satisfies your requirements and the requirements for your laboratory’s biosafety level.

Institutional Biosafety Committee

Q. What can I do if I don’t agree with a decision by the Institutional Biosafety Committee?

A. First, please communicate your concern with the individual from the Office of Research Compliance and Biosafety who communicated this information to you so that you understand the actual issue. It may be possible that once you have communicated your concerns, a solution that satisfies your requirements and IBC requirements can be developed.

Q. How can I “appeal” a decision/policy by the Institutional Biosafety Committee?

A. All determinations are based upon federal, state, and local regulations. We encourage PIs to come to an IBC meeting to request a change from existing University policy. Please contact the IBC Coordinator or the IBC Chair to make arrangements for your presentation. Email IBC@tamu.edu or IBCchair@tamu.edu or call 458-3624.

Q. Can I come to an IBC meeting?

A. Yes, IBC meetings are open to the public and the Institutional Biosafety Committee encourages researchers to attend. The schedule can be found here.

Q. Who makes Texas A&M biosafety policies?

A. The foundation for all Texas A&M biosafety policies is the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th edition and the NIH Guidelines for Research Involving Recombinant DNA Molecules. In addition, the Texas A&M rule 24.02.02.M1 Infectious Biohazards and/or rDNA in Research applies to all work at Texas A&M. Making use of these resources, the Institutional Biosafety Committee approves all biosafety policies for Texas A&M based on a majority vote.

Shipping

Q. Where can I find information about shipping hazardous materials?

A. The Environmental Health and Safety Department provides shipping information on their website: http://ehsd.tamu.edu/HazardousMaterialShipping.aspx.

Training

Q: When and where are training sessions for personnel working in BL2 & BL3 labs?

A. For upcoming training classes please see the following links: