IBC FAQs

The IBC is responsible for monitoring and ensuring compliance as well as reviewing and approving all research projects that involve biological material, including rDNA materials and human gene therapy/gene transfer protocols. IBC’s were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA.

Many institutions, including Texas State University, have chosen to assign their IBC’s the responsibility of reviewing a variety of experiments that involve biological materials and other potentially hazardous materials.

It is an NIH requirement to comply with the NIH Guidelines for Research Involving Recombinant DNA or Synthetic Nucleic Acid Molecules at Texas State University because our institution receives NIH funding for research projects.

It is institutional policy that all research involving biological materials be evaluated to ensure that the appropriate training, biosafety measures, and biosecurity measures are taken to minimize risk to research personnel, the Texas State community, and surrounding general community and environment.

It is expected that all personnel handling biological materials at Texas State comply with the institutional, state, and federal guidelines and regulations.

Per compliance with the NIH Guidelines for Research Involving Recombinant DNA and Synthetic Nucleic Acid Molecules and university policy, experiments involving the following must submit a protocol for review and approval by the IBC:

Experiments qualifying as exempt under Section III-F of the NIH Guidelines

Experiments involving low risk biological agents (risk group 1)

Blood draws performed on patients not known to be actively infected with any bloodborne pathogens

Teaching activities that involve any of the materials listed above

All other research must go through full IBC review and approval. All other research that requires IBC review and approval includes:

• Non-exempt experiments under Sections III-A, III-B, III-C, III-D, and III-E of the NIH Guidelines
• Experiments involving the use of known human pathogens or risky environmental biological agents, including bacteria, archaea, viruses, fungi, protozoa, helminths, arthropods, prions, and biological toxins
• Research involving human cells/ tissues/ organs (unpreserved) and bodily fluids. This includes use of established or primary cell lines, stem cells, urine samples, known infected blood samples, fecal samples, and other bodily fluids
• Experiments involving handling of non-human primate cells/ tissues/ organs/ bodily fluids
• Experiments involving handling of any other animal cells/ tissues if animal was infected with a biological agent. (Example: animal brought in for necropsy after being found dead in wild)
• Use of animals as models for studying biological agents and toxins
• Nanotechnology involving biological agents
• Teaching activities that involve any of the materials listed above

At present time, we do not have an electronic submission system in place but are working towards initiating an electronic protocol submission within Kuali. Current state and federal guidelines mandate that all the information on the form be asked of researchers to ensure we are being compliant with all policies and guidelines. Note that about half of the form may or may not need to be completed. Refer to Page 6 of the application to see if a section applies to your research. The information requested helps reviewers evaluate the research protocol quicker to speed up the approval process.

Go to the Texas State University IBC home page and click on “IBC Application Process.” The IBC Protocol Application and process will be available there. The application and any associated documents can be sent to ricibc@txstate.edu .

Yes. The Biological Safety Officer (BSO) is responsible for conducting annual laboratory inspections. All research protocols registered and approved with the IBC are required to have a current satisfactory biosafety inspection on file. Contact our BSO, Ms. Elsie Romano, at er20@txstate.edu to schedule a biosafety inspection.

This depends on what Biosafety Level (BSL) your research lab is designated as.

there are two options for training. RIC can register lab personnel for the ‘Basic Biosafety’ course on CITI. OR, personnel can contact our BSO, Elsie Romano within EHSRM, to be added to the CANVAS training site. Lab personnel can complete the ‘General Biosafety’ module, which is tailored to fit Texas State’s research population.

contact our BSO, Elsie Romano within EHSRM, to be added to the CANVAS training site. Lab personnel can complete the ‘BSL-2’ module.

Please contact EHSRM to be added to the CANVAS training site. The Bloodborne Pathogen training module will need to be completed.

You will need to complete an IBC Protocol Application to be assessed by members of the IBC. When your application is submitted to the IBC, you can present documentation to support the designation of the BSL for the materials you are working with. The IBC will determine if the research is acceptable in BSL-1 containment or if requirements have changed. All biological research at Texas State University is required to be documented with the IBC- not all will require IBC approval (but some may, depending on the type of research being conducted).

Yes. Whether or not the work needs to be documented or go to the IBC for full approval, depends on the genetic material that is being manipulated. Submit an IBC Protocol Application, or fill out the IBC Determination to help determine whether an application is required.

Yes.  Registration with the IBC is based on the biological materials used in your experiments, not on funding.

Yes. Texas State University receives funding from NIH grants, which, according to the NIH Guidelines for rDNA research, means all researchers are required to comply with the NIH Guidelines and University policies, regardless of funding source. All recombinant DNA research must be reviewed by the IBC.

Select agents are those agents and toxins that have been determined by the federal government to have the potential to pose a severe threat to public health and safety and are under special restrictions. At this time, we do not allow the handling of any of these agents at Texas State University and would require additional trainings, site visits, laboratory evaluations, etc. to allow for any of these agents/ toxins to be handled here.

If you intend to use certain biological agents and toxins known as “Select Agents” or research that may fall under the Dual Use Research of Concern (DURC), you must notify Elsie Romano, the Texas State University Biological Safety Officer, as soon as possible at (512) 245-2058 or ricibc@txstate.edu   

Yes, and you may require an IRB approved protocol as well. You are required to complete the IBC Protocol Application and submit to the IBC at ricibc@txstate.edu. To apply for an IRB Application, please visit the Texas State IRB site.

The IBC page has the deadlines posted. All protocols are due at least two weeks prior to an IBC meeting for review. This does not guarantee an approval, only that it will be reviewed at that monthly meeting. Please note that your protocol may not require a full committee review and may be eligible for an expedited review. This determination will be communicated to you, so that you will know whether or not you need to attend the monthly meeting.

Any research that falls specifically under the NIH Guidelines is not eligible for an expedited review. Please refer to the deadlines posted under ‘IBC Meeting Dates and Deadlines.’ Please fill out an IBC Determination Request to determine whether or not your research is eligible for an expedited review.  Expedited review times are dependent on response time from the PI as well as the reviewers. Please note that training and biosafety inspections must be completed prior to obtaining full approval from the IBC.

IBC Protocols are good for three years. Renewals must be submitted 60 days prior to the expiration date. If your research activities differ from the original approval (ex: adding any new biological/biohazardous material), then please submit an amendment to the IBC. IBC Amendment forms can be found on the IBC site.

Please complete the IBC Protocol Form and check ‘Amendment.’ Submit to ricibc@txstate.edu  for IBC review.

If your protocol has been completed or terminated, please notify RIC of the completion of the protocol. If the protocol lapses and has not been renewed, this may pose a problem for continuing work in the laboratory until the protocol has been reviewed and renewed.

If a protocol application is received before a submission deadline and requires full committee review, it will be reviewed at the next IBC meeting, which the PI will be invited to attend for commentary and feedback. After the IBC has reviewed the protocol, the PI will receive notice from RIC within 2-7 days of the meeting. Final approval is contingent on the speed in which questions are resolved, whether or not training has been completed, and whether or not the biosafety inspection has been completed.

If the protocol qualifies for an expedited review, times are dependent on response time from the PI as well as the reviewers. Any necessary training, as well as a satisfactory biosafety inspection, must be completed prior to obtaining full approval from the IBC.

If this is a renewal, you should submit your protocol 60 days before the expiration date. RIC will send reminders to the PI via e-mail 90, 60, and 30 days in advance, but it is the responsibility of the PI to know deadline dates.

No. Each PI is responsible for being in full compliance with institutional policies and NIH Guidelines for rDNA research. Protocol submissions only cover the specific research project outlined in the protocol, not an entire laboratory. There may be multiple protocol submissions for a laboratory and multiple submissions from a single PI. A separate IBC protocol application must be completed for each grant, project, or set of experiments conducted at Texas State University.

Responses to the additional questions from the IBC should be submitted via e-mail to ricibc@txstate.edu.

Yes. The IBC requires you to submit a revised application reflecting the answers to the additional questions.

The IBC is open to new members at any time. If you are interested in becoming a member of the IBC, please contact the Institutional Official, Dr. Michael Blanda, for more information. At this time, faculty members only are invited to inquire about membership. If openings become available for academic or university staff, the policy will be modified to reflect that.

IBC meetings are open to the public. Please contact RIC at ricibc@txstate.edu so that you may receive a zoom meeting invite to the next IBC monthly meeting.

Meeting minutes are available upon request as well.

It is the responsibility of the PI to work with the IBC and EHSRM to ensure the new lab space is in compliance with all institutional, state, and federal guidelines. Contact ricibc@txstate.edu to notify the BSO of this change. Additionally, ensure that you are compliant with laboratory safety guidelines and facilities guidelines.

Once you have set up your research facility in your new space, a biological safety inspection must be conducted to ensure compliance with the approved protocol(s). The BSO will conduct the inspection. It is the PI’s responsibility to have their biological safety cabinet re-certified before commencing work in the new facility.

Contact EHSRM to inquire when the certifications are being scheduled for your lab.

Note that a BSC must be certified when installed, whenever they are moved and at least annually, and a currently certified BSC is a requirement for most BSL-2 laboratories. This is part of the IBC approval process as well.