IBC FAQs

Q: What is a Biohazard?

A: Any microorganism (including, but not limited to, bacteria and their phages and plasmids, viruses, fungi, mycoplasmas, rickettsia, protozoa, parasites, or prions) or infectious substance; human and non-human primate tissues, body fluids, blood, blood byproducts, and cell lines; animal remains and insects that may harbor zoonotic pathogens; or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, animal, plant, or another living organism, or deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment.

Q: Why do I have to Register my protocol?

A: Per federal regulations, UNT’s Institutional Biosafety Committee is required to review, approve, and maintain documentation on all protocols involving recombinant DNA. If you intend to use certain biological agents and toxins known as “select agents”, you must notify the biosafety officer directly, as soon as possible at biosafety@unt.edu. 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. For additional information, go to www.selectagents.gov.

Q: What types of research must be registered with the IBC?

A: Experiments involving the following must obtain approval from the IBC:

  1. Select Agents and Toxins;
  2. Toxins of Biological Origin;
  3. Human or Non-Human Primate (NHP) Blood and Tissue;
  4. Recombinant and Synthetic Nucleic Acid Molecules;
  5. Environmental samples, such as water, air, soil, or plants, may contain pathogens (e.g., bacteria, viruses, spores) that could present a health hazard to people, animals, or the environment;
  6. Animal work done with controlled substances (for uses other than anesthesia or euthanasia), biological agents (bacteria, viruses, protozoa), or toxins, or any animal work done in laboratories outside of the vivarium;
  7. Hazardous or potentially hazardous biological agents;
  8. Dual Use Research of Concern (DURC), or
  9. Hemp use or growth.

Other biological research conducted at UNT that does not meet the above criteria, but uses biological materials (such as animal cells or tissues), still must be registered with the IBC as an exempt project. If you are uncertain if any of these categories apply to your work, or if you have other questions, contact biosafety@unt.edu.

Q: If I am working only with biohazardous materials and not with recombinant DNA, do I need to register my project with the IBC?

A: Yes. Experiments involving the following must obtain approval from the IBC

  1. Select Agents and Toxins;
  2. Toxins of Biological Origin;
  3. Human or Non-Human Primate (NHP) Blood and Tissue;
  4. Recombinant and Synthetic Nucleic Acid Molecules;
  5. Environmental samples, such as water, air, soil, or plants, may contain pathogens (e.g., bacteria, viruses, spores) that could present a health hazard to people, animals, or the environment;
  6. Animal work done with controlled substances (for uses other than anesthesia or euthanasia), biological agents (bacteria, viruses, protozoa), or toxins, or any animal work done in laboratories outside of the vivarium;
  7. Hazardous or potentially hazardous biological agents; 
  8. Dual Use Research of Concern (DURC); or
  9. Hemp use or growth.

Other biological research conducted at UNT that does not meet the above criteria (a-h), but uses biological materials (such as animal cells or tissues), still must be registered with the IBC as an exempt project. If you are uncertain if any of these categories apply to your work, or if you have other questions, contact biosafety@unt.edu.

Q: If I am registering an IBC protocol or a 3-year renewal, what forms do I need to complete?

A: At this time, both the New Application and the 3-Year renewal are the same form. You will need to complete the IBC New Registration Form.

Q: If I am modifying an already approved IBC project (not due for renewal), what forms do I need to complete?

A: You will need to complete an IBC BSP Amendment Form.

Q: What do I do if my protocol has been completed to terminated?

A: You will need to complete an IBC BSP Amendment Form.

Q: Where should I submit completed forms?

A: All forms should be submitted by the PI by "signing" the online form.  This will submit the BSP to the IBC.

Q: When is the deadline for my protocol/project submission?

A: The IBC meets every month, and requires at least three weeks of review after the initial submission to the BSO for review of the protocol. See https://riskmanagement.unt.edu/institutional-biosafety-committee-ibc-meeting-and-submission-deadlines-2021 for the next IBC meeting date.

Q: If I share a lab with an investigator who is registered with the IBC, does that registration apply to my work in the shared lab?

A: No. Each PI is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research and with University biosafety requirements. Investigators may not “piggy-back” on the existing IBC protocols of other investigators. Therefore, a separate IBC form must be completed for each grant, project, or set of experiments.

Q: I only work with plants and Agrobacterium. Do I have to register with IBC?

A. Yes. You must register with the IBC and comply with the USDA guidelines and regulations for containment of transgenic plant and plant materials. If your research involves infectious agents, potentially infectious material, or recombinant nucleic acids, you must register with UNT IBC. Since the University receives funding from NIH grants, ALL research conducted at UCI must comply with the NIH Guidelines and University policies.

Q: I work with Drosophila and create mutants of Drosophila with P element-mediated transformation. Do I have to complete the IBC form?

A. Yes. You must register with the IBC. Whether this research has to have full IBC review and approval depends upon the genes being introduced back into the Drosophila. The BSO and/or the IBC Chair will determine whether full review and approval are needed.

Q: I work with animal tissue culture and sometimes use human cell lines. Why am I considered to be doing BSL-2 research?

A. Any work with human cells or tissue cultures, even commercially derived (e.g. ATCC), is considered to be “other potentially infectious material” (OPIM) . This renders any work with this material to be at least at the BSL-2 level.

Q: Why must I notify the IBC if I only work with BSL-1 agents?

A. Your compliance requirements depend upon both the agent and how it is being used. It may be that the wildlife you have been working with for ten years is now infected with a zoonotic, infectious agent. Or it may be that the NIH Guidelines and interpretations of the Guidelines have changed. The BSO can determine whether you must simply register as an exempt project, or if you must complete a full IBC Project Registration Form for the IBC to review and approve. Contact the IBC/BSO at biosafety@UNT.edu to discuss.