Biosafety Research Requirements

All biological research projects require IBC notification and fall into one of two categories. (1) Projects Requiring IBC Registration (2) Exempt Projects

Projects Requiring IBC Registration

Registration is required for any project involving any of the following:

Select Agents and Toxins;

Toxins of Biological Origin;

Work with toxins of biological origin is subject to review and approval by the IBC. Cloning and expression of toxins with an LD50 in vertebrates of less than 100 micrograms/kilogram may require additional approval or registration with NIH. Those toxins that are on the Select Toxin List require registration and approval, regardless of amounts. Work with unregulated quantities of Select Toxins requires registration with the IBC and use of a log to track inventory and use of the toxin.

Human or Non-Human Primate (NHP) blood, blood products, tissues, secretions, excretions, or cell lines;

Clinical, diagnostic, research, and/or teaching activities involving collection/manipulation of human blood or potentially infectious material must be registered with the IBC, and work can be initiated only after review and approval of the IBC. This is in addition to enrollment in the UNT Bloodborne Pathogen (BBP) Program. Consult the UNT Biosafety Manual and UNT Bloodborne Pathogen Exposure Control Plan (ECP) for additional information. Depending on the source, work with human blood, cells, or tissue may require an Institutional Review Board (IRB) protocol. Please consult UNT Research Compliance and Integrity for additional requirements.

HUMAN AND NON-HUMAN PRIMATE CELLS AND ORGAN/TISSUE CULTURES

Work with all human or non-human primate cells and organ/tissue cultures including those that are potentially infectious or contaminated with bloodborne pathogens, well-established cell lines, human embryonic stem cells*, and pluripotent cells and their derivatives are subject to the UNT Bloodborne Pathogen Exposure Control Plan (ECP) and require review and approval by the IBC. Work may be initiated only after submission of a completed IBC protocol registry form and approval by the IBC. 

*Currently, work with human embryonic stem cells (hESC) are unable to be approved for use at UNT.

Recombinant (rDNA) or synthetic nucleic acid (sNA) molecule use

According to the NIH Guidelines, r/sNA are defined as molecules that:

a) are constructed by joining nucleic acid molecules and that can replicate in a living cell, i.e., recombinant nucleic acids; 

b) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or

c) Molecules that result from the replication of those described in (a) or (b) above

STOP. All experiments involving r/sNA molecules or r/sNA-containing materials and organisms must be registered with the IBC regardless of source, risk group, proposed use, or status under the NIH Guidelines.

Principal Investigators (PIs) registering a protocol with the IBC must reference the appropriate section(s) of the NIH Guidelines when manipulating r/s NA. To accomplish this, the PI must designate which sections of the guidelines best describe the proposed experiments. The applicable sections can be found in Section III-A through III-F of the NIH Guidelines. The applicable sections of the guidelines establish when proposed work may begin.

Research at UNT usually falls into Sections III-D, III-E, or III-F of the NIH Guidelines. Often, multiple sections of the NIH Guidelines apply to a given protocol.

  • Section III-D: Experiments may not begin until a protocol is submitted and committee approval is received;
  • Section III-E: Experiments may not begin until a protocol is submitted to the IBC. Work must stop if the protocol is not subsequently approved by the committee.
  • Section III-F: Although considered exempt from the NIH Guidelines, these experiments must be registered in an IBC protocol. Work must stop if the protocol is not subsequently approved by the committee.

USE OF GENETICALLY-MODIFIED ORGANISMS (GMO) PIs must register all work (use, creation, breeding, etc.) with genetically-modified organisms, (animals, plants, arthropods, etc.). Registration is required regardless of source. Work with genetically-modified organisms is described in certain sections of the NIH Guidelines. Guidance on applicable sections of the NIH Guidelines for animal work can be found here: https://osp.od.nih.gov/wp-content/uploads/Animal_Activities_Table.pdf

Work with transgenic organisms may require additional research compliance protocols or permits (IACUC, USDA-APHIS, etc.). Additional protocols or permits must be referenced in the IBC protocol. Applicable permits may also be attached to the protocol as a separate file.

IBC review and approval of genetically-modified plant experiments (including growing of transgenic plants; administration of any pathogenic microorganism, arthropod or nematode to genetically-modified plants, etc.) conducted in laboratory, growth chamber, or greenhouse settings is required (See Sections III-D-5, III-E and III-E-2 of the NIH Guidelines). 

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;

Animal work done with controlled substances (for uses other than anesthesia or euthanasia), biological agents (bacteria, viruses, protozoa), or toxins, or any animals (vertebrate or invertebrate) known to be vectors for disease, or are poisonous or venomous;Certain field work with wild animals requires review and approval by the IBC when there is risk of exposure to zoonotic diseases.

Hazardous or potentially hazardous biological agents

Principal Investigators working with human, animal, or plant pathogens must submit a registration protocol to the IBC protocol and describe the specific pathogen(s) and proposed experiments. In addition, a pathogen inventory must be submitted to EHS and updated on an annual basis (see EHS SOP, Pathogen Inventories). When preparing a protocol for IBC review involving pathogens, researchers must be aware of the following:

  • • Applicable risk group*;
  • • Pathogen host range;
  • • Presence of recombinant or synthetic nucleic acids;
  • • Proposed containment level (BSL-1, BSL-2, etc.);
  • • Suitable disinfectant;
  • • Decontamination and disposal requirements and procedures;
  • • Applicable medical surveillance for lab staff;
  • • Emergency procedures and spill response;

*Currently, risk groups are only assigned to human pathogens. The 4 risk groups, along with member species in each risk group can be found in Appendix B of the NIH Guidelines, ABSA Risk Group Database, and Canadian Pathogen Safety Data Sheets.

Dual Use Research of Concern (DURC);

Hemp Use or Production.

For additional information please refer to the Biosafety Manual

Exempt Projects

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.

Project Registration