What types of research do I need to register with the GS Institutional Biosafety Committee (IBC)?

Experiments involving the following must be registered with the IBC:

  • Pathogens affecting humans, animals, or plants;
  • Materials potentially containing human pathogens (e.g. unfixed human specimens, human blood);
  • Recombinant DNA molecules including viral vectors;
  • All cell and organ cultures of human origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives
  • Human or mammalian cell lines (including embryonic & established), human tissue or blood.
  • De novo generation of transgenic animals (using recombinant DNA technology to add foreign DNA or subtract a portion of the animal’s genome);
    • Generation of de novo transgenic animals: Defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. Examples of recombinant DNA technology include (1) Direct microinjection of a chosen gene construct from another member of the same species or a different species into the pronucleus of a fertilized ovum; (2) Insertion of the desired DNA sequence by homologous recombination into an in vitro culture of embryonic stems and cells; (3) Use of a plasmid or virus to transfer the genetic material into germ cells. Breeding animals to generate transgenics need not be registered with the IBC. Those transgenics that already exist or which have been purchased are not subject to IBC registration.
  • De novo generation of transgenic plants;
  • Introduction of recombinant DNA (plasmids) or gene transfer vectors (including viral vectors) into human subjects;
  • Introduction of genetically engineered micro-organisms or infectious agents into human subjects (including live vaccines if they are experimental in nature and/or not FDA approved for use in the specific study population.
Do I need to apply to the IBC if I am working with biohazardous materials but not with recombinant DNA?

Yes.  The GS IBC reviews and approves all research involving biohazardous materials, as defined below. IBC registration and approval of research involving these biohazards is required.

  • Naturally occurring or engineered micro-organisms or viruses capable of causing disease in humans and/or animals. These are Risk Group (RG) 2, 3 or 4 pathogens as defined by NIH (Note: this list is not all inclusive). Those agents not listed in RG 2, 3, and 4 are not automatically or implicitly classified as non-pathogens or in RG
  • A risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Consult the following web sites for guidance.
  • Human or mammalian cell lines (including embryonic & established), human tissue or blood.
  • Toxins derived from plants, animals or micro-organisms that will have adverse effects in humans or animals.
  • Plant pathogens or pests (arthropods, nematodes, weeds) that are regulated by state or federal policy or law. Consult the following web sites for up to date lists of regulated organisms.
  • Select biological agents that may adversely affect public health, animal or plant health, or animal or plant products. Note: all possession and use of Select biological agents requires special registration through the Biological Safety Officer.
Can I dispose of biological waste in the regular trash if I autoclave it?

The following steps are required to be met prior to a department/principal investigator/generator of waste disposing of non-sharp solid biological/biohazardous waste in regular trash:

The Environmental Health and Safety (EHS) Occupational Safety Manager must be contacted and permission obtained in writing (email accepted).  Department Chair awareness/permission should also be documented.

The decontamination must be done using a validated autoclave equipment (passed annual inspection by an outside vendor)  The autoclave should be able to record the temperature during each complete cycle to assure the attainment of 121°C or 250°F for a time appropriate to assure decontamination of the entire load.

Monitoring of the autoclave process through the use of biological or other approved indicators is to be accomplished by the investigator and maintained along with the temperature recording as proof of decontamination.

The department/principal investigator/generator of waste must maintain a data log record of the following information:

Autoclave User,
Date Used,
Materials Decontaminated,
Process Type,
Run Duration (Cycle Time),
Chemical/Biological Indicator Used,
Chemical/Biological Indicator Results

The above steps and information are required in accordance with the rules and regulations of the State of Georgia pertaining to Biomedical Wastes (391-3-4-.15).

Decontaminated wastes should not be transported in exposed red-bags or bags that are labeled as biohazardous material.   Place decontaminated waste into heavy gauge black trash bags.  Lab personnel are responsible for transporting wastes to the landfill transfer station or dumpster as determined by approval.  Custodial staff are not responsible for transporting this waste.

Autoclave tags should remain attached to the waste container.

If all of the above criteria cannot be met for any biological waste, a waste pick-up request should be submitted for the biohazardous/biomedical waste generated.  GS EHS will manage waste pick up and disposal.

Last updated: 10/15/2018

Office of Research Integrity • PO Box 8005, Statesboro, GA 30460 • General Inquiries: (912) 478-2359 • irb@georgiasouthern.edu