The Office of Research Integrity

Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) ensures that research involving recombinant DNA and biological materials follows designated guidelines.  The IBC follows the guidelines established by the National Institutes of Health (NIH) Office of Biotechnology Activities and The Center for Disease Control (CDC). If you have any questions regarding the IBC committee, the best way to contact us is by email at  ori@uncg.edu.

The UNCG IBC’s working definitions of biohazards and related materials are as follows:

1. Biohazards are infectious agents or hazardous biological materials that present a risk or potential risk to the health of humans, animals, or the environment. The risk can be direct through infection or indirect through damage to the environment. Any organism or virus listed in CDC/NIH Risk Group (RG) two, three, or four, or that requires Biosafety Level (BL) two, three or four containment, is considered biohazardous.

2. Biohazardous materials include certain types of recombinant DNA (e.g. that express potentially infectious entities or potent toxins), or organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia); and agents of biological origin (e.g. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community.

3. Biological materials are any materials containing genetic information and capable of reproducing itself or being reproduced in a biological system.

Biological materials may or may not be considered biohazardous, and include (but are not limited to):

  • Microorganisms
  • Recombinant DNA (rDNA) … The NIH Guidelines provide a list of covered experimental uses of recombinant DNA that are considered biohazardous and a separate list of exempt experimental uses of recombinant DNA that are not considered biohazardous. These lists are found in Section III of the NIH Guidelines.
  • DNA or RNA of natural or synthetic origin, but not recombinant and unable to self replicate (e.g. cellular DNA/RNA extracts, oligonucleotides such as PCR primers, siRNA, etc.) Usually not biohazardous per se.
  • Cell lines
  • Animals (live or tissues and biological fluids)
  • Plants
  • Human tissue or biological fluids
  • Microbial Toxins

INSTITUTIONAL BIOSAFETY COMMITTEE FORMS

Use the IBC Determination chart to help determine which of the following categories applies to your clinical/diagnostic, research, or teaching activities, then please complete the applicable form, if required:

Examples of activities NOT requiring IBC review:

  • Activities that are properly conducted at Biosafety Level 1, involving RG1 (non-pathogenic) organisms, do not require formal disclosure to the IBC.
  • Activities involving in vitro use of non-self-replicating forms of nucleic acids, as listed in definition 3.c. above (e.g. siRNA, PCR, DNA sequencing, chemical/analytical experiments) do not require disclosure to IBC.

Examples of activities requiring the IBC Exempt form are:

Some recombinant or synthetic nucleic acid molecules may be introduced, propagated and maintained in cells in tissue culture, without submission of a full IBC Protocol. This “Exempt” form may be used if:

  • The genetic constructs involved contain NO toxin gene or eukaryotic viral genetic material, or less than one-half of the genome of any eukaryotic virus from RG1 or RG2.
  • Recombinant or synthetic nucleic acids are cloned in non-pathogenic hosts such as E. coli K12, S. cerevisiae, and B. subtilis.

Examples of activities requiring a full IBC Protocol Form:

  • Activities involving potentially infectious human or animal tissues or biological fluids.
  • Anything involving live biohazardous toxins or organisms of RG2 or higher, or involving rDNA containing any amount of genetic material from RG3 or RG4 organisms, or greater than 50% of the genome of a RG2 eukaryotic virus.

Use the IBC-Renewal/Modification FOR ANYTHING DESCRIBING THE FOLLOWING:

a) Addition or deletion of project personnel or project location; termination of project
b) Change to experimental plan (i.e. addition or deletion of genes, hosts, agents) for any existing registration.

Please note that major changes may require a new registration.

Policy and Guidance

Training

Federal Guidance