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, contact us by email at firstname.lastname@example.org.
IBC meetings are open to the public. Please contact the UNCG Office of Research Integrity at email@example.com for more information.
All work with Biological Materials and Synthetic or Recombinant Nucleic Acid Molecules at UNC Greensboro are to be conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH GUIDELINES), the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), and the UNCG Biosafety Manual found on the UNCG Lab Safety website.
All such work at UNCG falls within one of categories outlined below. Review the regulatory documents and descriptions below to determine the appropriate category and corresponding registration or review process for your work. A flow chart is also available to aid in this determination: IBC-Determination-chart.
UNCG has implemented an electronic IBC submission system, Cayuse Hazard Safety. For helpful resources for navigating the Cayuse Hazard Safety electronic submission system, please visit the Cayuse Hazard Safety Resource site.
Non-Exempt Biological Materials requiring review by the IBC
Included in this category is any work with biological materials classified as Risk Group 2 or Biosafety Level 2 or higher and work with recombinant or synthetic nucleic acids or transgenic animals which does not qualify for exemption in the categories outlined above.
Experiments in this category must be reviewed the IBC.
- Significance: Does the project address an important problem in the field?
- Investigator: Are the PIs and other researchers capable of carrying out the project?
- Approach: Are the overall strategy, methodologies, and analyses appropriate to accomplish the specific aims of the project
- Environment: Is the scientific environment adequate for successful completion of the work?
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.
The IBC is specifically responsible for the review and approval of research protocols involving the use of biohazardous agents including, but not limited to:
- Recombinant or synthetic nucleic acid molecules in organisms including their use in animals (including arthropods) and plants,
- Human and other non-human substances (blood, body fluids, cell lines or tissues),
- Organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia),
- Biologically active agents (i.e. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community.
Biological Materials that may be exempt from IBC Review:
Work that does NOT involve:
- BSL-2 or Risk Group 2 materials;
- Recombinant or synthetic nucleic acids;
- Unfixed human sourced materials, cell lines, or OPIM (OPIM includes: human primary cells, cell lines, unfixed tissues, semen, vaginal secretions; cerebrospinal, synovial, pleural, pericardial, peritoneal, and amniotic fluids; and body fluids visibly contaminated with blood or in situations where it is difficult to differentiate between body fluids.)
Exempt Requiring Concurrent Registration with both IBC and EHS:
Work with human blood, unfixed human sourced materials, or OPIM, including human cell lines.
Exempt Requiring Registration with IBC:
Work with recombinant or synthetic nucleic acids is exempt from full IBC review if it meets any of the following conditions: THE PI MUST CONSULT WITH THE IBC CHAIR OR THEIR DESIGNEE (Dr. Yashomati Patel firstname.lastname@example.org)
Please complete the Exempt IBC Registration Form and send to email@example.com
- Experiments DO NOT involve use of a biological toxins or live infectious microorganism classified by the CDC as requiring Biosafety Level 2 or higher (Consult CDC/NIH BMBL).
- Recombinant or synthetic DNA or RNA molecules that are not in organisms or viruses.
- Only E. coli or Saccharomyces cerevisiae are used to clone and propagate DNA from an organism; AND
- Recombinant nucleic acids are derived entirely from non-viral sources; AND
- Fermentations do not exceed 10-liter volumes at any one time; AND
- The E. coli strain does not contain a conjugation proficient plasmid or a generalized transducing phage.
- For experiments with whole animals, the recombinant DNA vectors used either do not contain viral sequences or contain less than two-thirds of a eucaryotic viral genome. (Requires IACUC Approval).
- Experiments involving the generation of transgenic rodents that require BSL≤1 (Requires IACUC Approval).
- The purchase or transfer of transgenic rodents. It is not required to register transgenic animals modified only by gene knock-outs (Requires IACUC Approval).
Policy and Guidance
- Risks Group Determination
- Laboratory Biosafety Levels
- UNCG IBC Policy
- Biosafety levels at UNCG
- Importance of Biosafety/Dual Use
- CITI Training Instructions for IBC members
- Instructions for IBC CITI Training
- Dual Use Research of Concern
- BMBL: https://www.cdc.gov/labs/BMBL.html
- NIH Guidelines: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf
- ABSA Risk Group Database: https://my.absa.org/tiki-index.php?page=Riskgroups
- Pathogen Safety Data Guide: https://tools.niehs.nih.gov/wetp/public/hasl_get_blob.cfm?ID=10823