IBC Determination Form

Use this checklist to help determine if IBC registration is required.

Additional Notes & Definitions

• Risk Group (RG): Agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans and the available treatments for such disease. This does not account for instances in which an individual may have increased susceptibility to such agents, e.g., preexisting diseases, medications, etc. The chart below will help you with making this determination. Please review Appendix B of the NIH Regulations for more information on Risk Groups.

Biosafety Level	1	2	3	4
Potential to Cause Disease in Healthy Adult Humans	None	Rarely serious	Likely to cause serious or lethal illness	Likely to cause serious or lethal disease
Risk to Individual / Community	Unlikely	Unlikely	High individual risk, low community risk	High individual risk, high community risk
Engineering Controls	Available	Often Available	Possible / May be available	Not usually available
Examples	Asporogenic Bacillus subtilis, Bacillus licheniformis	Actinobacillus, Bacillus anthracis, Bordetella including B. pertussis, Blastomyces dermatitidis, Coccidia, Adenoviruses, human – all types	Bartonella, Mycobacterium bovis (except BCG strain), Coronaviruses	Bunyaviruses (Nairovirus), Filoviruses (Ebola viruses)

• Biosafety Level (BL or BSL): There are four biosafety levels (1-4). Each level has specific controls for containment of microbes and biological agents. BSL-1 requires the least containment while BSL-4 requires the most. The primary risks that determine levels of containment are infectivity, severity of disease, transmissibility, and the nature of the work conducted. Origin of the microbe, or the agent in question, and the route of exposure are also important.
  
  Each biosafety level has its own specific containment controls that are required for the following: laboratory practices, containment equipment, laboratory design.
   
  BSL-3 and BSL-4 agents are not approved for use at UNCG. Any UNCG investigator desiring to initiate work with BSL-3 or Select Agents must discuss this with the Vice Chancellor for Research & Engagement.
• Biological Containment Practices: The UNCG Biosafety Manual outlines the appropriate containment practices for each biosafety level. Appendix G-II of the NIH regulations also defines what is required when working in each containment level. Human cells, blood, and OPIM are handled under BSL-2 containment at UNCG.
• Other Potentially Infectious Materials (OPIM): any human-derived blood, body fluids, or tissues, where the presence of an infectious agent may be unknown. This can include 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.
• Gene Drive Modified Organisms (GDMO): “Gene drive” is defined as a technology whereby a particular heritable element biases inheritance in its favor, resulting in the heritable element becoming more prevalent than predicted by Mendelian laws of inheritance in a population over successive generations.
   
  Experiments involving GDMOs generated by recombinant or synthetic nucleic acid molecules shall be conducted at a minimum of BSL-2 (see Section III-D-8 of the NIH Guidelines). IBCs may require additional biosafety precautions, or a higher containment level based on their risk assessment of the specific research protocol.
• Dual Use of Research Concern (DURC): Biological research wherein the methodologies, materials, or results could be used to cause harm. Dual Use Research of Concern (DURC) is a small subset of life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
• Export control in the IBC: Federal regulations and policies that govern and protect certain commodities, software, and technology (collectively “items”) that could be considered dual use when they are being exported or exchanged with restricted countries/territories and sometimes, foreign collaborators from those areas. Fundamental research, defined below, is typically excluded from these regulations.
  • Fundamental research (Export Control): research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons. This type of research is typically excluded from export control laws and regulations. Example: University based research on vectors for salmonella typhi which is published broadly.
    
    There are two lists (EAR and ITAR) which identify which biological materials should be export controlled. For additional questions regarding export controls, please contact ori@uncg.edu.
    

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