Experiments Requiring IBC Approval

Experiments that require IBC approval include those that involve:

• the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally,
  
  
• the deliberate transfer of recombinant DNA or DNA or RNA derived from recombinant DNA into human research participants (human gene transfer),
  
  
• the deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight,
  
  
• using risk group 2 or risk group 3 agents as host-vector systems,
  
  
• the cloning of DNA from risk group 2 or risk group 3 agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems,
  
  
• the use of infectious or defective risk group 2 or risk group 3 agents,
  
  
• whole animals in which the animal's genome has been altered by stable introduction of recombinant DNA or DNA derived into the germ-line (transgenic animal),
  
  
• viable recombinant DNA-modified microorganism tested on whole animals,
  
  
• genetically engineered plants by recombinant DNA methods,
  
  
• more than 10 liters of culture, and
  
  
• the formation of recombinant DNA molecules containing no more than two-thirds of the genome of an eukaryotic virus.

Working with Select Agents

A sub-category of risk group agents referred to as Select Agents as defined in "The Antiterrorism and Effective Death Penalty Act of 1996, Public Law #104-132, Regulation 42CFR 72.6" are referred to as specific toxins and pathogens as regulated by the Department of Health and Human Services and/or the USDA.

These agents require special procedures for transfer and possession. Contact the UNMC Biosafety Officer for further information concerning these biohazardous agents.