What does the Institutional Biosafety Committee Review?
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 micrograms 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 microorganisms or cells tested in or on whole animals
- genetically engineered plants by recombinant DNA methods,
- more than 10 liters in a single vessel
- the formation of recombinant DNA molecules containing no more than two-thirds of the genome of an eukaryotic virus
- any research involving the use of Select Agents, Select Toxins, and/or any portion of their genome.
Experiments using biosafety level [BL] 2 or BL-3 containment must be reviewed and approved prior to the initiation of experiments. Experiments using BL-1 containment must also undergo IBC review however, this review process is expedited and research may commence simultaneously with protocol submission. Experiments requiring BL-4 containment will not be approved.
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 Biosafety Officer for further information concerning these biohazardous agents.