What does the Institutional Biosafety Committee Review?

Experiments that require IBC approval include those that involve:

1. the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally,
2. the deliberate transfer of recombinant DNA or DNA or RNA derived from recombinant DNA into human research participants [human gene transfer],
3. 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,
4. using risk group 2 or risk group 3 agents as host-vector systems,
5. the cloning of DNA from risk group 2 or risk group 3 agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems,
6. the use of infectious or defective risk group 2 or risk group 3 agents,
7. 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],
8. viable recombinant DNA-modified microorganisms or cells tested in or on whole animals
9. genetically engineered plants by recombinant DNA methods,
10. more than 10 liters in a single vessel
11. the formation of recombinant DNA molecules containing no more than two-thirds of the genome of an eukaryotic virus
12. 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.