Any research by SDSU faculty, staff, or students in the following areas must be reviewed by the Institutional Biosafety Committee (IBC):
- Recombinant or synthetic nucleic acid molecules
- Genetically modified organisms
- Pathogens/infectious agents (human, animal, or plant)
- Select/Biological Agents and Toxins (CDC and USDA)
- Any other activity that falls under the NIH Guidelines
The IBC assesses the risk of such research and confirms compliance with federal regulations to ensure that dangerous organisms are not created by genetic engineering and that all research involving biohazards is conducted in a manner that minimizes risk to personnel, the community, and the environment.
Any investigator planning such research should first determine which of the following NIH categories the study falls under. If not exempt, the investigator must complete the online IBC Registration form, print it as a PDF, and submit it for review via InfoReady.
Experiments that Require IBC Approval Before Initiation. [Biosafety Level 2 or higher containment is required.]
- Use Risk Group 2, 3, 4, or restricted agents as host-vector systems
- RG2: associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
- RG3: associated with serious or lethal human disease for which interventions may be available
- RG4: likely to cause serious or lethal human disease for which interventions are not usually available
- Clone DNA from Risk Group 2, 3, 4, or restricted agents into nonpathogenic prokaryotic or lower eukaryotic host-vector systems
- Use infectious or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems
- Alter a whole animal’s genome by stable introduction of rDNA into the germ-line, or test viable rDNA-modified microorganisms on whole animals
- Genetically engineer whole plants by rDNA, use or propagate such plants, or use with microorganisms or insects containing rDNA
- Involve more than 10 liters of culture
- Use influenza viruses generated by recombinant or synthetic methods
Experiments that Require IBC Registration Simultaneous with Initiation. [May be conducted at Biosafety Level 1 containment.]
- Form rDNA molecules containing no more than 2/3 of the genome of any eukaryotic virus
- Use of RNA-modified whole plants that doesn't fall under Sections III-A, III-B, III-D, or III-F of the NIH Guidelines.
- Involve transgenic rodents in BL1 containment
Recombinant or synthetic nucleic acid molecules that:
- Can neither replicate nor generate nucleic acids that can replicate in any living cell.
- Are not designed to integrate into DNA.
- Do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 ng/kg body weight.
- Are not in organisms, cells, or viruses and have not been modified or manipulated to render them capable of penetrating cellular membranes.
- Consist entirely of
- The exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.
- Nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host, or when transferred to another host by well-established physiological means.
- Nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
- DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent.
- Do not present a significant risk to health or the environment. [See Appendix C.]
Also exempt are genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA.