WHAT REQUIRES REGISTRATION AND APPROVAL?
Any recombinant DNA (this includes NIH Guidelines “exempt” and “non-exempt” materials) )(e.g., human gene therapy/transfer, viral vectors, plasmids, transgenic animals)
CDC/USDA regulated Select Agents/Toxins
Fixed and unfixed cadavers, mammalian cells, cell lines, tissues, organs, blood, urine or other fluids (e.g., human and non-human primate materials)
Whole animals, cells, cell lines, tissues, organs, blood, urine or other fluids (e.g., commercial, field caught, gained from a collaborator)
Microbial and/or potentially infectious agents (e.g., viruses, yeast, bacteria, fungi, parasites, prions )
Toxins of biological origin with an LD 50 <100ug/kg of body weight or poisonous, toxic or venomous plants, animals or insects (e.g., pertussis toxin, diphtheria toxin)
Large scale cultures10 liters at any one time of any biological substance
Shipping of biological materials (e.g., potentially infectious agents clinical/diagnostic specimens, cultures of microorganisms or cells, tissues, genetically modified organisms, toxins of biological origin) and dangerous goods (e.g. Dry ice, liquid nitrogen, fixatives)
If you are unsure whether your biological materials require registration, contact the Biosafety Office (firstname.lastname@example.org or 706-721-2663) for assistance.
HOW DO I REGISTER BIOLOGICAL MATERIALS?
1. Submission of an application
2. Review of your submission
3. Approval of your submission
Submission of an application allows the Institutional Biosafety Committee (IBC) and/or the Biosafety Office to perform a comprehensive risk assessment of the proposed research or teaching operation. A comprehensive risk assessment involves review of biological agents, experimental procedures, locations, personnel and their expertise, equipment and training. The risk assessment also addresses whether the safety methods proposed in the application are sufficient to mitigate the associated risks. All research involving biological agents must be reviewed and approved by the IBC and/or Biosafety Office before a PI is authorized to bring the agents to campus or initiate a research project.
Health Science Campus (CI-1001)
1405 Goss Lane, Augusta, GA 30912-7520
Note: In the case of a serious injury or life threatening emergency, seek immediate medical attention.