Institutional Biosafety Committee
The Institutional Biosafety Committee reviews research involving recombinant DNA, gene transfer, and select biological agents and toxins. This review is mandated by the NIH and is intended to provide local, institutional oversight of nearly all forms of research utilizing recombinant DNA, infectious agents, and other potentially hazardous agents such as carcinogens.
Generally the IBC seeks to review research where:
- Drug resistance traits are deliberately transferred to microorganisms that are not known to acquire the trait naturally, especially if such acquisition could compromise the use of drugs to control the disease agent in humans, veterinary medicine, or agriculture.
- Recombinant genetic constructs are deliberately created for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram of body weight.
- Recombinant DNA, or DNA or RNA is deliberately transferred into one or more human research subjects.
Institutions that fail to comply, risk the following:
- Suspension, limitation, or termination of financial assistance for:
- noncompliant NIH projects
- NIH funding for other recombinant DNA research at the institution
- Having to obtain prior NIH approval for any recombinant DNA projects
Experiments are exempt when they involve recombinant DNA that is:
- Not in organisms and viruses,
- Entirely 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,
- Entirely from a eukaryotic host, including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species,
- Entirely segments from different species that exchange DNA by known physiological processes, though one or more may be a synthetic equivalent; see Appendix A of the NIH Guidelines; or
- Not a significant risk to health or the environment, as listed on the “Select Agents and Toxins” list from the National Select Agent Registry
St. John's IBC Policy and Procedures
- Policy and Procedures for Research Involving Recombinant DNA (Including Human Gene Transfer research)
- SJU IBC Self-Evaluation Application Form
Registration Form for Infectious or Hazardous Biological Agents
Select Agent and Toxin Security Form
National Institutes of Health (NIH) Guidelines for research involving Recombinant DNA