Categories of Biomaterials Needing IBC Review and Approval

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Recombinant or Synthetic Nucleic Acid Molecules experiments involving animal, plant or microbial pathogens, whole plants or animals, or humans require IBC approval before initiation of the activities. If your research or teaching activity includes recombinant or synthetic nucleic acid molecules and/or artificial gene transfers (to include gene therapy clinical trials and the creation of transgenic animals), you should consult the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules for specific information on the requirements for registering your particular activity.

 

Agents (e.g., faculty, researchers, staff, students, and employees) of OSU may ONLY self-exempt from the NIH Guidelines for activities involving synthetic nucleic acid molecules that cannot replicate or generate nucleic acids that can subsequently replicate in any living cell (e.g., oligonucleotides). Examples of synthetic nucleic acid molecules which researchers CANNOT self-exempt include those designed for use in human gene transfer experiments, that contain genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 ng/kg body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin), and those that are designed for generation of transgenic plants or animals. All other “exempt experiments”, as defined by the NIH Guidelines, may be reviewed and approved by a subset of the Institutional Biosafety Committee before the research is started. Subcommittee reviews can normally be conducted within two weeks following submission of the protocol to the Office of University Research Compliance. Protocols involving recombinant or synthetic nucleic acids with Risk Group 2 organisms or higher require review and approval by the full IBC. Experiments may only be initiated after notification from the Office of University Research Compliance that the project has been approved.

 

The Recombinant or Synthetic Nucleic Acid Registration form may be found in the Forms and Permits section of this web page. Complete the form and submit a paper copy to the Office of University Research Compliance in 223 Scott Hall. This office will coordinate review by the IBC.