I. Summary

All non-exempt research​1 involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines, which are published in the Federal Register, define allowable practices for the construction and handling of recombinant or synthetic nucleic acid molecules and their introduction into viruses and cells. Under the NIH Guidelines the Institutional Biosafety Committee (IBC) is charged with assessing the risk of and determining the biosafety containment level required for all proposed recombinant or synthetic nucleic acid research.

Investigators intending to perform any non-exempt research involving recombinant or synthetic nucleic acids must describe such proposed research in a recombinant or synthetic nucleic acid Registration Document and submit it to the IBC for review. Research involving non-exempt recombinant or synthetic nucleic acids cannot be initiated without prior, specific IBC approval. Such approval is required regardless of the source of funding of the proposed research.

​Note:

1Exempt recombinant or synthetic nucleic acid research is defined under Section III-F in the NIH Guidelines.