NIH Guidelines

The NIH Guidelines covers a specific subset of potentially biohazardous materials involving recombinant and/or synthetic nucleic acid molecules.

There are 6 types of experiments covered by the Guidelines. Each requires increasing levels of oversight by the institution and federal government.

  • III-A: Federal/IBC Approval: These experiments involve the deliberate transfer of resistance genes to therapeutically useful antimicrobials.
  • III-B: Federal/IBC Approval: These experiments involve the cloning of toxin genes lethal for vertebrates with LD50’s less than 100 ng/kg BW.
  • III-C: Federal/IBC Approval: These experiments involve the deliberate transfer of these molecules into human research participants.
  • III-D: IBC Approval Only: This is a broad group of experiments related to the cloning of infectious microorganisms , use of plants/animals, influenza viruses and large culture volumes.
  • III-E: IBC Registration: Another broad group of experiments that can be conducted at BSL-1.
  • III-F: These experiments are exempt from the Guidelines.
  • Please refer to the Guidelines for more specific  information as to what section your proposed research may fall under.

Standards & Regulations

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules