Wayne State University

Recombinant DNA or Synthetic Nucleic Acid Molecules Exempt from NIH Guidelines

If the use of recombinant DNA in this research is limited to constructs which can only be propagated in E.coli K12, yeast, or similar cell types (plasmids, bacterial, yeast artificial chromosomes), and it DOES NOT involve the use of native or recombinant mammalian viruses, potentially infectious agents, biological toxins, or transgenic animals, it does not require approval from the IBC.

Unsure? See FAQs - Experiments that are exempt from the NIH Guidelines

If your research meets the exemption criteria, complete and submit:

Experiments are exempt under the following conditions:

  • not in organisms and viruses,
  • entirely DNA segments from a single nonchromosomal or viral DNA source,
  • 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 determined by the NIH Director; seeAppendix C of the NIH Guidelines for a detailed listing of these and other experiments that may be exempt.

Questions? Contact Richard Pearson, Biosafety Officer at 313-577-1200 or rjpearson@wayne.edu