Approval required for use of recombinant or synthetic DNA or RNA in animals


Environmental Health & Safety (EH&S) reminds researchers that all research with biohazardous agents at the University of Washington requires review and approval by the Institutional Biosafety Committee (IBC), and a Biological Use Authorization (BUA) from EH&S is required.

Administration of any form of recombinant or synthetic DNA/RNA into whole animals falls under Section III-D of the NIH Guidelines and requires review at a convened IBC meeting before the research can start.  Because the University is a recipient of research funding from the National Institutes of Health (NIH), all research involving recombinant or synthetic nucleic acids must adhere to the requirements of the NIH Guidelines.

IBC and BUA approval is required for any administration of recombinant or synthetic nucleic acids to an animal, including but not limited to:

  • mRNA vaccines (with or without liposomes, nanoparticles, or other carriers)zebrafish
  • Recombinant or synthetic nucleic acid molecules, or DNA/RNA molecules derived therefrom
  • Plasmids
  • Cells containing recombinant DNA/RNA
  • Viral vectors or cells transduced with viral vectors
  • Recombinant or genetically modified microorganisms

As a reminder, both your BUA and Institutional Animal Care and Use Committee animal protocol must list any biohazardous agents administered to animals. If you are adding biohazardous agents to an animal protocol, including recombinant or synthetic nucleic acids, you also need to update your BUA and obtain IBC approval.

For timely review at an IBC meeting:

  1. Review the BUA application submission deadlines.
  2. Submit a BUA application at least 4 weeks prior to the scheduled IBC meeting date in which you’d like your project to be reviewed.
  3. Update your animal protocol concurrently to add recombinant or synthetic nucleic acids or other biohazards to research animals.

You can find the BUA and BUA change applications and more information about IBC approval on the EH&S Biological Research Approval webpage

If you have questions or need assistance, contact EH&S Biological Safety.