IRB Notes: New NIH Regulations for Synthetic Nucleic Acid Molecules

Starting March 5, 2013, the NIH Guidelines will cover work with synthetic nucleic acid molecules in addition to current requirements for reviewing studies involving recombinant DNA molecules. With this change, the Institutional Biosafety Committee (IBC) will also review studies involving of the deliberate transfer into human research participants of synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:

  • Contain more than 100 nucleotides; or
  • Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
  • Have the potential to replicate in a cell; or
  • Can be translated or transcribed.

For further information on these new regulations, please review the NIH’s FAQs on these new regulations. Please contact the IBC as soon as possible if you think that these new regulations may apply to your research. Existing IRB studies that involve synthetic nucleic acid molecules in human subjects as described above will need to submit paperwork to the IBC and NIH for review by March 5, 2013.

Stay tuned for changes coming to the eIRB initial project questionnaire, the IBC web pages, and the electronic Proposed Project Questionnaire (ePPQ) to include synthetic nucleic acid review requirements.