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  2. Research Integrity & Compliance
  3. Environmental Health and Safety
  4. Biosafety for Research (IBC & IRE)
  5. Exempt or Non-Exempt Recombinant/Synthetic Nucleic Acids (rsNA) Work?
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Exempt or Non-Exempt Recombinant/Synthetic Nucleic Acids (rsNA) Work?

This page gives you some facts and a strategy for what you need to do about compliance when working with rsNA.

FACTS
  • If you will be working with rsNA and funded by NIH or working at an Institution where work involving rsNA is funded by NIH (like it is at UConn Health), you are working under the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules (NIH rsNA Guidelines). Compliance to these guidelines is required as a condition of NIH funding (and that of many other agencies) for research involving rsNA at the whole institution.
  • Institutions (UConn Health), Institutional Biosafety Committees (IBCs) and Principal Investigators (PIs) are all responsible for compliance under the NIH rsNA Guidelines.
  • All faculty are required to take the PI Biosafety & Biosecurity training available at the CITI training site every three years. Contact the BioSafety Program Coordinator if you need assistance with this.
  • Many rsNA experiments are exempt to the NIH rsNA Guidelines, but some that you might think are exempt may not be. Experiments that are not exempt need to be registered with the IBC before they are started. In some cases the application needs only to be submitted and accepted by the IBC before work may start.
  • Viral Vector rsNA experiments need to be registered with the IBC.
STRATEGY (What to Do and Not Do)
  • Determine if your experiment or set of experiments is exempt or not exempt.
  • If you know your experiment(s) is not exempt, contact the BioSafety Program Coordinator to begin the registration process.
  • Even if you believe your experiment(s) is exempt (or safe or used elsewhere), please contact the BioSafety Program Coordinator. The only way for a PI to be sure they have done all they can to ensure their compliance with the NIH rsNA Molecules Guidelines, is for the IBC to determine that the PI’s experiment is exempt and document it. Fortunately, exempt research can undergo an administrative review which can facilitate the process.
  • Do not begin any rsNA work without UCH IBC authorization or determination that the work is exempt by the Biosafety Office.

 

 Additional information regarding the IBC and rsNA experiments