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What If I’m Doing Exempt or Non-exempt Recombinant or Synthetic Nucleic Acids (r/s NA) Experiments?

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

FACTS
  • If you will be working with rDNA and funded by NIH or working at an Institution where work involving rDNA 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 r/s NA Guidelines). Compliance to these guidelines is required as a condition of NIH funding (and that of many other agencies) for research involving rDNA at the whole institution.
  • Institutions (UConn Health), Institutional Biosafety Committees (IBCs) and Principal Investigators (PIs) are all responsible for compliance under the NIH rDNA Guidelines.
  • To familiarize yourself with the NIH r/s NA Guidelines, read The Guidelines Explained. Relative to the real thing, it’s short and sweet. (Not complete, but it covers a lot.)
  • Many rDNA experiments are exempt to the NIH r/s NA 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 rDNA 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 IBC Coordinator to begin the registration process.
  • Even if you believe your experiment(s) is exempt (or safe or used elsewhere), please contact the IBC Coordinator. The only way for a PI to be sure they have done all they can to ensure their compliance with the NIH r/s NA Guidelines, is for the IBC to determine that the PI’s experiment is exempt and document it. Fortunately, the IBC Coordinator may serve as the IBC’s proxy to make this determination and perform the documentation. This makes the decision about whether an experiment needs to be registered or not, quicker and not too hard. The IBC Coordinator then brings such determinations to the IBC for review.
  • Do not begin any rDNA work without UCH IBC authorization.

 

 Additional information regarding the IBC and r/s NA experiments