Recombinant and Synthetic Nucleic Acids (r/sNAs)

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Recombinant and synthetic nucleic acid molecules are defined by the NIH Guidelines as:

  • Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell (recombinant nucleic acids);
  • Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (synthetic nucleic acids); or
  • Molecules that result from the replication of those described in (1) or (2) above.

Requirements for working with r/sNAs

To work safely and comply with all regulations related to r/sNAs, consider the following:

Conduct a risk assessment

Use your risk assessment to determine the required level of physical and biological containment in accordance with NIH Guidelines. In your risk assessment, consider the following

  • Off-target effects: How accurate are gene manipulations expected to be? How will you verify that the appropriate gene edits were made? What might be the effect of an off-target modification?
  • Delivery system: Are you using a viral delivery system? Are you using needles
  • Heritability: Is the intended modification permanent / heritable? Is it a gene drive?
  • Construct design: Are multiple genes being targeted using one construct / technology? Are required viral genes split between multiple constructs to prevent production of replication-competent viruses?
  • Personnel exposure: What are the risks to personnel if exposed to vectors or organisms? Are the organisms pathogenic / toxic? Are the gene targets of human origin?
  • Training & education: Do you have experience with the technology you plan to implement? Have you sought out expert guidance on your experimental design
  • Animals: Is an animal model being used? Will animals shed recombinant materials? How will cages and bedding be managed? Are you using humanized mice?

Submit your work for approval by the Institutional Biosafety Committee (IBC)

ALL recombinant and synthetic nucleic acid work, including work exempt from NIH Guidelines, must be submitted to and approved by the IBC. Protocols are approved for 3-year periods.

  • Submit to the IBC online via iManager. Click here to access the submission system and submission instructions. Fill out the form as completely as possible, and provide any additional pertinent information that may assist the committee in assessing risks associated with your work.
  • The IBC will determine the final biosafety level appropriate for the work proposed. Research should not begin until IBC approval is granted.

Review and understand the NIH Guidelines

Complete required training

NIH Guidelines training is required for all individuals conducting research with r/sNAs. Find complete biosafety training requirements on the Biosafety Training webpage.

Have a procedure for waste decontamination & disposal

ALL recombinant or synthetic nucleic acid molecules or materials that contain these molecules must be decontaminated before disposal. This includes Biosafety Level 1 materials and transgenic animals or plants.

University guidance on appropriate decontamination & disposal procedures can be found at the following webpages: