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Definition
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 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. Review and understand the NIH Guidelines Access the latest version of NIH Guidelines here. Pay special attention to sections relevant to your work. These sections may include: 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: