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Recombinant DNA (rDNA)


Recombinant DNA (rDNA) is a form of artificial DNA that is created through laboratory means by combining two or more segments of DNA (Natural or artificial) into sequences that would not occur naturally in the environment. The process of combining these sequences is referred to as genetic recombination or molecular cloning.

This process is made possible because all DNA from living organisms share the same chemical structure which allows genes to be transferred into different segments for research purposes, paving the way towards countless advancements in the pharmaceutical industry.


Why is rDNA Regulated?

Recombinant DNA is regulated because certain experiments regarding the transfer of genetic material is restricted. For example, the insertion of an antibiotic resistance gene into a bacterial cell is restricted because this experiment could result in the generation of bacterial cell line that is immune to standard antibiotics for treatment against infection.

In addition, rDNA is regulated because certain experiments may enhance or promote an agent to become "infectious" or promote disease in man. All experiments that involve a certain caliber of rDNA methods must have an approved protocol from the campus Institutional Biosafety Committee (IBC) before research can begin.


What Experiments are Regulated?

Recombinant DNA experiments listed as "covered" by the NIH Guidelines are required to submit Form 1 Registration of Research Involving the Use of Biological Materials. The scope of this form also includes all Recombinant DNA Research that is covered under the NIH Guidelines (Appendix A).

Note: additional forms may apply for genetically modified whole plants (Form 3) and/or for genetically modified animals (Form 4).

For more information regarding IBC forms, please visit the IBC Main Page.

For more information regarding the NIH Guidelines, please click here.

What Experiments are Exempt?

As stated in Section III-F of the NIH Guidelines, experiments are exempt when they involve recombinant DNA that is:

  • Not in organisms and viruses;
  • Entirely DNA segments from a single nonchromosomal or viral DNA source;
  • Entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well established physiological means;
  • Entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species,
  • Entirely segments from different species that exchange DNA by known physiological processes, through one or more may be a synthetic; see Appendix A of the NIH Guidelines; or
  • Not a significant risk to health or the environment as determined by the NIH Director, with advice from the RAC and public comment; See Appendix C of the NIH Guidelines for a detailed listing;

Unless these experiments also involve:

  • The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture [Section III-A];
  • Deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertabrates at an LD50 of less than 100 nanograms per kilogram of body weight [Section III-B]; or
  • The deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human research subjects [Section III-C].

Details on certain other experiments that may be exempt, as well as exceptions, may be found in Appendix C of the NIH Guidelines.