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.
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.
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.
As stated in Section III-F of the NIH Guidelines, experiments are exempt when they involve recombinant DNA that is:
Unless these experiments also involve:
Details on certain other experiments that may be exempt, as well as exceptions, may be found in Appendix C of the NIH Guidelines.