Recombinant DNA

The NIH Guidelines for Research Involving Recombinant DNA Molecules defines rDNA as either: 1)

molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA

molecules that can replicate in a living cell or 2) molecules that result from the replication of those

described above.

The NIH Guidelines document is composed of 5 sections and 15 appendices. The 5 sections cover: 1)

the scope of the Guidelines 2)safety considerations including risk assessment and containment 3)

descriptions of the types of experiments covered by the Guidelines 4) the roles and responsibilities of the

NIH, institution, IBC, BSO and PI and 5)references and footnotes. The appendices go into detailed

discussions of containment for microorganisms, plants, and animals; host-vector systems; risk group

classifications; exemptions; toxin production; shipment; and human gene research.

All NIH-funded projects and all non-NIH-funded projects conducted at institutions that receive NIH funding

for ANY rDNA research must comply with the NIH Guidelines. Noncompliance can result in suspension,

termination, or limitation of financial assistance for ALL NIH-funded research at that institution as well as

NIH approval for ANY subsequent rDNA research at that institution.

The IBC and BSO are available to help interpret the NIH Guidelines and assist the PI in becoming

compliant.

If you are a PI planning to do rDNA research, please read the NIH Guidelines at

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm

An on-line training for anyone using or planning to use rDNA technology can be found at the Training

page (https://www.citiprogram.org/). Please contact the Compliance Manager with questions.