RESEARCH INVOLVING RECOMBINANT DNA

Recombinant DNA (rDNA) molecules are defined as molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or DNA molecules that result from the replication of those molecules.  

Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart.  If the synthetic DNA segment is not expressed invivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH guidelines.

Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to the NIH guidelines unless the transposen itself contains recombinant DNA.  All laboratories working with rDNA must comply with the NIH Guidelines for Research Involving Recombinant DNA.

The NIH guidelines, from the Department of Health and Human Services, present general requirements for different types of experiments involving rDNA.  These guidelines divide rDNA research into the following classes:

1. Experiments that require the approval of NIH and the Institutional Biosafety Committee (IBC) and review by the Recombinant DNA Advisory Committee (RAC).  (NIH-DNA Guidelines, Section III-A)
2. Experiments that require NIH/ORDA (Office of Recombinant DNA Activities) and IBC approval prior to initiation (NIH-DNA Guidelines, Section III-B)
3. Experiments that require IBC approval before initiation. (NIH-DNA Guidelines, Section III-C)
4. Experiments that require IBC notification at the time of initiation.  Experiments in which all components are derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes (NIH-DNA Guidelines, Section III-D)
5. Experiments that are exempt from the procedures of the guidelines.  (NIH-DNA Guidelines, Section III-E)  The Safety Department must still be informed of exempt experiments. 

Consult these guidelines for specific project details and to make sure that research is conducted in full compliance with the guidelines. If you have any specific questions about a particular host-vector not covered by the guidelines, please call the Safety Department. (X8925)  Updates to the NIH Recombinant DNA Guidelines are published in the Federal Register. The above hyperlink will bring you to the table of contents of the most recent guidelines.

University of the Sciences in Philadelphia • 600 South Forty-third Street • Philadelphia, PA 19104-4495 • phone: 215-596-8800 • email: safety@usp.edu