Northwestern Office for Research


Recombinant DNA Safety Program

A knowledge and understanding of the information presented in this document is essential for those investigators using or contemplating the use of recombinant DNA technology in their research.


Research involving recombinant deoxyribonucleic acid (DNA) shall comply with the National Institute of Health's "Guidelines for Research Involving Recombinant DNA Molecules" (NIH Guidelines) as published in the Federal Register. The recombinant DNA guidelines are applicable to all recombinant DNA research within the United States or its territories, which is conducted at or sponsored by an institution that receives any support for recombinant DNA research from NIH. Any individual receiving support for research involving recombinant DNA must be associated with or sponsored by an institution that can and does assume the responsibilities assigned in the guidelines.

The safe conduct of experiments involving recombinant DNA depends on the individual conducting such activities. The guidelines cannot anticipate every possible situation. The NIH guidelines are intended to assist the institution, Institutional Biosafety Committee (IBC), Biological Safety Officer, and principal investigator in determining safeguards that should be implemented. It is the responsibility of Northwestern University and those associated with it to adhere to the intent of the NIH guidelines as well as to its specifics.

The purpose of the NIH Guidelines is to specify practices for constructing and handling:

  • recombinant DNA molecules
  • organisms and viruses containing recombinant DNA molecules

In the context of the NIH Guidelines, recombinant DNA molecules are defined as:

  • molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell
  • molecules that result from the replication of those described above

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 in vivo 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 transposon itself contains recombinant DNA.

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