Recombinant or Synthetic Nucleic Acid Molecules and Human Gene Transfer Experiments

Useful Information

Information for Researchers Using Recombinant or Synthetic Nucleic Acid Molecules

Recombinant DNA Registration

It is the policy of this University that the PI is responsible for complying with the NIH “Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules”, regardless of the source of the funds supporting that research. It is impossible to summarize the whole of those guidelines, but there are three groups of experiments that probably encompass the majority of work being done on campus. If your work does not fall clearly into one of these groups, consult the NIH Guidelines.

I. Exempt Experiments

Some recombinant or synthetic nucleic acid molecule work is exempt from the Guidelines (Section III-E). All such research must be conducted using Biosafety Level 1 Practices (BSL-1). This group includes (but is not limited to) experiments that:

  1. use as host vector systems E. coli K 12, Saccharomyces cerevisiae, Saccharomyces uvarum, or Bacillus subtilis, and their plasmids;
  2. rDNA molecules containing less than one-half of any eukaryotic genome that are propagated and maintained in cells in tissue culture.

II. Experiments Requiring Prior Approval

The following experiments require prior approval from either the NIH, Recombinant Advisory Committee (RAC), Food and Drug Administration, and/or the IBC. These experiments are to be described on the appropriate registration form, and sent to Environment, Health and Safety.

  1. Gene transfer experiments in humans
  2. Genes for toxins lethal for vertebrates
  3. Release of genetically engineered organisms to the environment
  4. Those using human or animal pathogens (biosafety level 2 and higher) as host-vector systems, including adenovirus vectors and murine retroviruses that infect human cells
  5. Cloning DNA from human or animal pathogens (biosafety level 2 and higher) into a non-pathogen host vector system
  6. Cultures of more than 10 liters
  7. Experiments involving whole plants or animals, including creation of transgenic organisms

III. Experiments Requiring IBC Notice Simultaneous with Initiation

Some recombinant or synthetic nucleic acid molecules work requires IBC review and approval, but prior approval is not required, and may be conducted at BL1 containment. These experiments are to be described on the appropriate registration form, and sent to Environment, Health and Safety. Examples include:

  1. Recombinant or synthetic nucleic acid molecules containing no more than 2/3 of the genome of any eukaryotic virus (with some restrictions) propagated and maintained in cells in tissue culture. It must be demonstrated that the cells lack helper virus for the specific families of defective viruses being used
  2. Many, but not all, experiments involving whole plants. Some plant experiments do not require prior approval. Work with recombinant or synthetic nucleic acid molecules in plants or any work with plant pathogens must also comply with USDA and EPA regulations.
  3. Purchase or transfer of transgenic rodents for experiments that require biosafety level 1 (BSL1) containment.

To obtain more detailed information about how your particular experiments are classified under the Guidelines, call Dan Eisenman of Environment, Health and Safety (919-962-5507).