What types of research do I need to register with the GS Institutional Biosafety Committee (IBC)?

Experiments involving the following must be registered with the IBC:

• Pathogens affecting humans, animals, or plants;
• Materials potentially containing human pathogens (e.g. unfixed human specimens, human blood);
• Recombinant DNA molecules including viral vectors;
• All cell and organ cultures of human origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives
• Human or mammalian cell lines (including embryonic & established), human tissue or blood.
• De novo generation of transgenic animals (using recombinant DNA technology to add foreign DNA or subtract a portion of the animal’s genome);
  • Generation of de novo transgenic animals: Defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology.
  • Examples of recombinant DNA technology include
    • (1) Direct microinjection of a chosen gene construct from another member of the same species or a different species into the pronucleus of a fertilized ovum;
    • (2) Insertion of the desired DNA sequence by homologous recombination into an in vitro culture of embryonic stems and cells;
    • (3) Use of a plasmid or virus to transfer the genetic material into germ cells. Breeding animals to generate transgenics need not be registered with the IBC. Those transgenics that already exist or which have been purchased are not subject to IBC registration.
• De novo generation of transgenic plants;
• Introduction of recombinant DNA (plasmids) or gene transfer vectors (including viral vectors) into human subjects;
• Introduction of genetically engineered micro-organisms or infectious agents into human subjects (including live vaccines if they are experimental in nature and/or not FDA approved for use in the specific study population.

Last updated: 7/5/2023