Environmental Health & Safety

Experiments Involving the Following must be Registered with the IBC

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• Pathogens affecting humans, animals or plants;
• Generation of transgenic plants. Contact the Biosafety Officer srosen22@safety.rochester.edu).
• Materials potentially containing human pathogens (e.g., unfixed human specimens, human blood; human tissue, tissue/fluids from experimental animals);
• Mammalian cells and cell lines (refer to Extended Help for Registering Mammalian Cells, Mammalian Cell Lines and Unfixed Tissue/Fluids)
• De novo generation of transgenic animals (Animal's genome has been altered by the stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived there from; into the germ-line).

Examples Include:

1. Direct microinjection of a chosen gene construct from another member of the same species or from a different species into a pronucleus of a fertilized ovum;
2. Insertion of the desired DNA sequence by homologous recombination into a culture of embryonic stem cells;
3. Use of a plasmid or virus to transfer genetic material into germ cells.

• Breeding and crossbreeding of animals which were originally created using recombinant DNA technology AND which are genetically different from each other;
• Backcrossing transgenic animals that were originally created using recombinant DNA with wild type animals ;

NOTE: Animals are defined as belonging to the Kingdom Animalia and include more than animals approved under UCAR protocols. Additional guidance can be found at this NIH website.

EXEMPTION:
NIH Guidelines provides exemption for breeding, crossbreeding, and backcrossing rodents as long as certain criteria are met. The criteria are listed in Appendix C-VIII.

• All research involving the use of recombinant or synthetic nucleic acid molecules or biohazards requires a minimum of Biosafety Level 1 containment.
• Animal Subjects: All research involving the use of recombinant or synthetic nucleic acid molecules or biohazards in whole animals requires both UCAR and IBC approval.
• Human Subjects: Complete instructions for any research involving the introduction of recombinant or synthetic nucleic acid molecules or biohazards into human subjects are available on the Human Subjects Studies page. Studies involving human subjects which must be approved by the IBC include the following:
• Clinical studies involving the introduction of Recombinant or synthetic nucleic acid molecules or gene transfer vectors (including viral vectors) into human subjects with or without specimen analysis.
• Clinical studies involving the introduction of genetically engineered microorganisms 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) with or without specimen analysis.
• Clinical studies which involve no introduction of the above mentioned agents to human subjects.  However, sera, blood products or other specimens collected from the study participants will be processed for shipment, analyzed or experimented within UR research labs or in areas not considered clinical lab space

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QUESTIONS or COMMENTS?
Contact EH&S at (585) 275-3241 or e-mail EH&S Questions.

This page last updated 2/19/15. Disclaimer.