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Research Activities Requiring IBC Registration and Oversight
Recombinant DNA. Recombinant DNA research is the use of recombinant DNA for any purpose, including transgenic plants and animals. All recombinant DNA research projects must be registered with the IBC. The IBC will decide which projects are exempt, review non-exempt projects, establish appropriate containment levels, and make other safety requirements as deemed necessary and appropriate for the protection of OSU personnel, students, and the community from potential biological hazards. The recombinant DNA oversight activities of the IBC will be conducted according to the most recent edition of the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Microbial Pathogens and Biological Toxins. All research activities involving pathogenic microorganisms of animals, humans or plants must be registered and approved by the IBC. The IBC will review projects, set appropriate containment levels, and make other safety recommendations. The IBC may delegate these activities to the Biological Safety Officer. Guidance for pathogen containment comes from the CDC publication Biosafety in Microbiological and Biomedical Laboratories (the BMBL), but requirements are established by a risk assessment process. Microbial pathogens include viruses, fungi, protozoans, helminth parasites, and bacteria that are capable of causing disease in humans, animals, or plants.
Human Pathogens. All projects which make use of human pathogens classified by the World Health Organization or National Institutes of Health as Risk Group 2 or 3 organisms, or classified by the Centers for Disease Control and Prevention as BSL-2, BSL-3 organisms must be registered and approved. Risk Group 1 organisms are not known to cause disease in healthy humans and registration of projects with these agents is not required unless they also fall into one of the animal, plant or select agent categories below. The use of Risk Group 4 / BSL-4 organisms at OSU is prohibited. Research involving possible contact with bloodborne human pathogens must be conducted in accordance with the additional requirements established in 29 CFR 1910.1030 (OSHA Bloodborne Pathogen Standard) and the OSU Exposure Control Plan. Some human pathogens are select agents and must meet the additional requirements described below.
Animal Pathogens. All projects that make use of zoonotic, livestock, or other animal pathogens must be registered and approved. Importation or interstate movement of livestock animal pathogens requires a permit from the United State Department of Agriculture (USDA) under the authority of 9 CFR 122. Some animal pathogens are select agents and must meet the additional requirements described below.
Plant Pathogens. All projects that make use of plant pathogens must be registered and approved. Plant pathogens include nematodes, bacteria, fungi, viruses, viroids, phytoplasmas, or any organisms similar to or allied with any of the foregoing which can directly or indirectly injure or cause disease or damage in plants. The USDA requires a permit for importation or interstate movement of plant pathogens under the authority established in the regulations 7 CFR 330. Some plant pathogens are select agents and must meet the additional requirements described below.
Biological Toxins. Research that makes use of toxins of biological origin requires registration and approval by the IBC. Some toxins are select toxins and must meet the additional requirements described below.
Select Agents and Toxins. Research that makes use of regulated select agents or toxins must be approved by the IBC and conducted under the oversight of the institutional Responsible Official. The Responsible Official has full authority to develop and manage the university’s select agent program. All select agent and toxin research must be carried out in accordance with the provisions of applicable federal regulations (42 CFR 73, 9 CFR 121 and 7 CFR 331). All research and support personnel must have authorization granted by the Responsible Official and pass a security risk assessment. For a list of select agents and toxins, see http://www.selectagents.gov/.