Activities That Require an IBC Protocol
Interim Biosafety Officer: Amy Robison, [email protected] (406) 994-6733
MSU Office of Research Compliance
The IBC reviews and approves many laboratory activities which may include research, teaching, and diagnostic activities.
All activities (e.g. research, teaching, diagnostic) conducted/performed at MSU, or funded by a grant awarded to an MSU PI which conform to the descriptions listed below must submit an IBC protocol.
The IBC defines potentially biohazardous materials to include all infectious organisms (bacteria, chlamydia, parasites, fungi, prions, rickettsia, and viruses), toxins, and recombinant/synthetic nucleic acid materials which can cause disease or illness in humans, animals, or plants, or cause significant environmental or agricultural impact. Materials that may harbor infectious organisms, such as human or primate tissues, fluids, cells, cell cultures, soils, and infected plants are also considered biohazardous.
Projects involving materials included in any of these categories must secure IBC approval prior to initiation:
- Recombinant or synthetic nucleic acid molecules (e.g., rDNA).
- Genetically modified organisms (GMOs) including, but not limited to:
- Animals, plants, invertebrates, and/or other organisms created by MSU employees or in/on MSU property.
- Transgenic field trials, any regulated genetically modified organisms to be introduced into the environment.
- Field testing of plants engineered to produce pharmaceutical and industrial compounds.
- Pathogens/infectious agents and pests (RG2/BSL2 or higher), human and animal pathogens, non-indigenous plant pathogens as well as those plant and animal pests regulated by the USDA-APHIS.
- Select/Biological Agents and Toxins (CDC and USDA).
Note: the possession, use, or transfer of Select Agents and Toxins entails additional requirements – contact the ORC for additional information.
- Unfixed human and non-human primate cells (including cell lines), tissue, blood, and potentially infectious body fluids. (see MSU Exposure Control Plan for list of potentially infectious body fluids).
- Any isoloation of biological agents from human materials.
- Toxins of biological origin (see MSU Biological Toxin Policy).
- Work with animals or vectors known or suspected to be reservoirs of RG2 or RG3 infectious agents when such work increases potential exposure risks to personnel or other animals.
- Oncogenic viruses used in conjunction with animals.
If biological materials are in storage only (i.e., stored in a freezer) and are not part of active research an IBC protocol is not required. IBC approval must be received prior to starting active research with the stored materials. The materials may be added to an existing IBC protocol via an amendment, or an original protocol may be needed.
Risk Group (RG) 4 Agents cannot be used or stored at MSU. RG4 Agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. See the Center for Disease Control’s BMBL and the NIH Guidelines for a list of these agents.