Research Compliance and Tech Transfer

Institutional Biosafety Committee (IBC)

The Biosafety Program and Institutional Biosafety Committee (IBC) are dedicated to ensuring the safe, ethical, and responsible conduct of research involving infectious agents, human-derived materials, and recombinant or synthetic nucleic acid molecules (r/sNA). Our mission is to protect our faculty, staff, students, visitors, the surrounding community, and the environment by fostering a strong culture of biosafety throughout the institution. 

We achieve this by providing comprehensive oversight, clear guidance, and ongoing support to researchers and educators. Through training, risk assessment, and compliance with applicable federal and state regulations, we help ensure that all biological work is conducted with the highest standards of safety and integrity. 

Our commitment is to enable scientific innovation while safeguarding health and the environment. By working collaboratively with the research community, the Biosafety Program and IBC strive to create a safe, informed, and responsible environment in which discovery can thrive. 

Emergencies or Exposure Incidents

If you are concerned for the immediate safety of yourself or others, call 911. 

If you have been involved in a biosafety incident (spill, accident, potential exposure, or near miss), refer to your lab-specific SOP and the IBC Biosafety Manual, and contact the Biosafety Officer. 

Scope of IBC Authority

Biohazardous materials include anything that may carry or cause infection — such as certain bacteria, viruses, fungi, parasites, and toxins — as well as genetically modified or recombinant or synthetic nucleic acid molecules (r/sNA). Items that might contain these organisms, such as human or animal tissues, blood, cells, soil, or infected plants, are also considered biohazards because they can pose risks to people, animals, plants, or the environment. 

The IBC has jurisdiction over research occurring at the University of Montana, UM Western, and Montana Technological University, regardless of funding source, and may approve non-UM entities performing work on campus on a case-by-case basis. The IBC reports to the Vice President for Research, who has authority over this compliance area at UM, including appointment authority to the committee. 

When an IBC Protocol Is Required

As mandated by the NIH Guidelines, UM's Institutional Biosafety Committee is responsible for assessing the biosafety containment level for research involving r/sNA. The IBC also oversees research with other potentially hazardous biologics, including:  

• Recombinant DNA and synthetic nucleic acid molecules  
• Infectious agents pathogenic to humans, animals, and plants 
• Biological toxins 
• Human-derived tissues, fluids, cells 
• Certain animal-derived tissues, fluids, cells (i.e., from non-human primates, bats, ruminants, swine, chickens or other fowl, or wild vertebrate animals) 
• Genetically modified organisms (GMOs) and gene drive modified organisms (GDMOs), including animals, plants, invertebrates, or other organisms 

Any activity using these materials — for research, teaching, or diagnostics — requires IBC review and approval. 

Materials in storage only (e.g., in a freezer) that are not part of active research do not require an IBC protocol. IBC approval must be obtained before starting active research with stored materials; this may be added to an existing protocol by amendment or may require a new protocol. 

Risk Group (RG) 4 Agents cannot be used or stored at UM. 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. 

Principal Investigator (PI) Responsibilities

• Understand the requirements governing research involving potentially hazardous biologics, including recombinant/synthetic nucleic acids, infectious agents, and biological toxins 
• Submit an IBC application to secure required approval for all research and teaching activities
• Amend the approved IBC application before implementing changes to the research 
• Ensure all laboratory personnel have received the required training for the work they will perform 
• Adhere to and promote applicable biosafety procedures.  
• Fulfilling additional PI responsibilities detailed in Section IV-B-7 of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules