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, and surrounding community 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, please dial 911. 

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

Emergency Contact Information  

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, like 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, Montana Technological University, and it may give approval to non-faculty members (i.e., 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 UM Institutional Biosafety Committee (IBC) also oversees research with other potentially hazardous biologics. The UM IBC currently oversees:

• Recombinant or synthetic nucleic acid molecules (r/sNA)
• Infectious organisms and agents, which included:
  • Bacteria, viruses, fungi, parasites, prions, rickettsia, chlamydia, as well as human and animal pathogens and non‑indigenous plant pathogens or plant pests; work with these materials may also require federal permits (e.g., CDC, USDA‑APHIS, FWS).
• Biologically derived toxins
• Work with animals or vectors
  • Suspected to be reservoirs of RG2 or RG3 infectious agents when such work increases potential exposure risks to personnel or other animals.
• Genetically modified organisms (GMOs) and gene drive modified organisms (GDMO), including:
  • Animals, plants, invertebrates, and/or other organisms created by UM faculty, staff, students or in/on UM property.
• Human and Non-Human Primate Samples
  • Mammalian cells (including cell lines), tissue, blood, and potentially infectious body fluids.

These materials have the potential to cause disease or illness in humans, animals, or plants, or to create significant environmental or agricultural impacts. Any activity using these materials—whether for research, teaching, or diagnostics—requires IBC review and approval.

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.

Principial Investigator Responsibilities

• Understanding the requirements governing research involving potentially hazardous biologics, including recombinant r/sNA, infectious agents, and biological toxins.
• Submitting an IBC application to secure required approval for all research and teaching activities.
• Amending the approved IBC application prior to implementing changes to the research.
• Ensuring that all laboratory personnel have received the required training for the work they will perform.
• Adhering to and promoting applicable biosafety procedures, including:
  • Ensuring the use of proper microbiological practices and laboratory techniques at the approved biosafety level