The University of Minnesota Biosafety Program webpage, can be found here.
The Institutional Biosafety Committee (IBC) is responsible for the review of University research or teaching activities involving recombinant or synthetic nucleic acid molecules, potentially hazardous infectious agents, and potentially hazardous biologically-derived toxins as described in the University of Minnesota Board of Regents Policy and the administrative policy. The IBC reviews proposed research and teaching activities for compliance with the NIH Guidelines and the BMBL and approves the proposed research or teaching activities found to conform with the NIH Guidelines and the BMBL.
The following individuals and offices work in collaboration as part of the biosafety program to protect the University from risks associated with the use of potentially hazardous biological agents: Principal Investigators (PIs), the IBC, the OBAO, Health, Safety, and Risk Management (HSRM), the Biosafety and Occupational Health Department (BOHD), and University administration. Each contributes uniquely and in collaboration to the safety of the University community.
The IBC is made up of volunteer community members, and University faculty and staff members from a majority of campuses that have scientific expertise in subjects related to the research and teaching activities within IBC oversight. Additionally, the Biological Safety Officer role for the IBC is provided by HSRM/BOHD.
The IBC aims to have representation from every department on all campuses with activities subject to IBC oversight. If you have interest in serving on the IBC, please contact the OBAO (firstname.lastname@example.org).
Agents Definitions for IBC Oversight
Recombinant or Synthetic Nucleic Acid Molecules (r/sNAs)
Activities involving any of: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell (i.e. recombinant nucleic acids); (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); (iii) molecules that result from the replication of those described in (i) or (ii). In the context of the NIH Guidelines, both non-exempt and exempt research are subject to UMN IBC review. Included in these activities is the generation, acquisition, or purchase and use of pre-made, engineered organisms, cells or agents using r/sNA molecules (i.e., animals, plants, fungi, cell lines or cells – of any domain of life, and viruses). Some of these activities may pose a minimal biosafety risk by nature, but still require IBC review and approval.
NIH Exempt Work (use of GM/GE rodents, pre-generated cells, or cloning/use of K-12 E. coli)
IBC applications should be submitted for work involving r/sNA molecules, including work that falls within the NIH exempt category (III-F) such as GM rodent use and the use of recombinant K-12 E. coli or use of pre-generated recombinant cells.
Potentially Hazardous Biologically-derived Toxin
IBC approval is required for the use of unfractionated mixtures and purified preparations of biological toxins having high acute toxicity (i.e., a mammalian LD50 of less than or equivalent to 100 micrograms/kg body weight) or significant potential for serious subacute or chronic toxicity (e.g., carcinogenicity). Please note that experiments involving genes or r/sNA mol sequences coding for any toxin molecules must have IBC approval.
Potentially Hazardous Infectious Agent
Agents that are known to cause human disease in healthy humans and/or have been classified by the NIH Guidelines (see Appendix B) into Risk Groups 2, 3, or 4.
- Risk Group classification does not account for instances in which an individual may have increased susceptibility to agents.
- Those agents not listed in Risk Groups 2, 3, and 4, are not automatically or implicitly classified in Risk Group 1, and a risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed.
- Both the Principal Investigator’s and the IBC’s risk assessments are used in the final determination of the approved Biosafety Level (BSL).
Agents that may impact animals, plants or the environment but are generally not
considered infectious to humans - IBC Unit Policy 409
- i.e., USDA High Consequence Livestock Pathogens, some regulated agents of the USDA/APHIS Plant Pest and Disease Programs, or other animal or plant pathogens.
Prions and Prion-like proteins (PLPs) – IBC Unit Policy 410
- PLPs can be transmissible and replicate like an infectious agent, although they have not been shown to be the causative agents of disease.
- Due to their similarity to prions and other infectious agents, PLPs are included in IBC oversight to ensure risk mitigation when using them in some experimental procedures.
Resources for determining Risk Group and Biosafety Levels:
ePATHogen - Risk Group Database - note that this site classifies agents with risk groups for both humans and animals.
ATCC - products and materials are classified by the ATCC into biosafety levels for the purposes of packaging for safe shipment. Final biosafety level for use of the product or materials will on depend its Risk Group and activities proposed in the IBC application. This may differ from the biosafety level provided by the ATCC for packaging and shipping purposes.
Activities with Materials or Samples that may Contain Infectious Agents:
Research or teaching activities that include the use of uncharacterized materials where an infectious agent may be present may require IBC approval. Guidance can be found within the Infectious Agents application section webpage.
Examples of agents within our oversight include:
- Created or pre-made, engineered organisms/cells/agents
- Potentially hazardous biological agents that may impact animals or the environment but are not generally considered infectious to humans
- Agents that are NIH guidelines-exempt but require our approval:
- Escherichia coli K-12 host-vector systems
- Bacillus subtilis or Bacillus licheniformis host-vector systems
- The purchase or transfer of transgenic rodents
- A job aid for submission of an IBC application to account for the use of genetically modified rodents is available. Please send requests to email@example.com
Chemical agents that do not meet the above agent definitions are not subject to IBC review.
Meeting Dates & Application Submission Deadlines
Deadlines are important to meet for a timely review of your submission. See our guidelines on meeting deadlines.