Research and Sponsored Programs

Frequently Asked Questions About Biosafety Research Protocols

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The questions listed below are a snapshot of those that frequently come up regarding biosafety research protocols.

Please contact the IBC Administrator if your question or concern is not addressed below.

Updated: June 19, 2020

 What is the purpose/mission of the Institutional Biosafety Committee (IBC)?
  • The primary mission of the IBC is to ensure the safety of staff, students, and patients involved in biological research at our university, and to protect the public and environment from adverse consequences related to the research.
  • This includes meeting all required standards set by federal, state and local governments, and as necessary, development  of University of Toledo-specific policies to make any research conducted with hazardous, or potentially hazardous, biologic agents (either naturally occurring or synthetically created) "as safe as possible".
  What types of research need an IBC-approved research protocol.
  • Recombinant nucleic acids
  • Synthetic nucleic acids UNLESS they pass ALL 3 criteria below:
    • Can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase)
    • Are not designed to integrate into DNA
    • Do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight
  • Microbial agents (i.e., bacteria, virus, fungi, parasites, protozoa)
  • Biological nanoparticles and biological toxins
  • Animal and human cell lines
  • Animal tissues, fluids, and other products
  • Human tissues, fluids, and other products*
  • Human cadavers
  • Human stem cells
  • Select agents and toxins

*IBC approved is not required for research samples of human fluids or products that have been collected as part of a research project and sent to the hospital clinic of pathology lab for analysis. IBC approval is required for human samples analyzed in or brought to the research laboratory.

What are the policies that guide the activities of the IBC?  
 What is the difference between risk group and biosafety level?
  • Risk Group categorizes agents based upon their relative risk or association with disease
  • Biosafety Level prescribe procedures and levels for containment for particular agents
How do I initiate an IBC protocol?
  • Submissions are through IRB Manager
  • Pre-reviews are required for new investigators and strongly encouraged other investigators
  • Submit the protocol form by the last day of the month prior to the review meeting
  • IBC meetings occur on the third Thursday of the month
How long is an IBC protocol approved?
  • Protocols are approved for five years.
  • Post-approval monitoring audits are conducted periodically on all protocols within the approval period.
What are the risk groups and biosafety levels?
 RISK GROUP  BIOSAFETY LEVEL  EXAMPLES
RG1
Agents are not associated with disease
Low Risk
BSL1
Work is done on open bench tops, gloves and hand washing required
  • E. coli k12 derivatives
  • Ecotropic retrovirus
  • Most non-primate animal tissues
RG2
Agents are associated with disease
Moderate-High Risk
BSL2
Work is done in BSC for aerosolized agents, gloves required, eye/mask for aerosolized agents
  • Lentivirus
  • Amphitropic retrovirus
  • Adenovirus
  • Herpes virus
  • Human tissues/cell lines
RG2
Agents are associated with disease
Moderate-High Risk
BSL2+
Work is done in BSC for all agents, double gloves, eye/mask for all agents
  • Hepatitis (HBV, HCV)
  • HIV
  • LCMV
  • Rabies virus
  • SIV
  • Vaccinia virus
RG3
Agents are associated with serious risk
High Risk
BSL3
Work is done in BSC for all agents, double gloves required, eye/mask for all agents, disposal gown, secure facility
  •  Mycobacterium tuberculosis
  • Bacillus anthracis
  • Coxiella burnetii
  • Francisella tularensis
  • Burkholderia pseudomallei
Last Updated: 6/19/20