Research Compliance

• 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".

• 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.

• NIH Requirements for IBCs
  This describes the overall requirements for an institutional IBC
• NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids
  Issued by the NIH Office of Biotechnology Activities (NIH OBA). This provides the oversight on the precautions that must be taken when working with different types of nucleic acids.
• CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition
  This provides oversight on working with microbes, toxins, tissue/cell lines, and other bio-hazardous materials.
• OSHA Blood-borne Pathogens Standards
  This provides the oversight when working with human blood and other tissues.
• CDC /USDA Federal Select Agent Program Regulations | 42 CFR 73, 7 CFR 331
  This provides the oversight on the particular toxins and microbes that fall under the special category of being a "select agent" capable of being used as a weapon or bio-terror mechanism.

• Risk Group categorizes agents based upon their relative risk or association with disease
• Biosafety Level prescribe procedures and levels for containment for particular agents

• 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

• Protocols are approved for five years.
• Post-approval monitoring audits are conducted periodically on all protocols within the approval period.