IBC Process

The IBC process aims to ensure the appropriate use of biohazardous materials in teaching and researching, as well as the safety of research personnel and the campus community.  The general procedures for submission, review, approval, and post-approval responsibilities are listed below.

If you have any questions, please contact IBC Administration at biosafety@uwosh.edu or by calling (920)-424-3215.

Research Involving Recombinant or Synthetic Nucleic Acid Molecules and IBC Review

Exempt Research

Exempt status activities, as defined in the NIH Guidelines Section III-F (page 23) shall be determined by the IBC Chair or a member of the IBC designated by the chair.  The following experiments involving recombinant or synthetic nucleic acids are considered exempt from the NIH Guidelines:

• III-F-1:  Those synthetic nucleic acids that: (1) 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.
• III-F-2:  Those that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.
• III-F-3:  Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.
• III-F-4:  rDNA molecules consisting entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses where propagated only in that the host (or a closely related strain of the same species) or transferred to another host by know physiological means.
• III-F-5:  rDNA molecules consisting entirely of DNA from a eukaryotic host (including mitochondria, chloroplasts, or plasmids but excluding viruses) when propagated only in that host or a closely related strain of the same species.
• III-F-6:  rDNA molecules consisting entirely of DNA segments from different species that exchange DNA by known physiological processes and are described in Appendix A.
• III-F-7:  Those genomic DNA molecules that have acquired a transposable element provided the transposable element does not contain any recombinant and/or synthetic DNA
• III-F-8:  Experiments not posing significant risk to health or the environment, as determined by the NIH Director, and are described in Appendix C of the NIH Guidelines:
  • Appendix C Reference:
    C-I: Recombinant or Synthetic Nucleic Acid Molecules in Tissue Culture
    C-II: E. coli K-12 Host-Vector Systems
    C-III: Saccharomyces Host-Vector Systems
    C-IV: Kluyveromyces Host-Vector Systems
    C-V: Bacillus subtilis or Bacillus licheniformis Host-Vector Systems
    C-VI: Extrachromosomal Elements of Gram Positive Organisms
    C-VII: The Purchase or Transfer of Transgenic Rodents
    C-VIII: Generation of BL1 Transgenic Rodents via Breeding

If activities involving recombinant or synthetic nucleic acid molecules are determined to be Exempt by the IBC Chair (or their designee),  the PI will be notified of the determination in writing.  All research using rDNA and/or synthetic nucleic acids must be registered with the Institutional Biosafety Committee even if it is deemed Exempt from NIH Guidelines.

Non-Exempt Research

Projects that are considered Non-Exempt from the NIH Guidelines are generally those that fall under NIH Guidelines Sections III-A through III-E.  All protocols that fall under these categories must be reviewed and acted on at a convened meeting of the committee.  Research activities that are non-exempt include:

• III-A-1: The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire that trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
• III-B-1:  Deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
• III-B-2:  Experiments that have been Approved (under Section III-A-1-a) as Major Actions under the NIH Guidelines and determined by NIH/OBA.
• III-C-1:  Experiments involving the Deliberate Transfer of Recombinant or Synthetic Nucleic Acid Molecules, or DNA or RNA Derived from Recombinant or Synthetic Nucleic Acid Molecules, into One or More Human Research Participants.
• III-D-1: Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems.
• III-D-2:  Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.
• III-D-3:  Experiments involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems
• III-D-4:  Stable introduction of rDNA into an animal genome or testing of rDNA-modified microorganisms in whole animals.
• III-D-5:  Experiments to genetically engineer plants by rDNA methods, to use such plants for other experimental purposes (e.g., response to stress), to propagate such plants, or to use plants together with microorganisms or insects containing rDNA.
• III-D-6:  Experiments involving more than 10 Liters of Culture (in a single vessel)
• III-D-7:  Experiments involving Influenza Viruses
• III-E:  Experiments not included in Sections III-A, III-B, III-C, III-D, III-F and their subsections
• III-E-1:  Formation of rDNA molecules containing no more than 2/3 of any eukaryotic viral genome
• III-E-2:  Experiments with genetically modified plants
• III-E-3:  Experiments involving the generation of transgenic rodents

Following review of  non-exempt research at a convened IBC meeting,  the PI will be notified of the determination in writing.  IBC Protocol Approvals are valid for 3 years.  Lab assessments will be conducted by the biosafety officer at the start of a new project and mid-way through the project (approximately 18 months from the protocol approval).

3 Year Renewal Process

Principal Investigators will be notified approximately 30-60 days prior to their protocol expiration date.  At this time, the PI must decide whether they wish to request an IBC renewal or to close the project.  Principal Investigators who plan to renew their project must review and update their protocol if necessary, and re-submit their IBC Application selecting the 3 year renewal on the application cover page prior to the protocol expiration date.

The IBC will review the renewal IBC Application and notify the PI in writing of the determination.

Closures

If a PI wishes to close their protocol they must submit a closure form to biosafety@uwosh.edu

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