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Contact IBC

Chair
Eric Matson
(920) 424-2077
IBC Administrator
Kelly Schill
(920) 424-3375
IBC Administration
(920) 424-3215
biosafety@uwosh.edu

Office located in Dempsey Hall Suite 214

Quick Look

Tax ID: 39-1805963
DUNS: 071149041
Cage/NCAGE code: 0M5A5
Cong. District: WI-006
Cognizant Federal Agency:
Dept. of Health and Human Services
F&A Rates: 38.5% on campus; 13% off campus

Fringe Rates CLICK HERE

Mailing Address:
University of Wisconsin Oshkosh Office of Sponsored Programs & Faculty Development
800 Algoma Blvd.,
Dempsey Hall 214
Oshkosh, WI 54901-8610

General Inquiry:

Phone: 920-424-3215
Fax: 920-424-3221

Need More?

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.

 

Begin a Research or Teaching Project with Biological Materials

The UW Oshkosh IBC is registered with NIH Office of Science Policy (OSP) and renews its institutional registration on an annual basis.

Any faculty or staff member planning to utilize biological materials for research and/or teaching activities on campus must complete an IBC Application Form found on the IBC forms page and submit one signed, hard copy to the Office of Sponsored Programs and Faculty Development, Dempsey 214, and one electronic application it to biosafety@uwosh.edu.

Biological materials subject to review by the IBC include:

  • Bacteria, viruses, viral vectors, fungi, prions
  • Human/Non-human primate cell lines, tissues, or blood products
  • Animal cell lines, tissues, or blood products
  • Plants (exotic or grown in association with pathogenic or recombinant microbes/animals
  • Biological toxins
  • Recombinant DNA (rDNA) or Synthetic Nucleic Acids
  •  Administration of biological materials to live animals (vertebrate or invertebrate)

At this time UW Oshkosh does not have facilities available to conduct activities at Biosafety Level 3 or 4.

Training requirements for faculty, staff, and students based on project type (research vs. teaching) can be found on the IBC Training.

The IBC will conduct an initial lab assessment at the time of IBC Application submission.  Lab assessments will be conducted by the Biological Safety Officer and will focus on safe work practices. A copy of the Lab Assessment Checklist is located on the IBC website and may be given to PI’s in advance.  Lab assessments will be conducted periodically, approximately mid-project on an 18 month interval, unless the IBC requests a more frequent schedule for a specific project.  A comprehensive biological/chemical lab safety visit may be conducted if the Chemical Hygiene Officer or another member from EHS is available to attend.

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).

Modifications to Approved Projects

If a Principal Investigator (PI) would like to modify their active protocol, they can submit a Modification Form and revised IBC Application Form to biosafety@uwosh.edu.  (The IBC Application Form amendment box should be selected on the coversheet.)

Modifications may be reviewed through Administrative Review, Designated Member Review, or Convened IBC Review. Modifications allowable under Administrative Review must have no impact on biosafety.  Administrative changes may include, but are not limited to, Personnel changes (not including PI change) and verification of training,  typographical or grammatical errors, funding source information, linking IRB or IACUC protocols, contact information, or verification of biosafety cabinet certification.

The IBC Chair, Biological Safety Officer, or an IBC member delegated by the chair (designated member) may review modifications determined to be minor.

Significant changes to protocols that may have an impact on biosafety, must be reviewed by the Full Committee.

The PI will be notified in writing by IBC Administration of the determination made by the IBC.  Changes may not be implemented until a modification request has been approved.

All forms can be found on the IBC Forms page.

3 Year Renewal Process

Principal Investigators will be notified approximately 60 and 30 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

Incident Reporting

Any incident that has the potential to adversely affect researcher or public health and safety must be reported to the IBC and potentially to the Office of Science Policy (OSP) depending on the nature of the incident.  Incidents that are immediately reportable to IBC include:

  • Personnel exposure (skin puncture with needle containing rDNA)
  • Spill of high risk recombinant materials occurring outside a biosafety cabinet
  • Loss of Containment/Failure to follow approved containment conditions
  • Loss or improper disposition of transgenic animal
  • Failure to obtain IBC approval before procedure(s) commenced

Incidents that are reportable to the IBC within 72 hours include:

  • Minor spill of low-risk agent with no breach of containment and properly cleaned/decontaminated

If  you have a reportable incident, please submit an IBC Incident Report Form  to biosafety@uwosh.edu and notify administration at 920-424-3215. Forms can be found under the IBC Forms page. The IBC is responsible for reporting incidents involving recombinant materials to OSP.

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.

Begin a Research or Teaching Project with Biological Materials

The UW Oshkosh IBC is registered with NIH Office of Science Policy (OSP) and renews its institutional registration on an annual basis.

Any faculty or staff member planning to utilize biological materials for research and/or teaching activities on campus must complete an IBC Application Form found on the IBC forms page and submit one signed, hard copy to the Office of Sponsored Programs and Faculty Development, Dempsey 214, and one electronic application it to biosafety@uwosh.edu.

Biological materials subject to review by the IBC include:

  • Bacteria, viruses, viral vectors, fungi, prions
  • Human/Non-human primate cell lines, tissues, or blood products
  • Animal cell lines, tissues, or blood products
  • Plants (exotic or grown in association with pathogenic or recombinant microbes/animals
  • Biological toxins
  • Recombinant DNA (rDNA) or Synthetic Nucleic Acids
  •  Administration of biological materials to live animals (vertebrate or invertebrate)

At this time UW Oshkosh does not have facilities available to conduct activities at Biosafety Level 3 or 4.

Training requirements for faculty, staff, and students based on project type (research vs. teaching) can be found on the IBC Training

The IBC will conduct an initial lab assessment at the time of IBC Application submission.  Lab assessments will be conducted by the Biological Safety Officer and will focus on safe work practices. A copy of the Lab Assessment Checklist is located on the IBC website and may be given to PI’s in advance.  Lab assessments will be conducted periodically, approximately mid-project on an 18 month interval, unless the IBC requests a more frequent schedule for a specific project.  A comprehensive biological/chemical lab safety visit may be conducted if the Chemical Hygiene Officer or another member from EHS is available to attend.

Research Involving Recombinant or Synthetic Nucleic Acids & 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).

Modifications to Approved Projects

If a Principal Investigator would like to modify their active protocol, they can submit a Modification Form and revised IBC Application Form to biosafety@uwosh.edu.  (The IBC Application Form amendment box should be selected on the coversheet.)

Modifications may be reviewed through Administrative Review, Designated Member Review, or Convened IBC Review. Modifications allowable under Administrative Review must have no impact on biosafety.  Administrative changes may include, but are not limited to, Personnel changes (not including PI change) and verification of training,  typographical or grammatical errors, funding source information, linking IRB or IACUC protocols, contact information, or verification of biosafety cabinet certification.

The IBC Chair, Biological Safety Officer, or an IBC member delegated by the chair (designated member) may review modifications determined to be minor.

Significant changes to protocols that may have an impact on biosafety, must be reviewed by the Full Committee.

The PI will be notified in writing by IBC Administration of the determination made by the IBC.  Changes may not be implemented until a modification request has been approved.

All forms can be found on the IBC Forms page.

3 Year Renewal Process

Principal Investigators will be notified approximately 60 and 30 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

Incident Reporting

Any incident that has the potential to adversely affect researcher or public health and safety must be reported to the IBC and potentially to the Office of Science Policy (OSP) depending on the nature of the incident.  Incidents that are immediately reportable to IBC include:

  • Personnel exposure (skin puncture with needle containing rDNA)
  • Spill of high risk recombinant materials occurring outside a biosafety cabinet
  • Loss of Containment/Failure to follow approved containment conditions
  • Loss or improper disposition of transgenic animal
  • Failure to obtain IBC approval before procedure(s) commenced

Incidents that are reportable to the IBC within 72 hours include:

  • Minor spill of low-risk agent with no breach of containment and properly cleaned/decontaminated

If  you have a reportable incident, please submit an IBC Incident Report Form  to biosafety@uwosh.edu and notify administration at 920-424-3215. Forms can be found under the IBC Forms  page. The IBC is responsible for reporting incidents involving recombinant materials to OSP.

Contact IBC

Chair
Eric Matson
(920) 424-2077
IBC Administrator
Kelly Schill
(920) 424-3375
IBC Administration
(920) 424-3215
biosafety@uwosh.edu

Office located in Dempsey Hall Suite 214

Quick Look

Tax ID: 39-1805963
DUNS: 071149041
Cage/NCAGE code: 0M5A5
Cong. District: WI-006
Cognizant Federal Agency:
Dept. of Health and Human Services
F&A Rates: 38.5% on campus; 13% off campus

Fringe Rates CLICK HERE

Mailing Address:
University of Wisconsin Oshkosh Office of Sponsored Programs & Faculty Development
800 Algoma Blvd.,
Dempsey Hall 214
Oshkosh, WI 54901-8610

General Inquiry:

Phone: 920-424-3215
Fax: 920-424-3221

Need More?