Institutional Biosafety Committee (IBC)

The Institutional Biosafety Committee (IBC) has the responsibility to assure the safe use of recombinant DNA (rDNA) as outlined by the National Institutes of Health (NIH), to assure the safety of MCW personnel and others working with rDNA and/or biological materials, and to limit the environmental impact of rDNA and biological agents, including pathogens, utilized by investigators at the MCW.

The IBC follows recommendations and/or regulations outlined in the NIH Guidelines for Research involving Recombinant DNA molecules,  the 5th edition BMBL (Biosafety in Microbiological and Biomedical Laboratories) and the Federal Register 42 CFR 73.   The IBC currently falls under and reports to the Senior Associate Dean for Research.

 Committee Meetings

Medical College of Wisconsin Institutional Biosafety Committee (IBC) meetings are held the second Tuesday of every month, 1:30 - 3:00pm in MFRC 3075 and are open to the public. MCW reserves the right to hold executive sessions during IBC meetings.  Executive sessions are not open to the public. Please contact the IBC to arrange access to the campus.

MCW IBC meeting minutes are available to the public in a redacted format. If you wish to receive a copy of a meeting's minutes, please contact the IBC to arrange for a copy to be sent by registered mail.  The MCW reserves the right to redact any information which would jeopardize the health and safety of its staff members or the security of the research materials in use on site.

If any member of the MCW community or the general public wishes to forward comments or questions to the MCW IBC, please contact the IBC. The IBC will reply with a written copy of both comment and response forwarded to the NIH OBA.

The MCW IBC allows Principal Investigators with pending applications to attend IBC meetings during which their research will be discussed. Please contact the IBC to be placed on the meeting agenda for attendance.

 Committee Members

Co-Chairs

  • Dara W. Frank PhD
    Professor, Microbiology and Molecular Genetics
    Expertise: Bacterial toxins; bacterial pathogenesis, select agent research; bacterial secretion systems; vaccines
    Affiliation(s): Radiation Safety
     
  • David A. Wilcox PhD
    Associate Professor, Pediatrics
    Expertise: Gene Therapy for Inherited Bleeding Disorders

Community Committee Members

  • Jarrod Erbe PhD
    Professor of Biology & Department Chairman
    Expertise: Biology
    Affiliation(s): Chair of WLC IACUC
     
  • James Case
    Assistant Chief
    Fire Department
    City of Wauwatosa

Committee Members

  • Joseph Barbieri PhD
    Professor, Microbiology and Molecular Genetics
    Expertise: Protein toxins, microbial pathogenesis
     
  • L. William Cashdollar PhD
    Associate Adjunct Professor, Microbiology and Molecular Genetics
    Expertise: Virology and molecular biology
    Affiliation(s): MCW IACUC; Vice Chair of MCW Extremely Hazardous Chemicals
     
  • Guan Chen, MD, PhD
    Professor
    Pharmacology and Toxicology
    Expertise: molecular biology, signal transduction, and cancer research
     
  • Jenifer L. Coburn PhD
    Professor of Medicine
    Expertise: bacterial pathogenesis, host-pathogen interactions, vector-borne infections, zoonotic infections
     
  • Aron Geurts, PhD
    Assistant Professor, Physiology
    Expertise: Transgenic models, vectors, transposons, gene targeting, rat ES cells and IPS cells, gene delivery systems
     
  • Kelly Henrickson MD
    Professor, Pediatrics/Infectious Disease
    Expertise: Pediatric infectious diseases; respiratory virology; molecular diagnostics
    Affiliation(s): CHW Infection Control
     
  • Eric S. Jensen, DVM
    Assistant Professor, Pediatrics
    Staff Veterinarian, Biomedical Resource Center
    Expertise: lab animal medicine
    Affiliation(s): MCW IACUC
     
  • Sue Kehl PhD
    Associate Professor, Pathology
    Expertise: medical microbiology
    Affiliation(s): CHW HRRB, CHW Infection Control
     
  • Jozef Lazar MD PhD
    Associate Professor, Dermatology
    Expertise: manipulation of rat genome; delivery modify vector expressing gene; siRNA etc. using invivo/in vitro systems
     
  • Qizhen Shi, PhD
    Assistant Professor, Pediatrics - Hematology Oncology
     
  • Peter Sohnle MD
    Professor, Medicine
    Expertise: Infectious diseases and animal models of infectious diseases
    Affiliation(s): VA Pharmacy, Nutrition & Therapeutics
     

Support Member (Non-Voting)

  • Christopher Mol RN MBA COHN-S
    Manager, Occupational Health & International Travel Clinic
    Expertise: Occupational Health and International Travel
    Affiliation(s): MCW IACUC, Wellness Steering Committee; FMLH Infection Control

Administrative Support (Non-Voting)


Working with Biologicals


The Medical College of Wisconsin is committed to ensuring a safe, healthy and compliant workplace for all employees and visitors as well as environmentally sound practices. To achieve that goal the College has established the Institutional Biosafety Committee (IBC) which reviews all work with biological materials that could pose an occupational health or environmental release risk. Committee members work with Principal Investigators in the establishment of a safe working environment for employees and an environmentally sound waste stream process. The scope of Committee review includes the handling of bloodborne pathogens sources, biological toxins, infectious micro-organisms and genetically engineered constructs.

 What does MCW consider to be a biologic or biohazard?

The Medical College of Wisconsin requires a review of work involving any biologically hazardous or genetically engineered materials prior to onset of research. The scope of review includes infectious agents; biological toxins; all recombinant DNA, both exempt and non-exempt; and all human, non-human primate or sheep-derived materials including blood, tissue and bodily fluids.

 What approvals do I need to work with biohazardous materials?

Authorization
You must have an Institutional Biosafety Committee (IBC) approved protocol prior to initiating work involving biologics or biohazards.  Beginning December 21, 2013, IBC protocols must be submitted electronically via eBridge.  More information about the IBC eBridge submission process is available at Resources for eBridge IBC Applications Module.

For a guide on how to make changes to a current paper application, visit eBridge and Your Approved Paper IBC Application.

Human and non-human primate material registration is accomplished through Biological Safety Officer (BSO) review and approval, based on the need for bloodborne pathogens and/or infectious material shipping training.


Expiration Date
Approved protocols are valid for three years from the date of BSO or IBC’s approval. You must submit a full application to renew your study in advance of the expiration date if you wish to continue the research.


Modifications
Any modifications you wish to make to your current protocol must be approved by the IBC before it is implemented into your research by submitting an IBC Amendment via eBridge. 


Additional approvals
If biohazardous or genetically engineered materials will be used in animals, you must have an approved IBC protocol in place prior to obtaining approval from the Institutional Animal Care and Use Committee (IACUC).  Prior to initiation of live animal work, the Biomedical Resource Center (BRC) will arrange for a meeting with the animal care staff to discuss the hazardous nature of the biological agent to be used in animals. If your work involves the acquisition of human blood or tissue samples through an Institutional Review Board (IRB) application, you must have an approved Human Source Materials registration in place prior to obtaining approval from the IRB.

 What can I do to streamline the approval process?
 Is auditing or monitoring required?

The Environmental Health and Safety staff carries out routine laboratory assessments in order to ensure that federal and state requirements for the handling and storing of hazardous materials are being met. The Institutional Biosafety Committee (IBC) is authorized by the Institutional Official to limit or suspend any research that is not in compliance with the Medical College of Wisconsin's biosafety policies and procedures and the IBC-approved protocol(s) in place.  Occasionally, additional assessments must be conducted, depending upon the source of funding or acquisition of a specimen such as a pathogen or toxin from a commercial source.

 What can I do to prevent problems in the laboratory?

Top five tips to prevent problems in your laboratory:

  • Practice standard precautions and always assume material is potentially infectious. If your biosafety cabinet certification is more than one year old, contact the Environmental Health & Safety Department at safetyinfo@mcw.edu
     
  • Store infectious and toxic waste properly. Do not let waste accumulate.
     
  • Train your staff to work carefully and to minimize the creation of splashes and aerosols. Reduce the use of sharps such as needles and glass pipettes to limit potential injuries. If anyone gets injured, contact the Occupational Health Services for prompt follow up at 414-805-6699.
     
  • Make sure study-staff wear their safety equipment (e.g., gloves, eyewear)
     
  • Make sure all study-staff have reviewed the most current Institutional Biosafety Committee approved protocols. Contact the Biological Safety Officer for questions or problems at safetyinfo@mcw.edu.
 What training is required?

Branches of the federal government that have oversight over biological materials require regular training for employees. Training requirements are based upon both the types of materials handled and the activities involved using those materials such as shipping or genetic engineering activities. Listed below are the current training courses offered for researchers, both basic and clinical, that maintains compliance for the College with these agencies.  The courses offered for required training include:

  • Biosafety & Bloodborne Pathogens for Researchers
  • Bloodborne Pathogens for Clinical Staff
  • Lab-Specific Employee Orientation Checklist
  • Recombinant DNA Training

Complete details on training for researchers using biologicals can be found on MCW’s intranet site.  If you have access to InfoScope, search for keywords “safety training” and select the link for Environmental Health & Safety Training.

 What resources and additional training are available?

Biosafety training modules provided by the Medical College of Wisconsin include:

  • Biological Safety and Bloodborne Pathogens for Researchers,
     
  • IATA/DOT Biological Materials Shipping,
     
  • Animal Biosafety Level 2 Theory and Practice, and
     
  • Recombinant DNA. 

The Biological Safety Officer is available to provide additional agent-specific training for materials such as viral vectors. In addition, researchers who are assigned to work in the biocontainment facility are required to undergo annual in-person training covering BSL3/ABSL3 theory and practice, biosecurity and respiratory protection.

Complete details on training for researchers using biologicals can be found on MCW’s intranet site. If you have access to InfoScope, search for keywords “safety training” and select the link for Environmental Health & Safety Training.

 What are the relevant policies, procedures and guidelines?

To work with biological materials at the Medical College of Wisconsin (MCW), you must abide by all applicable Federal, State, and local regulations in addition to MCW's policies and guidelines for biological safety.  Faculty must maintain a current Institutional Biosafety Committee protocol, ensure that your study-staff stay current with their training requirements, and work with Environmental Health and Safety staff to ensure that your laboratory space is compliant with the following policies, procedures and guidelines:

  1. National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules, current edition (referred to as the NIH Guidelines) (59 FR 34496 and as amended)

  2. OSHA Bloodborne Pathogen Standard, 29 CFR 1910.1030

  3. Biosafety in Microbiological and Biomedical Laboratories, (pdf) (referred to as the BMBL), U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, 5th ed., December 2009
 Whom do I contact if I have additional questions?

The Institutional Biosafety Committee (IBC) lies within the Office of Research and reviews all applications at the Medical College of Wisconsin for the handling of biohazardous and genetically engineered materials. Contact the IBC administrative staff for guidance on your IBC application with respect to submission deadlines and application details at IBCSafety@mcw.edu. If you have specific technical questions about biological hazards, contact the Biological Safety Officer at safetyinfo@mcw.edu.

Contact the IBC

Phone: 414-955-4279

Email:  IBCSafety@mcw.edu

Web: If you have access to MCW’s intranet, view more detailed information by searching for keyword “IBC” on InfoScope.

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