Working with Biologicals

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.

Authorization

You must have an Institutional Biosafety Committee (IBC) approved protocol prior to initiating work involving biologics or biohazards.  IBC protocols must be submitted electronically via eBridge. More information about the IBC eBridge submission process is available through Research Systems.

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 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 IBC Human Source Materials registration in place prior to obtaining approval from the IRB.

• Visit eBridge Guides - IBC Applications on the Research Systems website.
• Register for the classroom course Introductory Training for eBridge IBC Applications offered by Research Systems Training.
• When in doubt, contact the Biological Safety Officer (BSO) for guidance
• Allow enough lead-time for the Institutional Biosafety Committee (IBC) and BSO to review your application, including time for you to reply to any questions they may have.

The Environmental Health & Safety staff carries out routine laboratory assessments 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.

Top five tips to prevent problems in your laboratory:

1. 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.  
2. Store infectious waste properly. Do not let waste accumulate.
3. 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) 805-7997.
4. Make sure study-staff wear their safety equipment (e.g., gloves, eyewear)
5. Make sure all study-staff have reviewed the most current Institutional Biosafety Committee approved protocols. Contact the Biological Safety Officer for questions or problems. 

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.

View complete details by downloading our Safety Training Checklist (PDF)

Additionally, the Biological Safety Officer is available to provide 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.

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 study-staff stay current with their training requirements, and work with Environmental Health & Safety to ensure laboratory space is compliant with the following policies, procedures, and guidelines:

1. National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, current edition (referred to as the NIH Guidelines)
2. OSHA Bloodborne Pathogens 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, current edition

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.

If you have specific technical questions about biological hazards, contact the Biological Safety Officer.