Biological Materials Research

The Institutional Biosafety Committee (IBC) reviews all activities that involve recombinant DNA and/or pathogenic substances and conducts yearly inspections of laboratories where such activities are conducted. Biosafety containment practices protect the faculty, staff, students, volunteers and visitors from exposure to infectious agents, biological toxins, Select Agents/Toxins and rDNA and prevent the release of biohazards into the environment.

IBC review and approval is required prior to using the following biohazardous agents:

• Recombinant DNA (rDNA), as defined by the NIH Guidelines, section 8.2. Some protocols may be exempt under section 1.7 (PDF); however these protocols still require review and approval by the IBC Chair.
• Any microorganism (including but not limited to bacteria, viruses, fungi, rickettsia, protozoa, or parasites) or infectious substance, or naturally occurring, bioengineered or synthesized component of any such microorganism or infectious substance that is capable of causing death, disease or other biological malfunction in a human, an animal, or a plant.
• Select Biological Agents and Toxins, High Consequence Livestock Pathogens and Restricted Plant Pathogens, as per 42 CFR 73, CFR121 and 7 CFR 331.
• Any biological toxin: a toxic material or product of plants, animals, or microorganism (including but not limited to bacteria, viruses, fungi, rickettsia, or protozoa), or infectious substance, or recombinant or synthesized molecule (whatever the origin and method of production).
• Any human blood or body fluid.
• Cell lines, tissues, bodily fluids, feces, or other biologics derived from human or non-human primates.
• The definition also includes projects involving known biohazards that do not appear to fall into one of the above criteria (e.g. prions or cell lines, known to be infected with viruses). If in doubt as to whether a material constitutes a potential biohazard, the NIU Biological Safety Officer should be consulted.

Although federal regulations allow exemptions for some types of rDNA and other agents, the principal investigator (PI) must submit an application for all projects using rDNA and biohazardous materials, agents and toxins so that the IBC is aware of the activities and can verify that they are exempt.

As a Principal Investigator,

I certify that the following training and information is provided for all laboratory personnel:

• The biosafety containment level requirements are posted in the laboratory.
• All investigative staff members are informed orally about the policies and procedures concerning handling and disposing of recombinant DNA molecules and organisms as required, based on the appropriate biosafety containment level.
• All investigative staff who have not taken microbiology and recombinant DNA courses are given appropriate instructions and must participate in laboratory demonstrations of the procedures for properly handling and disposing of recombinant DNA/organism-contaminated waste and laboratory materials.

I certify that the following laboratory environment safeguards are enforced at all time:

• Access to biohazard areas is restricted.
• Lab benches are disinfected before and after every experiment.
• Mouth pipetting is prohibited; mechanical pipettes are provided.
• Surgical gloves are required whenever lab personnel are working with biohazardous materials.
• Laminar flow cabinets are used according to the criteria specified by the CDC and the NIH in their publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition.
• Safety glasses used according to the criteria specified by the Occupational Safety and Health Administration (OSHA).
• Syringes, needles, broken glass and all other sharps are disposed of according to the procedures prescribed by the CDC and the NIH in their publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition.

I certify that the appropriate containment and disposal safeguards are enforced at all times:

• Disposable materials that are contaminated with the recombinant or infectious material are put into a biohazard bag and autoclaved.
• Non-disposable materials that are contaminated with recombinant or infectious materials are inactivated by autoclaving -OR- cleaning with bleach.

I certify that the information provided in my protocol submission form is accurate; and any protocol changes, including the DNA being cloned, the vector, the host organism, or any other toxic or infectious agents, will be submitted to the IBC for approval prior to initiation.

I further certify that I have read and will comply with all relevant publications, including but not limited to the NIU Institutional Biosafety Committee Policy (PDF), the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition and the Department of Health and Human Services National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules or Synthetic Nucleic Acid Molecules.

Regardless of the source of your funding, non-compliance with NIU biosafety policy may lead to suspension, limitation, or termination of all NIH funding to NIU. Specifically, non-compliance with the NIH Guidelines can result in:

• suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant DNA research at NIU, or
• a requirement of prior NIH approval of any or all recombinant DNA projects at NIU.