Michigan Technological University supports biological research involving organisms and materials that are safely managed at Biosafety Level 1 (BSL-1) and Biosafety Level 2 (BSL-2).
Institutional Biosafety Committee
Review of Research
Formal review by the University’s Institutional Biosafety Committee (IBC) is required for research involving organisms and materials that are managed at BSL-2. IBC review is also required for research that is subject to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids.
IBC review will include:
- independent assessment of the risks associated with the research and verification of containment levels assigned by the PI, and
- assessment of facilities, equipment, procedures, practices, training, and all other elements associated with the research.
The intent of the review and approval process is to ensure that all biological research at Michigan Tech is conducted in a manner that protects and maintains individual and community health as well as the health of the environment.
Submission for IBC Review
Research involving organisms and materials that require BSL-2 containment must be reviewed by the IBC before work begins and funding is awarded. All proposals for IBC review are submitted electronically through IRBNet.
Researchers should submit the following:
- Registration and Risk Assessment for Biological and Recombinant/Synthetic Nucleic Acid Research
- Standard operating procedure(s) for handling, storage, and disposal of biological organisms/materials.
- A laboratory-specific Biosafety Manual (The University’s Biosafety Manual may be used as a template and provides information on biosafety cabinets, laboratory setup requirements, disposal of biological organisms and materials, selection and use of personal protective equipment (PPE), and incident response/spill cleanup).
- A laboratory-specific Exposure Control Plan, if working with human blood or other potentially infectious materials (the University’s Exposure Control Plan may be used as a template).
If you have questions about the review process or whether or not your research requires review, contact David Dixon at 906-487-2131 or dcdixon@mtu.edu.
Regulations
It is expected that all Principal Investigators conducting biological research at Michigan Technological University will comply with the following standards/regulations.
Biosafety in Microbiological and Biomedical Laboratories (BMBL), published by the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), outlines the principles of laboratory biosafety, providing information on topics such as risk assessment and laboratory biosafety level criteria. The BMBL is accepted as the reference standard for safety in biological laboratories.
The NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules provide detailed procedures and practices for the containment and safe conduct of recombinant and synthetic nucleic acids research. All institutions receiving NIH funding for recombinant and synthetic nucleic acids research must comply with these guidelines. This requirement extends to all researchers working with recombinant and synthetic nucleic acids at the funded institution must also comply with the guidelines, regardless of their individual source(s) of funding.
The MIOSHA Bloodborne Infectious Diseases Standard applies to laboratories working with human blood, blood products, body fluids, unfixed tissues/organs and cell lines. The standard mandates the use of universal precautions, exposure control, engineering and work practice controls, PPE, housekeeping, and waste containment and disposal.
IBC Structure and Responsibilities
To meet NIH requirements, Michigan Tech’s IBC maintains a minimum of five members. Two of these members are unaffiliated with the University and represent the community and its interests. Additional members of the committee bring expertise in plant, animal, and recombinant and synthetic nucleic acids research. Collectively, members of the committee have the expertise needed to identify potential risks—to individual and public health and the environment—associated with research involving recombinant and synthetic nucleic acids, and infectious or potentially infectious biological organisms and materials.
IBC responsibilities include:
- Review and approval of all research using biological organisms and/or biological materials that require containment at BSL-2.
- Review and approval of all research conducted at the University that involves recombinant and synthetic nucleic acids subject to the NIH guidelines.
- Periodic review of recombinant and synthetic nucleic acids and biological research conducted at the University.
- Adopting emergency plans for accidental spills, personnel contamination, loss of containment, and research-related illnesses.
- Reporting any significant problems or violations of NIH guidelines and any significant research-related accident or illness to the NIH/OBA.