Biological Research and Recombinant and Synthetic Nucleic Acids Research.
Research involving hazardous and potentially hazardous biological organisms and materials is subject to review by Michigan Technological University’s Institutional Biosafety Committee (IBC).
Review of Research
Michigan Technological University supports research involving biological organisms and materials that are safely managed at Biosafety Levels 1 and 2 (BSL-1 and BSL-2). Formal review by the University’s IBC is required for research involving organisms and materials that require BSL-2 containment. Additionally, as a requirement of the National Institutes of Health (NIH), Michigan Tech’s IBC also reviews research that is subject to the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids:
- recombinant nucleic acid molecules that are: a) constructed by joining nucleic acid molecules, and b) that can replicate in a living cell;
- synthetic nucleic acids molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules; or
- molecules that result from the replication of those described in (i) or (ii) above.
IBC review will include:
- independent assessment of the risks associated with the research and verification of containment levels assigned by the Principal Investigator; 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 and the health of the environment.
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 NIH/OBA.
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.
Regulations
Biosafety in Microbiological and Biomedical Laboratories (BMBL), published by the Centers for Disease Control and Prevention (CDC) and 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. It is expected that all Principal Investigators conducting biological research at Michigan Technological University will comply with the standards and principles detailed in the BMBL.
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, personal protective equipment (PPE), housekeeping, and waste containment and disposal.