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COVID-19 Research Laboratory Biosafety Guidelines, 05/03/2021.
Biological and biomedical research offers tremendous opportunities for improving our understanding of biological mechanisms and processes and for targeting new and more effective therapies for devastating conditions. At the same time, however, this research involving recombinant DNA, infectious agents, and other potentially hazardous biologics carries inherent safety risks. Working at an appropriate biosafety containment level and with the appropriate safety precautions is essential for mitigating those risks.
About the Committee
As mandated by the NIH Guidelines, U-M's Institutional Biosafety Committee is responsible for assessing the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules. The U-M Institutional Biosafety Committee (IBC) also oversees research with other potentially hazardous biologics. The U-M IBC currently oversees:
- Recombinant DNA and synthetic nucleic acid molecules (this includes human gene transfer studies)
- Infectious agents
- Biological toxins
- Human-derived tissues, fluids, cells
- Certain animal-derived tissues, fluids, cells (i.e., from non-human primates, ruminants, swine, chickens or other fowl, or wild vertebrate animals)
- Federally-regulated Select Agents, experiments with Dual Use Research of Concern potential, and research requiring BSL3 containment
Scope of IBC Authority
The IBC has jurisdiction over research occurring at the University's Ann Arbor, Dearborn, and Flint campuses, and it may give approval to non-faculty members (i.e., non-UM entities performing work on campus) on a case-by-case basis. The IBC reports to the Vice President for Research, who has authority over this compliance area at U-M, including appointment authority to the committee.
IBC BSL3 Subcommittee
The Vice President for Research has established a BSL3 Subcommittee of the U-M Institutional Biosafety Committee to review proposals that would require the use of BSL3 containment facilities at U-M. This research may involve federally regulated Select Agents that require special review and oversight of security as well as safety measures. The BSL3 Subcommittee is further designated as the standing Institutional Review Entity required for identification and review of Dual Use Research of Concern (DURC), as specified in the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern.
Review of this work is performed by the IBC BSL3 Subcommittee, which operates under a separate charge. Investigators planning work with Select Agents should contact Janet Follo, the University's Responsible Official, at 734-647-3133 for more information or to initiate the required review processes.
Researcher Roles & Responsibilities
Principal investigators or project directors at U-M are responsible for:
- Understanding the requirements governing research involving potentially hazardous biologics, including recombinant DNA and SNA, infectious agents, and biological toxins.
- Submitting an IBC application to secure required approval for all research involving recombinant DNA or SNA before beginning the project.
- Amending the approved IBC application prior to implementing changes to the research.
- Ensuring that all laboratory personnel have received the required training for the work they will perform.
- Adhering to and promoting applicable biosafety procedures, including:
- Ensuring the use of proper microbiological practices and laboratory techniques at the approved biosafety level
- If working at BSL2, downloading and compiling a BSL2 Biosafety Manual for use by lab personnel
- If working at BSL2, scheduling and completing an annual BSL2 laboratory inspection with U-M Environment, Health & Safety (see the EHS Inspection Checklist for details)
- Fulfilling any additional PI/PD responsibilities as detailed in Section IV-B-7 of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.