Institutional Biosafety Committee (IBC)
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.
WHAT SHOULD I DO NEXT?
Working with recombinant DNA or synthetic nucleic acid molecules at BSL1 or BSL2? Register with the IBC.
Proposing a human gene transfer project?Obtain approval from a U-M IRB and from the IBC.
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.
IMPORTANT IBC DATES
Submit application by last Friday of the current month for consideration at IBC meeting on 3rd Friday of the next month.
Review the IBC FAQs!
The FAQs cover the range of IBC processes, including guidance on the registration process, the IBC Application form, and EHS-related work and more!
Last updated: 4/28/2022.
WORKING AT BSL2?
Contact U-M Environment, Health & Safety (734-647-1143) to schedule a lab inspection.
Before approval will be issued, your lab must have been inspected within the last 12 months and any corrective actions must be completed.
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(link is external) of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
- 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
Funding for projects or the transfer of incoming materials may be delayed, pending IBC registration and approval.
References and Resources
U-M Life Sciences Dual Use Research of Concern Policy
University of Michigan policy that outlines U-M’s oversight requirements for life science research that may be considered to be “dual use research of concern” (DURC) and subject to the federal DURC policy.
NIH GUIDELINES
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
HTML version of NIH Guidelines for rNDA/sNA research, April 2019.
IBC RESOURCES
University of Michigan Institutional Biosafety Committee Charge
Updated 09/15/2015
University of Michigan Institutional Biosafety Committee BSL3 Subcommittee Charge
Outlines the charge for the University of Michigan’s IBC Biosafety Level 3 Subcommittee, which provides oversight for research with federally regulated Select Agents and Toxins and other research that requires BSL3 containment.
COVID-19 Research Laboratory Biosafety Guidelines
Guidance describing the types of research activity, appropriate biosafety levels, and contacts for questions and institutional approvals required for University of Michigan researchers working in laboratories during the COVID-19 pandemic. Last updated: 05/03/2021.
OTHER USEFUL U-M WEB PAGES
University of Michigan Vector Core The Vector Core produces biological products (gene transfer vectors) that facilitate the transfer of specific genes into cells and provides intellectual and technical advice to researchers regarding the use of these products.
LABORATORY & RESEARCH SAFETY
Environment, Health & Safety (EHS) – Topics A-Z
Questions?
For more information about the IBC, call 734-936-3934 or e-mail [email protected].