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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 NIH/RAC approval as well as review and approval by U-M's IRB and IBC.
Research involving recombinant DNA 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 type of research 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) oversees:
- ALL research involving recombinant and synthetic nucleic acid molecules
- Research requiring BSL3 containment, including work with Select Agents and Toxins (through the BSL3 Subcommittee)
- Human gene transfer studies (as an ancillary committee to the IRB)
Scope of IBC Authority
The IBC has jurisdiction over research with recombinant or synthetic nucleic acid molecules 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 as the executive officer who has authority over the compliance area including appointment authority to the committee. The U-M Office of Research (UMOR) administratively manages the committee.
IBC BSL3 Subcommittee
The IBC also has oversight responsibility for federally-regulated Select Agents and Toxins and other research that requires BSL3 containment. 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
Compliance with IBC processes is a term and condition of your research at U-M, and funding for projects may be withheld until compliance is established.
Specifically, principal investigators or project directors at U-M are responsible for:
- Understanding the requirements governing research involving recombinant DNA and SNA.
- Submitting an IBC application to secure required approvals for any research involving recombinant DNA or SNA before beginning your project (i.e., registering your research).
- Amending their approved IBC registration prior to implementing changes to the research.
- Ensuring that all laboratory personnel have received the required training and vaccinations.
- 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, compiling a BSL2 Biosafety Manual for project team and staff use
- If working at BSL2, scheduling and completing a BSL2 laboratory inspection with U-M OSEH (see the OSEH Inspection Checklist for details)
- Fulfilling additional PI/PD responsibilities as detailed in Section IV-B-7 of the NIH Guidelines.