INTRODUCTION TO THE IBC
The Institutional Biosafety Committee oversees recombinant DNA research at the University of Michigan. The UM adheres to the NIH Guidelines for Research Involving Recombinant DNA Molecules with regard to all uses of recombinant DNA at the University. The UM requires that all use of recombinant DNA at the University be registered with the Institutional Biosafety Committee even if such use is exempt from the requirements of the NIH Guidelines. The IBC also has oversight responsibility for Select Agents and for "experiments of concern."

View the IBC Charge

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PI RESPONSIBILITIES
The principal investigator or project director at UM is responsible for registering rDNA work and for ensuring the use of proper microbiological practices and laboratory techniques at the approved biosafety level. Additional PI/PD responsibilities are detailed in Section IV-B-7 of the NIH Guidelines.

PI RESPONSIBILITIES: Laboratory Inspections
The principal investigator or project director of a BL2, BL2+, or BL3 laboratory must ensure that a working Biosafety Manual is available for the research project and that all staff have attended the OSEH Comprehensive Laboratory Safety Training course. Laboratories planning BL2, BL2+, or BL3 work must be inspected by OSEH before work can begin. A checklist of items required in addition to a Biosafety Manual and personnel training is located at http://www.oseh.umich.edu/pdf/BL2checklist.pdf.

PI RESPONSIBILITIES: Personnel Training
Individuals planning to work with viral vectors are highly recommended to enroll in the course "Working Safely with Viral Vectors" which is offered quarterly by the Vector Core and OSEH (February, May, August, November). Free. Pre-registration required.

PI RESPONSIBILITIES: Approval for Human Gene Transfer Research
Principal investigators performing human gene transfer work have special responsibilities and reporting requirements that are detailed in Appendix M of the NIH Guidelines, and in the section below on human gene transfer.

PI RESPONSIBILITIES: Approval for Select Agents Research
Investigators planning work with Select Agents should read the Introductory Guide and contact Michael Hanna, the University's Biosafety Officer, at 734-647-2318, to initiate the required review processes.

CONTAINMENT LEVELS: BL1, BL2, BL2+, BL3
Please note that at least BL1 lab practices should be used with all recombinant DNA work, even if the work is exempt from NIH Guidelines.

Recombinant DNA work at BL2, BL2+, or BL3 requires an OSEH laboratory inspection before the work can begin. The initial lab inspection process is prompted through your registration with the IBC. In addition to a completed Biosafety Manual and appropriate training for personnel involved with the project, the OSEH will cover items on the BL2 checklist.

An outline of BL1, BL2, and BL3 lab practices can be found in Appendix G of the NIH Guidelines, and the CDC/NIH Biosafety Guideline contains a chart of biosafety practices for work with infectious agents.

Work requiring BL3 containment must be approved on a case-by-case basis by the IBC.

Experiments requiring containment ABOVE BL3 will not be permitted without the prior approval of the Regents.

TRAINING
All laboratory personnel must attend the OSEH Comprehensive Laboratory Safety Training course. Free. Pre-registration required.

Individuals planning to work with viral vectors are highly recommended to enroll in the course "Working Safely with Viral Vectors" which is offered quarterly by the Vector Core and OSEH (February, May, August, November). Free. Pre-registration required.

VIRAL VECTOR STANDARD OPERATING PROCEDURES & GUIDANCE

OSEH is developing a series of SOPs for commonly used viral vectors:
View the Adenoviral Vector SOP

See NIH OBA (RAC) guidance on biosafety with Lentiviral Vectors.

REPORTING LAB ACCIDENTS AND ILLNESSES WITH rDNA
Any situation involving recombinant DNA that poses a threat to an individual's health, safety, or welfare should be handled with the appropriate care including emergency response (911) if necessary. Following this, reporting must occur to:

• Principal Investigator or Director of Lab (immediately)
• Biosafety Officer, 734-647-2318 (immediately)
• Work~Connections (within 24 hours)
• IBC (may be reported through the Biosafety Officer)
• NIH/OBA (report will be coordinated by the IBC)

ANIMALS AND rDNA
IBC registrations include questions about your use of animals and recombinant DNA. Based upon your responses, the IBC will assign a containment level for your work with (housing of) the animals. It is usually denoted as "BL1N" or "BL2N," etc., and corresponds to the commonly used "ABSL1," "ABSL2," etc. The animal containment level may be different from the containment level approved for handling your recombinant construct in the lab. The IBC has developed a virus-specific containment reference for the housing of animals injected with recombinant virus.

The containment conditions for animal work involving viral vectors are conditioned on proof that each batch of virus used is substantially free of replication competent virus. ULAM may require such proof prior to commencement of animal experimentation.

All work with animals must be approved by the University Committee for the Use and Care of Animals (UCUCA). Contact UCUCA and the Unit for Laboratory Animal Medicine (ULAM) for additional guidance on work with animals.

Investigators planning to administer recombinant DNA to animals should refer to Appendix Q and Section III-D-4 of the NIH Guidelines for information on biological and physical containment practices.

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HUMAN GENE TRANSFER PROPOSALS: PROCEDURES FOR SUBMISSION AND APPROVAL
If you are planning a human gene transfer proposal please note there is a special review process for this type of work:

1) NIH OBA Recombinant DNA Advisory Committee Review Process
All human gene transfer research proposals must undergo review by the Recombinant DNA Advisory Committee (RAC) of the NIH Office of Biotechnology Activities (NIH/OBA). The RAC determination on the proposal must be obtained PRIOR TO the proposal receiving local Institutional Biosafety Committee (IBC) approval.

NIH OBA has an excellent set of FAQs about human gene transfer and the RAC review process.

NIH OBA also provides guidance on informed consent for gene transfer research.

Please refer to Appendix M of the NIH Guidelines for complete information on NIH/OBA/RAC requirements for submission, review and reporting in connection with human gene transfer clinical trials.

Please keep in mind that the IBC cannot formally approve a human gene transfer proposal until review by NIH OBA/RAC has been completed and a letter has been received with the outcome of the NIH OBA/RAC review. The schedule of RAC meetings and corresponding RAC deadlines is displayed at the NIH OBA website.

No research participant may be enrolled in a human gene transfer clinical study until the RAC review process is completed AND IBC and IRB approvals and applicable regulatory authorizations are obtained. Furthermore, investigators are required to submit specific additional materials to NIH OBA prior to the enrollment of any research participant (for additional clinical trial sites being added to multi-center trials) OR no later than 20 working days after the enrollment of the first research participant (for the primary site identified with a clinical trial).

2) Local Review Process
Please inform the IBC as early as possible when you are considering submission of a human gene transfer proposal to the RAC. The IBC will attempt to conduct reviews simultaneous with RAC reviews though no IBC determination may be made until the RAC outcome is known. The IBC meets on a monthly basis and needs two to three weeks prior to a meeting for review of human gene transfer proposals. The upcoming IBC meeting schedule is below.

All human gene transfer clinical trials require IRB approval in addition to IBC approval, and there is a section of the IRB application in eResearch which is devoted to human gene transfer. When you complete that section of your IRB application, the IBC will be notified automatically. The IBC functions as an "Ancillary Committee" to the IRB's review of human gene transfer clinical trials.

The IBC requires submission of the same materials required by NIH OBA/RAC: 1) scientific abstract, 2) non-technical abstract, 3) clinical protocol including tables, figures and relevant manuscripts, 4) responses to NIH Guidelines Appendices M-II through M-V, 5) informed consent draft, and 6) curriculum vitaes for all key personnel. Submission of these materials to the IBC can be made through the eResearch system as part of your IRB application for the human gene transfer clinical trial.

Please contact the IRBMED (763-4768) regarding the full process for human subjects review and approval.

SAFETY REPORTING: SERIOUS ADVERSE EVENTS IN HUMAN GENE TRANSFER
Please see Appendix M-I-C-4 of the NIH Guidelines for safety reporting requirements, including serious adverse event reporting and the reporting of findings from tests in laboratory animals suggesting risk for human research participants.