IBC Review Process

IBC Staff Review

After you submit your application (i.e., initial application, amendment, or renewal), Insitutional Biosafety Committee (IBC) staff review the submission for completeness and consistency. If they identify issues that need to be corrected, they will return it to you in the eResearch Regulatory Management (eRRM) system for changes before assigning it for committee review.

Committee Review

After the IBC staff review, the application is assigned for committee review.  IBC reviewers evaluate your:

• Description of the proposed work, including the proposed biosafety containment level
• Understanding of the safety risks posed by both the biological materials and the experimental techniques you intend to employ

The more specific you are about the work you plan to conduct, the easier it will be for the IBC to assess the risk involved with your work and whether the proposed biosafety containment level is adequate. The IBC consists of both scientists, non-scientists, and members of the public, some of whom may not be familiar with lab jargon, gene abbreviations, etc. It is your responsibility to make your registration understandable to the IBC.

If IBC reviewers have questions about the work described, or would like you to revise part of the application, it will be sent back to you with a request for changes/clarification. Responding in a timely manner to these requests will help ensure that the committee's decision on your application is not delayed.

Other Reviews

The IBC coordinates with other compliance entities at U-M to better ensure your work receives the needed reviews. If you indicate that you will be administering any of the biologics in your application to vertebrate animals or that you will be working with transgenic vertebrates, your application will be reviewed as well by a member of U-M's Insitutional Animal Care and Use Committee (IACUC) staff to assess consistency with your IACUC protocols. Separate approval by the IACUC is required for all work with vertebrate animals

In addition, the IBC and the U-M Department of Environment, Health & Safety (EHS) review what lab safety practices are necessary based on a risk assessment of the work described.

IBC Review Outcomes

The IBC meets monthly to deliberate on the applications submitted for the committee's review. At the meeting, a vote is taken regarding the outcome of that review. The committee may vote to:

• Approve: the PI can proceed with the proposed work at the indicated biosafety containment level
• Approve with contingencies: the PI must complete certain requirements before proceeding with the proposed work at the indicated biosafety containment level (e.g., an EHS biohazard laboratory inspection for BSL2 containment with resolution of any corrective action items identified by EHS).
• Disapprove: the PI may NOT proceed with the proposed work.

Another possible outcome is that the committee may table an application because the PI needs to provide further information for the committee's review.

IBC Approval

The outcome of IBC review consists of confirmation of the appropriate biosafety containment level for the work. IBC review will also cover the animal housing containment level, if applicable.

Specifically, the approval issued by the IBC includes an outcome letter with the following elements:

• A link to the Approved Application Summary portion of your IBC application, where details about your approved work and risk mitigation practices are listed. 
• A summary of the biosafety level(s) assessed for each type of work -- rDNA, infectious agents, biological toxins, materials derived from humans or certain vertebrate animals.
• A summary of animal housing containment levels, if applicable. 
• Housing containment for animals administered human derived substances.
• The approval period for the application: IBC applications are valid for three years, at which time they must go through a renewal process. 
• Amendment requirements: If your work changes before the end of the three-year approval period, you must submit an amendment to your approved application.  See IBC Registration Process for a summary of the types of changes to your work that require an amendment to your application.
• Training requirements and recommendations for those conducting the work described.
• Important information about reporting and responding to needle sticks, spills, and exposures.

Ultimately, the content of your IBC application after committee review and outcome should represent only the work for which you are approved by the IBC.