IBC Application Process

Submitting an Application

Log into the eResearch Regulatory Management (ERRM) system with your uniqname and UMICH password.
Initiate your application.
When finished and ready to submit, click "Submit" or "Submit Changes" from the Activities menu on the left hand side of the page.

If you do not see the state change to "IBC Staff Review", you have not submitted your application.

For step-by-step system instructions, see the eResearch Help documents in References & Resources.

IBC Application Exceptions

For Federally Regulated Select Agents & Other BSL3 Work:
Do not use eResearch to apply for approval. Call 734-936-3934 for a separate application form. The IBC BSL3 Subcommittee reviews this work.

For Human Gene Transfer Clinical Trials:
The IBC reviews your project via your IRB Application. See Human Gene Transfer Proposals for complete information.

Any U-M investigator planning a research project that involves recombinant DNA (rDNA) or synthetic nucleic acid (SNA) molecules must submit an application for Institutional Biosafety Committee (IBC) review and approval before initiating the work. U-M investigators must also register their work with other potentially hazardous biologics.

The IBC application process includes submissions of:

An initial application to obtain IBC approval for a three-year period.
Amendment(s) to obtain approval for changes to the research.
Renewal(s) to extend IBC approval for ongoing work for another three-year approval period.

IBC Application

The Institutional Biosafety Committee (IBC) application is an online questionnaire/form that you complete in the eResearch Regulatory Management (eRRM) system to describe all of your work with potentially hazardous biologics, including recombinant DNA and synthetic nucleic acid molecules. U-M requires that you obtain IBC approval for this research regardless of the funding source and regardless of whether the rDNA or SNA research is considered exempt from the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. In the IBC application you will be asked to:

List lab personnel involved with this work
List your laboratory space used for this work
Explain your research goals and identify the types of potentially hazardous biological materials you plan to use: rDNA, including transgenic animals and plants; infectious agents; biological toxins; materials derived from human sources; and/or materials derived from certain vertebrate animal sources (i.e., from non-human primates, ruminants, swine, chickens or other fowl, or wild vertebrate animals)
Describe any administration of these potentially hazardous biological materials to animals or to plants

Allow 3-8 weeks for IBC review, considering the submission date in relation to the IBC meeting schedule, and the availability of the PI to respond to any requests for clarification from the committee.

Lab Inspection Requirement

In order for the IBC to issue approval for work at BSL2 containment, the laboratory where the work will be performed must have had a satisfactory biohazard inspection by U-M Environment, Health & Safety (EHS) within the past 12 months (including the resolution of any corrective action items). See the EHS web site for a complete inspection checklist.

If you are proposing work for BSL2 containment or above, then, at the same time you initiate your IBC application, contact EHS at 734-647-1143 or [email protected] to schedule your lab inspection. Although the IBC can review your application before your lab inspection is complete, it will not issue an approval until EHS has inspected your lab and you have corrected any identified action items.

Amendments

You will need to amend your approved IBC application in the eResearch Regulatory Management (eRRM) system if you are adding or changing:

genes studied or host/vector systems used in your rDNA work
infectious agents or biological toxins
work with substances from humans
work with substance from certain vertebrate animals (i.e., from non-human primates, ruminants, swine, chickens or other fowl, or wild vertebrate animals)
transgenic animal work
administration of biologics to animals
administration of biologics to plants
anything else that may have an impact on the biosafety level of the work being performed
BSL2 laboratory space

Renewals

IBC approvals are valid for three years and must be renewed if you intend to continue the work described.

FAQs

Do I need different IBC applications for different work?

Investigators register once with the the IBC, and an approved application is valid for three years. You should submit an amendment if your work with potentially hazardous biologics (including rDNA/SNA) changes, and you will need to renew your registration before expiration.

Do I have to register for PCR work?

You need to register the work with the IBC if you are cloning the PCR product first, prior to sequencing. The direct sequencing of PCR products does not need to be registered with the IBC - as long as there is no cloning involved.

Can I use another investigator's IBC application if we share lab space?

In some cases you can. Investigators sharing laboratory space may also share registration and training obligations. The work may be registered either under the investigator in whose lab the work is occurring or under the principal investigator of a project. For example, investigators in charge of labs where work involving potentially hazardous biologics occurs are responsible for ensuring that there is a application with the IBC for all the work involving these potentailly hazardous biological materials that occurs in their lab space. In addition, they must maintain documentation of the training status for all the individuals working in the lab with these potentially hazardous biologics at BL2 containment.

Do I need an IBC application for work involving potentially hazardous biologics performed in my colleague's lab?

Principal investigators who are not themselves registered for BSL2 work, and who are having this work performed in another investigator's lab, are responsible for ensuring that it is occurring in a laboratory that is registered with the IBC for that type of work and that it is conducted by individuals who have received training for the work they are performing.

References and Resources

IBC Application: Applicant's Guide to Common Areas of Improvement
Lists common issues applicants encounter when completing an IBCA and provides fixes and tips to improve the accuracy and detail of the application information. Last updated: July 2024
IBC Policy for U-M Managed Research Cores
Defines and describes the guidelines that U-M Core Research Facilities must follow to comply with the University of Michigan's Insitutional Biosafety Committee (IBC) regulations for the safe handling of potentially hazardous biological materials.
IBC Approval Needed for Research Involving E. coli Strains
(PDF) Lists of exempt, not exempt non-pathogenic, and not exempt pathogenic E. coli strains that require IBC approval prior to use in research per NIH Guidelines III-F-8 appendix, III-E, and III-D respectively.
Lentiviral Vectors: a Biosafety Primer
Lentiviral Risk Assessment Guide
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules HTML version of NIH Guidelines for rNDA/sNA research, April 2024.
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.
Institutional Animal Care & Use Committee
Transgenic Animal Model Core
Submitting an IBC Application eResearch system instructions to submit a completed IBC Application (IBCA) for committee review
IBC Application Overview Orientation to the features and functions of the online IBC Application (IBCA) form in the IBC tab of the eResearch Regulatory Management (eRRM) system
IBC Application Tasks A guide to accessing and viewing your IBC Application (IBCA) in eResearch during the submission, amendment, or renewal processes. Provided by ITS.

Questions?

For more information about the registration process, call 734-936-3934 or email [email protected]

Enterprise