All investigators registered with the IBC in the old registration system will be required to eventually register in the new system. To accomplish this we will be dividing up the population of currently registered investigators into small groups and notifying these groups of consecutive three-month windows of time when they should complete the form. We expect this overall process to take 3 years.

However, you do not necessarily need to wait for us to tell you when to register in the new system:

• If you plan to begin new recombinant DNA work (that is, different work than is described in your old IBC registration) before your assigned time to complete the new registration, then please do go right ahead and complete a registration in the new system.

• Also, if you are an investigator planning to initiate your first recombinant DNA work (that is, if you are a new investigator or if you have simply not been registered with us in the past), please go right ahead and complete a registration in the new system.

The information below will help you to determine at what point you need to complete the IBC registration process in relation to the initiation of your recombinant DNA work. Please keep in mind that laboratories performing work at BL2 containment or above must be inspected by OSEH prior to initiation of the work. (The inspection process is prompted when you complete an IBC registration.)

UM IBC registration required simultaneous with initiation of experiment:
Experiments involving recombinant DNA in an exempt category of the NIH Guidelines. (See Section III-F of the NIH Guidelines for further information and examples.)

IBC notice required simultaneous with initiation of experiment:
Experiments in which all components derive from non-pathogenic organisms. (See Section III-E of the NIH Guidelines for further information and examples.)

IBC approval required before initiation:
Experiments using higher risk organisms (Risk Groups 2-4 or restricted agents) as DNA source or host-vector system. (See Section III-D of the NIH Guidelines for further information and examples.)

IBC and IRB approval and NIH RAC review required before initiation:
Experiments involving the deliberate transfer of recombinant DNA to humans. (See Section III-C of the NIH Guidelines for further information and examples.) Please note that human gene transfer clinical trials require review and approval by the IBC and the IRB through the human subjects component of eResearch.

IBC approval and NIH review for containment determinations before initiation:
Experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram body weight; or transfer of recombinant DNA from or to restricted agents. (See Sections III-B-1, III-D-1-d, III-D-2-b, III-D-3-d of the NIH Guidelines for further information and examples.)

IBC, RAC review, and NIH Director review and approval before initiation:
Experiments involving the deliberate transfer of a drug resistance trait to microorganisms, not known to acquire it naturally, that could compromise control of disease agents. (See Section III-A of the NIH Guidelines for further information and examples.)

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Click here to view the complete
NIH Guidelines for Research with Recombinant DNA Molecules online.

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This page last updated April 6, 2007.