Examples of emergency situations include (but are not limited to):

• A serious, research-related unanticipated problem that requires immediate IRB attention
• “Emergency use” (i.e., treatment) of a patient with an agent unapproved by the FDA when that treatment must commence within 24 hours
• Enrollment of a ward of the state on a study approved under 45 CFR 46.406 or 407.
• Enrollment of a patient who is also a prisoner onto a research trial (when the study has not been previously approved under the prisoner regulations and certified with OHRP). See “Subject Incarceration” guidance for more information.
• Health and well-being reasons to continue a research intervention on a subject who becomes incarcerated (when the study has not been previously approved under the prisoner regulations and certified with OHRP). See “Subject Incarceration” guidance for more information.

Additional Resources

NCRC Maps and Directions webpage

The University of Michigan Registrations with FDA and OHRP

• Registration Name and Number: U of Michigan, IORG0000144  
• UM Federalwide Assurance (FWA) #00004969

The University of Michigan's Institutional Review Boards (IRBs) are registered with the HHS Office of Human Research Protections and, in compliance with the new HHS Food and Drug Administration (FDA) rule issued on July 14, 2009, with FDA.

FDA’s new requirement operates in coordination with the Office for Human Research Protections (OHRP), which already requires registration for IRBs reviewing federally-supported research.  A single database of all U.S. IRBs, regardless of whether they review research regulated by FDA or other federal agencies, has been established.

Registration information can be accessed via the HHS Registration page. In the search field "Institution/Organization" enter "U of Michigan" to verify UM registration.

If you have any questions about this information please contact the IRBMED Office.

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