HUMAN RESEARCH PROTECTION PROGRAM

Office of the Vice President for Research

UM IRBs are Registered with FDA and OHRP

 

The University of Michigan's Institutional Review Boards (IRBs) have successfully registered with the Food and Drug Administration (FDA) in compliance with the new FDA rule issued on July 14, 2009. The rule requires all U.S. IRBs reviewing clinical investigations involving FDA-regulated products to register with the FDA. The 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.

IRBs are required to renew registration every three years, or sooner if contact information changes. IRBs do not provide specific protocol numbers as part of the registration process or routinely update registration information with the current number of active protocols under review. IRB registration does not represent accreditation or certification by the FDA or OHRP. The agencies do not provide certificates confirming an IRB's registration.

Registration information can be accessed via OHRP's online database.