IRB Assurances and Accreditations

Federalwide Assurances

University of Minnesota FWA#: 00000312
Fairview Health Services Research FWA#: 00000325
Gillette Children's Specialty Healthcare FWA#: 00004003

Expires: November 16, 2010

If you have any questions regarding the University's assurance, then please call (612) 626-5654.

About FWA

This IRB holds a Federal Wide Assurance, number 00000312 from the Office For Human Research Protection (OHRP) in the Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and the University of Minnesota and is updated and renegotiated at regular intervals. This Assurance remains in effect until 6/2/09 unless the University of Minnesota is otherwise notified.

OHRP FWA Information

Other IRB Compliance & Audits

The IRB at the University of Minnesota is in compliance with the guidelines promulgated by the International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines for IRBs.

This IRB is regularly audited by the Food and Drug Administration (FDA). At this most recent audit, completed in July 2002, no deficiencies were noted in the membership composition of the Institutional Review Board (IRB).