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IRB Assurance & Registration Information

On July 14, 2009, the new Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations requiring registration of institutional review boards (IRBs) that were published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358) went into effect. The Office for Human Research Protections (OHRP) IRB registration system is compatible with the requirements of both the HHS and FDA regulations. To access the assurance and registration information for the University of Utah IRB, please visit the OHRP Database for Registered IORGs & IRBs, Approved FWAs and enter the University Assurance number.

Statements of Regulatory Adherence

GCP ADHERENCE LETTER

Signed statement of adherence to federal regulations & ICH-GCP.

 
FDA INSPECTION HISTORY

Signed statement regarding the IRB's FDA inspection history.

 
GCP ADHERENCE POLICY

Explanation of the IRB's adherence to Good Clinical Practice GCP- ICH E6.

 
E-SIGNATURE POLICY

Memo regarding the ERICA System Electronic Signature Policy.

 

University of Utah IRB Registration

Assurance: FWA00003745 - U of Utah
IORG: IORG0000072 - U of Utah
Panel 1 ID: IRB00000104 - U of Utah IRB #1
Panel 2 ID: IRB00000105 - U of Utah IRB #2
Panel 3 ID: IRB00000106 - U of Utah IRB #3
Panel 4 ID: IRB00000107 - U of Utah IRB #4
Panel 5 ID: IRB00006644 - U of Utah IRB #5
Panel 6 ID: IRB00007857 - U of Utah IRB #6
Panel 7 ID: IRB00008865 - U of Utah IRB #7
Panel A ID: IRB00012049 - U of Utah IRB #8 - A
Panel B ID: IRB00012079 - U of Utah IRB #9 - B
Panel C ID: IRB00012834 - U of Utah IRB #10 - C
Expiration Date: OHRP Registration:   11/16/2025
FWA:                            06/17/2025

Affiliated Institutions with a Current Memorandum of Understanding (MOU)

  • Biofire Diagnostics (formerly Idaho Technology)
  • Intermountain Health Care
  • Shriners Children's Hospital - Intermountain
  • VA Salt Lake City Health Care System

Please note: Associated Regional & University Pathologists (ARUP), Eccles Institute of Human Genetics, Huntsman Cancer Institute, Moran Eye Center, and all other centers and clinics managed by University Health Care and all main campus departments are considered affiliated with the University of Utah and do not require a separate MOU.

Accreditation History

  • AAHRPP Accreditation: The University of Utah Institutional Review Board has the Full Accreditation by the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
    • The University of Utah IRB achieved initial full accreditation by AAHRPP on June 15, 2007.