Compliance with HHS & FDA

The University of Illinois at Chicago (UIC) holds a Federalwide Assurance (FWA) #00000083 from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS). This FWA is an agreement between DHHS and UIC to review and approve research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46.  UIC’s Assurance is in effect through September 28, 2023.

In addition, The University of Illinois at Chicago IRB complies with the IRB registration requirements for DHHS and the U.S. Food and Drug Administration (FDA).   The IRB registration expires on May 22, 2022.  The UIC IRB registration information is as follows:

  • IRB Organization #: IORG0000080
  • University of Illinois at Chicago IRB #1 ID: IRB00000115
  • University of Illinois at Chicago IRB #2 ID: IRB00000116
  • Chicago Area Institutional Review Board (CHAIRb) ID: IRB00009693

Investigators and sponsors may verify the above information on the Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in the Last 60 Days website.

 

Compliance regarding Electronic Signatures.  The UIC IRB allows electronic signatures to document informed consent as long as the regulatory requirements under 21 CFR parts 11, 50, and 56 for FDA regulated studies and DHHS regulatory requirements under 45 CFR 46 are met.

As per 21 CFR 11.100, UIC notified the FDA of its intention to accept electronic signatures as the legally binding equivalent of the traditional hand-written signatures of individuals whose identity the UIC has verified.