Thursday, June 27, 2024

The External IRB SOP has been updated.  A track change and clean version can be found on the External/Central IRB Reliance Model page of the HSO website.  The two major changes are:

  • Updates to the WCG process in connection with the June IRB Efficiency Initiative (EI) rollout  
  • IRB Reliance agreement flexibility
    • Formal Reliance agreements will no longer be required for research determined to meet a standard regulatory exemption category of review under the first six exemption categories (§45CFR46.104). 
    • There are a few exemption determinations that require a limited IRB review.  A reliance agreement will be required only in these instances.

An external IRB submission is still required in HawkIRB for any external IRB review and approval.  This submission is required for institutional tracking purposes.  The University of Iowa remains responsible for ensuring local context issues are addressed prior to the initiation of the research. The Human Subjects Office (HSO) serves as the Human Research Protection Program (HRPP) hub to facilitate these reviews.  The University of Iowa remains responsible for all research conducted by or with University of Iowa faculty, staff, or students regardless of IRB of record. The external IRB submission materials must clearly reflect extension of IRB oversight to University of Iowa research related activities. If it does not, a IRB-01 or IRB-02 exemption application will be required.  If you have questions, contact the external review team at