External and Central IRB Reliance Models (Using a Single IRB of Record)

Single IRB of Record Submission Process

A Central (or Single) IRB of Record is a single board that reviews research studies for multiple sites. A Central (or Single) IRB of Record can be any registered IRB that functions to review multiple sites. Regardless of the IRB providing it, centralized IRB review is one review for a number of sites. Commonly, the sponsor determines which sites are to participate and suggests or requires those sites to use the Central IRB selected to perform the centralized review. In this model, UI may serve as either the IRB of Record or relying role.  A request to serve as a relying or a lead IRB of Record can be completed via the eResearch Application (HawkIRB).  Depending on the role of the University of Iowa IRB and the study sponsor, a fee structure may apply.  Studies with an industry sponsored\initiated have a fee structure outlined in the IRB Fee memo.  Contact the HSO for additional information and fees when the University of Iowa IRB serves as the lead IRB for a federally funded study.  

When relying on an external or centralized IRB of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of record.  In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail.  However the Principal Investigator will also be required to continue to follow all University of Iowa institutional policies as well as state and local laws governing human subjects research.  The HawkIRB application is designed to capture the majority of the information necessary to identify the Human Research Protection Program review requirements and various institutional policies.  This is completed by submitting an External IRB application selecting the external IRB of record in question I.1 of HawkIRB. For IRBs not designated specifically by name in I.1, select "Other" and add the name of the IRB in the free text field.    

What do I do next?

If you are interested in pursuing human subjects research utilizing a Single IRB model, please contact the HSO as soon as possible (ASAP) to discuss the project.  There are some instances where the UI IRB can not serve as the single IRB of record or rely on an external IRB.  An example of this would be providing IRB oversight to private or non profit organizations located in a state with more stringent human subjects research state laws.  

If you have a grant proposal from a federal source requiring a sIRB (Single IRB of Record) model, complete the Pre Grant Submission Survey as soon as you become aware of the award notice.  A representative will contact you with required documentation you will need from the HSO\IRB for the sIRB portion of the grant submission. 

6/17/24: The SOP for the use of a Single or External IRB has been updated.  

A track change version reflecting the updates and a final clean version are located at the bottom of this page.  The changes include two major updates:

  • Reflection of the allowance for WCG review and approval to occur concurrent with HRPP reviews and approvals.  See the June IRB Efficiency Initiative announcement for additional details.
  • Allowance to rely on an external IRB in certain instances where an exemption determination is approved.
  • Regulatory flexibility has been applied to the IRB Reliance Agreement process.  A full reliance agreement (or SMARTIRB) reliance is no longer required in certain instances where IRB approval of certain exemption regulatory category(ies) is granted.

Review the Single or External IRB SOP at the bottom of this page for all above noted changes.  Contact the external IRB team if you have questions at uirb-external@uiowa.edu.

Great Plains Collaborative

SMART IRB - the preferred single IRB (sIRB) of record reliance model.

StrokeNet

NCI CIRB

Western IRB  (WIRB) For use as a commercial IRB

Western IRB (WIRB) as a Central IRB

Investigators seeking to use any other type of multi site central IRB or other External IRB model not previously described should contact the Human Subjects Office via email. Please refer to the guidance document below for additional details.

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