IRB Reliance Agreements

The University of Houston Institutional Review Board (IRB) may either rely on another institution’s IRB for review or serve as the reviewing IRB for another institution through an IRB Reliance Agreement. Reliance arrangements may be established between institutions or between an institution and an independent IRB.

IRB reliance is most commonly used for multi-site research studies in which participating institutions are conducting the same research protocol or procedures.

Type of Agreements

  • SMART IRB

The University of Houston is a signatory to the SMART IRB master reliance agreement. It is the preference of UH IRB to use the SMART IRB agreement as the basis of reliance for all studies where we rely on an external IRB or serve as the sIRB. For all NIH-funded research and where possible for all other research, the SMART IRB agreement will be used as the basis for reliance.

  • IRB Authorization Agreement

In cases where an institution does not meet the eligibility criteria to sign onto the SMART IRB agreement, UH may use an IRB Authorization Agreement to establish a reliance relationship with an external institution.

  • Master Agreements

UH IRB has executed broad reliance agreements with central IRBs and consortium groups. If you believe your study may fall under the scope of an existing master reliance agreement, or if you are interested in entering into a master reliance agreement with UH, please contact reliance@central.uh.edu.

Requesting Reliance Agreements

Relying on UH IRB

To request a reliance arrangement where UH serves as the reviewing IRB, first contact the UH IRB Reliance team at reliance@central.uh.edu to determine if UH is willing to serve as the IRB of Record (reviewing IRB) for other participating sites. 

A full protocol must be submitted by the UH investigator, to include procedures and personnel at all sites. The answer to Smartform Question #8 in ICON must be either “Multisite Study” or “Collaborative Study,” which will open a new Question #9, where the request for one or more IRBs to rely will be initiated.

Relying on an External IRB

Step 1: Contact reliance@central.uh.edu before submitting any materials to confirm that the UH is willing to rely on the external IRB. Completing this step first can help avoid delays.

Step 2: Once UH approval to rely has been confirmed, submit an “External” protocol through the IRB module in the ICON online system.

An abbreviated external protocol application is activated in ICON when Question #7 on the SmartForm (“Will an external IRB act as the IRB of record for this study?”) is answered “yes.”

Upload the following documents in ICON:

    • Study protocol or IRB application approved or being reviewed by the external IRB
    • Informed consent(s) and HIPAA authorizations that will be used by UH PI
    • Approval letter for the study from the external IRB
    • PI’s curriculum vitae

Throughout the IRB reliance process, the IRB team will work closely with the UH Principal Investigator and, as needed, the external IRB to complete and document the reliance arrangement.