External IRB - Reliance Agreements

 

What is a Reliance Agreement?

A Reliance Agreement is a formal agreement that allows an institution engaged in research to delegate or cede IRB oversight of a research study or group of studies to an independent IRB or IRB of another institution.  Different terminology may be used to describe the arrangement covered by a Reliance Agreement:

  • Reliance Agreement
  • Central IRB
  • Single IRB (sIRB)
  • IRB Authorization Agreement (IAA)
  • Defer IRB oversight
  • Rely on an external/central/single IRB

     

Procedures to Request Reliance on an External IRB 

At OUHSC, researchers may be permitted to rely on a non-OU or external IRB upon request. These determinations are made on a case-by-case basis by the OUHSC IRB, HRPP and appropriate University officials.

University Investigators should contact the OUHSC HRPP as soon as possible to request reliance on an external IRB before initiating any agreements. Upon receipt of the request:  

  1. The HRPP will send you a form to complete regarding the proposed research and the external IRB.
  2. Return the completed form to the HRPP for evaluation.
  3. The HRPP will notify you of the determination.
  4. Attach the HRPP determination and the external IRB’s reliance agreement to an existing ticket in SoonerTrack for processing by ORA. 

     

Responsibilities of the OUHSC Investigator Following Approval:  

  1. Once the Reliance Agreement is executed by ORA, investigators must submit the individual study/studies into iRIS as an External IRB Application.
  2. Research activities cannot begin until the OUHSC investigator has received an OUHSC HRPP Acceptance Letter (via iRIS), final approval from the external IRB, and confirmation of the finalized signed contract (if applicable).
  3. All changes to key study personnel, conflicts of interest or other local context changes not covered by the external IRB must be submitted to the OUHSC HRPP via iRIS for administrative review and acceptance. 
  4. The External IRB or study coordinating center may require additional forms for you to complete, including information asking about local context. The OUHSC HRPP is available to assist you with these forms.