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Reliance Consultation

We provide Reliance Consultation services to help investigators initiate a SIRB model for their multisite studies. 

To facilitate this process, we communicate directly with participating site investigators, data coordinating centers, and representatives of the sites' Human Research Protection Program (HRPP).

We recognize that some institutions and sites will not have a full human research protection program. In these cases we expect at least one individual at the institution/site to help with the Human Research Protection (HRP) review. 

Get started by submitting a reliance consultation request form

  • Tell us a little about your study.

  • We will contact you to set up a time to talk.

  • We'll ask you about your project, what SIRB services you need, and make sure you know what to do next.

OUR SERVICES

HOW YOU CAN PREPARE

Reliance Consultation Meeting

This meeting is the first step in setting up a SIRB process at the UU. Even if you aren't sure about your funding or only want to get a better feel for what the UUIRB can offer, this meeting can get your started.  

You will be contacted to set up a meeting by phone or in-person. Each meeting is led by an IRB Manager experienced in SIRB processes. 

Note that this meeting should include at least one investigator on the study, as well as any key study personnel (or data coordinating center staff) involved in the regulatory process.

During this meeting, we will help you determine if UU SIRB services are a good fit and provide you with guidance on your roles and responsibilities when using the SIRB model.  You will also receive written instructions for how to move your study through the SIRB process at the UU. 

Grant Language for Single IRB

The UUIRB provides grant language describing our expertise and ability to perform SIRB review for your study. 

This language is only provided for studies that have been preliminarily accepted for UU SIRB services through a Reliance Consultation Meeting.  

 
  • Participate in a Reliance Consultation Meeting.

Single IRB Fees & Budgeting

The UUIRB charges for SIRB services and can provide you with a signed quote that can be used in a budget proposal.  If funds are awarded to your study and SIRB services commence, you will be billed at the time services are provided. 

Fee quotes are only provided for studies that have been preliminarily accepted for UU SIRB services through a Reliance Consultation Meeting.  

 
  • Participate in a Reliance Consultation Meeting.

  • In addition to the draft proposal & list of potential sites, provide the potential funding period.

Reliance Invitation Packet

The IRB Managers will work with the lead investigator to officially invite institutions to rely on the UUIRB for SIRB services.  This invitation is timed appropriately for each study, but is only sent after

  • Participating site investigators have at least preliminarily agreed to collaborate on the study
  • The protocol is ready to submit to the UUIRB for review

The reliance invitation packet is sent via email to each participating site investigator and an HRP representative at their institution.  While the IRB Managers will send initial reminders to help follow up on the invitation, it is the responsibility of the participating site investigator to ensure the institution completes all elements outlined in the reliance invitation packet.  

The reliance invitation packet includes instructions for the HRP representative, including

  • Executing an IRB reliance agreement
  • Documenting a site's reliance decision for the study
  • Providing information about the institution, the community, and HRP review components relevant to the study
 
  • Finalize the protocol.

  • Prepare the email contact information for all participating site investigators.

  • Provide contact information for HRP representatives when requested.

  • Follow-up with participating site investigators to ensure completion of requirements at each site.

Reliance Agreement Negotiation

The UUIRB prefers to utilize the SMART IRB Master Common Reciprocal IRB Authorization Agreement for reliance purposes. However, there may be some cases where a different reliance agreement will be negotiated.  The IRB Managers will work with the HRP representatives at participating sites to ensure the appropriate agreements are in place.  

Note that the University of Utah does not require agreements to include reciprocal indemnification provisions, but we will use the Letter of Indeminfication to accompany the SMART IRB Agreement when necessary for the participating site.  

 
  • Be available to help answer questions about the project and follow up with participating site investigators. 

Documenting Reliance Decisions, Institutional Profiles, & HRP Reviews

The UUIRB tries to be flexible with this documentation and accepts it from a number of different sources, including

At the UUIRB, all of this documentation ends up linked to the IRB submission in the ERICA system. 

The UUIRB requires positive confirmation of receipt of the reliance decision and the institutional profile before a participating site will receive SIRB approval.

The UUIRB does not require the HRP reviews to be reported unless there is a concern or management plan identified by the HRP. The UUIRB will require amended materials if the study is not compliant at a given site. HRPs are under no obligation to allow the study to be conducted at their site, even if SIRB approval is granted for the site.  

 
  • Instruct participating investigators to initiate their HRP reviews.  Investigators must work closely with their HRP representatives to complete the HRP review.  Every site has different processes for performing this review, so submit to the HRP according to their policy.  Provide the HRP with the information they request. 
     
  • Instruct participating investigators to follow-up with the HRP representative on submission of the reliance decision and the institutional profile. 

  • You have the option to gain an account for accessing IREx Online.  Contact the IREx Administrator for details. 

 

Last Updated: 4/7/21