Reliance Consultation Services
The Reliance Consultation 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 UU IRB can offer, this meeting will get you 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: 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.
How you can prepare
- Prepare a draft version of your proposal.
- Prepare a list of potential sites & investigators.
- Review the Reliance Consultation Checklist.
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.
How you can prepare
- 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.
How you can prepare
- 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.
How you can prepare
- 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 Indemnification to accompany the SMART IRB Agreement when necessary for the participating site.
How you can prepare
- 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:
- The SMART IRB Online Reliance System
- The IREx Online System
- The UUIRB Online Forms
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. HRPPs are under no obligation to allow the study to be conducted at their site, even if SIRB approval is granted for the site.
How you can prepare
- 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.