If you would like to request that we serve as the SIRB for your study, or if you would like to request that we rely on an external SIRB, please begin by submitting a Reliance Consultation Request form.
What Happens After I Submit a Consultation Request?
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Team Review After you submit a Reliance Consultation Request, a member of the SIRB Reliance Team will review your request. We may contact you for more information or to schedule a conference call to discuss the details of your request. Please allow at least three (3) business days to process your request form. |
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Make a Plan Your assigned Reliance Reviewer will help make a plan to complete the IRB process. |
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Keep in Touch If you would like to send us more information, or attachments we may need to consider your request, you can send them to our Team email address at: uuirbreliance@utah.edu. Once your request has been assigned to a member of our team, send all correspondence related to your request directly to them instead. |
The University of Utah as Your SIRB
We are willing to consider serving as the single IRB (SIRB) for multi-site research on a case-by-case basis. If you are interested in using the UU SIRB for your research, the first step is to submit a Reliance Consultation Request form.
About the University of Utah Single IRB
The University of Utah IRB has vast experience applying the regulations and policies of the Common Rule, FDA, HIPAA, Veterans Affairs, and the Department of Defense. The IRB oversees more than 7,000 active human research projects, including clinical trials and related biomedical research, social and behavioral sciences research, and research involving all vulnerable populations described in the Common Rule and related regulatory guidance. The IRB has particular expertise for reviewing molecular and genetic research using biospecimens and data.
The UU SIRB is one of the leading developers of the SIRB process for academic and local institutions. We have been at the forefront of designing and evaluating SIRB methodology through empirical evidence and experience (See: Publications). The University of Utah IRB serves as the SIRB for many multi-site trials, with up to 40 participating sites per trial. The IRB has also served as a SIRB for several research networks, including the Trial Innovation Network designated by the National Center for Advancing Translational Sciences (NCATS).
The University of Utah has an active Federal-wide Assurance (FWA) with the Office for Human Research Protections (FWA00003745). The University
of Utah IRB adheres to 45 CFR Part 46 (Common Rule); 21 CFR Parts 50 and 56 as well
as other parts of 21 CFR as appropriate for clinical investigations regulated by the
Food and Drug Administration (FDA); the principles of the International Conference
on Harmonization’s Good Clinical Practice (ICH-GCP) to clinical investigations, as
adopted by the FDA; and the HIPAA Privacy Rule. The IRB also has a vast experience
applying the regulations and policies of Veterans Affairs and the Department of Defense.
The IRB oversees more than 7,000 active human research projects, including clinical
trials and related biomedical research, social and behavioral sciences research, and
research involving all vulnerable populations described in the Common Rule and related
regulatory guidance. The IRB has particular expertise for reviewing molecular and
genetic research using biospecimens and data.
The University of Utah Institutional Review Board has Full Accreditation by the Association
for Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
The UU SIRB has a dedicated team of experienced staff who consult with study teams, provide guidance and education on these processes, help with system access and troubleshooting, and handle all aspects of reliance agreement negotiations.
The University of Utah has joined the SMART IRB Master Authorization Agreement, allowing for a streamlined SIRB reliance process with the more than 1000 institutions who have also joined. The IRB has an established process for engaging with site investigators and HRPP representatives in order to secure IRB reliance and approval for each participating site. Use of the University of Utah IRB as a SIRB provides investigators with access to the ERICA Online System, an electronic system that streamlines submission, review, communication, and documentation for studies. Additionally, investigators have access to a comprehensive SIRB consultation process for navigating issues related to study design, methods, and consent documentation for multi-site studies.
If you would like to request that the UU IRB serve as the SIRB for your study, please begin by submitting a Reliance Consultation Request form.
Relying on an External Single IRB
We are willing to rely on an external SIRB on a case-by-case basis. The University of Utah has long been supportive of the single IRB (SIRB) effort and has successfully worked with many SIRBs around the country for more than six years.
If you would like to request that the UU IRB rely on an external SIRB for your study, please begin by submitting a Reliance Consultation Request form.
OUR SERVICES |
HOW YOU CAN PREPARE |
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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. |
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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. |
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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. |
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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
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
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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. |
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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. |
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