SIRB Implementation Plan for Study Teams: Step 1
Develop Your SIRB Strategy
When the University of Utah serves as the single IRB (SIRB) for your study, we offer several support services to help you secure initial IRB approval for your study, and then IRB approval for your Participating Sites (pSites). This guidance will walk you through each step of our startup process for lead study teams using the University of Utah as their SIRB.
For Step 2, go to Timelines & Milestones Meeting.
Step 1a: Reliance Consultation
This step will help you connect with the IRB and start building a good foundation for your study.
First, submit a Reliance Consultation Request form. This is the IRB’s intake form that gets your study in our queue, assigned to a point of contact on the SIRB Reliance Team, and gets the conversation started. On the Consultation Request form, there’s a place for you to request a fee quote. Make sure you request a quote – the University of Utah IRB charges fees for services when we are serving as the single IRB for multisite research.
Your assigned Reliance Reviewer will send you the fee quote and any other support materials you have requested via email. The fee quote includes a Supplement with important information about what services our fees cover. We may schedule a conference call to chat about your study plans and introduce ourselves.
If you are in the early stages of obtaining funding and need language about single IRB review for your grant application, you can find our recommended grant application language on our website. If you need a letter of support or Just-in-Time documentation as part of the grant application process, we can also help you with that.
Begin the consultation process by submitting a Reliance Consultation Request Form. Even if you aren't sure about your funding or only want to get a better feel for what we can offer, this meeting will get you connected with a member of our SIRB Reliance Team.
Step 1b: Site Assessment
While you wait to hear back about funding, you can start assessing your Participating Sites (pSites). Make a list of the sites you will invite to participate in your research and begin determining how “ready” the site is to be onboarded for IRB approval. We have a page on our website to help you with this, and a tool called a Site Readiness Tracker where you can begin your sites assessment.
Step 1c: Study Confirmation
After you have your funding secured and you are certain the study is moving forward, its time to contact the IRB again. Let us know that you have received your funding and are ready to move forward with IRB approval. Be ready to provide the IRB with some key information:
- The official title of the study. You should also have a final (or almost final) version of the study protocol ready, and a template for your consent document started. We can provide you with a template and guidance for preparing your consent template.
- Who will serve in key roles for the lead study team. The Responsible Principal Investigator (R-PI) and at least one Lead Study Manager are essential, other roles (e.g. site PIs) can be defined later.
- A list of your planned study sites. Its okay if the list isn’t finalized yet, but it helps the IRB plan workload commitments for supporting your study if we know how many pSites you will have. If you’ve completed your Site Readiness Tracker, send it to us.
When you have this information ready, we will send you our Scope of Work Agreement for review/signature and schedule a “Timelines & Milestones Meeting”. Learn more about this in the next step.
Your "Step 1 To Do List"
- Submit a Reliance Consultation Request
- Get SIRB Fee Quote and review the Fee Quote Supplement Handout
- Include SIRB Grant Language in your Grant Application
- Secure your Notice of Award (NOA)
- Request Just-in-Time documentation from the IRB, if required by your grant officer.
- Assess Your Participating Sites (pSites) and Complete a Site Readiness Tracker
- Select who will be the study’s Responsible Principal Investigator (R-PI) and Study Manager(s)
- Contact your IRB Reliance Reviewer after Funding is Secured to Begin Step 2
Frequently-Asked Questions
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Responsible Principal Investigator (R-PI):
The investigator at the local institution who is responsible for overseeing the conduct of the study at their site. The R-PI for an SIRB study is responsible for overseeing the study at all participating sites, ensuring compliance with institutional policies, applying and local requirements, maintaining appropriate study oversight, and serving as the primary point of contact between the study team, the reviewing IRB, and institutional stakeholders.Key responsibilities may include:
- Ensuring local study activities comply with institutional requirements.
- Overseeing study staff and research conduct at the site.
- Coordinating with the reviewing (single) IRB regarding local context information and reportable events.
- Maintaining required regulatory and study documentation.
When the University of Utah is the SIRB for your research, the R-PI must be well-versed in how to use our electronic IRB application submission system (“ERICA”), as well as the IRB Reliance Exchange (IREx). The R-PI or their designee are responsible for training their personnel and participating sites in how to use these resources, as well.
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Study Manager:
This is the individual responsible for coordinating the administrative and operational aspects of the study's IRB reliance activities. The Study Manager supports the R-PI by preparing submissions, tracking approvals, coordinating communications among participating sites, and maintaining study records related to the single IRB arrangement.Key responsibilities may include:
- Preparing and submitting reliance and IRB documentation.
- Coordinating communications with the reviewing IRB and participating sites.
- Tracking approval statuses, continuing review requirements, and study modifications.
- Maintaining study regulatory files and documentation.
When the University of Utah is the SIRB for your research, the R-PI must be well-versed in how to use our electronic IRB application submission system (“ERICA”), as well as the IRB Reliance Exchange (IREx). The R-PI may designate the Study Manager as responsible for training their personnel and participating sites in how to use these resources, as well.
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IRB Reliance Reviewer:
This is an institutional IRB or Human Research Protection Program (HRPP) representative who evaluates and facilitates reliance requests involving a single IRB. The IRB Reliance Reviewer assesses proposed reliance arrangements, confirms institutional requirements are met, and serves as a liaison between the institution and the R-PI.Key responsibilities may include:
- Reviewing requests to rely on or serve as a reviewing IRB.
- Assessing local institutional requirements and regulatory considerations.
- Coordinating execution of reliance agreements when applicable.
- Providing guidance to investigators regarding reliance processes and institutional expectations.
- Assisting with navigation through the IRB approval process.
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Participating Site Principal Investigator (pSite PI):
The investigator responsible for the conduct of the research at a Participating Site (pSite) that is relying on the reviewing single IRB (SIRB). The pSite PI oversees study activities at their local site, ensures compliance with local institutional and regulatory requirements, and works with the Responsible Principal Investigator (R-PI), Study Manager, and reviewing IRB to support study oversight.Key responsibilities may include:
- Leading and overseeing research activities at the participating site.
- Ensuring study staff are appropriately trained and qualified.
- Complying with local institutional policies and ancillary reviews.
- Providing local context information and site-specific study details as needed.
- Reporting events, protocol deviations, and other required information through established SIRB processes.
- Maintaining required regulatory and study documentation for the participating site.
For Step 2, go to Obtain SIRB Approval.