Single IRB Institutional Review Board

Selecting Participating Sites (pSites) for a multisite study requires careful evaluation. Beyond assessing a site’s suitability for the research protocol, it is essential to determine its readiness to rely on a Single IRB (SIRB). Early identification of site readiness can significantly reduce delays and streamline study startup.

While all multisite research requires an assessment of a site’s infrastructure, staffing, experience, and protocol familiarity, SIRB readiness is a distinct consideration. Confirming that sites meet the administrative and regulatory requirements for SIRB reliance is critical to an efficient onboarding process.

Determining pSite Readiness

When deciding which sites to submit for IRB approval first, consider whether the site:

• Is critical to early study startup (e.g., lead site, high recruitment potential, essential facilities).
• Has its own IRB (“IRB of record”).
• Maintains an active Federalwide Assurance (FWA).
• Employs staff experienced in multisite research and single IRB processes.
• Has a strong Human Research Protection Program (HRPP).
• Has joined version 3 of the SMART IRB Reliance Agreement.
• Has prior experience participating in SIRB-governed studies.
• Has a dedicated study coordinator to manage site-specific requirements and documentation.

The University of Utah SIRB can onboard sites that do not meet all of these criteria; however, additional time and support may be required to address gaps. Engaging sites early to complete these requirements can improve efficiency.

Below is a checklist version of this guidance that can be used as a planning or tracking tool:

Single IRB Site Readiness Checklist

pSite Batching

As you consult with the SIRB during study planning, it is recommended that you group pSites based on their readiness to complete the SIRB reliance process. Categorizing sites as Ready, Nearly Ready, or Support Needed can help prioritize onboarding, allocate resources appropriately, and set realistic timelines for site activation.

SIRB Site Readiness Tracker

The University of Utah SIRB will work with you to onboard sites that do not meet every consideration listed here, but additional reliance negotiation and onboarding time will be required to address the site’s needs. You can also work with your sites early to get more of these items completed.

Supporting a Smooth Onboarding Process

To facilitate efficient pSite onboarding:

• Provide training. The University of Utah IRB offers SIRB training for the Responsible Principal Investigator (R-PI) and lead study team. The R-PI or their designee is responsible for extending this training to pSite personnel and ensuring teams are prepared to use the SIRB submission systems.
• Establish clear communication. Designate a single member of the lead study team as the primary liaison with the IRB. This individual should consolidate questions from all sites and communicate with the IRB as needed. Centralized communication helps prevent delays and inconsistencies.
• Prepare standardized templates. Develop templates for commonly used documents, including consent forms using the two-part consent model. Provide clear instructions for site-specific customization and ensure all formatting requirements are followed to avoid processing delays.
• Coordinate with local HRPPs. Sites with their own IRB or HRPP may require local submissions. Encourage site investigators to initiate these processes early and confirm completion prior to site activation.
• Understand site-specific policies. Familiarize yourself with each pSite’s requirements for reporting adverse events, confidentiality breaches, and unanticipated problems. As R-PI, you are responsible for ensuring compliance with SIRB and local policies.
• Plan for ongoing review. Track approval expiration and anniversary dates, and initiate continuing review submissions well in advance. Ensure pSites are prepared to provide required updates.
• Clarify fee payment processes. Establish procedures for prompt payment of IRB fees and provide any required invoicing details to the IRB in advance.

This proactive, structured approach to assessing site readiness and supporting pSites can significantly improve the efficiency and consistency of SIRB onboarding and study startup.