The Food and Drug Administration’s (FDA) impending single Institutional Review Board (sIRB) mandate will streamline clinical trial processes by requiring multi-site studies to partner with one IRB reviewer. Taking proactive steps to implement a central IRB and understanding best practices for identifying and preparing sites will ensure a smooth transition to an sIRB process.
On Oct. 15, 2024, WCG experts Matthew Staves and Cristin MacDonald presented the webinar, “Maximizing the Power of Central IRBs Prior to the FDA’s sIRB Mandate.” The panelists provided an overview of the impending sIRB mandate, discussed strategies for streamlining clinical trial processes to meet the new requirements, and shared how the role of site selection fits into the picture. Live questions submitted by the audience were addressed, summarized below.
- When the sIRB becomes mandatory, how will WCG work with local IRBs? Is there no role for local IRBs?
WCG already has decades-long experience working with local sites and their IRBs. In fact, we have contractual relationships with 3,600+ institutions and have supported 300K+ sites. You can review our partnerships with sites and institutions here. At many institutions, local IRBs have taken on numerous ancillary roles, such as overseeing conflict of interest issues, ensuring training, managing reliance agreements, etc. However, they will not have a role of reviewing proposed research as the IRB of record under the sIRB requirement.
- If a study currently utilizes a central IRB and local IRBs, do sponsors need to switch to an sIRB model once the sIRB mandate is implemented?
Sponsors already have the ability to determine what IRB(s) they want to utilize for a given trial. A sponsor can change the IRB during the course of the study, but this could be complicated and require obtaining agreements from research leadership at sites.
- Under the sIRB mandate, how will “local language” requirements of universities be handled? Or will the central IRB’s informed consent form (ICF) be the template?
In general, the central IRB-approved ICF template will be the one used at all sites. However, WCG has decades of experience working with sites to incorporate site-level language where appropriate, such as local risk injury language. Discover our vast partnerships with sites and institutions here.
- How will this impact ongoing studies, especially if the ongoing study is using multiple IRBs?
The sIRB rule would not be applied retrospectively. This rule would be applied going forward after a transition period. Ongoing studies would be allowed to continue as they were originally approved.
- Will non-federally funded studies need to utilize an sIRB when this transition happens? Specifically, will sponsor-funded studies be required to use an sIRB?
The rule will apply to multi-site studies in the United States (US) regulated by the FDA.
- How do we expect the sIRB requirement to impact sites using their local IRBs?
Sites would need to agree to use the sIRB as a condition of participation in a multi-site, FDA-regulated trial, or they would need to opt out of the study.
- Will the sIRB requirement be for just US sites or will there be a global impact?
This will only apply to US sites with limited, not-yet-specified exceptions.
- Will sponsors have to choose one central IRB? Or can they have more than one for a study? We currently have two central IRBs for one study.
If the regulation has language identical to the Common Rule, then the requirement will be one sIRB per multi-site clinical trial. It is possible that the FDA will allow sponsors to select more than one sIRB for large trials, but we won’t know until the actual rule is published.
- Will sites that like to use a local IRB still be able to require their local IRB to review prior to central IRB submission? Will reliance agreements still be required?
Until the final rule is published, one can only speculate, but if it mirrors the Common Rule, there is no provision or requirement for local IRB review. The Office for Human Research Protections (OHRP), which implements the Common Rule, discouraged local IRB review in addition to sIRB review as the goal of the rule was to reduce burden by simplifying IRB review. There can only be one IRB of record for a site and adding local IRB review can create confusion.
- What might IRB review/approval look like under the new rule? Is the expectation that local IRBs and other central IRBs may still exist in a multi-center study and the chosen central IRB will liaise between the sponsor or those IRBs? Or will there only be two layers: the sponsor and one central IRB?
The regulation will be written in a way where the sponsor identifies a central IRB and works directly with them. Local IRBs will not have a role in reviewing, approving, or otherwise acting as the IRB of record.
- How will the sIRB mandate affect reliance agreements when you have an IRB for oversight? Will reliance agreements still be required for sites with local IRBs?
There would be no change. Reliance agreements can be executed as needed and sites/institutions can have active agreements with multiple external IRBs. Sites with local requirements for a reliance agreement or a Federalwide Assurance (FWA) may still require a reliance agreement.
- What happens if sites still have local IRBs?
Sites can retain their local IRBs, and many institutions will do so. However, for multi-site, FDA-regulated research, sites/institutions will need to rely on an sIRB chosen by the sponsor, as they already do for research funded by the National Institutes of Health (NIH).
- Currently, if the sponsor requires an sIRB, and the site agrees to use the sIRB, some sites still use their local IRB after the sIRB approval. Doesn’t this create duplicative work and cause delays in study timelines?
It certainly can create duplicative work and can cause delays! When the Common Rule was revised, the OHRP was clear that the intent was to not have additional site-level IRB reviews for these reasons. It is not clear how the FDA will enforce the regulation.
- Are there penalties in place for sites that do not comply with the mandate?
It is not clear how the FDA will enforce the sIRB regulation, but, in general, the FDA can issue sites or local IRBs a form 483 at inspection or a warning letter.
Looking Ahead
Preparing now for the sIRB mandate enables you to maximize the benefits of a central IRB and avoid last-minute adjustments to meet the upcoming requirements. Understanding the process of identifying the right sites is essential for the success of your studies. Take proactive steps today to elevate clinical trial efficiency.
Have more questions? Connect with a WCG expert.
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