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Impact of sIRB Mandates on Study Teams

Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research protection programs (HRPPs). But what about the study teams at institutional research sites?

Investigators and the research professionals supporting them face unique challenges in implementing sIRB mandates – challenges sometimes overlooked in the sIRB conversation.

In this blog, we review some common ways an sIRB mandate impacts an institutional study team. We also discuss strategies to help ensure study teams understand sIRB processes and institutional policies.

What is an sIRB Mandate?

In the U.S., sIRB review for research involving multiple sites (i.e., multisite research) is now required by the National Institutes of Health (NIH) and the Common Rule. Additionally, the Food and Drug Administration (FDA) is now in the process of enacting its own sIRB requirement.

sIRB review can help reduce administrative burdens for those conducting and managing the study, helping streamline processes and timelines. sIRB review also helps ensure consistent participant information at every study site and supports better data for approvals.

The institutions historically relying predominantly on local IRB review, by reviewers physically onsite at the institution, may find sIRB mandates especially challenging. However, sIRB requirements have been in place since at least 2018, and many organizations have already adapted their polices.

Cost of sIRB Review

The costs associated with sIRB review are one of the bigger surprises for research teams, especially for those with little or no experience conducting industry-sponsored trials.

IRB review fees are often not contemplated by organizations relying exclusively on local IRB review, or it may be assumed that only commercial IRBs charge fees. This is not the case.

At some organizations, the costs for operating an IRB are often baked into an institution’s overall budget (e.g., indirect cost capture), so research teams may not realize they need to include IRB costs in study planning.

Additionally, local IRBs sometimes aren’t certain of the true cost of their services, making it even more challenging to serve as a study’s sIRB. Identifying these costs is possible, though it takes some work.

This lack of knowledge becomes problematic when grant applications incorrectly budget for IRB review services, especially when it comes to other ancillary needs, including translating subject facing materials and consent forms. Study teams may find themselves scrambling for funds.

In addition to the maybe-obvious review fees, additional costs may be associated with coordination activities. If your organization will be a multicenter study’s lead site, you may also require a dedicated liaison or group to work with the other sites. Among other things, this role is responsible for getting study documentation to the sIRB from the participating sites, and similarly obtaining IRB approval materials from the sIRB and distributing to the individual study teams.

Some institutions have begun hiring dedicated staff to perform the coordinating center functions on behalf of the study team and lead site. Some sites have also begun engaging regulatory resources or “reliance experts” to handle IRB application tasks in support of and on behalf of researchers.

sIRB Reporting Requirements

Clinical trial reporting requirements can be tricky in general, and the regulations don’t always provide clear definitions or expectations (for example, noncompliance). To address such regulatory gray areas, individual IRBs have developed their own policies and requirements.

While many initiatives have sought consensus on these murky matters, a variety of IRB approaches still exist. For researchers conducting multiple studies with different sIRBs, this aspect further complicates the already challenging task of managing reporting obligations.

For example, some participating sites may have different reporting requirements than the sIRB for unanticipated problems and events. Each site (both lead and local sites) should become informed on the sIRB and local site reporting requirements.

This reporting problem may have been an impact not initially anticipated when sIRB mandates were developed. Anecdotally, some study teams have developed spreadsheets to better organize the various reporting criteria, timelines, and processes.

Local Obligations

Some assume when sIRB review is required, it eliminates site-level reviews. This is not true. Before a study can commence, many sites also must satisfy local institutional requirements, in addition to IRB approval.

Local requirements may include ancillary committee reviews like conflict of interest (COI) review, radiation safety assessment, pharmacy review, and billing and Medicare/Medicaid compliance. The institution may also require a feasibility and/or scientific review to ensure the study aligns with organizational goals and appropriate expertise is available to actually conduct the trial.

At some institutions, these local reviews were historically bundled with IRB reviews as “approvals needed before a study can start.” While technically independent of the IRB requirements, ancillary reviews can still impact review timelines.

The bundling of these initial reviews has sometimes led to criticism like “local IRBs are just too slow,” with the local IRB bearing the brunt of delays. However, since sIRB mandates are separating IRB back out from the ancillary reviews, local IRBs have gotten faster – but these other requirements have continued to impede startup schedules.

Institutions are working to improve the processes associated with these ancillary requirements so they do not unnecessarily hold up sIRB review timelines. That said, researchers should be sure to factor all local reviews and requirements (i.e., not just IRB review) into study estimates.

Selecting an sIRB

In instances where the investigator is responsible for selecting a study’s sIRB, those used to relying on a local IRB may simply assume their local IRB will be the sIRB. It’s better to confirm than assume, however, as not all local IRBs are equipped to support multiple sites.

Some IRBs may limit the number of sites they will review as sIRB, or they may choose to serve as sIRB for only certain therapeutic areas or only when a coordinating center or CRO assists in managing communications. Some local IRBs may simply decide they will not provide single IRB review.

Before committing their institution to serving as a study’s sIRB, researchers should always confirm this with their IRB or human research protection program (HRPP) office. There are often good reasons for a local IRB to limit its sIRB activities or to say no.

How Study Teams can Prepare for sIRB

At a minimum, ensure you understand which regulatory requirements apply to your multisite studies: If it falls under the Common Rule, sIRB review may be required; if it’s FDA regulated, sIRB review may be required in the near future.

Also find out whether your study’s funding source requires sIRB review in addition to any regulatory mandate – for example, many therapeutic research networks have instituted such requirements for their multisite studies.

For grant applications, be sure your budget includes IRB review fees for initial and continuing review, amendments, study closure, translations, and any other IRB submission. If you’ll serve as the lead site, factor in the coordination costs too. Some granting agencies require additional documentation regarding sIRB review, so ensure you understand all requirements – and communicate those requirements with stakeholders at your institution.

If you have questions about your sIRB obligations, it’s always appropriate to check with your site’s research administration office, regulatory team, or HRPP office. These groups should also be able to help you understand the institution’s sIRB policies.

Study teams who feel their institution is not properly prepared for sIRB requirements should start sounding the alarm now. For multicenter trials, sIRB review is becoming standard – so to get ready, there’s no time like the present.

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