For decades, many research sites have primarily relied on institutional review board (IRB) oversight provided by committees that are administered by the local institution conducting the research. IRBs administered by independent organizations have long been an option for research sites who do not administer their own local IRB. They’re also an option for all other types of sites to reduce internal burden and potentially help decrease study startup timelines.
Recently, federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for oversight at all participating sites, specifically for any multisite research receiving support from the U.S. government. This eliminates the patchwork of multiple local IRBs reviewing a single trial, instead channeling every site to an sIRB reviewing for participant protections for the entire study.
In addition, the FDA has issued a draft rule indicating their goal of requiring sIRB review for all studies falling under the FDA purview (including any clinical trials involving experimental products – drugs, devices, etc.). While there is no current timeline for implementation of this new rule, many institutions are actively working to determine how to manage these studies moving forward.
What is an sIRB?
Single IRB review (also sometimes known as central IRB review) means a single IRB of record reviews for all clinical trial sites participating in a multisite study.
While central IRB review has been an option in the U.S. for decades, in recent years, the practice has become required for many organizations who fund or support clinical research.
The sIRB movement seeks to streamline a critical research process and reduce administrative burdens while maintaining appropriate participant protections.
Why Does my Study Need an sIRB?
When the human subject protection regulations were originally established, clinical trials primarily took place at institutions and academic medical centers, with few (if any) trials conducted at independent research sites. Due to the regulations governing human subjects research, these institutions established IRBs locally to review the research conducted at their own institution.
In recent years, research conduct has evolved to also include commercial or unaffiliated sites, which might or might not have a local IRB to rely on. Commercial sites in particular are set up to conduct only research activities, compared to sites adding research activities to existing clinical responsibilities.
All research is moving toward more streamlined conduct because of factors such as costs and competition. Because of this, sites can choose to rely upon any IRB their sponsor or contract research organization (CRO) designates.
A CRO’s Role in sIRB Review
A CRO is tasked with facilitating the operational aspects of the research on behalf of the trial’s sponsor, assuming the sponsor’s regulatory compliance obligations (21 CFR 312.52). Sponsors expect CROs to utilize their expertise so the trial is conducted as responsibly and efficiently as possible.
In recent years, CROs and study sponsors are having all sites (or as many as possible) rely on the same sIRB. By doing so, they reduce the administrative burden of managing disparate reporting requirements and submission systems/processes for multiple IRBs.
For example, any time there’s an amendment, the sIRB can handle it for all sites, rather than submitting the amendment to several IRBs through their individual processes, portals, review timelines, etc. This ensures efficient startup, and ensures amendments are efficiently and consistently introduced across all sites and participants.
The Rise of Central IRBs
In the later years of the 20th century, CROs proliferated and competed to improve study timelines for their sponsor clients. Sponsors also began to push for greater research efficiencies internally and with their partners. More commercial and unaffiliated sites then entered the research field, and central IRBs began playing a larger role.
Within the last two decades, institutions began to establish relationships with external IRBs for a few reasons, including to:
- Make their programs more competitive for sponsored research
- Augment internal resources
- Expand bandwidth
- Replace dismantled local IRBs
In 2006, the FDA published guidance making it clear the agency supports the use of centralized IRB review, paving the way for future regulatory actions. The guidance emphasizes sIRB’s value in increasing efficiency and reducing administrative burden.
Subsequent sIRB Initiatives
In 2016, the National Institutes of Health (NIH) announced its Single IRB Policy, requiring domestic awardees and domestic sites conducting NIH-funded multisite research to move to an sIRB of record. The revised Common Rule mandated sIRB oversight for cooperative research, effective January 2020.
Signed into law in 2016, the 21st Century Cures Act suggested centralized IRB review as a way for the U.S. government to reduce “duplication of effort” in human subject protections. It also removes “local” from “IRB” in the device regulations, another step to enable sIRB review. FDA’s 2022 NPRM may be considered a response to the Act’s requirement to harmonize FDA regulations with the Common Rule.
Single IRB (sIRB) vs Central IRB (cIRB) – What’s the Difference?
How to Rely on an sIRB
When relying on an sIRB, there are certain policies and processes organizations should consider establishing to support a collaborative and compliant working relationship.
Reliance Agreement
As soon as you determine you will rely on an sIRB, each site and the sIRB should work to establish a reliance agreement, if one isn’t already in place. This helps define responsibilities between the sIRB and the institution conducting research.
Establishing a reliance agreement lets them understand each other’s priorities and obligations, brings stakeholders together to discuss, and allows institutions to understand what’s worked for other institutions and how they can maximize their relationship with their sIRB.
A reliance agreement is required for Federalwide Assurance (FWA)-holding institutions to rely on another (or external) IRB. While this is not required for all relationships, it’s best practice to have an agreement in place.
Communicate Effectively
Almost as important as the reliance agreement is your communication plan with the sIRB. This benefits both parties since everyone is working toward doing things correctly and efficiently while maintaining compliance.
Effective communication goes beyond establishing a plan. Institutions need to be comfortable going to their sIRB for any questions they have, whether that’s clarification about a decision or to request meeting minutes. It’s important to remember this relationship should be collaborative and transparent for all stakeholders.
Communicate Internally
After the sIRB working relationship is established, the rest of the institution’s research team should be trained on sIRB policies and processes. Making sure everyone understands the local requirements and submission processes and procedures will help keep the right people informed throughout the process and move research forward.
Benefits to sIRB Review
Partnering with an sIRB provides significant benefits to sites and sponsors:
- For sponsors, they are assured the research will be reviewed and conducted under a single IRB review framework, and ongoing reviews and amendments will be processed with speed and precision.
- For sites, there can be a tangible decrease in staff workload, as well as reduced risk to the institution in knowing an organization with the appropriate policies, procedures, and expertise is conducting IRB reviews.
Note: This article was originally published on July 21, 2022, and has been updated to include new and clarifying information.
