What is an sIRB and Why Does my Study Need One?
For decades, many research sites have primarily relied on institutional review board (IRB) oversight provided by committees administered by the local institution conducting the research. Additionally, IRBs administered by independent organizations have always been an option for research sites who do not administer their own local IRB.
Recently, federal requirements have shifted to require most multisite clinical trials rely on a single IRB (sIRB) for oversight at all participating sites. This eliminates the patchwork of multiple local IRBs overseeing a single trial, instead channeling every site to an sIRB overseeing participant protections for the entire study.
Why the Shift to sIRBs?
When the human subject protection regulations were originally established, clinical trials primarily took place at academic institutions. At the time, it made sense to establish IRBs locally to oversee the research conducted at each institution.
However, research conduct has evolved since then. In addition to institutional sites, we also now have 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, especially for industry-sponsored trials. 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.
One way to increase startup efficiency is to have as many sites as possible relying on the same single IRB. By doing so, this reduces the administrative burden of managing disparate reporting requirements for multiple IRBs. For example, any time there’s an amendment, the sIRB will 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, who began pushing for greater research efficiencies internally and with their partners. More commercial and unaffiliated sites also 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 oversight’s value in increasing efficiency and reducing administrative burden.
Subsequent sIRB Initiatives
In 2016, National Institutes of Health (NIH) announced its Single IRB Policy, requiring domestic awardees and domestic sites conducting NIH-funded multisite research to move to a single IRB 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.
Single IRB (sIRB) vs Central IRB (cIRB) – What’s the Difference?
Relying 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.
As soon as you determine you’ll be relying on an sIRB, you should put a reliance agreement 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, and while it is not required for all relationships, it is a best practice to have an agreement in place.
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.
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 submission processes, local requirements, and submission procedures will help ensure the right people are informed throughout the process and keep research moving forward.
Benefits to sIRB Oversight
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 oversight 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 organization knowing an organization with the appropriate policies, procedures, and expertise are conducting IRB reviews.