sIRB Oversight for Multisite Research
Single institutional review board (sIRB) review means there is a single IRB of record overseeing all clinical trial sites participating in a multisite study.
A designated sIRB may be completely independent, or it may be associated with an institution involved in the study. Relying on an sIRB eliminates the patchwork of multiple local IRBs overseeing a single trial, reducing the administrative burden of managing multiple IRBs’ requirements and turnaround times. sIRB oversight also helps ensure consistent participant protections for the entire study.
Why do we Need sIRB Review?
Reduced Administrative Burden
Reducing the burden of managing multiple IRB requirements throughout the life of a multisite clinical trial has been cited as a key sIRB benefit in every mandate. Working with a sIRB for initial review, amendments, modifications, and event reporting takes much less time than managing such submissions with multiple IRBs with disparate requirements.
Increased Efficiency
With a single IRB overseeing all participating sites, only one review timeline must be considered during study startup, helping trials to start more quickly. sIRB oversight efficiencies continue as the trial goes on, with amendments and modifications being reviewed and implemented more quickly through a single review process.
Consistent Human Subject Protections for Multisite Studies
When all sites rely on the same IRB, participants receive consistent study information across the entire trial. The single IRB also has a better understanding of potential safety issues when it receives reports from all participating sites.
sIRB Mandates: What is Required When?
sIRB review is not always required, however there are some specific situations when it is. To be subject to an sIRB requirement, a multisite study must meet the following criteria:
- The study is subject to the revised Common Rule. This could be because:
- The study was initially approved by the IRB on or after January 21, 2019; or
- An institution determined — and an IRB or institution documented — a study initially approved under the old rule would instead be subject to the new rule
- The study is non-exempt human subjects research
- The study meets the definition of cooperative research
- The study (or a portion of it) is supported or conducted by a Common Rule department/agency
- View complete details: Revised Common Rule Criteria (45 CFR 46.114)
- Any of the following apply to the study:
- Submitted for an NIH grant application on or after January 25, 2018
- Submitted for an NIH Research & Development (R&D) contract solicitation issued on or after January 25, 2018
- Submitted for an NIH intramural research study with initial review on or after January 25, 2018
- Received initial IRB approval on or after January 20, 2020
- Transitioned the study at one or more sites to the 2018 Requirements
- Applicable for domestic sites of NIH-funded multisite studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program
- Does not apply to career development, research training, or fellowship awards
- Policy applies to domestic awardees and participating domestic sites
- Foreign sites participating in NIH-funded multisite studies will not be expected to follow this policy
- Applicants/offerors will be expected to include a plan for sIRB use in the applications/proposals they submit to NIH
- NIH’s acceptance of the plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award
- View complete details: NIH Criteria
- To be determined
- In September 2022, FDA released notices of proposed rulemaking (NPRMs) to modify regulations at 21 CFR 50.114
- This is the first step in the formal rulemaking process
- The NPRM public comment period is currently open through December 28, 2022
- View complete details: FDA Proposal
What happens if one rule applies, and one does not?
If the revised Common Rule doesn’t apply, but the NIH policy does, the study is still subject to the NIH sIRB requirement. Similarly, if the NIH policy isn’t applicable, but the revised Common Rule is, the study is still subject to sIRB review requirements.
How to Prepare for sIRB Oversight
When preparing for sIRB review, it’s important to start early. A proactive approach means fewer surprises as you begin working with the sIRB.
Investigators
- Determine the rules of the working relationship before you send your first sIRB submission
- Establishing a communication plan is one of the most important things you can do to set up your organization for success. Consider:
- What other committee requirements must be completed before research can commence
- State laws potentially impacting the research
- Unique features or – general considerations as well as concerns specific to a given study
- If you require a cover sheet for sIRB submissions, or if there’s special language to include in every informed consent form (ICF)
- Establishing a communication plan is one of the most important things you can do to set up your organization for success. Consider:
- If you know your site is going to work with an external sIRB, it may be beneficial to establish a reliance agreement in advance
- This agreement formalizes the IRB reliance relationship, and defines responsibilities for the relying institution and the IRB of record
- Communicate with your local IRB to understand the requirements when relying on an external IRB
Institutions/IRBs
- Review your IRB policies to identify necessary updates and training needs
- How your policies, procedures, and review processes impact the sIRB’s review process
- This will help to ensure sIRB oversight is conducted compliantly and in a way that meets organizational expectations
- Communicate with your research teams and share options for using external IRBs, requirements to defer IRB oversight, etc
- Instead of requiring a full local IRB submission on top of a separate sIRB submission, consider developing an abbreviated local form covering only those local requirements
- Such an approach avoids having your investigators and teams duplicate work and takes better advantage of sIRB efficiencies
More Institutions Rely on Advarra than any Other IRB
Working relationships with research institutions, academic medical centers (AMCs), and hospital systems
NCI-designated clinical and comprehensive cancer centers supported
Who works with Advarra’s IRB?
sIRB Services for Every Need
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