Single IRB

“Our experience has enabled us to develop a collaborative, streamlined Single IRB service that is consistent with NIH Policy.”

Linda Reuter, CIP
Director, BRANY IRB

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Our Single IRB (sIRB) service offers a robust, proven infrastructure that ensures regulatory compliance while delivering exceptional customer support.

Meet NIH Expectations for Single IRB Review
Our fully AAHRPP-accredited Single IRB supports organizations in meeting the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. With over 20 years of experience in multi-site and local research studies, we provide an expert solution for your IRB needs.

IRB Reliance Agreements Coordination
We ensure IRB reliance agreements are established with all sites relying on our IRB for review. As a participant in the SMART IRB initiative, we utilize the SMART IRB Agreement to streamline reliance between our IRB and other institutions.

Efficiency & Flexibility
Our efficient and adaptable IRB review process includes:

IRB meetings twice weekly
Expedited daily reviews for qualifying submissions
Notification of IRB decisions within 2 days of meetings
Formal communication of IRB decisions within 5 days

Our solutions-oriented IRB team is dedicated to helping clients achieve their research goals while complying with regulatory requirements.

Connected IRB Model
Our Connected IRB Model ensures institutions stay informed and connected to their research programs. Features include:

Email alerts for investigators and research coordinators
Alerts for critical trial concerns, such as unanticipated problems involving risks

Expert Committee & IRB Staff
Our IRB committee comprises members from leading academic medical centers, supported by experienced IRB Administrators. Clients gain access to IRBManager™ for seamless online study submission and management.

Privacy Board
BRANY IRB can also serve as the Privacy Board, ensuring compliance with the HIPAA Privacy Rule for research involving protected health information.

Frequently Asked Questions
Get answers to common questions related to single IRB services.

What is a single IRB?

In 2018, the NIH policy on the Use of a Single IRB for Multi-Site Research became effective. The policy required NIH-funded multi-site research studies involving non-exempt human subject research to use a single IRB for ethical review and IRB oversight. As a result of the launch of this NIH policy, the term “single IRB” began to be utilized when referring to the “one IRB” identified to review research studies funded by NIH that involved multiple participating sites. The single IRB is charged with reviewing the overall research study, including the protocol, informed consent, if applicable, and all related research materials, as well as reviewing research applications for each participating study site.

The Revised Common Rule, which went into effect in 2019, included a single IRB mandate that U.S. institutions engaged in cooperative research rely on a single IRB to approve the portion of the research conducted in the U.S.

Sometimes the terms “single IRB” and “central IRB” are used interchangeably.

Why is the use of a single IRB important?

The rationale for shifting to the single IRB model included the need to:

Reduce duplicative reviews when multiple IRBs are reviewing the same research project
Reduce delays with study startup
Reduce administrative burden for investigators and study sponsors
Enhance the consistency of IRB review and oversight across all study sites

What is the FDA single IRB mandate?

In an effort to harmonize FDA regulations with the Common Rule, the FDA issued a Notice of Proposed Rulemaking in September 2022 that would require any institution located in the U.S. participating in FDA-regulated cooperative research to rely on review and approval by a single IRB for that portion of the research that is conducted in the U.S., with some exceptions. This proposal has not yet been finalized by the FDA.

What factors should be taken into consideration when selecting an IRB to serve as the single IRB for a multi-site research study?

Universities, academic medical centers, industry sponsors, and CROs may all be in need of selecting a single IRB (also known as a central IRB) for a multi-site research study. Factors to consider include:

Years of experience processing multi-site research studies
Therapeutic area expertise
Accreditation history
Staff certification and experience
Site network
Electronic submission system in place
Timelines
Processes and procedures