Commercial IRB

A commercial IRB (also called an independent IRB) is an Institutional Review Board that operates as a standalone, for-profit or non-profit business providing human-subjects ethics review as a paid, fee-for-service function -- rather than as an internal department of the university, hospital, or research institution whose studies it reviews. It is registered with OHRP and, for FDA-regulated research, meets the same 21 CFR Part 56 requirements as any other IRB; the distinguishing feature is organizational independence and a client-billing relationship with the sites and sponsors it reviews for, not a lower regulatory bar. Commercial IRBs (WCG/WIRB and Advarra are the two largest in the U.S. market) are frequently designated as the single IRB (sIRB) of record for multi-site trials, but sites also route single-site industry-sponsored studies to a commercial IRB even when no sIRB mandate applies -- typically because the sponsor requires it, the site has no local IRB, or the site's own IRB lacks capacity or relevant expertise for the study type.

ByCASRAI Editorial Board

· Last updated 18 Jul 2026

Worked examples

Is an instance

A biotech sponsor running a Phase II oncology trial at 40 unaffiliated community oncology practices designates a commercial IRB as the single IRB of record; every site relies on that one review under an IRB Authorization Agreement instead of each practice standing up its own IRB.

Is an instance

A small private clinic with no institutional IRB of its own contracts with a commercial IRB on a per-study, fee-for-service basis to obtain ethics review for an industry-sponsored device trial -- the clinic has no in-house alternative.

Is an instance

A device manufacturer's protocol requires all participating sites to use its named commercial IRB rather than each site's local IRB, as a condition of the sponsor's study budget and timeline, even at large academic medical centers that have a fully functioning institutional IRB of their own.

Looks similar, but isn't

Not an instance

A university's own Institutional Review Board, staffed by university employees and funded through the university's operating budget rather than per-review client fees, reviewing a faculty investigator's federally funded study -- this is an institutional IRB, not a commercial IRB, even though it may also serve as the sIRB of record for a multi-site study led from that university.

Not an instance

An academic medical center's central IRB reviewing studies on behalf of its own affiliated network of hospitals and clinics -- organizationally still part of the parent institution, so it is a central/single IRB by function but not a commercial IRB by structure.

A commercial IRB (also called an independent IRB) is a standalone Institutional Review Board that provides human-subjects ethics review as a paid service, rather than functioning as an internal department of the university, hospital, or research institution whose studies it reviews. The two largest commercial IRBs in the U.S. are WCG (WIRB-Copernicus Group) and Advarra; both review protocols for academic and non-academic sites nationwide on a fee basis, typically billed to the study sponsor.

The distinction is organizational, not regulatory. A commercial IRB is subject to the same rules as an institutional IRB: registration with the Office for Human Research Protections (OHRP) under 45 CFR 46 Subpart E, operation under an institution’s Federalwide Assurance (FWA) or its own, and — for FDA-regulated research — the same IRB requirements under 21 CFR Part 56 as any other board. See IRB/REC Approval Process for what a review covers regardless of which type of board performs it. Many commercial IRBs also hold accreditation from AAHRPP, the same voluntary accreditation institutional IRBs pursue.

Why sites and sponsors use a commercial IRB

Three situations commonly send a study to a commercial IRB instead of a site’s own institutional board:

No local IRB exists. Many community hospitals, private practices, and standalone clinical trial sites have no institutional review infrastructure of their own and rely on a commercial IRB for every study, as a standing arrangement rather than a one-off.
The site is one of many in a multi-site trial. Under the NIH single-IRB (sIRB) policy and comparable requirements elsewhere, a multi-site study needs one IRB of record rather than a separate review at every participating site. Sponsors frequently name a commercial IRB as that single IRB of record precisely because it has no organizational tie to any one participating site, and every site then relies on that review through an IRB Authorization Agreement or a mechanism like SMART IRB.
Sponsor requirement or capacity/turnaround. A sponsor’s protocol may specify a named commercial IRB as a condition of participation, or a site’s own IRB may lack the review capacity, meeting cadence, or subject-matter familiarity a given study needs — commercial IRBs generally review a higher volume of industry-sponsored protocols and can offer faster, more predictable turnaround for standardized study types.

Commercial IRB vs. institutional IRB vs. central/single IRB

These three terms describe different things and are easy to conflate:

Institutional IRB describes organizational placement: an IRB that is a department of the university, hospital, or research institution it serves, funded through that institution’s budget rather than per-review client fees.
Commercial IRB also describes organizational placement, but the opposite structure: a standalone entity that reviews for many unaffiliated clients on a fee-for-service basis.
Central IRB / single IRB (sIRB) describes a functional role — the one IRB designated to review a multi-site study on behalf of every participating site — and says nothing about organizational type. A central IRB can be a commercial IRB, or it can be an academic medical center’s own institutional IRB acting for its affiliated network. Most large-scale multi-site sIRB arrangements in industry-sponsored trials happen to use a commercial IRB, which is why the two get conflated, but the sIRB role does not require independence from any institution — only a single point of review that every site agrees to rely on.

Cost is a related, frequently raised distinction: commercial IRB fees are billed per review action or per study/site and vary by IRB and study type, with no federal fee schedule or cap, whereas an institutional IRB’s cost is typically absorbed into the institution’s overhead rather than itemized to individual studies.

Use in your systems

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Schema.org DefinedTerm (JSON-LD)

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