Advarra IRB

Advarra is one of the largest commercial IRBs operating in the United States, and one of the two most commonly encountered by research administrators alongside WCG (WIRB-Copernicus Group) — a separate, competing commercial IRB company, not a related or merged entity. Because Advarra appears so frequently as a named central IRB in multi-site trial documentation, sponsor contracts, and site reliance agreements, it is worth understanding both as a specific company and as a concrete instance of the broader commercial-IRB and central-IRB/sIRB concepts already covered elsewhere in this dictionary.

Corporate history

Advarra was formed in November 2017 through the merger of two previously independent commercial IRBs, Chesapeake IRB (Columbia, Maryland) and Schulman IRB (a New York-based board operating since 1983). In February 2019, Advarra expanded further by acquiring Quorum Review IRB, another established independent IRB. The combined entity operates today under the single Advarra name and also provides Institutional Biosafety Committee (IBC) review and broader research compliance services alongside its core IRB business. Advarra is privately held; researchers and administrators generally do not need to track its ownership structure to work with it, since its regulatory obligations as an IRB do not change with ownership.

What Advarra reviews, and under what authority

Advarra is subject to the same regulatory framework as any other IRB, commercial or institutional: registration with the Office for Human Research Protections (OHRP) under 45 CFR 46 Subpart E, operation under a Federalwide Assurance (FWA), and — for FDA-regulated research such as drug and device trials — the IRB requirements of 21 CFR Part 56. Being a commercial entity changes who pays for review and how the board is organized; it does not lower or alter the substantive review standard a protocol must meet. Advarra holds full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the same voluntary accreditation many institutional IRBs pursue. See IRB/REC Approval Process for what a review covers regardless of which board performs it.

Advarra as a central IRB (sIRB) for multi-site trials

Advarra’s most common role in large industry-sponsored and NIH-funded research is serving as the central IRB, or single IRB of record (sIRB), for a multi-site study — the one IRB designated to review a protocol on behalf of every participating site, rather than each site convening its own separate review. This is the arrangement the NIH sIRB policy requires for qualifying domestic multi-site studies, and it is also common practice in industry-sponsored trials independent of any NIH funding, where a sponsor’s protocol simply names a commercial IRB as a condition of every site’s participation.

When Advarra serves as the sIRB, participating sites do not stop having obligations — they rely on Advarra’s review rather than duplicating it. That reliance is formalized through an IRB Authorization Agreement or, increasingly, through a standing mechanism like the SMART IRB Reliance Agreement, which lets a site adopt a single master reliance framework instead of negotiating a bespoke agreement for every study and every relying institution. Local matters — informed consent administration, local-context review, and reporting of local unanticipated problems — typically stay with the site even when the substantive protocol review sits with Advarra. Advarra can also act as a site’s local IRB of record on a standing basis for sites, such as many community hospitals and standalone research clinics, that have no institutional review infrastructure of their own.

Advarra, commercial IRB, and central IRB / sIRB: three related but distinct concepts

These terms are easy to conflate and worth distinguishing precisely, since research administrators encounter all three in the same sentence of a protocol or reliance agreement:

• Advarra is a specific company — one particular commercial IRB provider, among several (WCG being the other most frequently encountered).
• Commercial IRB is the general organizational category Advarra belongs to: any standalone IRB that reviews protocols for unaffiliated clients on a fee basis, as opposed to an institutional IRB that is a department of the institution it serves.
• Central IRB / single IRB (sIRB) is a functional role, not an organizational type: the one IRB designated to review a multi-site study for every participating site. A central IRB can be commercial (Advarra, WCG) or institutional (an academic medical center’s own IRB acting for its affiliated network) — Advarra frequently fills this role but the two concepts are not synonyms.

In practice, a study document that says a site is “relying on Advarra as central IRB” is really invoking two separate facts at once: which specific board is doing the review (Advarra), and what functional role it is playing (central/single IRB for the study). Understanding the distinction matters when a site later needs to relate to a different sponsor’s study that uses a different commercial IRB, or a different NIH-funded study where an academic medical center itself serves as the sIRB — the mechanics of reliance are the same functional pattern even though the specific board changes.