Sterling IRB: Who Can Use It and How

Sterling IRB is a commercial institutional review board headquartered in Atlanta, Georgia, that reviews human-subjects research for sponsors, contract research organizations, investigators and institutions. An investigator cannot simply submit to it: for most academic studies the home institution must first agree that Sterling will be the IRB of record, usually through a reliance arrangement. This guide separates what Sterling says about itself from what an independent university page confirms, and lays out how a reliance on Sterling typically works. Everything below is as described on the official pages on 2026-10-29.

What it is and who runs it

Sterling describes itself on its own site as a company that has, in its words, helped “lead the way in protecting the rights and welfare of clinical research participants” for 30 years. The UC Berkeley Committee for Protection of Human Subjects describes it as “a commercial IRB headquartered in Atlanta, GA that provides services for academic and non-academic institutions” (as described on that page on 2026-10-29). That university page, not Sterling’s marketing, is the source for the headquarters and the commercial status.

The services Sterling lists on its homepage are central and local IRB review in the United States and Canada, informed consent document preparation, certified translation, a web portal called SilverLink, support for decentralized trials, IND safety report guidelines, and training and education. It names four audiences: sponsors and CROs, investigators, institutions (academic and hospital) and participants. The homepage does not state an owner, a registration number, a phone number or fees.

For the general concept, see CASRAI’s entries on commercial IRBs and institutional review boards.

Accreditation and how to read it

Sterling’s homepage footer carries the line “Full Accreditation – Association for the Accreditation of Human Research Protection”, and the Berkeley page states that Sterling is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Neither page gives an accreditation date or term. Accreditation of the IRB is a statement about the IRB’s own program. It does not by itself authorize your institution to rely on that IRB; that is a separate institutional decision, covered below.

Eligibility: who can use Sterling

Sterling’s homepage describes three submission pathways: new sponsor or CRO study designs, new registry study designs, and single-site or investigator-initiated studies, with a separate page for submitting a new site. Access is through the SilverLink portal, which you log into or request access to.

Whether a particular academic study may use a commercial IRB is decided by the institution, not by Sterling. As one worked example, Berkeley’s page says the following studies qualify for a commercial IRB:

industry-authored or industry-funded studies;
federally funded multisite trials where the funder has authorized payment for the IRB;
unfunded or PI-sponsored studies only if unrestricted funds are used to pay the commercial IRB’s expenses.

The same page says collaborative research with other academic institutions does not qualify, and neither does research that needs Radiation or Radioactive Drug Research Committee review. These are one university’s local rules. Another institution will set its own, so treat Berkeley as an illustration of the kind of screen that exists, not as a general rule.

What it funds or requires

Sterling is a reviewer, not a funder. Nothing on the official pages says Sterling pays for research. What it requires of a study, in practice, is an institutional pathway to its review and a way to pay for it. The official pages do not state Sterling’s fees, so this guide does not quote any. For how commercial IRB charges generally work, see CASRAI’s guide to IRB approval cost.

The Berkeley page adds that Sterling is a SMART IRB signatory, that reliances are set up through SMART IRB’s Letter of Acknowledgement (LOA), and that the University of California has no master agreement with Sterling. In other words, at that institution the reliance is built study by study through the SMART IRB mechanism rather than under a standing system-wide contract.

Application and compliance steps

Sterling’s own instruction is short: to submit a new study, log into or request access to SilverLink. The institutional steps that come before that vary. The Berkeley page describes a five-step sequence for commercial IRBs generally, which is a useful template for what to expect on the generic commercial-IRB path:

Confirm that the institution has an agreement with the commercial IRB.
Submit a Request for Authorization of Services and a conflict-of-interest checklist to the campus human-subjects office.
The office obtains the institutional clearances that apply, such as conflict of interest, biosafety, laser safety and the contract.
The office issues a Letter of Clearance.
Only then submit the study to the commercial IRB.

Sterling is handled differently at Berkeley. Because Sterling is a SMART IRB signatory, the reliance is documented through the SMART IRB Letter of Acknowledgement (LOA), and Berkeley’s page says steps 3 and 4 (the institutional clearances and the Letter of Clearance) do not apply when Sterling is used. Other institutions may set up Sterling differently, so confirm the local process with your own human-subjects office.

Because the institution still holds the regulatory commitment to protect participants, check how it documents its designation of an outside IRB. CASRAI covers that background in obtaining and renewing a Federalwide Assurance and in the comparison of FWA and IRB registration.

Typical timeline phases

No calendar dates apply, and the official pages publish no turnaround commitments beyond Sterling’s marketing statements. Sterling’s homepage advertises a 5-day protocol review, a 24-hour site review and 24/7 support. Those are Sterling’s own claims, not independently confirmed figures, and what they count as the start and end of a “review” is not defined on the page. The phases a study moves through are:

Institutional authorization phase: funding screen and request for authorization of services. On the generic commercial-IRB path this also includes clearances and a Letter of Clearance; at Berkeley those two steps do not apply when Sterling is used.
Reliance phase: executing the SMART IRB Letter of Acknowledgement where the institution requires it.
IRB review phase: submission through SilverLink and Sterling’s review.
Site activation phase: new sites are added through Sterling’s separate new-site submission.

Common mistakes

Applying the generic clearance sequence to Sterling without checking. At Berkeley the clearance and Letter of Clearance steps do not apply when Sterling is used, because reliance runs through the SMART IRB LOA. Ask your own office which steps apply, and do not skip the reliance arrangement.
Treating accreditation as authorization. AAHRPP accreditation describes the IRB’s program. Your institution still decides whether it will rely on that IRB for your study.
Assuming a master agreement exists. At Berkeley there is none with Sterling; the SMART IRB LOA is used instead. Ask whether your institution has a standing agreement or builds each reliance separately.
Reading advertised speeds as guarantees. The 5-day and 24-hour figures are Sterling’s marketing statements.
Using it for a study that does not qualify. Unfunded studies with no authorized payment source can fail the institutional funding screen.

Related programs

Option	What it is
Sterling IRB	Commercial IRB in Atlanta, GA serving academic and non-academic institutions; AAHRPP-accredited and a SMART IRB signatory, per the Berkeley page (as described on 2026-10-29).
Institution’s own IRB	The board run by the research institution; reliance on an outside IRB is an institutional choice, as the Berkeley page shows (see IRB).
Single IRB (sIRB) of record	One IRB of record reviews a multi-site study on behalf of all participating sites, as an alternative to each site using its own board (see central and single IRBs).
Other commercial IRBs	Sterling is one of several; CASRAI has a separate entry for Advarra IRB.

FAQ

What is Sterling IRB?

A commercial institutional review board based in Atlanta, Georgia, that provides ethics review for academic and non-academic institutions, per the UC Berkeley human-subjects page as described on 2026-10-29.

Is Sterling IRB accredited?

Sterling’s homepage displays a full accreditation logo and the Berkeley page states AAHRPP accreditation. Neither page gives an accreditation date or term.

Can an academic investigator use Sterling IRB?

Sometimes. The institution decides. At Berkeley, industry-funded studies and some federally funded multisite trials qualify, and collaborative academic research does not.

How do I submit a study to Sterling?

Through its SilverLink web portal, after any clearance your institution requires. Sterling lists pathways for sponsor and CRO studies, registry studies, and single-site or investigator-initiated studies.

How much does Sterling IRB cost?

The official pages do not state fees. Request a quote from Sterling and confirm who pays under your institution’s rules.

Sources

Sterling IRB homepage, https://www.sterlingirb.com/, checked 2026-10-29.
UC Berkeley Committee for Protection of Human Subjects, “Commercial IRB” page, https://cphs.berkeley.edu/commercialirb.html, checked 2026-10-29.