Selecting the Reviewing IRB

Applies to: Agreement V3.0 · SMART IRB SOPs

The institutions engaged in a study decide together which IRB will review it (Agreement §3.2). The Overall PI's institution makes the initial call on whether a reliance request is appropriate, consults the other institutions, and then has the first option to serve as Reviewing IRB; if it declines, the involved institutions decide together. Under the SMART IRB SOPs, the Reviewing IRB is identified in this order of priority:

1. The IRB designated by the sponsor, funder, or grant, or one already established by prior arrangement (for example, a network's central IRB). Where a federal agency prescribes how the Reviewing IRB is chosen (a Mandated Process), that controls.
2. The IRB of the Overall PI's home institution. It has the right of first refusal and is the default in most investigator-initiated studies.
3. Another Participating Institution's IRB, chosen for its expertise with the procedures or subject population, to avoid a conflict of interest, or because sites are unwilling to rely on the first choice.

Does the Overall PI's IRB have to be the Reviewing IRB? No. It has the first option, not an obligation.

What if the Overall PI's institution declines? Its Point of Contact decides whether the institution is willing to cede review to another IRB. If so, the POC (with the Overall PI as needed) approaches alternate Reviewing IRBs and, once one accepts, notifies the Overall PI. If not, the home IRB reviews for its own study team or the institution declines to participate, and the other sites are referred to a different Reviewing IRB. In the Reliance System this plays out as the reliance pre-check, right of first refusal, and "proposed Reviewing IRB" steps.

Can an IRB from an institution that is not in the study serve? Yes — for example, a sponsor-designated IRB, a network central IRB, an IRB chosen for expertise, or one chosen to avoid a conflict. A commercial or independent IRB that is a Participating Institution can also serve.

Can a site disagree with the choice? Yes, unless policy (such as the NIH single IRB policy) or the terms of a consortium prevent it. A site that declines to rely on the chosen IRB may use its own IRB or another Participating Institution's IRB, or decline to participate — see Sites that choose not to rely.

Can there be more than one Reviewing IRB? Yes, though a single IRB minimizes duplication. Two or more Reviewing IRBs may make sense where sites differ substantially in procedures or populations, or where some sites decline to rely on the first IRB. Each Reviewing IRB needs its own reliance request (Reliance ID) in the Reliance System.

See also

• How a reliance request moves through the system
• Sites that choose not to rely
• Consortia and designated central IRBs