Selecting the Single IRB

Choosing the single IRB (sIRB) for a project is a new responsibility for UW investigators who will be the lead site or coordinating center for multi-institutional research. There are many issues to consider. For large projects or networks, choosing the sIRB may involve significant work and should be done as early in the planning process as feasible.

Who decides?

In some cases, NIH (or another funding sponsor) may specify the sIRB in the FOA or RFP funding announcement. However, for most funding opportunities, the funding agency expects the lead PI to select the sIRB, subject to the acceptance of the agency. NIH has explicitly stated that the proposed sIRB will not be evaluated as part of the peer review process and will not affect the overall assigned score of an application/proposal or the overall rating of the acceptability of the Protection of Human Subjects section.

The decision-making process should include the study leadership and HSD. HSD is the only UW office authorized to agree to IRB reliance arrangements. HSD cannot guarantee that it can commit to single IRB arrangements, including the use of the UW IRB as the sIRB, for which it has not been consulted.

What are the options?

Any IRB with a Federalwide Assurance (FWA), or federal registration can serve as a sIRB. This includes the independent IRBs such as WCG IRB and Advarra that are not affiliated with any institution that conducts research. The sIRB may or may not be affiliated with any of the institutions involved in the research. For NIH-funded research, domestic sites may only rely on domestic IRBs as the sIRB.

The UW IRB is available to serve as the single IRB for many research projects led by UW PIs. Read the UW IRB as a Single IRB for more information.

The UW PI may also select a non-UW IRB, subject to the acceptance of HSD. The PI will need to approach the proposed IRB to ensure that the IRB is willing to be the sIRB, determine whether the IRB charges fees, and obtain cost estimates for the grant budget. Consult HSD’s webpage for more information about costs.

Options for single IRB review for UW lead PIs

IRBs that do not charge fees
A NIH IRB named in the FOA or RFP you are submitting under	This means that NIH has already identified the IRB for you. Unless the FOA or RFP state otherwise, you do not need to contact that IRB before submitting your funding application and you do not need to describe IRB fees in your proposal.
An IRB specifically set up or identified for research conducted under an already established and funded research network or consortium (for example StrokeNet, PETAL Network)	This means that NIH has already identified the IRB for you. Unless the FOA or RFP state otherwise, you do not need to contact that IRB before submitting your funding application and you do not need to describe IRB fees in your proposal.
IRBs that may or may not charge fees
The IRB of one of the other institutions participating in the research	Work with the site PI to contact their IRB office to ask about sIRB review and fees.
IRBs that do charge fees
WCG IRB, a large, independent accredited IRB	To contact WCG IRB about sIRB review and obtain study-specific fee estimates: Email: Charlie Eibeler, ceibeler@wcgclinical.com Be prepared to provide some specific information about the study.
Advarra, a large, independent accredited IRB	To contact Advarra about sIRB review and obtain study-specific fee estimates: Email: institutions@advarra.com Be prepared to provide some specific information about the study.
Any other independent IRB	Contact HSD at hsdrely@uw.edu if you are interested in using another independent IRB, such as BRANY. HSD will discuss the options with you and work with you to contact the IRB and obtain fee estimates.
Fred Hutch IRB	sIRB review at Fred Hutch IRB is only available to UW Cancer Consortium PIs when the study involves only consortium sites (UW, Fred Hutch, and SCH). Contact iro@fredhutch.org to discuss the possibility of sIRB review and obtain more information about their fees.

Factors to consider

Selecting an IRB is a new responsibility for lead PIs. Depending on the size and scope of the study, you may want to consider several factors when selecting an IRB.

• The IRB’s history and reputation.
• The IRB’s capacity; for example if the study has 20+ sites, is the IRB prepared to review that number of sites quickly and efficiently?
• The IRB’s expertise in relation to the study procedures, populations or other special considerations.
• The IRB’s turnaround times. You may wish to obtain this information if a rapid study initiation is essential to the aims of the study.
• The IRB’s fees. You may wish to obtain quotes from several IRBs in order to compare costs and services.
• Your team’s familiarity with the IRB’s processes, policies, systems and forms.

HSD is available at hsdrely@uw.edu to consult about factors involved in selecting IRBs and how to approach each IRB.

How do you document the sIRB selection in your funding application?

NIH no longer requires a Single IRB Plan in the funding application for most proposals. PIs will be asked to provide the name of the selected single IRB during Just-in-Time. PIs should be careful to follow any special instructions in funding announcements for providing information about the single IRB.