Selecting the Single IRB
This is a new responsibility for UW investigators who will be the lead site or coordinating center for a multi-site study. There are many issues to consider. See the NIH FAQ Guidance and consult with the UW Human Subjects Division (HSD) by contacting firstname.lastname@example.org.
In some cases, NIH (or another funding sponsor) may specify the sIRB in the FOA or RFP funding announcement. However, for most grants, NIH expects the lead PI to identify a specific sIRB in the grant application. Note that NIH has explicitly stated its sIRB FAQ that “The proposed single IRB 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.
What are the options?
Any IRB with a federalwide assurance (FWA), or federal registration can serve as a sIRB, if NIH has not specified the sIRB in its funding announcements. This includes the “independent” IRBs such as WIRB and Advarra that are not affiliated with any institution.
The UW IRB will not serve as the sIRB for multi-site studies for the first two years of the NIH policy except in rare cases. Instead, HSD will work with UW lead PIs (and NIH, as needed) to select from several available options.
For some of these IRBs, the PI will need to approach the IRB to:
- Ensure that the IRB is willing to be the sIRB;
- Determining whether the IRB charges fees and obtain cost estimates for the grant budget. See this HSD 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 the IRB before submitting your grant 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 the IRB before submitting your grant and you do not need to describe IRB fees in your proposal.|
|IRBs that may or may not charge fees|
|One of the Trial Innovation Network (TIN) IRBs at Utah, Johns Hopkins or Vanderbilt||These IRBs may be able to provide no-cost IRB review when the PI is affiliated with any organization associated with ITHS (UW, SCH, FHCRC, etc.). To apply for IRB review and other services and obtain information about fees, consult with ITHS.|
|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|
|WIRB, a large, independent accredited IRB that has been reviewing UW industry clinical trials for many years.||To contact WIRB about sIRB review and obtain study-specific fee estimates:
Email: Christine Eckles, email@example.com and cc Stuart Horowitz firstname.lastname@example.org
Be prepared to provide some specific information.
|Advarra, a large, independent accredited IRB||To contact Advarra about sIRB review and obtain study-specific fee estimates:
Email: Bette Bayne, email@example.com
Be prepared to provide some specific information.
|Any other independent IRB||Contact HSD at firstname.lastname@example.org 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 Hutchinson Cancer Research Center (FHCRC) IRB||sIRB review at FHCRC IRB is only available to UW Cancer Consortium PIs when the study involves only consortium sites (UW, FHCRC, SCCA and SCH). Contact email@example.com 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 the lead PI. 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 with 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 to consult about factors involved in selecting IRBs and how to approach each IRB. in some cases, HSD can contact the IRB on your behalf. Send a consultation request to firstname.lastname@example.org.
How do you document the sIRB selection in your funding application?
The Single IRB Plan in the funding proposal must name the proposed sIRB and contain a statement that each participating site is willing to rely on the proposed IRB.