UW-Madison Single IRB Review (sIRB) Matrix

July 2019

The sIRB Matrix describes the options available to UW-Madison researchers for identifying an appropriate sIRB for multi-site or collaborative research projects. The options available depend on the type of funding, UW-Madison’s role in the study, and other factors. Generally, UW-Madison will have right of first refusal for retaining IRB oversight of multi-site research where UW-Madison is prime awardee for any funds supporting the project and/or is the home of the lead investigator. For studies where UW-Madison is not a prime awardee, the entity that is the prime awardee will typically determine which organization will provide sIRB services.

For non-exempt studies with more than 10 sites or include sites outside of Wisconsin that do not have an IRB or HRPP (human research protection program), consultation with a UW-Madison IRB office is encouraged to determine if an independent (commercial) IRB would better serve the researcher’s needs, including the study’s review timeline.

UW-Madison IRBs will consider serving as the sIRB for non-exempt studies in the following cases (please see sIRB Matrix for more details):

  • Federally funded studies: UW-Madison is either the prime awardee and/or lead investigator or participating site.
  • Private, for profit funded studies (including industry sponsors): UW-Madison is the lead site or the only academic partner on the project AND the funder does not have or is not contracted with another IRB.
  • Unfunded studies: UW-Madison is the lead site.

In all cases, UW-Madison will NOT charge fees to serve as the reviewing IRB.

Study teams should note that when using an independent (commercial) IRB for a study subject to NIH sIRB Policy, NIH will most likely pay IRB fees as direct costs. See guidance here.

Researchers are encouraged to contact the Reliance Team (irbreliance@wisc.edu) as soon as they become aware that sIRB may be required or preferred for their research study or program. The Reliance Team can assist researchers in identifying the best sIRB option for their study as well as facilitate securing any necessary approvals and agreements.

Keywords:Multisite, irb of record, external personnel, collaborators, site, IAA, IIA, irb authorization agreement, rely   Doc ID:92647
Owner:Monica E.Group:Health Sciences IRBs
Created:2019-06-24 11:32 CSTUpdated:2019-06-25 10:43 CST
Sites:Health Sciences IRBs
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