Collaborative Research and IRB Reliance Basics

Version date: March 2015

If your project or study involves collaboration with any sites and/or personnel outside the UW-Madison/UW Health/Madison VA then it is considered to be multisite research and IRB reliance issues will need to be addressed. Study teams conducting multisite or collaborative research should become familiar with IRB requirements for such studies, including what information needs to be included in the IRB application and protocol as well as how to address IRB reliance issues.

The IRB issues raised by collaborative research and IRB reliance requirements are often complex. To assist study teams in addressing these issues, the HS-IRBs office has a Reliance Team consisting of staff members with expertise in collaborative research and IRB reliance agreements. Please contact the Reliance Team if you have any questions regarding IRB requirements for collaborative research or IRB reliance agreements.

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Overview of IRB Requirements Collaborative Research

Whether additional IRB requirements apply to multisite /collaborative research often depends on whether an external site or personnel are engaged in human subjects research. UW-Madison relies on the federal guidance on engagement in research to determine whether IRB oversight for external sites or personnel is required and, if so, what IRB reliance mechanism to use to ensure oversight is in place. Study teams are encouraged to review the resources below to help determine what additional requirements may apply to their study and to contact the Reliance Team with any questions.

Tips for Completing IRB Applications for Multisite/Collaborative Research Studies

Study teams conducting multisite/collaborative research need to ensure that both the study protocol and the IRB application address the roles and activities of all external sites and/or personnel. The HS IRBs require that all multisite/collaborative research studies have a protocol, which must include information about how the study activities will be coordinated. Study teams are strongly encouraged to review all of the documents below when preparing their application materials to help ensure the review process goes smoothly.

IRB of Record Issues and Collaborating with Non-UW Researchers

In some cases, UW-Madison may agree to serve as the IRB of record for an external site or individual engaged in human subjects research as part of a study reviewed by a UW-Madison IRB. Please review the guidance below for information on when the HS or MR IRB may agree to serve as the IRB of record. For instructions on how to submit an IRB of record request, please see the FAQ below.

Relying on Another IRB

In some cases, the UW-Madison may cede IRB oversight to a non-UW IRB, particularly when the involvement of UW-Madison personnel is limited (e.g., data analysis). Studies eligible for review through an existing IRB reliance partnership also may qualify for review by a non-UW IRB. Please see the guidelines and FAQ below for additional information on when the HS-IRBs will consider ceding IRB review as well as how to request review by a non-UW IRB. NOTE: The HS-IRBs have the contracted with the Western IRB (WIRB) to serve as the IRB of record for most industry-sponsored trials. Please see the WIRB Gateway for more information.

Other Reliance

Keywords:WIC, Meriter, IRB of record, Defer IRB review, foreign, international, IIA, IAA, individual investigator agreement, irb authorization agreement, FWA, federalwide assurance, multicenter, multi center, federal wide assurance, multi site, multi-site, engagement in research, collaboration, WIC consent, WIC consent template agreements rely cede other university universities, Single IRB, Central IRB, External IRB   Doc ID:21707
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-12-13 11:28 CDTUpdated:2016-09-12 10:47 CDT
Sites:Health Sciences IRBs
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