IRB Guidance: Ceding IRB Review

This page addresses the ceding of IRB oversight to an external (non-UW Madison) IRB and describes what type of research is eligible for review by an external IRB.

The ED/SBS IRB strongly supports the use of single IRB review models to streamline the IRB review and approval process for multisite and collaborative research.  This includes ceding IRB review to an external IRB for eligible studies, as describe below.  All decisions regarding whether IRB oversight can be ceded to an external IRB are made on a case-by-case basis.  Study teams are encouraged to consult with the ED/SBS IRB Office about whether ceding IRB review is appropriate for their study.

What research is eligible for review by an external IRB?
  • Studies for which use of an external IRB is a requirement of the sponsor or funding agency for participation in the study.
  • Multisite or collaborative research studies that qualify for expedited or convened IRB review and are not otherwise ineligible as described below.
While the ED/SBS IRB will make every effort to ensure IRB review for eligible studies can be ceded to an external IRB, reliance arrangements cannot always be reached with the proposed external IRB and the study will then need to be reviewed the ED/SBS IRB.  It is recommended that researchers consult with the proposed external IRB to confirm it is willing to accept the responsibility of acting as the reviewing IRB prior to submitting a request to cede IRB review.

What research is NOT eligible for review by an external IRB?

Studies for which IRB review will not likely be ceded to an external IRB include:
  • Protocols where the funding is coming directly to UW-Madison or where the grant/contract specifies that UW-Madison will act as the reviewing IRB.
  • Research where a UW-Madison study team member has a potential financial conflict of interest relevant to the research and the proposed external IRB does not agree to adhere to (or be more strict than) any applicable management plan the UW has issued.

  • Research that qualifies for exempt review.
NOTE:  The ED/SBS IRB is acting on behalf of the institution and thus has the authority to decline ceding IRB review to an external IRB for any new research protocol and may consult with the institutional officials as necessary.

How to request ceding IRB oversight to another institution

If a collaborating site has agreed to serve as the reviewing IRB for a multi-site project, and appears to meet the eligibility criteria outlined above, the PI should submit a Request to Cede IRB Review application in ARROW. To do so, when you click start a new ARROW application select "IRB Application" and then select "Request to Cede IRB Review" and complete the application form.

If IRB oversight is ceded to another institution, UW-Madison personnel must be listed as Study Team members on the approved study of the institution accepting IRB oversight.

Once a determination is made that ceding IRB oversight is appropriate, an IRB Authorization Agreement (IAA) or other written agreement* will be needed to document the reliance agreement.

*UW-Madison is a participating member signed on to the SMART IRB Master Reliance Agreement, which can serve in place of an IAA if both institutions are signed on and agree to use SMART IRB for reliance.  If considering using SMART IRB for reliance on a collaborative project, please contact the ED/SBS IRB office for further instructions prior to submitting an application in ARROW when possible.

See also:

HRPP Policy: IRB Reliance
IRB Guidance: Research and Sponsored Programs (RSP) Release of Grant Funds When Studies are Ceded to Another Institution's IRB for Review and Approval
IRB Guidance: UW-Madison Acting as IRB of Record




Keywords:IRB oversight, ceding, cede, deferral, defer, IRB Authorization Agreement, IAA, IRB of record, collaborative project, collaborating site, multi-site, external IRB   Doc ID:67619
Owner:Laura C.Group:Education and Social/Behavioral Science IRB
Created:2016-10-06 14:37 CSTUpdated:2018-10-16 13:32 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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