Guidelines for Ceding IRB Review to an External IRB

Version: January 2017

The HS IRBs strongly support 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 described 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 HS IRBs Reliance Team about whether ceding IRB review is appropriate for their study.

NOTE: The HS-IRBs have the contracted with independent or commercial IRBs to serve as the IRB of record for most industry-sponsored trials and the eligibility criteria for those IRBs are slightly different. Please see the Central IRB Gateway for more information.

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. (IRB review for studies that qualify for exempt review is generally not ceded to an external IRB since it is often faster for the HS IRBs to review the project and some reliance agreements do not allow for ceding of exempt studies.)

While the Reliance Team 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 by the HS IRBs.

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

Studies for which IRB review cannot be ceded to an external IRB include research involving fetal tissue or embryonic stem cells. The UW-Madison does not have the authority to cede review to another IRB on behalf of the Madison VA. Any situations that may require single IRB review and involve the Madison VA will need to be discussed with the Madison VA Research Office.

NOTE: The UW HS-IRBs Reliance Team 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 institutional officials as necessary. For example, studies wherein a UW study team member has a potential financial conflict of interest relevant to the research can only be ceded to external IRBs that agree to adhere to (or be more strict than) any applicable management plan the UW has issued.

If the use of an external IRB is a requirement for participation in a study, please contact the Reliance Team.




Keywords:Multisite, Defer, deferring, deferral, oversight, IRB authorization agreement, IAA, cede   Doc ID:17758
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-03-30 19:00 CDTUpdated:2018-02-28 17:28 CDT
Sites:Health Sciences IRBs
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