How to Submit a Request to Cede IRB Review to an External IRB
Version date: January 2018 Please follow the steps below when considering submitting a request to cede IRB review to an external IRB. Except where noted, this process is the same regardless of the external IRB being used, including the NCI CIRB and independent or commercial IRBs. If you have any questions about these steps or whether relying on an external IRB is the best option for your study, please contact the HS IRBs Reliance Team. Step 1: Review the relevant guidelines for ceding IRB review to determine whether your study may qualify for review by an external IRB:
- For industry-sponsored studies: Eligibility
- For all other studies: Guidelines for Ceding IRB Review to an External IRB
- The study protocol or, if a protocol will not be used for the study, the completed IRB application. NOTE: For studies not industry-sponsored or NCI-sponsored, the protocol and/or IRB application should include UW-Madison as a study site and a description of study activities that will occur at UW-Madison. If such a description is not included and/or does not adequately describe the study activities occurring at UW-Madison/UW Health, the UW study team will need to provide that description.
- If subjects will be enrolled at UW-Madison, a copy of the proposed consent document (including assent documents and concise summaries or information sheets) that will be used at UW-Madison. If the HIPAA Privacy Rule applies to the study, a copy of the form used to obtain authorization also needs to be provided (a combined consent-authorization form is acceptable). For guidance on preparing consent and authorization forms for ceded studies, please see Preparing Consent and Authorization Documents When Relying on an External IRB Review.
- When applicable, the application will be routed to the UW Carbone Cancer Center PRMC and/or Clinical Research Unit for review, as with any application reviewed by the HS IRBs.
- Applications then undergo IRB administrative review before being assigned to a HS IRBs’ Reliance Team member for pre-review.
- A Reliance Team member will review the study protocol and/or IRB application and any consent documents to ensure they meet IRB and institutional requirements for ceding review. Pre-review comments may be sent to the study team if the Reliance Team has any questions about the request.
- After reviewing the request materials and working with the study team to resolve any outstanding issues, the Reliance Team will issue one of the following determinations:
- Reliance Accepted: This means all requirements for ceding IRB review have been met and the reliance agreement process has been completed. The UW study team can move forward with obtaining IRB approval from the reviewing IRB. Please note that the UW study team remains responsible for meeting all institutional requirements, some of which lie outside the IRB ceded review process.
- Not Engaged: This means the HS IRBs have determined that UW-Madison is not engaged in human subjects research for the study (as defined by federal guidance) and no IRB oversight for UW-Madison’s role in the study is needed. Any changes to the UW-Madison’s role in the study should be reported to the Reliance Team for assistance in determining whether IRB oversight requirements have changed as a result.
- Reliance Declined: This determination is rarely expected to be issued. In situations where ceding review may not be possible, the Reliance Team will work closely with the study team to determine the best course of action for their study, including submitting the study for review by a UW-Madison IRB.
- After receiving the reliance accepted determination letter via ARROW, the UW study team can then continue with the IRB review and approval process for the reviewing IRB for that study.
- Independent or commercial IRBs: One to two weeks, depending on whether UW-Madison is being added as a site to an IRB-approved protocol or if the protocol has not yet been IRB-approved
- NCI CIRB: One week
- Other external IRBs (e.g., other academic institutions): Two to three weeks