Improved Ceded Review Process FAQ

Starting February 17, 2018, ARROW will be updated to include a new application and review process for studies ceded to another IRB. These changes are being made to:

  • Help reduce administrative burden for researchers by streamlining the review process for studies ceded to an external IRB (regardless of the type of IRB);
  • Allow the UW-Madison to comply with recent changes to NIH policy and revisions to the Common Rule; and
  • Expand the number of commercial or independent IRBs that can be used by the research community.

While this FAQ covers the most significant changes to the ceded review process, researchers are encouraged to contact the Health Sciences IRBs Reliance Team with any questions.

What changes are being made to the ARROW application?

  1. The application type page for non-ceded projects is being revised to remove three application types:

    • Commercial (e.g, Western) IRB submission
    • National Cancer Institute Central IRB (NCI CIRB) facilitated review
    • Request for deferral of IRB oversight

    Instead, study teams will now submit a new form for ceded projects.
  2. The new application has been revised to remove questions no longer needed for review process and to better collect information that is required in order to cede IRB review. The overall length of the application is shorter than non-ceded projects but largely unchanged compared to the current deferral application.

What project type should I use when requesting review by an external IRB?

The Request to Cede IRB Review to an External IRB should be used for all requests to cede IRB review, including for the NCI CIRB and commercial or independent IRBs (e.g., Quorum, WIRB). The revised ceded review application replaces the former commercial IRB and NCI CIRB application types.

What changes are being made to the review process for ceded studies?

No changes are being made to the initial review process for requests to cede a study to an external IRB. As is currently the case, a member of the HS IRBs Reliance Team will review the application and work with the study team to complete the ceded review process for eligible studies. (Eligibility criteria for commercial or independent IRBs can be found here; criteria for all other studies can be found here.) The only difference in the initial cede process is that study teams will receive a formal letter from the IRB confirming IRB oversight for the study has been ceded to an external IRB.

After a study has been ceded to another IRB, the study will remain “active” in ARROW. This will allow study teams to submit changes and reportable events when needed. Currently, ceded studies do not remain active in ARROW and that can make it challenging for study teams to update funding or personnel as the need arises. Please see When to Submit Changes and Reportable Events for Ceded Studies for information on when a change or reportable event may need to be submitted.

Why may study teams need to submit changes and reportable events for ceded studies?

When a study is ceded to an external IRB, that IRB generally reviews all changes and reportable events for that study. That said, a change may need to be submitted in ARROW in situations such as the following:

  • Changes in personnel, which most reliance agreements require the relying institution to provide input on
  • Addition of new funding sources, which may be needed for Research and Sponsored Programs to formally link a funding source with an IRB action at the UW-Madison
  • Some IRBs still require changes to be submitted to relying institutions (to obtain local context information) even though the UW-Madison does not require this

Although expected to be rare, study teams may need to submit a reportable event for a ceded study in situations such as the following:

  • The reviewing IRB requires an event be reported to the HS IRBs, even if the UW-Madison does not require such reporting
  • An event occurs of such severity or significance that the HS IRBs will be assisting the reviewing IRB in addressing the event

Please see When to Submit Changes and Reportable Events for Ceded Studies for information on when a change or reportable event may need to be submitted.

Will I need to submit a continuing review for ceded studies in ARROW?

No. Although study teams may need to submit a continuing review application to the IRB reviewing the study, no continuing review application will be required at UW-Madison for the ceded study, as is currently the case. As a courtesy, ARROW will send study teams an annual reminder of responsibilities for ceded studies, but no action is required on the part of the study team. After a ceded study has been active for five years, study teams will have the option of letting the study close or renewing it for another five years via a very short activity form in ARROW. This process is similar to one currently used for exempt studies and does NOT require IRB review or a replacement application.

How will studies already ceded to an external IRB be affected by these changes?

Studies already ceded to an external IRB will not be affected by these changes and may continue to follow the review process already in place for those studies.



Keywords:ceded, cede, Reliance, multi-site, ceding, multisite   Doc ID:79643
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2018-01-24 17:50 CDTUpdated:2018-02-07 17:47 CDT
Sites:Health Sciences IRBs
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