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.
- 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
- 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.
- 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
- 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