When to Submit Changes and Reportable Events for Ceded Studies

When UW-Madison has ceded IRB oversight for a study to an external IRB, that reviewing IRB generally reviews all changes and reportable events for that study. This means UW study teams generally do NOT need to submit changes or reportable events for ceded studies for review by the HS IRBs. Different IRB reliance agreements and reviewing IRBs, however, may require that certain submissions be reviewed by the HS IRBs. This document describes the limited cases when UW study teams should expect to submit changes and reportable events for ceded studies. Please note, however, that the IRB reliance regulatory landscape is in flux and these requirements will be adjusted as needed to reflect any changes to those requirements.

Changes

  • Types of changes:

    Most IRB reliance agreements require relying institutions to retain responsibility for reviewing certain types of changes. As a result, study teams should submit the following types of changes for ceded studies for review by the HS IRBs:

    • Addition of study team members or change in Principal Investigator (PI)
    • Addition of new funding sources
    • Changes in conflict of interest management plans

  • Review process and fees:

    All changes for ceded studies will be reviewed administratively by HS IRBs staff and do not require IRB review. In the case of personnel changes, for example, the UW-Madison is required to provide some reviewing IRBs with confirmation that the research team members are qualified to perform study activities and have completed required trainings (e.g., human subjects protection, Good Clinical Practice) as well as communicate any applicable management plans related to conflicts of interest. No fees are charged for changes reviewed by the HS IRBs for ceded studies.

Reportable Events

  • Types of reportable events:

    The HS IRBs have no standing requirements for when reportable events for ceded studies should be submitted and of which study teams need to be aware. Importantly, however, study teams may be asked to submit a reportable event in the following situations:

    • Post-approval monitors request an event be reported to the HS IRBs
    • The reviewing IRB requires an event be reported to the HS IRBs
    • An event occurs of such severity or significance that the HS IRBs will be assisting the reviewing IRB in addressing the event

  • Review process and fees:

    The review process for a reportable event for a ceded study will depend on the nature and severity of the event being reported. No fees are charged for reportable events reviewed by the HS IRBs for ceded studies.



Keywords:ceded, multi-site, CPs, REs, COI, fees   Doc ID:79961
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2018-02-07 15:45 CSTUpdated:2018-02-07 15:46 CST
Sites:Health Sciences IRBs
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