This section of the Reliance Manual covers follow-on submissions for the reviewing IRB and UW-Madison.

To Reviewing IRB

After the reviewing IRB approves UW-Madison as a study site, it is primarily responsible for ongoing IRB oversight. This means that, apart from the exceptions noted in the section below, you do not need to report most follow-on submissions to the UW-Madison IRB. Although specific requirements may vary by IRB and you will need to work with the lead study team to understand those, general reporting parameters are:

  • Continuing review
    • If your study requires continuing review, the lead study team is responsible for collecting from you any information the reviewing IRB requires for the continuing review application (e.g., enrollment numbers, subject complaints).
    • Neither continuing review information nor approval need to be provided to the UW- Madison IRB.
  • Changes
    • All changes that affect UW-Madison’s role in the study (e.g., revised study documents, changes in recruitment plans) need to be submitted by the lead study team to the reviewing IRB. The lead study team should work with you when preparing such a change.
  • Reportable Events/Reportable New Information
    • Reportable events should be reported by the lead study team to the reviewing IRB. You generally do not need to submit these to the UW-Madison IRB unless the reviewing IRB determines the event to be severe or the reviewing IRB requires you to report the event to us.
    • If the reportable event is of sufficient severity (e.g., serious noncompliance, unanticipated problem that poses substantial risks to subjects) and/or requires assistance from UW-Madison (e.g., post-approval monitor) to assess, the reviewing IRB is likely to reach out to RELIANT and we will follow up with you regarding next steps.
  • Study Closure
    • When the study is complete at UW-Madison, you should submit a closure report here, even if the study remains open at other sites.

To UW-Madison

When UW-Madison has ceded IRB oversight to an external IRB, that reviewing IRB generally reviews all changes, continuing reviews, and reportable events for that study. This means you generally do NOT need to submit follow-on submissions (except as described below) for ceded studies. Different IRB reliance agreements and reviewing IRBs, however, may require that certain submissions be reviewed by the UW-Madison IRB. RELIANT can assist you in determining whether any additional reporting is needed.

No fees are charged for UW-Madison review of follow-on submissions for ceded studies. All follow-on submissions that need reporting to UW-Madison also need to be submitted to the reviewing IRB. The reviewing IRB may charge fees for these follow-on submissions and commercial IRBs will always charge for such submissions. You are responsible for finding out what fees may be charged by the reviewing IRB.

Follow-on submission that need to be submitted to or completed at UW-Madison include:

  • Changes
    • Change in PI
    • Updates to study team members (via the self-service personnel update activity)
    • Addition of new funding sources
    • Changes in conflict of interest management plans
    • Protocol or documents affected by state law or institutional policy (e.g., fetal tissue, adding HIV testing, new HIPAA authorization document)
    • New sub-study
    • New consent documents
    • Changes to consent documents that alter UW-Madison’s required institutional language. Please see HRP 502c-TEMPLATE-Institutional Consent Language for those areas of the consent document that must use UW-Madison’s language.
  • Continuing Review
    • All continuing reviews for ceded study are submitted to and reviewed by the reviewing IRB. No UW-Madison submission is required.
  • Reportable Events
    • The UW-Madison IRB has no standing requirements for when reportable events for ceded studies should be submitted apart from the following:
      • Post-approval monitors (at UW-Madison or elsewhere) request an event be reported to the UW-Madison IRBs
      • The reviewing IRB requires an event be reported to the UW-Madison IRB
      • An event occurs of such severity or significance (e.g., serious and/or continuing noncompliance, an unanticipated event that poses substantial risks to subjects or others) that the UW-Madison IRB will be assisting the reviewing IRB in addressing the event
  • Study Closure
    • A study closure must be submitted to both the reviewing IRB and the UW-Madison IRBs when a ceded study is completed.