IRB Member Checklist: Noncompliance

This page provides a checklist for the determinations that must be made by the convened IRB when reviewing potential reports of noncompliance.

If the IRB Staff Reviewer or IRB chair determines that a Reportable Event may constitute serious or continuing noncompliance per campus policy, the IRB staff or IRB chair will forward the issue to the convened IRB for review.

IRB members are provided the Reportable Event via the ARROW portal, and the report is added to the IRB agenda.

After reviewing the report, the IRB must determine:
Has noncompliance occurred?
      □Yes
      □ No

If the IRB determines that noncompliance has occurred, it must then determine whether:

The noncompliance was serious
The noncompliance was continuing
If reporting to the UW-Madison Institutional Official is required
If reporting to federal agencies is required
If reporting to other campus administrative officials, as relevant, is appropriate.
If any further action is required to prevent the noncompliance from recurring, including whether any changes to the study are required, if suspension or termination is warranted, and any other corrective actions. Although not all inclusive, some examples of corrective actions that can be required are: 
  • Modifying the consent process/document
  • Requiring that current participants re-consent to participation
  • Providing additional information to past participants
  • Requiring additional training of the investigator and/or study staff
If any new information has resulted that may affect participant's willingness to participate in the study, and how that information will be disseminated to subjects.

The IRB will notify the investigator in writing of its decision(s).



Keywords:noncompliance, serious, continuing, reporting   Doc ID:57932
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2015-11-03 10:50 CSTUpdated:2019-06-10 09:48 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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