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Reportable Events: Review Types & Timing

This page describes how an ED/SBS IRB Reportable Event application may be reviewed and typical timelines

Study teams must submit Reportable Event applications in accordance with campus policies (see Noncompliance and Unanticipated Problems).   For Reportable Events that also require a Change of Protocol to be submitted, study teams should allow adequate time within the standards outlined below for IRB review.

IRB Pre-Review
An ED/SBS IRB Reportable Event application is reviewed according to the ED/SBS standard operating procedures. Once an application has been pre-reviewed by the assigned Staff Reviewer, a determination will be made if the Reportable Event:
  • Does not meet the definition of an Unanticiapted Problem or Noncompliance, per campus policy
  • Can be administratively Acknowledged by the assigned Staff Reviewer (administrative errors that do not impact research participants, and are not serious or continuing as defined by campus policy)
  • Requires review by the IRB director or Chair to determine if review by the full IRB is required
The review type and timing of an ED/SBS IRB Reportable Event application can only be determined after pre-review is complete and any issues have been addressed.

See ARROW FAQ: Questions During Review to identify the assigned Staff Reviewer.

Full Review
Reportable Event applications that may require Full Review include:
  • those that constitute an unanticipated problem involving risk to participants or others
  • those that may constitute serious or continuing non-compliance
  • those involving subject populations that are considered vulnerable (prisoners, minors, participants with diminished capacity to consent, etc.), and potentially sensitive or complex situations/information.
If an ED/SBS IRB Reportable Event application has been through IRB pre-review and a determination is made that review by the full committee is required, the application will be assigned to the next available Full Review agenda.  The assigned meeting date will appear in the application workspace.

The ED/SBS IRB meets monthly to review submissions.  The Study Team will be notified via the ARROW portal, or in writing of the IRB determination, and of any corrective action required by the IRB once the meeting has occurred.

Keywords:unanticipated problem, noncompliance, new information   Doc ID:67631
Owner:Laura C.Group:Education and Social/Behavioral Science IRB
Created:2016-10-07 07:54 CSTUpdated:2021-04-19 07:29 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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