IRB Guidance: Reportable Events

This page provides guidance as to when a Reportable Event should be submitted to the IRB.

Reportable Events are generally issues of Noncompliance or an Unanticipated Problem (investigators are also required to report to the IRB any new information that may impact the determination of minimal risk. Those reports are rare, but would also be submitted via the Reportable Event application.)

Noncompliance is defined as the failure to follow:

(1)  federal regulations, state laws or institutional policies relevant to human subjects research; or

(2)  the requirements and determinations of the reviewing IRB (e.g. failure to follow the study protocol)

Although not all-inclusive, some examples of noncompliance reviewed by the ED/SBS IRB include:
Unanticipated Problem
  • Is more likely than not related to the research;
  • Negatively affects the risk/benefit ratio of the research, (this includes physical as well as psychosocial risks); and
  • Was not described in the protocol, IRB application, or informed consent document OR exceeds the specificity, frequency, or severity described in these documents.
Examples of an Unanticipated Problem may include:
  • Lost or stolen data (which could also include noncompliance if the data protection and storage practices outlined in the application have not been followed);
  • Unexpected emotional or other reaction to study activities.
The ED/SBS IRB does not review Adverse Event reports as they typically involve events that are life-threatening, disabling or incapacitating, are a significant emergency incident, or even fatal - all of which are unlikely with minimal risk research.

How
to Submit a Reportable Event


To create a new reportable event, select New Reportable Event on the main study page for the approved study. Choose the type of reportable event (noncompliance, unanticipated problem, new information). Complete the reportable event application. After clicking Finish, the PI must then click the Submit activity.


If the reportable event will require a change to what has previously been approved by the IRB, create a New Change in
addition to the Reportable Event. If unsure, consult the IRB office/your protocol staff reviewer with any questions as to whether a change should be created.