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:
  • Over-enrollment: The number of participants enrolled in a study should not exceed the total number approved by the IRB;
  • Consent forms: When a signed consent process is part of the approved study, only the forms stamped by the IRB can be used.  When a new consent form is approved by the IRB via a Change, the previously approved version is no longer valid;
  • Changes to the approved Study Design: Any changes to the study must be reviewed and approved by the IRB prior to implementation;
  • Personnel: Any personnel engaged in recruitment, consent,data collection or data analysis must be listed as members of the Study Team prior to engagement in research activity.
  • 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 Change in
addition to the Reportable Event. If unsure, consult the IRB office with any questions as to whether a change should be created.



Keywords:reportable events, noncompliance, unanticipated problems, new information   Doc ID:51917
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2015-06-04 06:00 CSTUpdated:2018-10-16 13:45 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
Feedback:  0   0