Events Requiring Reporting to the IRB

Federal regulations and IRB policy require study teams to submit reportable events to the IRB for review. Reportable events include noncompliance, new information, serious adverse event, and unanticipated problems. Below you will find additional information regarding reporting requirements for each type of reportable events. For a general overview of reporting time frames and examples of reportable events, see the following:

Additional topics on the reporting of adverse events, unanticipated problems, new information, noncompliance, protocol exception and deviations:

Noncompliance

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, failure to follow IRB policy, etc.). For information on when noncompliance requires reporting to the IRB, see the following:

UW-Madison Policy for Reporting Noncompliance

For guidance on how to present noncompliance reports to the IRB, see the following:

The HRPP has developed several guidance documents to help study teams both prevent noncompliance from occurring, as well as how to address noncompliance after it has occurred. Please see the following:

Unanticipated Problems and Serious Adverse Events

Unanticipated problems are types of reportable events that may require reporting to the IRB. Serious Adverse Events (SAEs) also may constitute unanticipated problems, depending on the nature of the event. In general, SAEs do not require reporting to the IRB unless they also potentially meet the definition of an unanticipated problem.

An unanticipated problem is an event that meets all of the following criteria:

  • Reasonably related to the research;
  • Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the study-related documents, such as the IRB-approved research protocol and informed consent document, and the characteristics of the participant population being studied; AND
  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

For information on when unanticipated problems require reporting to the IRB:

New Information

Researchers are expected to report new information to the IRB that affects the risks, benefits, or alternatives to study participation. New Information is a “catch-all” category for identification of unanticipated risks or findings that may affect a subject’s willingness to take part in the study and possibly lead to changes of protocol. For information on what and when New Information requires reporting to the IRB, see the following:

Reportable Events for VA Studies

VA reporting requirements generally parallel reporting requirements for non-VA studies, with the exception of the timeframe for report. Any event that occurs on a study under Madison VA purview that meets UW unanticipated problem or noncompliance reporting requirements must be reported to the IRB and Associate Chief of Staff within 5 business days of the local research team becoming aware of the event.

Please see the following for more information on these requirements:

How to Submit Reportable Events

For studies in ARROW:
For studies NOT in ARROW:



Keywords:adverse event, noncompliance, unanticipated problem, new information, protocol exception, deviation, reporting requirements, protocol violation, violation, non-compliance, reportable eventsDoc ID:18324
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-04-26 18:00 CSTUpdated:2017-11-17 14:54 CST
Sites:Health Sciences IRBs
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