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
- Unanticipated Problems and Serious Adverse Events
- New Information
- Reportable Events for VA protocols
- How to Submit Reportable Events
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
- Health Sciences IRBs Protocol Exceptions and Deviations Guidance
- Changes to Eliminate Immediate Hazards to Subjects Guidance
- When failure to report a Personnel Change is 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:
- Preventing Noncompliance Guidance
- Developing an Internal Quality Assurance (QA) Program Guidance
- Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans Guidance
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:
- Unanticipated Problems/Adverse Event Reporting Decision Guide
- Unanticipated Problems
- OHRP guidance on reporting Unanticipated Problems and Adverse Events
- Reporting Requirements for Studies Involving Investigational Devices
- Reporting Requirements for Studies Involving Other Investigational Agents, Including Investigational Drugs
- Changes to Eliminate Immediate Hazards to Subjects Guidance
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:
- New Information Reporting Guidance
- Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts
- I received an Action Letter/CAEPR or a revised IDB from the Sponsor. Does this need to be reported to the IRB?
- New Information Submission Timeline
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.
Any local research death that is both unanticipated AND related to the research must be orally reported to the IRB immediately after the local research team becomes aware of the death. Written notification of the death must be received by the IRB within 5 business days of the local research team becoming aware of the death.
Please see the following for more information on these requirements: