Reporting to the IRB

What to Report to the IRB

Report any of the events listed below to the IRB within five (5) working days of the research staff having knowledge of the event. Reportable New Information must be submitted via the electronic system.

If you are unsure whether an event needs to be reported to the IRB or not, please contact your IRB coordinator for a consultation.

1.  Harm: Any harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related to the research procedures. Example: Serious adverse event or unanticipated problem
2. Risk: Information that indicates a new or increased risk or a new safety issue. For example: safety monitoring report, drug or device changes, interim analysis, or investigator finding.
3. Non-compliance: Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
4. Audit: Audit, inspection, or inquiry by a federal agency or government agency.
5. Report: Written reports of study monitors or DSMB Reports.
6. Deviation (researcher error): Failure to follow the protocol due to the action or inaction of the investigator or research staff.
7. Confidentiality: Breach of confidentiality.
8. Unreviewed change: Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
9. Incarceration: Incarceration of a subject in a study not approved by the IRB to involve prisoners.
10. Complaint: Complaint of a subject that cannot be resolved by the research team.
11. Suspension: Premature suspension or termination of the research by the sponsor, investigator, or institution.
12. Unanticipated adverse device effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device.

Unanticipated Problems

Unanticipated problems, in general, include any incident, experience, or outcome that meets all of the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; (b) the characteristics of the subject population being studied; and

2. is related or possibly related to the research (this means that it is more likely than not, the incident, experience, or outcome was caused by the procedures involved in the research); and

3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

There are other types of incidents, experiences, and outcomes that occur during the conduct of human subjects research that represent unanticipated problems but are not considered adverse events.  For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events.  In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm occurs.

The following flowchart is designed to help investigators determine when an adverse event needs to be reported as an unanticipated problem to the IRB.