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Reporting Incidents

Last updated on March 16, 2023 0 min read Working with Human Subjects - Reporting Incidents

How to Report

Incidents must be reported to the IRB using the Event Form, ordinarily within five (5) days of the PI learning of the incident.

What to Report

The following incidents must be reported to the IRB:

Unanticipated problems, including unexpected adverse events and device effects, involving risks to subjects or others
Breaches in confidentiality
Protocol deviations or non-compliance with the approved protocol or study materials
Research subject complaints suggesting their rights, welfare or safety has been adversely affected
Suspension or termination of the research (e.g., by the sponsor, oversight agency, reviewing IRB, study site, etc.)
Incarceration of a research subject
Alleged or documented misconduct by research personnel
New information suggesting an increased risk to subjects or others

“Protocol Deviations and Issues of Non-compliance”
“Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others”
“Reporting Requirements to Authorities”

Read the full policies in our Policies and Procedures for Working with Human Subjects.