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Human research investigators are responsible for reporting any unanticipated problems involving risks to subjects associated with an approved IRB study or, in rare cases, with a study that is closed. In addition, any serious or continuing noncompliance with the federal regulations for the protection of human research subjects and/or University policy and/or the requirements or determinations of the IRB must also be reported. These reports are required for studies conducted by researchers from the General Campus as well as biomedical research.
- occurs at UCLA, or at an affiliated institution or other site where the UCLA IRB is the responsible IRB AND
- is determined by the UCLA PI to be related or possibly related to the research; unexpected (see definitions below); and serious, that is, placing subjects or others at greater risk or harm than previously known.
See examples on the form itself or in the guidance Post-Approval Reporting Requirements for Investigators. This guidance also provides additional information and guidance about the reporting of protocol violations, deviations and incident
- Protocol Violations, Deviations and Incident Reporting Form
- Decision Tree for Reporting Protocol Violations, Deviations and Incidents
- Protocol Violation, Deviation or Incident Summary Log
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