Investigators conducting research with human subjects should familiarize themselves with the Adverse Event and Unanticipated Problem Procedures outlined below. The Principal Investigator must provide all key personnel with procedures and contact persons in case of an adverse event.
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What is an adverse event or unexpected problem?
Any adverse event occurring in one or more subjects participating in a research protocol whose nature, severity, or frequency is not consistent with either:
- The unknown or foreseeable risk of adverse events associated with the procedures involved in the research that are described in the protocol related-documents, such as: the IRB-approved research protocol, applicable investigator brochure, the current IRB-approved informed consent document, and/or other relevant sources of information, such as product labeling and package inserts; or
- The expected natural progression of any underlying condition of the subject(s) experiencing the adverse event.
What is a related adverse event?
An adverse event that, in the opinion of the principal investigator, was more likely than not related to the investigational agent(s) or intervention. It is the responsibility of the University of Utah Principal Investigator to make the initial determination of a relationship between an adverse event (either internal or external) and any investigational agent(s), intervention, or research study procedure.
When is reporting required?
Adverse Event reports are required during the duration of the study and up to 30 days after the study has been completed (unless otherwise noted by the IRB). After 30 days, the Adverse Event Reports are no longer required for submission to the IRB unless the study meets one of the three criteria below:
- Study has closed
- The initial study involved something that could potentially have long term side effects
- The investigator is required to report the Adverse Event to funding agencies
Investigators are asked to report all unanticipated problems and adverse events to the IRB for review even if the investigator considers the event as being unrelated to the subject’s participation in the study. The IRB will review the event and determine if there is a direct relation to the study and will also determine if changes need to be made to the study as a result of the event.
Submitting a Report
Complete the Form P--Event Reporting on the Forms page and submit to the IRB office. Form P--Event Reporting is used for reporting Adverse Events, Unanticipated Problems, and Protocol Deviations. Serious events (by definition) need to be reported by the PI within 5 business days. Non-serious events can be reported as part of the Continuation process. Please review Form P and contact the IRB with specific questions.
Is follow-up information concerning an adverse event required?
A follow-up report is NOT required unless you receive information that suggests that the severity of an event has increased, OR that suggests the event is more likely to be related to the study than currently thought, OR that the event seems to affect the rights and welfare of current participants.
Definitions for Reporting
Serious Event: An adverse event that is fatal or life threatening, permanently disabling, requires or prolongs hospitalization, or results in significant disability, congenital anomaly, or birth defect.
Non-Serious Event: An adverse event that does not meet the definition of a serious event.
Unanticipated Event: An adverse event that has not been previously observed or is not consistent in nature, severity, or frequency with existing risk information, such as in the investigator brochure, research protocol, consent form, or other available information.
Related to the Study: Associated or having a timely relationship with; a reasonable possibility exists that an outcome may have been caused or influenced by the event in question (e.g., administration of a study drug), although an alternative cause/influence may also be present. Related events may be definitely, probably, or possibly related.
Unrelated to the Study: Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.
In the event that a research related injury or adverse event occurs, the investigator needs to notify the IRB Office. In addition, if a research subject feels that they have sustained injury or their rights have been abused, please contact the IRB Office immediately for guidance. If the injury is research related and medical care is warranted, the PI will be advised on how to proceed. For questions or further guidance, please contact the IRB Compliance Officer at (585) 395-2779 or by e-mail.