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Adverse Events and Protocol Deviations Overview

Unanticipated Problems

It is the responsibility of the Principal Investigator to assess events that occur during the course of a research protocol. Unexpected problems or events whose nature, severity and frequency are not described in the information provided to the IRB or to the subjects must be submitted to the IRB for consideration if they involve risk to the participants or others and are related to either a research intervention or interaction or to the conduct of the study in general.

Examples include, but are not limited to: subject experiences, new scientific  findings, unexpected complications, missteps in study procedures, or in consent  documentation, or breaches of confidentiality. The PI must determine which of  the following descriptions apply. The IRB will review reports and make a final  determination, indicating agreement or disagreement with the PI’s assessment,  and reasons for the determination.

Adverse Events

An Adverse Event is an event that occurs during the course of the research that either  causes physical or psychological harm or increases the risk of such harm or results in a loss of privacy or confidentiality to a research participant or to  others. The IRB must determine with the help of the PI if such events are anticipated or unanticipated, and also if they are serious and related to  the research.

Reporting

Adverse Events that occur at the University or at an off-campus study site are required to be reported to the IRB on an Adverse Event Report, Form IRB-4, within the following time frames:

  • If Serious and Related to the Research, within 2 days of discovery of the event.
  • For all other events, within 5 days of  discovery of the event.

Please see the Adverse Event Reporting Policy.

Protocol Deviations/Noncompliance

Protocol Deviations / Noncompliance are any actions or events that are not in accordance with the approved protocol, IRB Policies, Federal regulations, or IRB determinations but typically do not have a significant effect on the integrity of the research or on the subjects’ rights, safety or welfare. However, the IRB must determine if such events describe an act of noncompliance that is minor or serious, and also if there is a continuing pattern of noncompliance.