An adverse event is defined as: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (the event can be physical and/or psychological)
An unanticipated problem is defined as any incident, experience, or outcome that meets all three of the following criteria:
The primary investigator of research approved for the use of human subjects is responsible for reporting any adverse events or unanticipated problems to the Office of Research Compliance (753-8588, firstname.lastname@example.org) as soon as possible, but no later than 7 days after first becoming aware of the problem. The principal investigator must independently begin initiation of any measures necessary to ensure subject safety while preparing and submitting the required reports.
The report must contain sufficient information for the IRB to make an assessment of risk. The IRB may request additional information from the PI, which should be provided within one business week, or sooner if specified by the IRB.
Event reports will be reviewed by one or more IRB members, typically the Chair or Vice-Chair or member designated by the Chair. Upon receiving a report of an unanticipated problem or adverse event, the IRB reviewer(s) may take one or more of the following actions:
A suspension/termination may be appropriate for any of the following reasons:
In all cases, in a timely manner the IRB Chair or Vice-Chair will inform the Principal Investigator in writing of the suspension/termination. The letter to the Principal Investigator must state the reason for the suspension/termination. In cases of immediate, significant risk to human subjects, the IRB Chair or designee may communicate the suspension/termination orally while written materials are prepared. In the case of a suspension, the letter is to specify whether the suspension applies only to the enrollment of new subjects, or also requires the cessation of all study procedures on subjects who have already been enrolled.
In the case of a termination, no new subjects may be enrolled and all study activities involving enrolled subjects must cease. Exceptions may be made by the Chair or Vice-Chair in circumstances where subjects are receiving intervention that cannot be discontinued for safety reasons. These potential instances will be reviewed on a case-by-case basis. The IRB Chair or Vice-Chair will immediately notify the Institutional Officials and the Research Compliance Coordinator of the suspension or termination.