Unanticipated Problem Reporting
All unanticipated problems must be reported to the IRB within 5 working days of learning of the event. Evaluating whether an event is an unanticipated problem is the responsibility of the principal investigator.
An unanticipated problem involving risk to subjects or others (UP) is any event that meets all of the following three criteria:
- Was not anticipated or foreseen
- Was possibly, probably, or definitely related to, or caused by, the research activity in the judgment of the investigator; and
- Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
It is important to note that only those AEs that meet all three criteria above are unanticipated problems that need to be reported promptly to the IRB.
Read more about identifying unanticipated problems in WPP VII-6.
Noncompliance in the conduct of the research must be reported to the IRB. There may also be times when a sponsor requires reporting to the IRB or there is other information the investigator feels the IRB should know, in which case a report may be submitted to the IRB.
Submitting a Report in RAMS-IRB
- Login to RAMS-IRB and open the workspace for the study needing a report
- Click the “New Report to IRB” button
- Complete a report form and upload relevant documentation.
Please see the RAMS-IRB Submission System Guide for details on submitting a Report.
Ongoing Submissions for Western IRB Approved Research
Once an initial submission is approved by WIRB, the Principal Investigator is responsible for directly submitting all future submissions to WIRB including unanticipated problems. All unanticipated problem determinations made by an external IRB regarding a VCU research setting should also be submitted in a Report to the VCU IRB.
A copy of ALL submissions must be provided to ORSP via IRBIntake@vcu.edu, as well as to WIRB.
Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by referring directly to the WIRB forms site.