Problem Reporting

Events such as unanticipated problems, protocol deviations or violations, and noncompliance need to be reported to the VCU IRB.

RAMS-IRB Studies: Submit reports in RAMS-IRB using the Reporting submission type within an approved study workspace.

Paper Studies: Submit Prompt or Non-Prompt reports in paper at the ORSP office, 3rd Floor of BioTech One Building.

Unanticipated Problem Reporting

All unanticipated problems must be reported to the IRB within 5 days of learning of the event.

An unanticipated problem involving risk to subjects or others (UP) is any event that meets all of the following three criteria:

  1. Event is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol related documents, such as the IRB approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  2. Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  3. 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.

Examples of events that may meet the criteria and require reporting to the IRB:

  • Adverse event (AE)
  • Protocol deviation
  • Protocol violation
  • New information that increases risk
  • Sponsor-imposed protocol suspension
  • Changes in labeling or withdrawal from marketing
  • Breach of confidentiality
  • Complaint by research participant that indicates unexpected risk

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.

Determining whether an event meets the three criteria is the responsibility of the principal investigator.

Read more about identifying unanticipated problems in the OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.

Other Reporting

Noncompliance in the conduct of the research must be reported to the IRB and can be done so via the reporting function in RAMS-IRB or on either the Prompt or Non-Prompt form paper forms.

Most other events occurring in a research study do not need to be reported to the IRB unless they are unanticipated problems. However, there may 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 on a Non-Prompt paper form or using the reporting function in RAMS-IRB.