Unanticipated Problems

Definition
An unanticipated problem is any event, experience, issue, instance, problem, or outcome meets all 3 of the following criteria:

• Unexpected in terms of nature, severity or frequency given the research procedures that are described in the protocol –related documents AND the characteristics of the subject population being studied.
• Related or possibly related to participation in the research. This means that there is a reasonable possibility that the incident, experience or outcome may have been caused by the procedures involved in the research study
• The event, experience, issue, instance, problem or outcome suggests that the research places the subject or others at greater risk of harm that was previously known or recognized

Unanticipated Problem and Adverse Event
A small number of Adverse Events are considered Unanticipated Problems. If an Adverse Event meets ALL 3 the criteria listed above, then the event is considered an Adverse event AND an Unanticipated Problem: Those events that meet the definition of both adverse event and unanticipated problem are reported to the IRB-HSR through the Adverse Event reporting system as previously described using IRB Online.

Unanticipated Problem and Protocol Violation

A small number of Protocol Violations are considered Unanticipated Problems ONLY if they meet all 3 of the criteria listed above. Events that meet the definition of both protocol violation and unanticipated problem are reported to the IRB-HSR using the Protocol Violation or Enrollment Exception Form

Unanticipated Problem and Data Breach

A data breach may also meet the criteria for an Unanticipated Problem if the Data Breach meets all 3 of the following criteria:

• Unexpected in terms of nature, severity or frequency given the research procedures that are described in the protocol –related documents AND the characteristics of the subject population being studied.
• Related or possibly related to participation in the research. This means that there is a reasonable possibility that the incident, experience or outcome may have been caused by the procedures involved in the research study
• The event, experience, issue, instance, problem or outcome suggests that the research places the subject or others at greater risk of harm than was previously known or recognized.

If the Data Breach meets the criteria of an Unanticipated Problem, the researcher must follow the IRB-HSR requirements for reporting an Unanticipated Problem IN ADDITION TO the UVa requirements for reporting a Data Breach as written in the protocol. 

REPORTING TIMELINE REQUIREMENTS FOR UNANTICIPATED PROBLEMS

If an Unanticipated Problem should occur during the conduct of any study under the jurisdiction of the IRB-HSR, the PI should notify the IRB-HSR within 7 days from the time the PI/Study team receive knowledge of the event.

HOW TO SUBMIT A REPORT OF AN UNANTICIPATED PROBLEM

Events that meet the definitions of  adverse event and unanticipated problem are reported to the IRB-HSR through the Adverse Event reporting system as previously described using IRB Online.

Events that meet the definition of both protocol violation and unanticipated problem are reported to the IRB-HSR using the Protocol Violation or Enrollment Exception Form.

Unanticipated problems that that are not the result of an adverse event or protocol violation must be submitted to the IRB-HSR within 7 calendar days from the time the study team receives knowledge of problem using the Unanticipated Problem Report.