True or False: An adverse event that is clearly unrelated to the research and anticipated does not need to be reported as an unanticipated problem.

True or False: An adverse event that is clearly unrelated to the research and anticipated does not need to be reported as an unanticipated problem.

• A. True
• B. False
• C. Only if consent was obtained
• D. Only if the IRB approves

Answer: (B)

In this area of study, unanticipated problems are events that are not expected, are related to the research, and indicate greater risk to participants than was known. If an adverse event is clearly unrelated to the research and is anticipated, it does not fit the criteria for an unanticipated problem. However, that does not mean it can be ignored entirely. Safety oversight normally requires that all adverse events be documented and reported through the appropriate channels (such as to the sponsor or safety office), even if they are not reported as unanticipated problems. So the statement is false: while the event wouldn’t be categorized as an unanticipated problem, it may still require reporting in another safety/reporting pathway.

In this area of study, unanticipated problems are events that are not expected, are related to the research, and indicate greater risk to participants than was known. If an adverse event is clearly unrelated to the research and is anticipated, it does not fit the criteria for an unanticipated problem. However, that does not mean it can be ignored entirely. Safety oversight normally requires that all adverse events be documented and reported through the appropriate channels (such as to the sponsor or safety office), even if they are not reported as unanticipated problems. So the statement is false: while the event wouldn’t be categorized as an unanticipated problem, it may still require reporting in another safety/reporting pathway.