or recognized? It the answer to all three questions is yes, then the adverse event is an unanticipated problem and must be reported to appropriate entities.
For further clarifications as to whether or not a particular adverse event is an unanticipated problem that requires reporting, researchers should consult the OHRP guidance.
The following are situations that may meet OHRP's definition of unanticipated problems involving risks to subjects or others and should be reported:
Any serious accidental or unintentional change to the IRB-approved protocol that involves risk or has the potential to recur.
Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research subject.
Any publication, safety monitoring report, interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research.
Any breach in confidentiality that may involve risk to the subject or others.
Any complaint of a subject that indicates an unanticipated risk.
According to OHRP guidance, an investigator should include the following information when reporting an adverse event or any other incident, experience, or outcome as an unanticipated problem to the IRB:
appropriate identifying information for the research protocol, such as the title, investigator's name, and the IRB project number.
a detailed description of the adverse event, incident, experience, or outcome.
an explanation of the basis for determining that the adverse event, incident, experience, or outcome represents an unanticipated problem.
a description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem.
Once the report is ready, the investigator should submit it to the OSP, and OSP staff will in turn immediately provide the report to IRB members. After the IRB receives a report of an unanticipated problem involving risk to subjects or others, the IRB Chair in consultation with other IRB members and OSP staff will evaluate and make a decision on the reported event as quickly as possible. The IRB Chair may recommend that the problem be