What constitutes an unanticipated problem according to OHRP?

An unanticipated problem, as defined by the Office for Human Research Protections (OHRP), refers to an incident that is unexpected, related to the research activity, and indicates a potential for increased risk to research subjects. This understanding is crucial in the context of human subjects research, where the safety and well-being of participants should be prioritized.

Such incidents may arise from unforeseen situations or adverse events that were not predicted during the study's design and therefore require careful assessment and often prompt reporting to the Institutional Review Board (IRB). Recognizing these factors helps researchers to respond appropriately and adjust their protocols to ensure participant safety.

Other options do not align with the definition. Planned incidents or pre-identified risks fall within the anticipated realm of research design, while incidents requiring immediate attention are a narrower focus that may not encompass all unanticipated problems. Thus, the comprehensive definition of an unanticipated problem is crucial for maintaining ethical standards and participant safety in research.