A problem is considered "unanticipated" if it meets which criterion according to OHRP?

A problem is considered "unanticipated" when it is unexpected, related or possibly related to the research, and suggests a greater risk to participants. This criterion is set by the Office for Human Research Protections (OHRP) to ensure the safety and ethical treatment of human subjects involved in research. When a problem meets these characteristics, it raises concerns that may necessitate a reevaluation of the study's risk-benefit analysis or the implementation of additional safety measures.

The emphasis on it being "unexpected" indicates that the issue was not anticipated by the researchers, which could lead to potential harm that had not been previously identified. The relatedness to the research emphasizes that the problem arises from the research activities themselves, further affirming that it is directly connected to the study's parameters. Finally, the indication that it suggests greater risk motivates researchers and institutional review boards (IRBs) to take immediate action to protect participants and ensure compliance with ethical standards.