What defines an "unanticipated problem" according to OHRP?

An "unanticipated problem," as defined by the Office for Human Research Protections (OHRP), is characterized by being unexpected, and it is either related or possibly related to the research context. The significance of this definition lies in the implication that such problems can indicate an increased level of risk to participants involved in the research study. Unanticipated problems require careful consideration and appropriate reporting, as they can affect participant safety and the integrity of the research.

When an issue arises that is not expected by the researchers or participants and is linked to the research activities, it suggests that there may be unrecognized risks that need to be addressed. This could involve unexpected adverse events or new findings that change the understanding of risks involved, prompting the need for additional oversight or changes to the study protocol.

The other definitions provided do not capture the full scope of what constitutes an unanticipated problem. For instance, an unexpected issue that is unrelated to the research does not pertain to the safety or integrity of the study itself. Similarly, if a problem is related to the research but not unexpected, it falls within the realm of anticipated challenges rather than unexpected risks. Lastly, anticipated issues that arise during the study do not meet the criteria of being "unanticipated," as they are