Under what condition is a researcher required to report an unanticipated problem to the IRB?

A researcher must report an unanticipated problem to the Institutional Review Board (IRB) under the stipulation that it poses risk of harm to the subject, is related to the participant's current state, and is not predicted by the researcher. Each of these factors highlights essential aspects of ethical research conduct.

When an issue is related to the participant's current state, it implies that the problem may have immediate implications for their health or well-being. Thus, any unanticipated events that affect a participant's welfare should trigger a report to ensure that the research remains ethical and protective of participants.

Additionally, the necessity to report events that the researcher did not predict underscores the dynamic nature of research. As research progresses, unforeseen problems may arise that could affect subject safety. Promptly reporting these ensures that the IRB can take necessary considerations to mitigate risks.

Finally, the emphasis on problems that pose a risk of harm aligns with the primary responsibility of researchers and IRBs to protect participants. If an unanticipated problem is likely to lead to harm or discomfort, it is critical that the IRB is informed so that appropriate steps can be taken to safeguard participant welfare.

Therefore, all three conditions—relationship to the participant's state, unpredictability by the researcher, and the potential