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What is an unanticipated problem in research?

An unanticipated problem is by definition unexpected, whereas an adverse event may be either expected or unexpected. Unanticipated problems may or may not be adverse events. Adverse events relate to harm to participants; unanticipated problems may involve an increased risk of harm even if no actual harm occurred.

Is this an example of an unanticipated problem that requires reporting to the IRB?

Is this an example of an unanticipated problem that requires reporting to the IRB? No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention.