A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. 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 conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?
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Yes, this is an example of an unanticipated problem that requires reporting to the IRB. An unanticipated problem involves any incident that affects a subject’s welfare or safety, especially when it occurs after participation in a study involving sensitive information. Even if the researcher assesses it as unrelated, the IRB needs to be informed to ensure participant safety and the integrity of the research process. It allows the IRB to evaluate potential risks related to the study.