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 to the IRB since the researcher reported it to the sponsor of the study. Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. Yes, this must be reported because it involved a subject in a research study and it is up to the IRB to determine if it was related to participation.

The research shown in the above question shows that the researcher's goal was to evaluate the influence of illicit drug use and other illegal behaviors on college students. For this reason, only situations that were influenced by the two factors that would be evaluated during the execution of the research would be relevant to the research. Well, as you read in the question above, one of the research participants had a car accident, two weeks after their participation in the survey, even though that participant's illicit drug use and illegal behavior contributed to the accident, his participation The research has already been completed, so the researcher may consider the accident unrelated to the study.