a researcher conducting behavioral research c...

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? 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. 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. no, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. no, this does not need to be reported to the irb since the researcher reported it to the sponsor of the study.

Answer

# Brief Explanations: The IRB (Institutional Review Board) is concerned with protecting the rights and welfare of research subjects. An unanticipated problem is one that was not foreseen in the research design. If the researcher assesses that the automobile - accident is unrelated to the research study, it does not need to be reported to the IRB. Reporting to the sponsor is not the same as reporting to the IRB, and just because it was unexpected or involved a research subject does not mean it must be reported if it's unrelated to the research. # Answer: No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.