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?
The Correct Answer and Explanation is:
Yes, this is an example of an unanticipated problem that requires reporting to the Institutional Review Board (IRB).
An unanticipated problem in research is an event or occurrence that was not anticipated or foreseen in the original study design or its risk assessments, particularly when it involves harm or increased risks to participants. When conducting research involving sensitive topics, such as illicit drug use or other illegal behaviors, the risks to participants are often complex and multifaceted, including legal, psychological, and social implications.
In this case, the researcher has collected sensitive, personally identifiable information from college students about illicit drug use and illegal behaviors. This data is considered highly sensitive and confidential, which can put participants at risk for legal or social consequences if it were ever disclosed or misused. If one of the participants is involved in an automobile accident and this event is linked to their participation in the study, there may be a potential for legal ramifications, such as the disclosure of illegal behavior to law enforcement or the insurance company, especially if the participant’s behavior was influenced by the substance use disclosed in the study.
Even if the study itself does not directly relate to the automobile accident, this event is considered an unanticipated problem because it could lead to unforeseen risks. Since the study involves sensitive information, the potential for harm (whether direct or indirect) has increased, requiring the researcher to report the situation to the IRB. The IRB would then assess whether additional protective measures need to be implemented to safeguard the participants’ privacy and mitigate potential risks.
In addition, the IRB’s role is to ensure that participants’ well-being is prioritized throughout the research process, and any new risks, even if indirectly related to the study, should be immediately addressed and reviewed.