Answer:
It is considered as an <em>unanticipated problem.
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Explanation:
An unanticipated problem occurs when an investigation arises in a situation that was not considered in advance by the investigator.
In this investigation, which is a study with drugs, the risks rise, and an unforeseen event arises. Therefore the investigator must modify the informed consent, and the subjects must reaffirm the same to continue in the study.
<em>I hope this information can help you.</em>
