A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher’s car on the way home from work. This is an unanticipated problem that must be reported because the incident was
(a) unexpected (in other words, the researchers did not anticipate the theft);
(b) related to participation in the research; and
(c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

According to the Unanticipated Problems Involving Risks & Adverse Events Guidance (2007), the OHRP considers unanticipated problems to any incident or outcome that meets the following criteria: 1. unexpected 2. related or possibly related to participation in the research 3. suggests that the research subjects are at a greater risk of harm.

The HHS regulations work under a principle of prompt. Therefore, unanticipated problems that are serious adverse events should be reported within 1 week of the investigator becoming aware of the problem and any other unanticipated problem should be reported to the IRB within 2 weeks.