A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students.

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?

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?
Your Answer No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
Result Correct
Comment An unanticipated problem in keeping with OHRP’s guidance is unexpected, related or possibly related to the research, and puts subjects or others at greater risk of harm. The car accident was not related to the research study, even though it may have been related to the subject’s behavior about illicit drug use and other illegal behaviors. If the PI assessed the event as unrelated, it does not need to be reported to the IRB.

Question 2

Question The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
Your Answer Determined by the institution in its written policies and procedures
Result Correct
Comment

Question 3

Question 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?
Your Answer Promptly
Result Correct
Comment OHRP guidance (2007) states that the federal regulations do not specify a timeframe for reporting, except to say this must be done “promptly.” For a more serious incident, this may mean reporting to the IRB within days. For a less serious incident, a few weeks may be sufficient. Researchers should check with their local IRB to determine their institution’s procedures.

Question 4

Question A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB?
Your Answer No, this does not need to be reported because it is unrelated to participation in the study.
Result Correct
Comment An unanticipated problem, in keeping with OHRP’s guidance, is unexpected, related or possibly related to the research, and puts subjects or others at greater risk of harm. What matters here is that the heart attack was not related to the focus group research and does not meet reporting criteria.

Question 5

Question According to OHRP, a problem is an “unanticipated problem” when it meets which of the following criteria:
Your Answer Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
Result Correct
Comment