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?

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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's 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: No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

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 (i.e., 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?

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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 (i.e., 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?


Promptly


Within 48 hours


Within 24 hours


Within two weeks


Answer: Promptly

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

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According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:


Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk


Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk


Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk


Expected, related or possible related to the research, suggests the research puts others at greater risk


Answer: Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

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The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:


Stated in the human subject protection regulations, but not in the drug or device regulations


Included in the consent process


Determined by research staff


Determined by the institution in its written policies and procedures


Answer: Determined by the institution in its written policies and procedures
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