Question

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.

Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?
a.The researcher will not be interacting/intervening with subjects and the data has no identifiers.
b. The researcher is satisfied with the individuals whose data has been collected
c. The researcher will be interacting/intervening with subjects and the data has some identifiers.
d. None of the above

Answer 1

Answer:

a) The researcher will not be interacting/intervening with subjects and the data has no identifiers.

Explanation:

The federal definition of human subjects is based in two things:

• Human subject refers to a living individual about whom an investigator conducting research obtains

1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

The IRB needs to determine that a human subjects research meets both of these requirements.

In the case of the example, the data doesn't include any identifiers (therefore there is no identifiable private intervention). Also, the researcher did not participate in the initial collection of the data and since there are no identifiers, he won't be able to interact with the subjects.

That's why the correct answer is a)

NOTE:

b) Is false since the researcher doesn't mention anything about his satisfaction with the data.

c) Is false since the statement itself is false (it says the data has SOME identifiers while the question says the database does not include ANY identifiers)

d) Is clearly false because we already stated that a doesn't meet the requirements.