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 CDC is a federal agency.
C) The database reflects data collected originally for surveillance purposes.
D) The data was collected between 1996-2006.

Answer 1

Answer:

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

Explanation:

           IRB stands for Institutional Review Board. It is board which protects the rights of the human subjects in a research study made.

          According to the IRB, a human subject is the living being on which a researcher or an investigator is conducting a research study.

          In the context, a researcher wishes to conduct a study from the database collected publicly which have no identifiers and the IRB makes a point that individuals whose records will be reviewed does not meet the official definition given by the federal body regarding human subjects.

         Thus it is confirmed by the fact that the researcher was not interacting with the subjects and the data which have no identifiers, that this research activity  does not constitutes research based on human subjects.

Hence the correct option is (A).