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?

Answer 1

The researcher will not be interacting/intervening with subjects

The data has no identifier.

Explanation:

Institutional Review Board served as a third party in research. it is a committee governed by federal regulations and managing the risk for human as well as animal participants. This regulation only applied to the research funded by the federal committee.

IRB specific goals and consideration for research:

• To promote the well being of human participants.
• To take care of ob ethical code and rules regulation.
• To ensure that the research is ethically valid and not harmful to human participants.
• To take concern from general public related to conduct research.