Which scenario qualifies for IRB exemption when using existing data that are publicly available or de-identified?

• A. Prospective clinical trial
• B. Use of publicly available data or de-identified data
• C. New survey data from minors
• D. Interviewing participants about health behaviors

Answer: (B)

The key idea is that research using existing data that are publicly available or de-identified can be exempt from full IRB review because it poses minimal risk to individuals’ privacy. When data are publicly accessible, or when they are stripped of direct and indirect identifiers so that individuals cannot be re-identified, the study does not involve interactions with participants or new measurements, and the potential harm is negligible. This fits exempt Category 4 in the Common Rule, which covers the use of existing data, documents, records, or specimens that are publicly available or that are recorded in a way that subjects cannot be identified.

So using publicly available data or data that has been de-identified is the scenario that qualifies for IRB exemption. In contrast, collecting new data from living individuals—such as conducting a prospective clinical trial, gathering new survey data from minors, or interviewing people about health behaviors—typically requires at least some IRB oversight because it involves interaction with participants or identifiable information and potential risk.