
IRB Review
The determination of human subjects research
In order to determine if a study qualifies as "human subjects research" that is subject to IRB oversight, the IRB assesses whether the study meets certain key criteria. The key criteria used to determine if a study is human subjects research are:
- The involvement of living, human participants who are research subjects, either through direct interaction, the use of their identifiable private information, or biological specimens.
- If the research is intended to contribute to a broader understanding of a specific topic and the results may be applicable beyond the immediate study context.
- If the study collects data from or about living individuals through interaction, intervention, or observation. Data collected can include surveys, interviews, experiments, medical tests, and observations of participants.
- Collecting, using, or accessing private information about individuals, such as medical records or educational records.