Which qualification is necessary to categorize a study as "research" under federal guidelines?

To categorize a study as "research" under federal guidelines, it is necessary for the study to include data collection from living individuals. This requirement ensures that the research is directly engaging with human subjects, which is crucial for the ethical considerations outlined in regulations like the Common Rule. By focusing on living individuals, the research can gather valuable data that contributes to our understanding of human behavior, health, and other social phenomena.

The distinction of data collection from living individuals is essential because it entails the application of specific ethical and regulatory frameworks designed to protect participants in research. These protections are necessary because studies involving living subjects can pose ethical concerns related to consent, privacy, and potential risks. Therefore, the inclusion of living participants is a key determining factor for a study to be recognized as research under federal guidelines.