According to federal regulations, what defines a 'human subject'?

The definition of a 'human subject' is rooted in the context of research involving individuals. A human subject is specifically defined as an individual from whom data is collected through various means, such as intervention, interaction, or identifiable private information. This encompasses a wide range of scenarios where the individual's responses, behaviors, or biological samples are collected for research purposes.

This definition is crucial as it ties directly to ethical considerations outlined in the Belmont Report, which emphasizes respect for persons, beneficence, and justice. By identifying who qualifies as a human subject, regulations create a framework to ensure that research respects participants' rights and welfare, ensuring there are protocols in place to inform them, obtain consent, and provide protections throughout the research process.

The other options do not accurately capture the specific definition of a human subject in the research context. While someone with a medical condition or from a vulnerable population may indeed be a human subject under certain circumstances, that specificity is not part of the broad definition. Similarly, an individual conducting research is not classified as a human subject under these regulations, as they are typically viewed as the investigator rather than a participant in the research study.