According to federal regulations, who qualifies as a human subject in research?

The definition of a human subject in research, as per federal regulations, specifically refers to living individuals from whom data is collected through intervention or interaction. This includes methods such as surveys, interviews, or other forms of direct engagement that can lead to obtaining personal data or biological samples. In this context, the term "intervention" encompasses both physical procedures or manipulations and interactions through which information is gathered.

This is particularly important as the protection of human subjects focuses on ethical considerations concerning the rights and welfare of individuals participating in research. Since living individuals can experience risks associated with research—whether physical, psychological, or emotional—they are afforded specific protections under federal regulations.

In contrast, individuals surveyed anonymously do not qualify as human subjects under federal regulations because these cases typically lack individual identifiers that connect to the living persons involved, thus failing to meet the criteria for intervention or interaction. Similarly, individuals whose data is collected retrospectively may also not qualify if it is done without their consent or awareness, particularly if no active intervention occurs. Finally, deceased individuals do not qualify as human subjects since the regulations focus on the rights and protections of living participants, thereby maintaining that ethical considerations only apply to those who are alive and capable of being personally affected by the research.