What is human subject research?

A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1),(2))

Intervention includes physical procedures, manipulations of the subject, or manipulations of the subject's environment for research purposes. Interaction includes communication between the investigator and the subject. This includes face-to-face, mail, e-mail, and phone interaction as well as other modes of communication.

Identifiable private information “includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place,” (such as a public restroom) “and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, student school records, health care information, etc.).” (45 CFR 46.102(f)(2)) “Identifiable” means the information contains one or more data elements that can be combined with other reasonably available information to identify an individual (e.g. name/address, job title/geographic location, etc.).

In analyzing a particular activity, it is important to focus on what is being obtained by the investigators. If the investigators are not obtaining data through intervention or interaction with living individuals, or identifiable private information about the individual, then the research activity does not involve human subjects.

Observational studies of public behavior (including television and internet chat rooms) do not involve human subjects as defined when there is no intervention or interaction with the subjects and the behavior is not private. Also, studies based on data collected for non-research purposes may not constitute human subjects research if individual identities are not identifiable (e.g. data such as service statistics, school attendance data, crime statistics, or election returns).

Studies based on data that are individually identifiable but are also publicly available may not constitute human subjects research. However, the term “publicly available” is intended to refer to record sets that are truly readily available to the broad public, such as Federal census data, labor statistics, and health statistics. An investigator should not assume information qualifies as “publicly available” without verifying this through OPHS.

My project is research and it involves human subjects. What now?

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