Defining Human Subjects

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)) 

Living individual – The specimen(s)/data/information must be collected from or be about live subjects. Research on cadavers, autopsy specimens or specimens/information from subjects now deceased is not human subjects research.

“About whom” – a human subject research project requires the

data received from the living individual to be about the person.

Intervention includes physical procedures, manipulations of thesubject, manipulations or changes of the subject's environment for research purposes. (i.e. for example, venipuncture, exercise, use of a computer mouse)  Interaction includes communication between the investigator and the subject. This includes face-to face, mail, and phone interaction as well as other modes of communication, such as completion of a questionnaire, survey, interview procedures, or focus groups.

Identifiable private information3   “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, a health care record).” (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. Social Security #).

Observational studies of public behavior (including television and open 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 individuals 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 census data, or federal health, labor, or educational statistics.  It is fair to say the IRB may make a final determination of whether or not a specific set of data meets the requirements of publicly available.  

Researchers must take caution since disclosure of private information may place the subjects at risk of criminal or civil liability and/or damage their financial standing, employability, or reputation.