Question #2       Are the participants in my project considered to be human research participants?

“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
            (1) data through intervention or interaction with the individual, or
            (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.  Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, 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 medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”          45CFR46

When the answer is “yes” to all of the following questions, you are involving human participants in your research.

1. Is/was the information collected from a living person?
2. Is the information actually about 'the individuals’ from whom it is/was collected?
3. (a)       Was the information collected via direct interaction or intervention with  participants?  (primary data collection)
   or
   (b)        Does the researcher obtain identifiable private information?             (secondary data analysis)

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