• Human Subject Research - Definition

Definition of Human Subjects Research:

According to the federal regulations, RESEARCH is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

A HUMAN SUBJECT is defined 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."

• INTERVENTION includes both physical procedures by which data are gathered 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). In order for a project to constitute research involving human subjects, the data collected 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).
• GENERALIZABLE KNOWLEDGE includes the dissemination of research findings beyond the boundaries of the institution (e.g., publication (including thesis or dissertation) or presentation or use outside the specific instructional setting.

If you are not sure whether your project falls into the definitions outlined above, then you should contact the Office of Research and Sponsored Projects.

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