Includes communication or interpersonal contact between investigator and subject.

• Communication 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.

Includes physical/psychological procedures, manipulations of the human subject, or manipulations of the subject’s environment for research purposes.  

• Examples or physical procedures include measuring brain function, venipuncture, use of a computer mouse

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))

A human subject research project requires that the data received from the living individual is about the person—not about something else (such as a product or service).

Any untoward or unfavorable medical occurrence in a human subject; including any abnormal sign, symptom, or disease that is temporally related to the research, whether or not it is related to the subject's participation in the research.

Examples of adverse events include:

• an upper respiratory tract infection
• a broken wrist
• nausea and vomiting
• nightmares