Determination of Whether an Activity Represents Human Subject Research
Determination of Whether an Activity Represents Human Subjects Research at UIC
Human Subject is defined by the Common Rule as a living individual about whom an investigator (whether a professional or student) conducting research obtains either: 1). data through intervention or interaction with the individual, or 2). identifiable private information.
Intervention includes physical procedures by which data are gathered (e.g., 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 (i.e., student record, medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator [whether an investigator at UIC or at another institution] or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Human Subject is defined by the FDA as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. For research involving medical devices, a human subject is also an individual in either normal health or with a medical condition or disease on whose specimen an investigational device is used or who participates as a control.