Glossary of Terms
From 45 CFR 46.102
|Human subject/participant||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.
|Interaction||includes communication or interpersonal contact between investigator and subject.|
|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.|
|Minimal risk||the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.|
|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.