1. Information about behavior that occurs in a context
in which an individual can reasonably expect that no observation or recording
is taking place.
2. Information that has been provided for specific purposes by an individual
and which the individual can reasonably expect will not be made public.
An individual's medical record, for instance, is considered private information,
and a study that extracts information from medical records may constitute
research that is subject to Institutional Review Board (IRB) review. If
private information is used without any direct or indirect identification
of the individual, this would not constitute research involving human
subjects.
3. Information that
can be readily identified with individuals, even if the information was
not specifically collected for the study in question.
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.
