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What
is Human Subject Research?
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According
to federal regulations, 'human subject' means 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.
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
is individually identifiable data (i.e., the identity
of the subject is known or may readily be ascertained
by the investigator or associated with the information).
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 school
or medical record). |
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