Human Subjects
The term human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains individually identifiable, private information.
Intervention includes both physical procedures (e.g.,
venipuncture) by which data are gathered and manipulations
of the subject (e.g., by deception) or the subject's
environment (e.g., by introducing extreme heat) that
are performed for research purposes.
Interaction includes communication or interpersonal
contact between investigator and subject.
Private information includes information about a subject that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also refers to information that has been provided for specific purposes by an individual with the reasonable expectation that it will not be made public (for example, a medical record).
Information is individually identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information.
For IRB purposes, research is defined as a systematic
investigation, inquiry, or analysis—such as scholarly
or critical study or inquiry or scientific investigation,
development, testing, or evaluation—designed to develop
or contribute to generalizable
knowledge. Research includes activities that aim to test
a hypothesis, discover or collate facts, principles, or effects,
reach new conclusions, or reexamine information by the critical
study of a subject or by a course of scientific inquiry. Examples
of human subjects research include
- studies in which a substance or stimulus is administered
to a subject, or responses or states are measured;
- studies that involve changes in the subject's physical
or psychological state or environment, or changes in diet;
- interviews, surveys,
tests, inquiries, and observations designed to elicit or
obtain nonpublic
information; and
- studies of existing records where the identity of the
subjects is known or could be readily ascertained by the
investigator.
Activities meeting this definition constitute research for purposes of human subjects policies, whether or not they are considered research for other purposes. For example, some demonstration and service programs may include research activities.
TopIf results are not disseminated (published, presented, or shared) externally, the term research is not intended to apply to data acquisition resulting from
- routine course, workshop, or curriculum development activities
using accepted educational practices sponsored by the University
of Illinois at Urbana–Champaign (UIUC), including evaluations
to determine student or participant satisfaction, attitude
change, or knowledge gained during the educational experience;
or
- aid or services provided by professionals to their clients
that are consistent with accepted and established practice,
and intended only to meet the clients' own personal needs.
If results from these activities are disseminated externally, the activities constitute human subjects research and must receive IRB approval.