Vulnerable and Special Populations
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Vulnerable and Special Populations
The University of Illinois at Urbana-Champaign IRB ensures that additional safeguards are included in the research design to protect the rights and welfare of research participants who have limited autonomy and are at risk for coercion and undue influence.
Research and Human Subjects Defined
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 subject 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 subject policies, whether or not they are considered research for other purposes. For example, some demonstration and service programs may include research activities.
If 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, 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.