HSC Definitions

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Definitions (45 CFR 46.102)

Human Subject:  Any living individual about whom an investigator (whether professional or student) conducting research (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 

Intervention:  includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) 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: 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.  

Identifiable Private Information: private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Identifiable biospecimen: a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of human subjects oversight at SIUC, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of human subjects oversight at SIUC, the following activities are typically deemed not to be research:

  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  4. Authorized operational activities (as determined by federal agency) in support of intelligence, homeland security, defense, or other national security missions.

Systematic Investigation:  includes, but is not limited to, a hypothesis or research question, research development, testing, and evaluation.

Generalizable Knowledge:  includes conclusions or information that are applicable to populations outside the research subjects, can be used to predict future events, and/or can be broadly applied to enhance scientific or academic theories or principles.