HSC Definitions

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Definitions

Human Subject:  Any living individual about whom an investigator obtains (1) data through interaction or intervention, or (2) identifiable private information (45 CFR 46.102(f)).

Data:  Information collected together for reference or analysis.

Intervention:  includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (45 CFR 46.102)

Interaction: includes communication or interpersonal contact between investigator and subject (45 CFR 46.102)

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.  Private information must be individually identifiable (45 CFR 46.102).

Research:  Systematic gathering and analysis of information designed to develop or contribute to generalizable knowledge.  (45 CFR 46.102(d)).

            Note:  Although most activities that are considered journalism (e.g., investigations and interviews that focus on specific events, views, etc., and that lead to newspaper/news publication, documentary production, or are part of professional training in journalism) are not research, care should be taken to assure that such activities do not meet the definition of research that must be reviewed by the HSC.  When faculty or students conduct activities normally considered research that is intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test theories or develop models), these activities are subject to HSC review.  This may include publications in journals, thesis and dissertations and even presentations.  In such cases investigators should consult with the HSC before proceeding with the research.

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.