Definition of Human Subjects Research
Human subjects research (as defined and regulated by federal law and Virginia Tech policies) involves a systematic investigation, including research and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102d).
This is generally interpreted to mean that if the results of the work are meant to be published or disseminated to an unrestricted audience, it is considered as regulated human subjects research. However, the benchmark/goal of 'publishing' is not a part of the federal code. If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research.
Examples of regulated human subjects research include: surveys, interviews, observations of activities or behaviors, exercise tests, blood collections, psychological or medical measurements or intervention, sensory responses to taste, smell, etc., and any research involving responses from people or access to records about people.
Definition of Human Subject
Human Subject is defined as a living individual about whom a research investigator (whether a faculty professional, research staff or student), conducting research, obtains either data through intervention or interaction with the individual, or specific identifiable private information about that individual (45 CFR 46.102f).
Generally, any University research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review, irrespective of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture, electrocardiogram, electroencephalogram, muscle biopsy) 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.