Definition of Human Subjects Research

Definition of Human Subjects Research

The CSUB definition of research with human subjects is from Title 45: Part 46, which has been adopted in the CSUB IRB Policies & Procedures.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

"Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [CSUB Policies & Procedures].

Common examples are: [a] using test scores of students in the classroom to compare two teaching methods, [b] conducting interviews, [c] having persons fill out surveys, [d] observing persons in a natural setting, [e] accessing data that already exists, such as test scores or patients' records. All of these qualify as research if the activities are designed to lead to "generalizable knowledge." It does not matter whether the investigators are faculty or students. The IRB assumes that the intent is to contribute to "generalizable knowledge" if the results may be presented in any forum, including meetings or publications, external to this institution. All Master's Theses and Culminating Projects involving human subjects are considered contributions to generalizable knowledge and therefore must be submitted for IRB review. In summary, the criteria used to determine if an activity is research involve both the nature of that activity and the use of the data gathered.