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 Policy.

"Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowlege" [p.5, CSUB Policy].

Making behavioral observations of humans in a natural setting, having persons fill out surveys, collecting data to compare effectiveness of several teaching methods, or studying patient records qualify as research if the activities are designed to lead to "generalizable knowlege." It does not matter whether the investigators are faculty or students. The IRB assumes that the intent is to contribute to "generalizable knowlege" if the results may be presented in any forum, including meetings or publications, external to this institution. All Master's Theses and Projects involving human subjects are concidered contributions to generalizable knowlege 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.