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Human Subjects Division (HSD)


Is Your Project Considered Research

Does your project meet the federal definitions of research described below? If not, it may not need to be reviewed by the IRB. See our page regarding projects that are usually not human subjects research for examples.


Definition 1. This definition is for all projects that are not regulated by the FDA.

Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.


Systematic investigation: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.
Generalizable knowledge: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
  • Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
  • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.


Definition 2. This definition is for all projects involving the use of a drug, device, or other item that is regulated by the Food and Drug Administration (FDA).

See the WORKSHEET: Human Subjects Research (linked below) for the complete regulatory definition and interpretation details. HSD uses the following two criteria to determine whether an activity is "research" as defined by the FDA. The activity is research if both conditions are met:

  1. The intent of the activity is to develop information about the test article for submission to, or inspection by, the FDA in connection with any type of premarket review by the FDA.
  2. The activity involves the prospective physical use of a test article regulated by the FDA, in a way that is not completely up to the discretion of a clinical practitioner.

Other Resources


Next Steps

Now that you know your project is research, what do you do? Continue on...

Change Notes

  • Noted 05/31/2012 @ 12:06pm
    Keyword newly added.
    - sherrye