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Human Subjects Division (HSD)

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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.

 

Investigation: A searching inquiry for facts, or detailed or careful examination.
Systematic: Having or involving a prospectively identified approach to the investigation, based on a system, methods, or plans.
Designed: The activity has a predetermined purpose and intent.
Develop: To form the basis for a future contribution.
Contribute: To result in.
Knowledge: Truths, facts, information.
Generalizable: The data and/or conclusions are intended to apply more broadly beyond the individuals studied or beyond a specific time and/or location, such as to other settings, circumstances, or categories. Publishing or presenting does not necessarily make a project generalizable.

 

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