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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).

Research is any clinical investigation that involves an item regulated by the FDA, and involves one or more humans subjects and involves:

  • Any use of a drug (whether approved or unapproved) in one or more living persons other than use of an approved drug in the course of medical practice.
  • The use of a device (whether approved or unapproved) in one more more living persons that evaluates the safety or effectiveness of the device.
  • The use of a test article (drug, device, biologic, etc.) regulated by the FDA to obtain data that is intended to be eventually submitted to the FDA.

Items Regulated by the FDA include: Any drug (including biological products) for human use, medical device for human use, human food additives, color additives, and electronic products intended for clinical use by or with humans.
 

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