What is Human Subject Research?

Only projects that meet the definition of Human Subject Research must be submitted for IRB Review

When considering whether an activity meets the definition of human subject research per 45 CFR 46.102(e)(1), investigators should consider the federal definitions of both research and human subject.

What is Research?

Research is a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge (45 CFR 46 102.d).

Who is a Human Subject?

A Human Subject is a living individual about whom an investigator conducting research obtains data through intervention or interaction with individual and/or identifiable private information (45 CFR 46 102.f).

This includes:

  • A person who becomes a participant in research
  • Data obtained from medical records
  • Data obtained from surveys
  • Tissue used in research that possesses or is linked to any kind of identifiable information

Common Examples of Not Human Subject Research

  • Analyzing de-identified data
  • Analyzing publicly-available data
  • Case studies involving up to two individuals (Although these may still require patient authorization)
  • Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
  • Quality assurance, quality improvement, or program evaluation activities

Research vs Quality Improvement

Although quality improvement can be a systematic investigation, is it not considered research if there is no intent to share the information with others or contribute to generalizable knowledge. These projects should be designed to only improve the quality or performance of a department or program. For more information on this, please refer to COMIRB's Quality Improvement and Program Evaluation Guidance.


If you have any questions, please contact us at comirb@ucdenver.edu. We are happy to answer your questions or to schedule a meeting to discuss your project. COMIRB also holds office hours every Monday at noon.
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