Human Subjects Tutorial, University of Wisconsin-Milwaukee

Module 1


To determine whether your project will be subject to human subjects guidelines, you need to understand how the UW-Milwaukee and federal agencies use the terms research and human subjects.

What is research?

Research is defined in the federal rules as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR 46.102(d)).

Research can include:

  • Formal investigations
  • Pilot projects
  • Exploratory studies
  • Student independent studies, theses, or dissertations
  • Some demonstration activities
  • Some service programs

Generally, research does NOT include:

  • Classroom activities that teach research methodologies or simulate research activities
  • Activities conducted to improve the quality of teaching in a particular classroom
  • Activities required for quality assessment (QA) or quality improvement (QI)


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