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Human Subjects Division (HSD)

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Not Human Subjects Research

To determine whether an activity is subject to the UW’s Human Research Protection Program (HRPP), three questions must be answered:

  • Is the activity “research?”
  • Does it involve “human subjects?”
  • Is it under the jurisdiction of the UW?

A clear "yes" or "no" answer to the above questions can pose challenges to researchers. Below are some examples of activities that are typically NOT considered to be human subjects research.

  • Research projects involving certain publicly available data sets pre-approved by the UW IRBs. (See Public Datasets Guidance).
  • Data collection for internal departmental, school, or other UW administrative purposes (e.g., teaching evaluations, “customer service” surveys).
  • Surveys issued or completed by UW personnel for the intent and purposes of improving services and programs of the UW or for developing new services or programs for students, employees, or alumni, as long as the privacy of the individuals is protected, the confidentiality of individual responses is maintained, and survey participation is voluntary.
  • Fact-collecting interviews of individuals where questions focus on things, products, or policies, rather than on people or their experiences (e.g., canvassing librarians about inter-library loan policies or rising journal costs).
  • Course-related activities designed specifically for educational or teaching purposes, where data is collected from and about human subjects as part of a class exercise or assignment that is not intended for use outside of the classroom.
  • Instruction on research methods.  (Note: If the classroom research is more than minimal risk or involves vulnerable populations, it should be submitted to the IRB for review).
  • Searches of existing literature.
  • Research involving a living individual, such as a biography, that is not generalizable beyond that individual.
  • Procedures carried out under an independent contract for an external agency (examples: personnel studies, cost-benefit analyses, customer satisfaction studies, biological sample processing).
  • Innovative therapies designed solely to enhance the well being of an individual patient or client.
  • Quality improvement projects are generally not considered research, as they do not contribute to generalizable knowledge. The intent to publish does not automatically make project outcomes generalizable. However, for example, if a quality improvement project delivers an untested intervention which has the dual purpose of improving quality, and establishing scientific evidence that the intervention achieves its intended results, then yes, that project may constitute nonexempt human subjects research. Please contact HSD, or see a full discussion on Quality Improvement Activities at the Health and Human Services website if you have further questions.
  • Case histories which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient.

Related Questions And Answers

  • Does my research require review?

    If you are a faculty or staff member, or a student at the University of Washington, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires human subjects review and approval before beginning the research.

  • What is research?

    "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the purposes of the regulations that guide and govern how research is conducted in the United States, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. It may be important to understand the following about research:

    • It is basically a study that is done to answer a question.
    • Scientists do research because they don't know for sure what works best or to better understand why or how things happen.
    • Some other words that describe research are clinical trial, protocol, survey, or experiment.
    • Research is not the same as treatment.