Studies That Are Human Subjects Research

  1. Studies that utilize test subjects or their specimens for new devices, products, drugs, or materials.

  2. Studies that collect data through intervention or interaction with individuals. Examples of this type of research include drug trials, internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors that contribute to generalizable knowledge.

  3. Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.

  4. Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if one did not collect these materials for the study. However, such research may be considered exempt or not human subjects research if the materials/data are coded and the investigator does not have access to the coding systems. Guidance on research involving coded private information or biological specimens is available on the web at:(

  5. Studies that produce generalizable knowledge about categories or classes of subjects from individually identifiable information.

  6. Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications to their living or working space or test chamber.