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A Guide for Investigators and Research Staff                 


Examples of Human Subjects Research:

  • Studies that evaluate the safety and effectiveness of drugs, biologics, devices, products, or materials in humans.
  • Studies that collect data through intervention or interaction with individuals.  Intervention includes not only physical procedures (e.g., drawing blood) but also manipulation of a subject’s environment.  Interaction includes surveys, questionnaires, interviews, and focus groups.  Data collection using non-individually identifiable information may be exempt. Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for your study.
  • Studies that use bodily fluid and materials such as cells, blood, urine, tissues, organs, hair or nail clippings, even if you did not collect these materials.  However, such research may be considered exempt or not to involve human subjects if materials are not personally identifiable.
  • Studies that produce generalizable knowledge about categories or classes of subjects from individually identifiable information.

For more information on the definition of human subjects research and guidance for determining the level of review or type of submission for a specific research activity, please refer to following decision trees, policies and guidance:

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