Decision Tool: Am I Doing Human Subjects Research?

Question One

The Office of Extramural Research (OER) has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. This tool should not be used as the sole determination of exemption.

Note: Please keep in mind that this tool uses the pre-2018 requirements, so stay tuned for the upcoming changes with the final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). For more information, please visit OHRP’s page.

Please check which best describes your research:

  • For the purpose of this study, at some point there will be an intervention or interaction with subjects for the collection of specimens or biological material or data (including health or clinical data, surveys, focus groups or observation of behavior).
  • This study will involve only the use of secondary analysis of biological material/tissue/specimens or data not collected specifically for this study.
  • This study will involve materials/specimens or data from deceased individuals only.
  • My study does not fit any of these categories.