EXAMPLES OF
HUMAN SUBJECTS RESEARCH

Legal requirements to protect human subjects apply to a much broader range of research than many investigators realize. In addition to covering traditional biomedical studies, legal obligations to protect human subjects also apply, for example, to research that uses:

• Human beings to test devices, products, or materials that have been developed through research.
• Data collected through intervention or interaction with individuals. Intervention includes not only physical procedures, but also manipulation of a subject's environment and some observations
• Private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question. Examples include student records and medical records.
• Bodily materials such as cells, blood or urine, tissues, organs, hair, and nail clippings even if you did not collect these materials (such research may be considered Exempt (link to General Information page) if materials are not personally identifiable and if the materials were collected prior to the initiation of the research project).
• Studies conducted to gain generalizable knowledge about categories or classes of subjects, such as Meharry employees, students, and/or patients. This includes a doctoral dissertation and a master's thesis.
• Human beings to evaluate environmental alterations.

If you have questions about whether your planned studies constitute human subjects research that are not addressed by the Definitions or these above examples, please contact the Human Protections Administrator in Meharry Medical College’s IRB office.