Human Subjects Research Program Overview

Legal Requirements

Legal requirements to protect human subjects apply to a much broader range of research than many investigators and program managers realize. In addition to traditional biomedical studies, regulations cover, for example, research that:

  • Uses humans to test devices or products or materials that have been developed through research including using humans to examine human-machine interfaces.
  • Uses data collected through intervention or interaction with individuals. Intervention, such as physically drawing blood, could also include manipulation of a subject's environment. Interaction includes interpersonal contact, surveys, and other kinds of communication.
  • Uses private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question. Information is private if the individual can reasonably expect it not to be made public or if the information concerns behavior that the individual can reasonable expect not to be observed or recorded.
  • Uses bodily materials such as cells, blood, urine, tissues, organs, hair, and nail clippings even if you did not collect these materials.
  • Uses humans to evaluate environmental alterations - for example, weatherization options or habitat modifications.

If your research meets any of these definitions, you should be aware that ...

  • It is the policy of Oak Ridge Associated Universities (ORAU) to conduct all research and development activities involving human subjects in a manner that adequately protects the individual as well as their rights and welfare and that complies with pertinent laws, regulations, and U.S. Department of Energy orders.
  • It is an ORAU responsibility to review all proposals and applications to ensure that all research involving human subjects is identified.
  • It is the responsibility of the researcher to make known to the facility and obtain approval before proceeding with research involving human subjects.