The Oak Ridge Institute for Science and Education (ORISE) Human Subjects Research Program

Oak Ridge Associated Universities (ORAU) is responsible for ensuring the protection of human subjects involved in research/projects that are:

  • proposed or conducted by ORAU or ORISE,
  • conducted by or under the direction of any employee or agent of these institutions in connection with his/her institutional responsibilities,
  • conducted by or under the direction of any employee or agent of these institutions using any property or facility of these institutions, or
  • involves the use of these institutions’ nonpublic information to identify or contact human research subjects or prospective subjects.

To ensure human subjects protection, ORAU administers the Oak Ridge Sitewide Institutional Review Board (ORSIRB). This is administered under a Federal-Wide Assurance (FWA 00005031) with the Office of Human Research Protection (OHRP) of the Department of Health and Human Services (DHHS). The ORSIRB conducts the reviews required for the approval of proposed or continuing studies involving human subjects. 

By direction of the U.S. Department of Energy (DOE), the ORSIRB also serves as the site-specific IRB for research conducted by or involving current or former workers at the DOE Oak Ridge complex.


Welcome to our website! Here you will find resources and information related to ORISE’s Protection of Human Subjects in Research program.

Human Subjects Protection Resource Book
Synthesizes the information currently available on the protection of human subjects in research, the continuing application of such information to new areas of endeavor, and the ever-changing rules, regulations, and guidance. For investigators, Institutional Review Boards, research organizations, research subjects, and others.