•  
  • Purpose/Mission
  • Legal Requirements

•  
  • Overview
  • Forms
  • Membership List
  • Operating Procedures (pdf)
  • "How to" for PIs (pdf)

•  
  • Overview
  • Forms
  • Membership List
  • Operating Procedures (pdf)
  • "How to" for PIs (pdf)

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.

ORAU also administers the Central Beryllium Institutional Review Board (CBeIRB). It serves as DOE's IRB of record for purposes of satisfying the human subject protection requirements of the DOE and HHS for research protocols that include or are explicitly funded as beryllium research. Specifically, ongoing programs that are subject to review by the CBeIRB are the beryllium screening component of the Former Worker Medical Surveillance Program, and any site or off-site research activities related to beryllium exposure, medical testing, or pathogenesis of chronic beryllium disease.