An Institutional Review Board (IRB) is a federally mandated entity that oversees the protection of human subjects in research. The role of the IRB is to ensure that the rights and welfare of human research subjects are protected. All research conducted at the U.S. Department of Energy (DOE), supported with DOE funds, or performed by DOE employees, including classified and proprietary, must comply with federal regulations and DOE Orders to protect human subjects.

While each organization that submits to the Oak Ridge Sitewide Institutional Review Board (ORSIRB) holds a Federal Wide Assurance with the Office of Human Research Protection (OHRP), Oak Ridge Associated Universities (ORAU) is responsible for operation of the Human Subjects Protection Program (HSPP). This program is comprised of the many elements that go into protection of Human Subject Research, not only the IRB. The Intuitional Official at ORAU has responsibility for the operation of the program.

The ORSIRB must review and oversee research conducted at participating sites to assure that it meets ethical principles and complies with federal regulations that pertain to human subjects protection and the research cannot begin until the IRB has reached a determination. The ORSIRB reviews research from ORAU, Oak Ridge National Laboratory (ORNL), Y-12 National Security Complex (Y-12), and other DOE facilities under of the purview of the Oak Ridge Site Office as applicable.

The ORSIRB is composed of members with both scientific and non-scientific backgrounds. Membership is drawn from DOE facilities in the Oak Ridge area, as well as representatives from the local community. Priority is placed on diversity of membership in terms of gender, race, ethnicity, and sufficient representation of both scientific and non-scientific expertise.

Function

The function of the IRB is to ensure adherence to all federal, state, local, DOE Order, and institutional regulations concerning the protection of human subjects in research. For regulations specific to your institution, contact your local organizational Human Subjects Protection Manager.

Administration

ORAU established and will maintain the ORSIRB in accordance with the DOE Order 443.1C, 10 CFR 745, and 45 CFR 46.