An Institutional Review Board (IRB) is a federally mandated entity that oversees the protection of human subjects who participate in research. The role of the IRB is to ensure that the rights and welfare of human research subjects are protected regardless of whether the research is domestic or international, classified or proprietary. Often researchers only work directly with the IRB, but it is only one of the elements that are critical to a robust Human Research Protection Program (HRPP). This includes the researchers themselves.

All research that includes humans conducted at the U.S. Department of Energy (DOE) institutions, supported with DOE funds, or performed by DOE or its contractor employees, must comply with federal regulations and DOE Orders to protect human subjects. For DOE facilities under the purview of the Oak Ridge Site Office, Oak Ridge Associated Universities (ORAU) operates the Human Research Protection Program (HRPP) which is responsible for ensuring this compliance.  The Institutional Official at ORAU has responsibility for the operation of the program.

The ORSIRB reviews and oversees research conducted at participating sites to assure that the research meets ethical principles and complies with federal regulations that pertain to human subjects protection. The research cannot begin until the IRB provides 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 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, Chg. 1 (or current version), as well as the Federal Policy for the Protection of Human Subjects (i.e., 45 CFR 46) and the DOE counterpart, 10 CFR 745.