Federalwide Assurance and IRB Registration

The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by the Department of Health and Human Services (DHHS), Office of Human Research Protection (OHRP) for institutions engaged in human subjects research conducted or supported by DHHS. Under an FWA, an institution commits to DHHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.

FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support.

Federalwide Assurance

The FWA approved for each institution by OHRP is listed below. 

Oak Ridge Associated Universities (ORAU) FWA number: FWA00005031

Oak Ridge National Laboratory (ORNL) FWA number: FWA00012860

Y-12 National Security Complex (Y-12) FWA number: FWA00031760

You may also confirm our FWA status and search by our FWA number.

IRB Registration Number

The IRB number is IRB00000547.

Central DOE IRB

When a study involves more than one DOE site or DOE and non-DOE sites, the study will typically be sent to the Central DOE IRB for review, unless the ORSIRB or another IRB internal or external to DOE is determined to be the preferred IRB of record. This alternate approach must be authorized by ORSIRB IOs and the DOE Human Subjects Protection Program Manager (as required by DOE Order 443.1C, Chg. 1 or current version). A reliance agreement must be put in place between the institutions participating in the research. Both ORAU and ORNL have executed Reliance Agreements with the Central DOE IRB.

  • Department of Energy IRB #1 (IRB00007622)

Central DOE IRB-Classified

Review of research involving human subjects that is classified or funded through the Strategic Intelligence Partnership Program will be referred to the Central DOE IRB-Classified as required by DOE Order 443.1C, Chg. 1 (or current version). Both ORAU and ORNL have executed Reliance Agreements with the Central DOE IRB-Classified.

  • Department of Energy IRB #2 (IRB00008956)