Institutional Review Boards (IRBs)

The Institutional Review Board (IRB) is a committee charged with the responsibility of reviewing and overseeing all research proposals that involve human subjects. The board is comprised of scientists, non-scientists, and community members.

The review process is designed to protect the rights and welfare of human subjects by ensuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality. The IRB reviews all human subjects research protocols in accordance with federal regulation, state and local laws, and Department of Energy (DOE) directives.

Within the DOE complex, some DOE sites have their own IRBs and others do not. For sites without an IRB, the protocols are typically reviewed by one of the central DOE IRBs (CDOEIRB or CDOEIRB-C).

There are two central IRBs within DOE:

The CDOEIRB

The CDOEIRB, which was established in January 2010, serves as DOE’s IRB of record for study protocols that involve employees of DOE or its contractors and/or are explicitly funded by, or conducted by, DOE or other agencies or institutions in the following areas:

  • Beryllium exposure-related studies sponsored by DOE or involving the DOE workforce.
  • Human subjects research in which multiple DOE laboratories/sites are engaged.
  • A portion of the human subjects research involving manipulation of the human environment that is funded by DOE.
  • The Former Worker Medical Screening Program, including the beryllium sensitization screening component.

The CDOEIRB also serves as the IRB of record for several DOE sites that do not have their own site IRB. The scope of the CDOEIRB excludes those projects that are classified, in part or in totality.

The CDOEIRB-Classified

The CDOEIRB-Classified (C), which was established in 2012, serves as DOE’s IRB of record for all human subjects research conducted at/by DOE sites through the Strategic Intelligence Partnership Program (regardless of whether this research is classified or not).  This IRB also serves as the IRB of record for other types of human subjects research that is classified (in part or totality) from sites that do not have a cleared IRB, as well as for classified protocols that involve multiple DOE sites.