DOE Worker Health-Related Studies and Programs

DOE-Wide Central IRB Review of Beryllium Research

The Office of Science (SC), with support from the Office of Health, Safety, and Security (HS), under the authority of 10 CFR 745, Protection of Human Subjects and DOE O 443.1B, Protection of Human Research Subjects, supports a Central Beryllium Institutional Review Board (CBeIRB).

The CBeIRB provides a high-level of expertise and diverse, experienced members to address beryllium-related human subjects protection issues. It provides DOE, DOE contractors, and any other organization(s) engaged in research on Be exposure, testing, or disease funded by DOE and/or involving the DOE workforce with a thorough and consistent review that is essential to protection of the volunteer subjects in these programs.

Ongoing programs subject to review by the CBeIRB are:

  1. All related research activities; and
  2. The beryllium screening component of the Former Worker Medical Surveillance Program

The CBeIRB is administered by Oak Ridge Associated Universities (ORAU) under a Federal-Wide Assurance (FWA 00005031) with the Office for Human Research Protection (OHRP) of the HHS, consistent with responsibilities in 10 CFR 745, Protection of Human Subjects and DOE O 443.1B, Protection of Human Research Subjects where applicable. It serves as DOE's IRB of record for satisfying the DOE and Department of Health and Human Services human subjects protection requirements for all research protocols that include or are explicitly funded as beryllium research.

When there is an IRB at a DOE site (site IRB), the input of the site IRB is solicited prior to the CBeIRB review of any beryllium research protocol for the site. As questions or uncertainties arise regarding the applicability of human subjects protection regulations, the final resolution is determined by the Secretary of Energy who is responsible for the conduct of DOE-related human subjects research.  This authority has been delegated to SC for DOE activities, and to NNSA, as appropriate, which hold this responsibility within the Department. *

The following links offer more information.

History and Rationale for the CBeIRB

Scope and Definition of the CBeIRB

Procedures for the CBeIRB

Former Beryllium Workers Medical Surveillance Program - DOE Sites

Former Worker Program - DOE Sites

Questions regarding this process may be addressed to:

Elizabeth White
DOE Human Subjects Protection Program Manager
humansubjects@science.doe.gov
301-903-7693

* DOE O 443.1B, Protection of Human Research Subjects

Content reviewed: May 7, 2012