DOE Worker Health-Related Studies and Programs

History and Rationale for the Central Beryllium Institutional Review Board

History

Since the Manhattan Project era, the Department of Energy (DOE) and its predecessor agencies have had the obligation and responsibility, under the Atomic Energy Act of 1954, to protect the health of its workers. The prevalence of chronic beryllium disease (CBD), as a result of the use of beryllium in weapons production and research, has been increasing across the DOE complex.

This has sparked an increased awareness of and concern about this serious occupational illness and has resulted in DOE-wide beryllium sensitivity testing of current and former workers, the publication and implementation of DOE's Chronic Beryllium Disease Prevention Program Final Rule, 10 CFR 850, and an expanded Beryllium Disease research program.

Rationale for a Central Beryllium IRB (CBeIRB)

DOE is obligated to ensure that research related to beryllium exposure, to beryllium medical testing and to understanding the pathogenesis of berylliosis is conducted in accordance with the highest prevailing ethical standards. Adherence to this obligation is vital because of the potential impact on quality of life of the beryllium exposed or ill workforce, namely: employability, insurability, health status and privacy. Heightened sensitivity to the information given and support offered to workers before participation in beryllium research is essential to allow the worker to make informed choices about such participation. Because of the potential for significant social and economic hardship to the worker resulting from diagnosis issues or loss of confidentiality, IRB review and approval of the beryllium research protocol is required before any workers can be asked to participate in the research activities.

The requirement for IRB approval poses a problem at some DOE sites that have workers exposed to beryllium but have no IRB. Even if the DOE site or DOE-funded grantee has access to an IRB, that IRB may have insufficient experience with beryllium-related research to adequately evaluate issues concerning protection of human subjects.

The purpose of the CBeIRB is to provide the DOE workforce, DOE, DOE contractors, and any organization(s) engaged in research on beryllium exposure, testing, or occupational disease funded by DOE and/or involving the DOE workforce with expertise and consistency in addressing human subjects protection issues.

Return to CBeIRB page.

Content reviewed: May 3, 2007