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  • Purpose/Mission
  • Legal Requirements

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  • Overview
  • Forms
  • Membership List
  • Operating Procedures (pdf)
  • "How to" for PIs (pdf)
  • ORSIRB Operations (pdf)

 

•  
  • Overview
  • Forms
  • Membership List
  • Operating Procedures (pdf)
  • "How to" for PIs (pdf)
  • CBeIRB Operations (pdf)

Department of Energy Central Beryllium Institutional Review Board

Overview

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 (Be) 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 Institutional Review Board (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.

Definition and Scope of the CBeIRB

The Office of Science (SC), with support from the Office of Health, Safety, and Security (HSS), consistent with responsibilities in 10 CFR 745, Protection of Human Subjects and Department of Energy DOE 443.1A, Protection of Human Subjects, supports the CBeIRB.

The Be IRB is administered by Oak Ridge Associated Universities (ORAU) under a Federal-Wide Assurance (FWA 00005031) with the Office of Human Research Protection (OHRP) of the DHHS, consistent with responsibilities in 10 CFR 745, Protection of Human Subjects and Department of Energy Policy DOE 443.1, Protection of Human Subjects where applicable. 

The CBeIRB serves as DOE's IRB of record for purposes of satisfying the human subject protection requirements of the DOE and HHS for research protocols that include or are explicitly funded as beryllium research. Specifically, ongoing programs that are subject to review by the CBeIRB are the beryllium screening component of the Former Worker Medical Surveillance Program, and any site or off-site research activities related to beryllium exposure, medical testing, or pathogenesis of chronic beryllium disease.

Membership of the CBeIRB is broadly based and include representatives from all stakeholders in the beryllium research community. To capitalize on the experience of IRBs located at DOE sites (site IRBs) with a history of beryllium research, one member from each of three site IRBs serves a 2-year renewable term on the CBeIRB. Pacific Northwest National Laboratory, Lawrence Livermore National Laboratory, and Rocky Flats Environmental Technology Site were the first three site IRBs to provide one member each to serve on the CBeIRB as voting members. Current sites represented on the CBeIRB are: Brookhaven National Laboratory, Los Alamos National Laboratory, and Sandia National Laboratory.

When there is an IRB located at a DOE site, the input of the site IRB is solicited by the CBeIRB prior to review of the beryllium research protocol for that site. Although beryllium issues transcend local mores, the perspective of the site IRB is also valued.

Reconciling the need to conduct timely beryllium research at DOE sites with the equally compelling need for review of the beryllium research protocols by the site IRB and the CBeIRB presents unique challenges. This need for coordination is especially true when a beryllium research protocol is conducted by a grantee whose institution has its own IRB. For this reason, time requirements have been established for the review process to allow for site IRB and CBeIRB review.