DOE Worker Health-Related Studies and Programs
Definition and Scope of the Central Beryllium Institutional Review Board
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 DOE O 443.1B, Protection of Human Research Subjects (1), supports the Central Beryllium Institutional Review Board (CBeIRB). The CBeIRB is administered by Oak Ridge Associated Universities (ORAU) under a Federal-Wide Assurance (FWA 00005031) with the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (HHS).
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 includes representatives from all stakeholders in the Be 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 described to allow for site IRB and CBeIRB review.
- 10 CFR 745, Protection of Human Subjects
- Department of Energy Order (DOE O) 443.1B, Protection of Human Research Subjects
- Access Handbook, Conducting Health Studies at Department of Energy Sites, Appendix 2: DOE/CDC Institutional Review Board (IRB) Procedures.
Return to CBeIRB page.
Content reviewed: May 7, 2012