Project Identifier: ORAU-92-87
Project Title:
Y-12 Beryllium Workers Follow-Up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease
Principle Investigator:
Dr. Donna L. Cragle
Principle Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 30, 1995
IRB Approval Number: 87
Number of Human Subjects in the Last Reporting Period for this Project: 1,000
(Reporting periods vary.)
Type of Human Subjects Involvement:
A. Summarize the objectives and methodology of this research project.
The overall purposes of the Y-12 Beryllium (Be) Workers Study, sponsored by the U.S. DOE and conducted by the Center for Epidemiologic Research (CER) at the Oak Ridge Institute for Science and Education (ORISE) are to (1) investigate variables that may contribute to interlaboratory differences in results from the peripheral blood Lymphocyte transformation test (LTT) for chronic beryllium disease (CBD); (2) assess the sensitivity, specificity, and predictive value of the peripheral blood LTT and other non-invasive procedures and their potential use as routine screening tests for CBD; and (3) determine the prevalence of CBD among current and former Be exposed employees at the Oak Ridge Y-12 Plant.
The first two objectives are addressed under a research protocol. The third objective is addressed through an initial screening program and a subsequent follow-up surveillance program, both designed to incorporate findings from the research phase. Several cases of CBD have already been diagnosed at the Y-12 Plant. The screening program will be developed to identify other cases if they exist, and those who are sensitized to Be, so that they may be placed under medical surveillance and/or early treatment. The rationale for the surveillance program is based on the implied assumption that early detection of Be sensitization or CBD among present and former Be workers will result in a more favorable prognosis.
(2) Specify the number of human subjects involved each year.
Approximately 1,000
(3) Describe the involvement of human subjects and the risks, if any, to which they are exposed.
All study participants receive a physical examination, chest x-ray, complete blood count, and breathing test. Blood for LTT is drawn at the same time as that for the blood count. There is little physical risk in drawing the blood. In a few people slight pain and bruising may occur. An infection from the needle puncture is possible but rare.
A small number of participants (2-5%) are referred for a definitive diagnosis, including bronchoscopy, bronchial alveolar lavage, and lung biopsy.
Discomfort from the bronchoscopy is modest and consists mainly of pressure in the nose and some coughing until the bronchial tubes are numbed. An intravenous tube (iv) is in place during the procedure. A minor risk from the IV may occur if it slips out of the vein and fluid enters the tissues possibly causing pain or allowing medication which is being injected through the tubing to leak and cause inflammation. Before the procedure, the study participant is sedated. If a person is extremely sensitive to the medication, they may enter a deep sleep, in which case medication to counteract narcotics is required. Bronchoscopy with biopsy may result in bleeding in some people, possibly requiring hospitalization for observation. An additional risk of the bronchoscopy with biopsy procedure is rupture of the outer lining of the lung resulting in an air leak, requiring the insertion of a small tube to remove the air that escapes into the chest cavity. Other possible risks are development of fever, or rarely, development of pneumonia. Extremely rarely, a very sensitive individual could die from a complication from the procedure (much less than 1%). These risks are discussed with the individuals prior to their undergoing the definitive diagnosis procedures.
(4) List the chemical or radioactive materials, if any, that are used in the study, and identify the route of exposure.
None