USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-89-111

Project Title:

Biodosimetry for Low Levels of Ionizing Radiation

Principle Investigator: Ronald H. Jensen
Principle Investigator's Institution: LLNL/University of California, San Francisco

Project started in: 1989

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Explanation:

Funding of ongoing project terminated May 1994. Project was completed with no added funding.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: September 14, 1994
IRB Approval Number: 89-111

Number of Human Subjects in the Last Reporting Period for this Project: 5
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of cells cultured in a laboratory.
• Use of bodily materials collected from subjects specifically for this project.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of existing data that were collected for another purpose or project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

A. Objectives

Determine the sensitivity of the GPA-based somatic mutation assay and the chromosome painting translocation analysis assay for measuring the amount of ionizing radiation exposure of individuals who are exposed to low doses over extended periods of time. Since the British Nuclear Fuels, LTD. (BNFL) workers have had very good physical dosimetry, the results of this study will be used as a standard for future uses of these two biodosimetric techniques.

B. Methodology

Individuals are selected from a BNFL listing of its workers and asked if they will donate small amounts of blood to this research study. The selected workers include those that have been exposed to at least 50 cSv of ionizing radiation as well as matched controls. During the next year, approximately 75 such workers will be sought. The samples will be serotyped for MN blood group antigens and a 1 ml aliquot will be sent to LLNL for the glycophorin A-based assay. In addition, the cytogenetics laboratory at BNFL will prepare fixed lymphocytes from each sample for chromosomal analysis, and send these fixed lymphocytes to LLNL.

C. Ionizing Radiation, etc.

None

D. Involvement of Human Subjects

1. Procedures
The exposed individuals are being studied for the frequency of mutations at the glycophorin A locus by analysis of red blood cells in flow cytometry. The lymphocytes of these same individuals are screened for the frequency of chromosomal anomalies. This requires that lymphocytes be cultured in vitro to obtain metaphase chromosomes for the cytogenetics. Using these two assays, it should be possible to relate the level of radiation exposure as obtained by physical dosimetry to the different somatic cell endpoints.

2. Risks
The risks to the individual from the drawing of the blood sample are bruising at the site of venipuncture and minor infection. These are unlikely events. Any adverse effects will be treated by the appropriate British health service.