USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-88-105

Project Title:

Dosimetry of Human Red Blood Cells from Victims of the Chernobyl Power Plant Accident

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

Project started in: 1988

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-DOE Federal: National Cancer Institute (NCI)-Radiation Effects Branch

Amount: $1,171,158 (Est.)

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: March 22, 1995
IRB Approval Number: 88-105

Number of Human Subjects in the Last Reporting Period for this Project: 266
(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 data collected from subjects specifically for this 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

Cleanup workers for the Chernobyl accident which occurred in 1986 were exposed to moderate amounts of ionizing radiation. To detect early biological effects of radiation exposure on these individuals, peripheral blood samples are obtained and analyzed for cytogenetic and somatic mutations in lymphocytes and erythrocytes. In addition, peripheral blood samples are obtained from spouses and children of such workers to determine whether germinal mutations are induced by radiation exposure by detection of such mutations in DNA from children with detailed comparison to parents.

B. Methodology

Our method for accomplishing these goals is to simultaneously obtain genotoxicity measurements using four different analytical techniques on blood samples from approximately 1,000 individuals, including people who were exposed to ionizing radiation as a result of the accident at the nuclear power plant in Chernobyl, Ukraine, in April-May 1986 and their progeny.

Data from the four areas of research will be used in two ways. For each individual assay of somatic cells, a dose-response from ionizing radiation will be generated by comparing the analytical results with physical dosimetry and with immediate biological dosimetry that was performed by the Soviet medical scientists in 1986, shortly after the Chernobyl accident. This should provide a means for interpreting each of the bioassays for its capabilities as a monitoring biodosimeter for similar radiation exposures (both sensitivity and precision will be determined). In addition, the combination of measurements from the four different research areas will allow an overall effect of exposure of each individual to be determined. A weighted sum of these effects will be derived, and in the future this may serve as an individual dosimeter for dose, an indicator for higher susceptibility to damage, and an estimator for that individual's risk to develop cancer.

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 and mutations at the HPRT locus. This requires that lymphocytes be cultured in vitro to obtain metaphase chromosomes for the cytogenetics and also to detect HPRT mutant lymphocytes, which become resistant to thioguanine poisoning. Using these three assays, it should be possible to relate the level of radiation exposure as obtained by physical dosimetry to three 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 Russian health service.