USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-94-103-H01

Project Title:

Biodosimetry for Long-Term Exposures to Low Levels of Ionizing Radiation

Principle Investigator: Dr. Ronald H. Jensen

Project started in: 1994

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-Federal: Interagency Agreement with National Cancer Institute

Amount: $96,000 (Est.)

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1

Protocol/Subproject # 1
Protocol/Subproject Identifier: CPHS 94-6-78

IRB Review:
Type of Review: Expedited
Most Recent Approval: June 19, 1995
IRB Approval Number: 95-6-109

Number of Human Subjects in the Last Reporting Period for this Project: 65
(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 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])

OBJECTIVES

Individuals in populations who are occupationally or accidentally exposed to ionizing radiation are being followed by collaborators for possible health effects of their exposure. A correlation is drawn between the aberrant cells or chromosomes measured in blood samples and the amount of radiation exposure experienced by the donors to determine the dose response and sensitivity of the samples. These data will benefit persons who have experienced long-term exposure to ionizing radiation and will help determine the effect of such exposures.

METHODOLOGY

Human blood samples will be obtained by contractors of the National Cancer Institute (NCI) at sites throughout the U.S. as well as in Tibet and Lithuania. Samples are sent to the University of California at San Francisco (UCSF), where the samples are fixed with formaldehyde or methanol-acetic acid. These samples are then labeled with either monoclonal antibodies or DNA probes by in situ hybridization. Each sample is then analyzed by fluorescence microscopy or fluorescence flow cytometry at LBNL. The samples are then returned to UCSF where they are correlated with epidemiological life-style information and reported to NCI.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

None.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

No samples are drawn at either UCSF or LBNL. The principal investigator on this project holds a joint appointment with LBNL and UCSF. Any samples received at UCSF which are identified with the subject's name are coded at UCSF before being sent to LBNL for analysis. No additional risk to subjects is incurred by LBNL's analysis.