USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-95-102

Project Title:

Cytogenetic Analyses of X-Ray Technologists

Principle Investigator: Dr. James D. Tucker

Project started in: 1995

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)

Amount: $96,000

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: March 22, 1995
IRB Approval Number: 95-102

Number of Human Subjects in the Last Reporting Period for this Project: 40
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• Other use of external ionizing radiation:

  Subjects received occupational or accidental radiation exposure only. No radiation was deliberately administered.

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])

The objectives of this work are to: (1) validate the measured radiation doses experienced by radiologic technologists; (2) provide an evaluation of the possible range of exposures experienced by this well-characterized cohort of 143,000 radiological technologists; and (3) provide guidance on estimating radiation doses for pioneering technologists in the 1920s through 1940s for whom dosimeter measurements are not available. Each subject provides a sample of peripheral blood (~3 ml) which is cultured to obtain metaphase cells for cytogenetic analysis. The subjects received occupational exposure to X-rays, but do not receive any radiation or chemical exposure as part of this study. The risks to the subjects are those associated with venipuncture, and include temporary pain, bruising and/or soreness of the affected tissue or surrounding tissue, formation of scar tissue, infection, and fainting.