USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-94-113

Project Title:

Molecular Cytogenetic Studies of Human Lymphocytes

Principle Investigator: Dr. James D. Tucker

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:

DOE: Office of Health and Environmental Research (OHER)

Amount: $100,000 (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: July 19, 1995
IRB Approval Number: 94-113

Number of Human Subjects in the Last Reporting Period for this Project: 28
(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.
• Use of existing bodily materials that were collected for another purpose or 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.
• 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])

The objectives of this work are to quantify the frequency of cytogenetic damage in healthy, unexposed people of various ages, and to relate this damage to different genetic polymorphisms and lifestyle factors obtained by a questionnaire. The subjects' involvement is limited to phlebotomy (less than 30 ml total volume), followed by routine tissue culture of the blood to obtain metaphase chromosomes and binucleated cells from the peripheral lymphocytes. In addition, a portion of each blood sample will be used to obtain DNA for analysis of genetic polymorphisms. Subjects also complete a questionnaire inquiring about lifestyle factors that may be useful for interpreting the results of our validation and quality control analyses. No ionizing radiation or chemicals are administered to these people as part of this project. 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.