USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-88-111

Project Title:

Cytogenetic Studies

Principle Investigator: Dr. James D. Tucker

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:

DOE: Office of Health and Environmental Research (OHER)

Amount: $5,000 (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: November 16, 1994
IRB Approval Number: 88-111

Number of Human Subjects in the Last Reporting Period for this Project: 2
(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])

The objectives of this work are to provide peripheral blood for cytogenetic analyses, which will include calibration, validation, and quality control for laboratory purposes. In addition, metaphase chromosomes will be utilized for mapping genes, and developing or evaluating potential new cytogenetic methods that require human peripheral blood cells. The subjects' involvement is limited to phlebotomy (less than 50 ml total volume), followed by tissue culture to obtain metaphase chromosomes from the peripheral lymphocytes. 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.