USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-91-102

Project Title:

Glycophorin A-based Somatic Cell Mutation Measurements in Blood Samples from Normal Individuals

Principle Investigator: Dr. Richard G. Langlois

Project started in: 1991

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: $60,000 (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: March 22, 1995
IRB Approval Number: 91-102

Number of Human Subjects in the Last Reporting Period for this Project: 35
(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.

(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

The glycophorin A (GPA) human mutation assay was developed at LLNL, and this assay is now being extensively used for studies of genetic damage in human populations with exposure to potentially mutagenic agents and populations that are potentially unusually susceptible to mutational damage. Thus, the GPA assay provides an important approach for studying the human risk from exposure to genotoxic agents. Blood samples from normal donors are required both for quality control, and for defining the distribution of GPA variant frequencies in unexposed individuals for comparison with individuals with potential mutagen exposure.

B) Methodology

Blood samples (5-30 ml) from volunteers at LLNL will be obtained by standard venipuncture done by members of the LLNL Medical Department. All samples will first be M,N typed to identify which samples are of blood type MN, as the assay can only be performed on samples of this blood type. Blood samples will be fixed, labeled with monoclonal antibodies and propidium iodide, and analyzed by flow cytometry. The flow cytometer data will be used to calculate the frequency of variant phenotype erythrocytes in each sample.

C) Ionizing Radiation, Radioactive Substances, or Chemical Substances

None

D) Involvement of Human Subjects

Blood samples will be obtained from normal donors in the LLNL employee population for use in the glycophorin A (GPA) assay for somatic cell mutations in humans. Samples from normal donors will be used for instrument calibration, for quality control tests on assay performance, and as test samples for modifications of the GPA assay method. Assay data from normal donors will also be combined with data from other normal donors to provide information on the distribution of variant cell frequencies in unexposed individuals.

Each donor will be assigned a code number by the principal investigator, Dr. Richard G. Langlois. Subject names will be known only to him and appropriate laboratory personnel. Data obtained from individual subjects will be referred to only by the code number so that the identity of donors will be protected.

Blood samples are obtained by standard venipuncture procedures, and it is expected that the subject will be able to function normally immediately. Possible risks and discomforts that may result from the procedure are considered unlikely but include:

a. Temporary pain
b. Bruising and/or soreness of the affected tissue or surrounding tissue
c. Formation of scar tissue
d. Infection
e. Fainting