USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-89-112

Project Title:

Glycophorin A-based Somatic Mutation Analysis of Blood Samples from Grain Agricultural Workers that Apply Pesticides or

Principle Investigator: Dr. Richard G. Langlois

Project started in: 1989

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: $70,000 (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: 89-112

Number of Human Subjects in the Last Reporting Period for this Project: 85
(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 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])

A. Objectives

The glycophorin A (GPA) human mutation assay is being extensively used for studies of genetic damage in human populations with exposure to potentially mutagenic agents. Blood samples from agricultural workers exposed to pesticides or herbicides and matched unexposed control individuals will be used to determine if occupational exposure to pesticides or herbicides produces an elevated frequency of mutant-phenotype red cells in exposed individuals.

B. Methodology

Coded blood samples from both exposed workers and matched controls will be provided by Dr. Vincent Garry, Laboratory of Environmental Medicine and Pathology, University of Minnesota. Samples will be collected by Dr. Garry, or his staff, and coded aliquots will be sent by express mail to LLNL. The blood samples will be serotyped for the MN blood group. Samples from individuals with MN phenotype will be tested at LLNL using the glycophorin A mutation assay to determine if exposed workers have elevated frequencies of variant red blood cells compared with matched controls.

C. Ionizing Radiation, Radioactive Substances, or Chemical Substances

None

D. Involvement of Human Subjects

Blood samples from agricultural workers exposed to pesticides or herbicides and matched unexposed control individuals will be used to determine if the exposed workers have an elevated frequency of glycophorin A (GPA)-based somatic mutations in red blood cells.

Samples from outside collaborations will be encoded by the collaborator, so the names of the participants will not be known by anyone at LLNL. Samples from LLNL volunteers will be encoded by the Principal Investigator, Dr. Richard Langlois, and all data and records will use code numbers only.

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