USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-90-105

Project Title:

Center for Genome Research

Principle Investigator: Dr. Anthony V. Carrano

Project started in: 1990

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: $20,000 (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: January 18, 1995
IRB Approval Number: 90-105

Number of Human Subjects in the Last Reporting Period for this Project: 4
(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.

(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])

Genome mapping is a nationally funded project with strong links to the medical community. Livermore's Human Genome Center mapping work is recognized worldwide. Many researchers working on specific diseases have established collaborations with the Center. Some examples of disease whose genes are localized to chromosome 19 include myotonic dystrophy, familial hypercholesterolemia, dominant autosomal stroke, and a form of diabetes.

As a part of this project, human blood samples are obtained specifically to culture lymphocytes and produce chromosomes on microscope slides for physical mapping. Prior to obtaining samples, all donors sign an informed consent form and they receive "The Experimental Subject's Bill of Rights." A small sample (5-10 ml) of venous blood is drawn at the LLNL medical facility from volunteers. Risk to the donor is minimal, but may include local bruising or fainting. Blood donors are not subjected to any in vivo procedures, nor to any procedures associated with in vitro fertilization, long-term cell culture or genetic engineering.

Blood samples are coded before culturing, and all data linked to sample codes. Blood is cultured for two days, and lymphocyte chromosomes harvested. Chromosomes are used as "target" templates for determining order of fluorescently labeled markers used as probes. Data are scored directly from coded microscope slides.