USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-95-103

Project Title:

Analysis of Genetic Damage in Somatic Cells

Principle Investigator: Dr. James D. Tucker

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Study received full IRB approval, but was canceled for scientific reasons. Samples were no longer needed.

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: 95-103

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

(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])

This project was canceled soon after receiving full IRB approval. No human samples were obtained. Our initial goal was to obtain peripheral blood samples from Russian citizens visiting the Lawrence Livermore National Laboratory. These individuals would have served as controls for our Chernobyl Program Project (Dr. Ron Jensen, P.I.), which was experiencing difficulty obtaining suitable controls from Russia. Peripheral blood would have been drawn for analysis of background (i.e., control) levels of genetic damage, including chromosome aberrations, HPRT mutations, and variants at the glycophorin A locus. No ionizing radiation or chemicals would have been administered to these people as part of this project. Shortly after IRB approval was granted, we began receiving suitable control samples from Russia, and the need for this project no longer existed.