USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-91-82a

Project Title:

Studies to Establish and Define ORAU Laboratory Standards for Lymphocyte Proliferation Tests (LPT)

Principle Investigator: Dr. L. G. Littlefield
Principle Investigator's Institution: Oak Ridge Associated Universities

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 Epidemiology and Health Surveillance

Amount: $250,000 (Est.)
Comments:

This is an estimate of total costs for Lymphocyte Proliferation Test studies related to the Y-12 beryllium Workers enhanced Medical Surveillance Study.

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: August 03, 1995
IRB Approval Number: 82a

Number of Human Subjects in the Last Reporting Period for this Project: 14
(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])

Objectives are to define the range and variability in proliferative response of human lymphocytes to in vitro exposure to beryllium salts. This specific study involves blood samples from control persons who have never been at risk for exposure to beryllium in the work place. Standard laboratory methods for separating and culturing cells are used. The only procedure that directly involves the blood donor is the venipuncture that is used to collect the blood sample. The only risk anticipated is the minor bleeding at the site of the venipuncture.