USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory


Project Identification:

Project Identifier: BNL-86-C1

Project Title:

Renal Sequelae of Excessive Lead Store

Principle Investigator: Dr. Keith Jones

Project started in: 1986


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:

Non-DOE Federal: National Institutes of Health (NIH)
Amount: $0 (Est.)
Comments:
BNL is not funded for this project. Our collaborator is funded by NIH.


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: November 02, 1994

Number of Human Subjects in the Last Reporting Period for this Project: 17
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

Abstract:
(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])

The purpose of this study is to determine tibial bone lead in subjects suspected of excessive past lead absorption. Tibial lead determined by x-ray fluorescence (XRF) will be compared to other estimates of lead exposure, e.g., past history, blood lead, and ethylene diamine tetra acetate (EDTA) lead mobilization test. The BNL contribution to the studies will be participation in the bone lead concentration measurements using K-shell x-ray fluorescence. These measurements will be part of the larger studies involving renal sequelae and other health effects of excessive lead stores. The studies are being carried out at the University of Medicine and Dentistry of New Jersey. No subjects are seen at BNL. BNL's participation is the original design and testing of the equipment for obtaining values for bone lead concentrations. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.


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