USDOE Human Subjects Research Database, Fiscal Year 1999

Lovelace Respiratory Research Institute

Public Information Contact:

Dr. Joe L. Mauderly
Inhalation Toxicology Laboratory
P.O. Box 5890
Albuquerque, NM 87185-

Phone: 505-845-1075
Fax: 505-845-1193
E-mail: jmauderl@lrri.org

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Lovelace Respiratory Research Institute
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1479

Human Subject Projects:

Number of Human Subjects projects reported: 1

LRRI-95-IRB#96027
"In Vivo Measurements of Lead-210 in Former Uranium Miners (IRB#96027; formerly listed as LRRI-95-IRB#95-030/IRB#96027 in FY98 database)"
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Project Identifier: LRRI-95-IRB#96027

Project Title:
"In Vivo Measurements of Lead-210 in Former Uranium Miners (IRB#96027; formerly listed as LRRI-95-IRB#95-030/IRB#96027 in FY98 database)"

Principal Investigator: Dr. Raymond A. Guilmette, Lovelace Respiratory Research Institute

Project started in: 1995

Project Funding Information:

This project received funding during fiscal year 1999.
This project used human subjects in fiscal year 1999.

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)
$450,000.00 for: Fiscal Year 1999

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: IRB#96027

Institutional Review Board (IRB) Review:
Type of Review: Expedited
Most recent IRB approval: 07/11/99

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 58
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
Other types of human subjects involvement. Explanation:
External radiation counting of endogenous lead-210 within subjects. No materials are administered.
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])

OBJECTIVES
The hypothesis of this study is that the measurement of lead-210 (210Pb) in the skeleton of uranium miners, compared to control subjects, will provide an improved estimate of an individual miner's integrated exposure to radon (Rn).

Rn progeny decay to 210Pb. The lead locates in the skeleton of the individual who inhaled Rn. The 210Pb is then calculated into working level months (WLM) using a standard biokinetic model. Data from control subjects (non-miners) are used to determine background levels of 210Pb in the general population from which the miners are drawn.

METHODS AND PROCEDURES
All participants are consented using an IRB approved consent form. After informed consent is obtained, a survey is used to determine work history. The amount of 210Pb in participants is then measured by using dual crystal scintillation detectors positioned around the head. Participants are asked to sit in a reclining chair with the detectors in place for approximately 90 minutes. Participants can pause the data collection and get up at any time during this period.

POTENTIAL RISKS
Participants are not exposed to any test substances. There are no risks to the subjects.

CONFIDENTIALITY
Privacy and confidentiality are assured. Study records containing individual identifiers are kept in a locked cabinet. No individual identifiers will be used in any publication resulting from the research.

Go to list of projects at Lovelace Respiratory Research Institute