USDOE Human Subjects Research Database, Fiscal Year 1997

Lovelace Respiratory Research Institute

Public Information Contact:

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

Phone: 505-845-1123
Fax: 505-845-1193
Email: jmoderl@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 Subjects Projects:

Number of Human Subjects Projects reported: 1

ITRI-95-IRB#95-030/IRB#96027

In Vivo Measurements of Lead-210 in Former Uranium Miners (See: Project ITRI-96-IRB#96-019 in FY96 Database)

Project Identifier: ITRI-95-IRB#95-030/IRB#96027

Project Title:

In Vivo Measurements of Lead-210 in Former Uranium Miners (See: Project ITRI-96-IRB#96-019 in FY96 Database)

Principal Investigator: Dr. Raymond A. Guilmette

Project started in: 1995

Fiscal Year 1997 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $267,700

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1

Protocol/Subproject # 1
Protocol/Subproject Identifier: IRB#95-030/IRB#96027

IRB Review:
Type of Review: Expedited
Most Recent Approval: July 09, 1997

Number of Human Subjects who participated in this project/protocol during FY 1997 (10/1/96 - 9/30/97): 105

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.

Other use of human subjects:

survey study

(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 hypothesis of these studies is that the measurement of lead-210 (210Pb) in the skeleton of uranium miners 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 amount of 210Pb in uranium miners is measured by using dual crystal scintillation detectors positioned around the head. The 210Pb is then calculated into working level months (WLM) using a standard biokenetic model.

There are no risks to the miners.

All miners are consented using an IRB approved consent form. All forms of privacy and confidentiality are assured.