USDOE Human Subjects Research Database, Fiscal Year 2000

University of Nevada Las Vegas

Public Information Contact:

Mr. Thomas M. Flagg
News and Public Information (1012)
University of Nevada, Las Vegas
Las Vegas, NV 89154-1012

Phone: 702-895-3101
Fax: 702-895-4057
E-mail: tomflagg@ccmail.nevada.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

UNLV-00-DE-FG03-00ER63059

"Medical Records Knowledge Discovery and Information Management for Radiation Workers"

Project Identifier: UNLV-00-DE-FG03-00ER63059

"Medical Records Knowledge Discovery and Information Management for Radiation Workers"

Principal Investigator: Dr. Stephen L. Rice, University of Nevada Las Vegas

Project started in: 2000

Project Funding Information:

Funding for Human Subjects Research:

DOE: Life Science Division

$1,405,000.00 (Est.) for: Fiscal Year 2000

Information on Use of Human Subjects:

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

Identifier or number: 990F0900-092

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Nevada Las Vegas
Most recent approval: 10/11/00
Explanation of IRB approval:
Project grant effective 09/15/00. Research involving human subjects has not begun. The protocol is pending review 10/11/00, and approval will be required before research involving human subjects can begin.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 2000 (10/1/99-9/30/2000)

Type(s) of Human Subjects Involvement:

Other types of human subjects involvement. Explanation:

The work involves access to private data, specifically medical records. There will be approximately 126,000 medical records consisting of an average of 80 pages of information each. Included are physician notes and test results from medical exams, x-rays, film badges, and health histories. The record period spans from the 1940's to the present. The subjects for whom these medical records exist were employees of DOE, its predecesor (AEC), the military, or employees of DOE/AEC contractors.

(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 proposed research addresses the problem of correlating radiation worker health with exposures occurring in the course of their employment. This will be achieved by the development of methodology for archiving significant medical data across the DOE complex in a consistent electronic format suitable for knowledge discovery ("data mining"). An Advisory Board of stakeholders will oversee the process, and a research team will address medical records at the Nevada Test Site, including architecture definition, requirements management, data management, configuration management, information assurance, product engineering management, investment management, and knowledge discovery. This work will be conducted as Phase I of a larger effort which will integrate this process across the DOE complex.