University of Nevada Las Vegas

Funding for Human Subjects Research:

DOE: Life Science Division

$4,000,000.00 for: Fiscal Year 2006
Percent of funding associated with the use of human subjects: 81-99

Information on Use of Human Subjects:

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

Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: University of Nevada Las Vegas
Most recent approval: 06/28/06

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 10000
Reporting period for number of human subjects: Fiscal Year 2006

Type(s) of Human Subjects Involvement:

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

• Using existing data that were collected for other purposes or projects.

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 1940s to the present. The subjects for whom these medical records exist were employees of DOE's predecessor, the Atomic Energy Commission (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])

This 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.

A Certification of Confidentiality for all persons working on this project has been issued and documented. The project has been approved for a "waiver of informed consent" by the UNLV Institutional Review Board as regulated by 45 CFR 46.116(d)(1-3) and 45 CFR 46.117(c)(2).