USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-78-60

Project Title:

Comprehensive Epidemiology Study of Department of Energy Atomic Workers

Principle Investigator: Dr. Donna L. Cragle
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1978

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

This is a records-based study.

Funding Sources:

DOE: Office of Epidemiology and Health Surveillance

Amount: $75,000 (Est.)

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: August 03, 1995
IRB Approval Number: 60&60a

Number of Human Subjects in the Last Reporting Period for this Project: 1,200
(Reporting periods vary.)

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

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

• Use of existing data that were collected for another purpose or project.

(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 study is a records-based study to determine if there are health effects related to employment at Department of Energy facilities. Data collection has focused on data pertaining to the employment period of workers at specific DOE facilities. Work history, exposure history, demographic, and mortality data are collected. The data collection activities for FY95 were limited to the Pittsburgh Energy Technology Center in Pennsylvania.