USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-91-80

Project Title:

Study of Morbidity and Mortality From Selected Causes Among Oak Ridge Y-12 Sheet Metal Workers

Principle Investigator: Dr. Elizabeth A. Dupree
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1991

Fiscal Year 1995 Funding for Research on Human Subjects:

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

Explanation:

No additional information was collected from human subjects in 1995. The study is at the analysis stage.

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: 80

Number of Human Subjects in the Last Reporting Period for this Project: 250
(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 data collected from subjects specifically for this project.
• 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])

The objective of this study is to evaluate the health status of a group of sheet metal workers who worked in metal fabrication operations at the Oak Ridge Y-12 Plant between 1947 and 1988. Both morbidity and mortality will be examined with special emphasis on those cause-specific cancer outcomes of expressed worker concern and any outcome expected to result from known or suspected occupational exposures encountered during metal fabrication operations.

A case series study design will be used. The study population will be all workers ever employed in the metal fabrication operations at Y-12 between May 1947 and December 1988. Work histories will be used to identify these workers. Non-radiation exposures will be identified through monitoring records and interviews with knowledgeable workers. From this information a telephone questionnaire will be developed to collect information about cancer incidence, medical and occupational history, and specific demographic and life-style information. The study subjects will be contacted by mail to ask them to participate, with a telephone contact attempted for non-respondents. Next of kin will be contacted if the study subject is deceased. Death certificates will be requested for those study subjects who have died. The study population will be matched against the Tennessee Cancer Reporting database to identify incidence of cancer cases.

None of the study subjects will be exposed to ionizing radiation, radioactive substances or chemical substances in the course of this study.

The human subjects are not exposed to any risks.