USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-80-62

Project Title:

The Department of Energy Equal to or Greater Than 5 Rem Study Follow-up Program

Principle Investigator: Dr. Ronald E. Goans
Principle Investigator's Institution: Oak Ridge Associated Universities

Project started in: 1980

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 study is part of a larger study which has been placed on standby for the present time.

Funding Sources:

DOE: Office of Occupational Medicine

Amount: $0 (Est.)
Comments:

No funding used for work with human subjects.

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: 62

Number of Human Subjects in the Last Reporting Period for this Project: 3,214
(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 is a Department of Energy registry to document workers who received equal to or greater than 5 rem of occupational exposure to ionizing radiation.

a. Objective:

The current study is part of the larger epidemiologic study sponsored by DOE. The purpose of the current study is to test the hypothesis that the risk of death from lung cancer will be quantitatively related to uranium dust exposures among workers that were employed for at least six months at any three uranium processing or fabrication facilities. Cases are identified using cause-of-death information from death certificates already obtained from the state where the death occurred.

b. Methodology:

The name and address of the hospital and/or confirming certifier found on the death certificate is used in order to contact the hospital or certifier to request information confirming the diagnosis and identifying the histology of the lung cancer for the cases. The importance to this study of the confirmatory and histologic information is to eliminate misdiagnosed cases of lung cancer and to investigate whether exposure to radiation alters the distribution of the histologic type of lung cancer from that found in the general population. All abstracted data are used for statistical purposes only.

c. Involvement of human subjects:

No direct human subject involvement. Data are obtained from death certificates and from hospital records. Data furnished with individual identifiers are not transmitted or redisclosed to other investigators for further use of any kind. All death certificates and documents used to validate cause of death are destroyed by shredding.

d. The IRB review includes an assessment of all existing and/or proposed contact letters, telephone techniques, questionnaires, and consent forms used in the death record followback investigations. These were all deemed to be satisfactory. The privacy of the individual is protected.