USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge National Laboratory

Project Identifier: ORNL-95-47

Project Title:

Melatonin Levels of Electric Utility Workers

Principle Investigator: Dr. Paul C. Gailey

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Energy Management

Amount: $68,000

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: August 03, 1995

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

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

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.

(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])

a. To study whether exposure to electric and magnetic fields (EMFs) has an effect on the production of the hormone melatonin in humans.

b. Personal measurements of EMF exposure are made with a dosimeter and compared with melatonin production over a one week period. The amount of melatonin byproduct in urine is analyzed. Subjects provide two urine samples daily for 4 days. At the end of the period a questionnaire is administered to obtain health status information, diet, and use of electrical appliances.

c. None.

d1. Subjects wear a small dosimeter about the size of a pocket calculator and complete a questionnaire.

d2. No physical risks are involved. Social risks are minimized by making completion of the questionnaire optional. All data are kept confidential. Only group data are released without link to specific individuals.