USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-93-88

Project Title:

A Study of the Health Effects of Exposure to Elemental Mercury: A Follow-up of Mercury Exposed Workers at the Y-12 Plant

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

Project started in: 1993

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:

Non-DOE Federal: Centers for Disease Control and Prevention

Amount: $200,000

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: July 28, 1994

Number of Human Subjects in the Last Reporting Period for this Project: 220
(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.
• 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])

a. The overall hypothesis to be tested is whether occupational exposure to inorganic mercury is associated with long-term adverse effects on the nervous system.

b. To evaluate the potential mercury-related long-term effects, we have utilized a questionnaire, a neurological/medical examination, and a series of standardized neurological and neurobehavioral tests on the exposed workers and their controls who were frequency matched for age, gender, work status (active, terminated, or retired), and job title.

c. None

d. The number of subjects involved each year is 220. The only risk in this study is the risk associated with drawing blood. Nerve conduction tests are administered which may be slightly uncomfortable but do not pose a risk to the study participant. No chemical or radioactive materials are applied to the human subjects in this study.