USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-95-91

Project Title:

Biodosimetry of Exposed Populations

Principle Investigator: Dr. Alfred F. McFee
Principle Investigator's Institution: Oak Ridge Associated Universities

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:

Non-DOE Federal: National Institutes of Health (NIH)

Amount: $149,500 (Est.)
Comments:

National Cancer Institute

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
IRB Approval Number: 91

Number of Human Subjects in the Last Reporting Period for this Project: 15
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• Other use of external ionizing radiation:

  Industrial exposures.

Collection of Bodily Materials:

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

• Use of cells cultured in a laboratory.
• Use of bodily materials 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])

This project uses fluorescence in situ hybridization techniques to measure translocation rates among the chromosomes of human subjects who have potentially been exposed to sources of industrial or accident-related radiation. These rates are used to estimate exposures received many years earlier such as in the Chernobyl accident or those accumulated over a lifetime by radiation workers. Blood samples obtained from populations of interest identified by National Cancer Institute (NCI) are cultured in the laboratory and analyzed after the application of "chromosome painting" techniques. The only risk to subjects is that involved in the drawing of a blood sample. Limited numbers of samples are also taken from control individuals.