USDOE Human Subjects Research Database, fiscal year 1995

Oak Ridge Institute for Science and Education

Project Identifier: ORAU-94-89

Project Title:

Childhood Cancer and Parental Exposure to Ionizing Radiation

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

Project started in: 1994

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: $20,000 (Est.)

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: 89

Number of Human Subjects in the Last Reporting Period for this Project: 150
(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 study is a records based study to determine if there is a relationship between the development of leukemia, non-Hodgkins lymphoma, and central nervous system tumors in children and their parents' pre-conceptual exposure to radiation. Children with any of the cancers listed above who were residents of the counties surrounding the Oak Ridge nuclear complex between 1947 and 1991 were ascertained from hospital records and death certificates. For each child with cancer, four children of the same age and sex were selected from birth listings to serve as controls. Employment records for the nuclear facilities in Oak Ridge will be searched to find evidence of employment of the parents in this industry. Radiation exposure data for parents who worked at the facilities will be abstracted for both case and control parents. Statistical analyses will be performed to determine what relationship, if any, pre-conceptual radiation exposure has to subsequent development of certain cancers in the children.