USDOE Human Subjects Research Database, Fiscal Year 2003

Agency for Toxic Substances and Disease Registry

Public Information Contact:

Ms. Patti R. Seikus
NCEH/ATSDR
Mail Stop E-28
1600 Clifton Road, NE
Atlanta, GA 30333

Phone: 770-488-4443
Fax: 770-488-4178
E-mail: PQS9@cdc.gov

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

ATSDR-01-Hanford Cohort Study

"Hanford Birth Cohort Study"

Project Identifier: ATSDR-01-Hanford Cohort Study

"Hanford Birth Cohort Study"

Principal Investigator: Dr. Caroline Cusack, Agency for Toxic Substances and Disease Registry

Project started in: 2001

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH-6, Deputy Assistant Secretary for Health Studies

$143,995.00 for: Fiscal Year 2003

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Agency for Toxic Substances and Disease Registry
Most recent approval: 02/03/03

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1295
Reporting period for number of human subjects: Fiscal Year 2003

Type(s) of Human Subjects Involvement:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using 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])

OBJECTIVES: This ATSDR intramural research project will (1) identify and seek participation of known residents who were born or lived in Adams, Benton, and Franklin counties near the Hanford Nuclear Reservation during 1945-1951 and exposed to radioactive releases and a control (less exposed) cohort of individuals born or who lived in Mason, San Juan, and Whatcom counties; (2) explore the relationship of radioactive releases and prevalence of selected autoimmune diseases and cardiovascular diseases by comparing rates between the two groups and Washington State; and (3) provide information on the selected diseases and relationship to possible radiation exposure to participants that may help improve their knowledge and health, even though individual exposure histories cannot be confirmed.

METHODS: Study population uses all births in the six-county area and random selections of 15 percent of births in exposed counties and 20 percent in the less exposed counties. Study goal was to interview by telephone 2,000 eligible persons or their proxies who are still alive (1,000 per group). Computer assisted telephone interviews collected demographic information, life style factors, occupational history, residential history, and self-reported, physician confirmed diagnoses. Medical records were accessed to verify the health conditions reported. For rare conditions and low study power, only descriptive statistics will be used.

RADIATION: The major contaminant of concern was iodine-131.

HUMAN SUBJECTS: This project was deemed minimal risk since it is an interview survey of living subjects. Study subjects provided verbal informed consent at the start of the interview and written permission to access their medical records. All study information collected is retained in a secure database. Analyses are performed only on data files without personal identifiers. Summary reports and findings will be presented so that no individual can be identified.