USDOE Human Subjects Research Database, Fiscal Year 2001

Agency for Toxic Substances and Disease Registry

Public Information Contact:

Ms. Donna B. Garland
OPEA, ATSDR
Mail Stop E-60
1600 Clifton Road, N.E.
Atlanta, GA 30333

Phone: 404-498-0080
Fax: 404-498-0039
E-mail: dbg3@cdc.gov

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

ATSDR-96-1624

"Iodine-131 Exposure Subregistry: Hanford Birth Cohort Study"

Project Identifier: ATSDR-96-1624

"Iodine-131 Exposure Subregistry: Hanford Birth Cohort Study"

Principal Investigator: Dr. Ginger Gist, Agency for Toxic Substances and Disease Registry

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

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

$13,580.00 for: Fiscal Year 2001
Small level of funding in FY 2001 was used for the development of a pilot project for the exposed population.

Information on Use of Human Subjects:

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

Identifier or number: 1624

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Agency for Toxic Substances and Disease Registry
Most recent approval: 07/01/01

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2000
Reporting period for number of human subjects: Fiscal Year 2001

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.
• Using existing data that were collected for other purposes or projects.

(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])

As part of the National Exposure Registry, an iodine-131 subregistry is being established. Persons who received the greatest exposure and considered to be the most vulnerable at the time of exposure (persons born during the period 1940-1951 in Washington's Benton, Franklin, and Adams counties) will constitute the potential registrants. A pilot Hanford birth cohort study is under development that will explore the potential relationship of radioactive releases into the environment and the prevalence of autoimmune diseases and cardiovascular diseases. Approximately 2000 individuals (randomly selected) from both the exposed cohort and a comparison cohort (persons born in San Juan, Whatcom and Mason counties) will be included. A questionnaire assessing health problems will be administered and compared for the two study cohorts. Should excess reporting be noted for specific health outcomes, consideration will be given to further related studies. Policies and procedures are in place to protect confidential information within the limits of the Federal Privacy Act. Up until now, the registry had traced over 7,000 individuals of the exposed birth cohort to determine where they now live.