USDOE Human Subjects Research Database, Fiscal Year 1999

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: 404-639-0500
Fax: 404-639-0522
E-mail: dbg3@cdc.gov

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 2

ATSDR-96-1594

"Hanford Infant Mortality and Fetal Death Analysis"

ATSDR-96-1624

"National Exposure Registry: Iodine-131 Subregistry Site Specific Protocol, Hanford Nuclear Reservation, State of Washington"

Project Identifier: ATSDR-96-1594

"Hanford Infant Mortality and Fetal Death Analysis"

Principal Investigator: Dr. Lilith M. Tatham, Agency for Toxic Substances and Disease Registry

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH/Office of Epidemiologic Studies

$0.00 (Est.) for: Fiscal Year 1999
Funding of contractor and their activities took place in a previous fiscal year. This project was completed in FY99 with agency staff funding only.

Information on Use of Human Subjects:

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

Identifier or number: 1594

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 05/22/99

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

Type(s) of Human Subjects Involvement:

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

• 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])

Populations living in communities surrounding the Hanford DOE facility in southeastern Washington were exposed to radionuclides, particularly iodine-131, during the mid to late 1940's. The purpose of this project is to investigate whether rates of infant mortality and fetal death differ according to the iodine-131 exposure classification of mother's residence at the time of birth in an 8 county region surrounding Hanford for the years 1940 through 1952. In order to do this analysis, birth, infant death and fetal death certificates were abstracted for the 13 year study period. The mother's place of residence at time of birth was geocoded and the location was assigned a dose level from the Hanford Environmental Dose Reconstruction project for each record. The analysis will look at gradations of maternal dose by rates of adverse outcomes and causes of death. The study only involves the use of existing data records retained by the State of Washington. Only aggregate information will be reported and no individuals will be identified or contacted for this study. Permission for access to birth and death vital records was reviewed and approved by the state health agency.

Project Identifier: ATSDR-96-1624

"National Exposure Registry: Iodine-131 Subregistry Site Specific Protocol, Hanford Nuclear Reservation, State of Washington"

Principal Investigator: Dr. JeAnne R. Burg, Agency for Toxic Substances and Disease Registry

Project started in: 1996

Project Funding Information:

Funding for Human Subjects Research:

DOE: EH/Office of Epidemiologic Studies

$0.00 (Est.) for: Fiscal Year 1999
Contractor had been funded in previous year and conducted tracing activities during FY98 and FY99

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
Most recent IRB approval: 07/10/99

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7000
Reporting period for number of human subjects: Fiscal Year 1999 (10/1/98-9/30/99)

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. The purpose of the subregistry is to assess a wide-variety of potential health effects of iodine-131 exposure in this cohort. A questionnaire assessing health problems will be administered and compared across dose gradients and to national norms. Should excess reporting be noted for specific health outcomes, consideration will be given to further related studies. The project is a response to assess the impact on general health rather than a limited focus on thyroid disease or cancer. Policies and procedures are in place to protect confidential information within the limits of the Federal Privacy Act. Currently, the registry is in an initial phase of tracing individuals of the cohort to determine where they now live. When further funds are obtained from DOE, the full subregistry will be implemented.