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
Email: dbg3@cdc.gov
Projects are approved by an IRB located at: Agency for Toxic Substances and Disease Registry.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1141
Number of Human Subjects Projects reported: 2
Project Identifier: ATSDR-96-1594
Project Title:
Hanford Infant Mortality and Fetal Death Analysis
Principal Investigator:
Dr. Lilith M. Tatham
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Data collection and coding by a contractor was performed in an earlier year. ATSDR staff are doing the analysis now and will be preparing the final report. Project involves analyzing birth and death records; no human contact is made.
Funding Sources:
Funding of contractor and their activities took place in the previous fiscal year.
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 1594
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 22, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 81,600
Type of Human Subjects Involvement:
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
Project Title:
National Exposure Registry: Iodine-131 Subregistry Site Specific Protocol, Hanford Nuclear Reservation, State of Washington
Principal Investigator:
Dr. JeAnne R. Burg
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Contractor had been funded in previous year and conducted tracing activities during FY98
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 1624
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 10, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 5,933
Type of Human Subjects Involvement:
As part of the National Exposure Registry, an iodine-131 subregistry is being established. Persons who received the greatest exposure to 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.