USDOE Human Subjects Research Database, Fiscal Year 2003

Washington State University

Public Information Contact:

Dr. Ronald E. Filipy
United States Transuranium and Uranium Registries
Washington State University
2710 University Drive
Richland, WA 99352-1671

Phone: 509-372-7317
Fax: 509-375-1817
E-mail: rfilipy@tricity.wsu.edu

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

WASU-68-50181

"United States Transuranium and Uranium Registries"

Project Identifier: WASU-68-50181

"United States Transuranium and Uranium Registries"

Principal Investigator: Dr. Ronald E. Filipy, Washington State University

Project started in: 1968

Project Funding Information:

Funding for Human Subjects Research:

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

$1,000,000.00 for: Fiscal Year 2003
Operation of the United States Transuranium and Uranium Registries

DOE: Office of Biological and Environmental Research (OBER)

$55,000.00 for: Fiscal Year 2003
National Radiobiology Archives. This is not a human research program.

Other: University of Colorado

$15,000.00 for: Fiscal Year 2003
Subcontract - final year - ends 7/31/03.

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: Washington State University
Most recent approval: 09/22/03
IRB approval number: 1821-o

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 914
Reporting period for number of human subjects: Fiscal Year 2003

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using cells cultured in a laboratory.
• Using bodily materials collected specifically for this project.
• Using existing specimens or samples of bodily materials collected for another purpose.

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])

The Registries study the biokinetics, dose, and possible biological effects of actinide elements, such as plutonium, in persons with documented occupational or other intakes. Tissues, or in some cases the whole body, are obtained at autopsy from volunteer donors and are analyzed radiochemically. These data are evaluated in conjunction with the occupational exposure and medical histories obtained during life to determine biokinetic parameters fundamental to the development, verification, or refinement of radiation protection standards; possible biological effects attributable to radiation; and risk coefficients. An archival tissue material repository is also maintained and tissue materials made available to other researchers. The participants in the program are selected from volunteers who have been previously exposed occupationally or otherwise have exhibited a positive bioassay. The Registries do not expose persons to radiation or chemicals nor administer drugs or substances of any kind. Permissions for tissue samples and medical and dosimetry records are typically obtained from fully informed donors well in advance of their death, or in some cases, are volunteered by next-of-kin after death. A few registrants may be asked to participate in special studies that involve excreta collection and whole body (in vivo) counting. There are no known risks to the volunteer participants in this research.

The privacy of participants is protected in strict accordance with the Federal Privacy Act and applicable laws of the state of Washington. In practice, personal identifiers are not published and all hard copy records are maintained in locked fire-proof storage; automated data are protected with multilevel security to provide access only to authorized individuals. Data users must sign a confidentiality agreement before access can be granted.