USDOE Human Subjects Research Database, Fiscal Year 1998

Washington State University

Public Information Contact:

Mr. Ronald L. Kathren
United States Transuranium and Uranium Registries
Washington State University
2710 University Drive
Richland, WA 99352-1643

Phone: 509-375-5643
Fax: 509-375-1817
Email: rkathren@tricity.wsu.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Washington State University.
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-1344

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

WASU-68-50181

United States Transuranium and Uranium Registries

Project Identifier: WASU-68-50181

Project Title:

United States Transuranium and Uranium Registries

Principal Investigator: Mr. Ronald L. Kathren

Project started in: 1968

Fiscal Year 1998 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.

Funding Sources:

DOE: EH/Office of Epidemiologic Studies

Amount: $1,000,000
Comments:

Operation of the United States Transuranium and Uranium Registries

DOE: Office of Biological and Environmental Research (OBER)

Amount: $0
Comments:

National Radiobiology Archives. This is not a human research program.

DOE: Office of International Health Programs

Amount: $260,000 (Est.)
Comments:

JCCRER Project 2.1

DOE: EH/Office of International Health Programs

Amount: $112,000 (Est.)
Comments:

Establishment of a Russian Tissue Repository

Total Funding: $1,372,000

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: August 17, 1998

Number of Human Subjects who participated in this project/protocol during FY 1998 (10/1/97 - 9/30/98): 892

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of cells cultured in a laboratory.
• Use of bodily materials collected from subjects specifically for this project.
• Use of existing bodily materials that were collected for another purpose or project.

Questionnaires, Surveys, Epidemiological Studies:

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

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or 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])

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 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.