USDOE Human Subjects Research Database, Fiscal Year 2002

Office of Health Studies (EH-6)

Public Information Contact:

Dr. Ruth Neta
Office of Health Studies
EH-6, US DOE
1000 Independence Ave, NW
Washington, DC 20585

Phone: 301-903-1757
Fax: 301-903-1413
E-mail: ruth.neta@eh.doe.gov

Institutional Review Board (IRB):

Human Subject Projects:

Number of Human Subjects projects reported: 1

EH6-00-01

"Russian Human Radiobiology Tissue Repository for the Exposed Mayak Workers"

Project Identifier: EH6-00-01

"Russian Human Radiobiology Tissue Repository for the Exposed Mayak Workers"

Principal Investigator: Dr. Ruth Neta, Office of Health Studies (EH-6)

Project started in: 2000

Project Funding Information:

Funding for Human Subjects Research:

DOE: Office of Health Studies (EH-6)

$140,000.00 (Est.) for: Fiscal Year 2002
Funds to cover personnel effort, purchase of supplies, and equipment are provided to the Southern Urals Institute of Biophysics (SUBI) in Russia where the Repository is located.

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: Expedited
Approving Institution: Lawrence Livermore National Laboratory
Most recent approval: 09/01/00
Explanation of IRB approval:
The proposal for conduct of the Repository and the Informed Consent Forms for blood and biopsy specimens collection were reviewed and approved by the IRB Chair at the Lawrence Livermore Laboratories (Dr. Andrew Wyrobek). No research activities are conducted by the repository.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 500
Reporting period for number of human subjects: Fiscal Year 2002

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.

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])

The Russian Human Radiobiology Tissue Repository has been established at the Southern Ural Biophysics Institute, in Ozyorsk, Southern Urals in the Russian Federation, supported jointly by the Russian Ministry of Health and the Office of Health Studies, U.S.DOE. It is anticipated that this repository will serve as a resource to the radiobiology scientific community in current and future studies on the effects of chronic radiation exposure on human health. The inventory of archived tissues includes specimens from 700 deceased workers, employed from 1948 to 1972, at the first nuclear weapons facility “Mayak”. In addition, donations of blood and buccal cells, as well as of tissues removed at the time of surgery and/or biopsy from the members of the Mayak cohort undergoing medical treatment or diagnostic procedures, are also being included. To date 680 archived autopsies, which consist of formalin-preserved organs, paraffin blocks, and histology slides were inventoried. For all these cases occupational, dosimetry and detailed medical information is available. For 342 individuals malignant tumors at different sites are available, mainly solid cancers of lung, stomach, liver, intestine, as well as cases of leukemia. Almost all the registrants at the Repository started their work at Mayak PA during the early years, at the time of highest radiation exposure. For the 680 inventoried cases, the external gamma exposures are known for 649 workers (95.5%), of whom 545 were exposed to protracted doses exceeding 0.5 Gy, with known maximum annual doses ranging from 0.01 – 0.5 Gy for about 44%, and 49% of the 680 individuals have annual doses exceeding 0.5 Gy. Pu body burden is known for 66%. Of these, 245 individuals had exposures greater than 1.48 kBq, and 52 individuals, greater than 23.7 kBq. Malignant tumors were the cause of death in almost half of the cases. A computerized database of the Repository has been set up.

In addition to the collection of archived tissues, efforts are under way to obtain and store donations of new specimens (frozen lymphocytes, EBV-immortalized B-cells, frozen erythrocytes, tumors of different sites, and extracted DNA). Donations were obtained to date from 430 individuals. Of these 430, the external doses of exposure ranged from 1 to 5 Gy for 80%, and were higher than 5 Gy for 5.6%. Pu body burden ranged from 1.48-11.84 kBq for 40% and were greater than 11.84 kBq for 1.9%. More than 5,000 members of the 19,000 cohort of the workers employed from 1948 to 1972 are still residing in the city of Ozyorsk, with more than 2,000 of these individuals exposed to doses exceeding 0.5 Gy.