USDOE Human Subjects Research Database, Fiscal Year 1995

National Academy of Sciences

Public Information Contact:

Mr. Daniel Quinn
News & Public Info Office
National Research Council
2101 Constitution Avenue, NW
Washington, DC 20418

Phone: 202-334-2138
Fax: 202-334-2158
Email: dquinn@nas.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: National Academy of Sciences.
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-1219

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

NAS-90-DEFG0590ER60960
Activities of National Academy of Sciences in Relation to the Radiation Effects Research Foundation

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Project Identification:

Project Identifier: NAS-90-DEFG0590ER60960

Project Title:

Activities of National Academy of Sciences in Relation to the Radiation Effects Research Foundation

Principle Investigator: Dr. John D. Zimbrick

Project started in: 1990


Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Environment, Safety and Health (EH-63)
Amount: $13,647,000 (Est.)
Comments:
Funding for management role of the National Academy of Sciences with respect to RERF. DOE also provides funds for RERF operational costs, which are sent to Japan via State Dept.


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: January 04, 1990

Number of Human Subjects in the Last Reporting Period for this Project: 2,927
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

Collection of Bodily Materials:

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

Questionnaires, Surveys, Epidemiological Studies:

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

Abstract:
(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 Radiation Effects Research Foundation (RERF) is a bi-national organization dedicated to the study of the long-term health effects of radiation in the survivors of the atomic bombs detonated in Hiroshima and Nagasaki in 1945. RERF, which superseded the Atomic Bomb Casualty Commission in 1975, is funded equally by the governments of Japan and the United States. Funding from the United States is by contract from the Department of Energy to the National Academy of Sciences. The current contract between DOE and NAS for the 5-year period April 1, 1990 through March 31, 1995 has been extended for a sixth year, April 1, 1995 through March 31, 1996. This project had 72 active protocols during fiscal year 1995.

At the time of the renewal of this contract in 1990, the NAS Committee to Review Human Subjects reviewed the application and determined that the RERF protocol met the requirements of 45 CFR 46 and gave approval for continued NAS participation. The arrangement for sending funds to the RERF via the State Department was implemented and arranged by the Office of International Health Studies, Office of Health Studies, Environment, Safety and Health, at the Department of Energy. Please contact Mr. Timothy Fox for details.

All the atomic bomb survivors in the Adult Health Study undergo standard medical examination on a voluntary basis, biennially. These participants receive chest x-rays and ultrasonography examination (when necessary), as well as blood sampling for standard tests. With the participant's approval, some of the blood is used for a variety of research purposes. Serum is stored for future epidemiological studies, lymphocytes may be analyzed cytologically to determine chromosome aberration, red blood cells are examined to screen for somatic gene mutations in order to assess the effects of the atomic bomb. Immunological assays are also performed in vitro to determine if the A-bomb radiation affects the specificity of lymphocytes response over time and aging. Blood cells are also cryogenically preserved for future epidemiological and biochemical studies. Lymphocytes from 1000 families (mother, father, child(ren)) are stored for future research in order to assess the frequency, in the progeny, of induced DNA changes that resulted from mutations in the germ cells of the parental generation from A-bomb exposure. About 800 family (cells) have been collected.


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