USDOE Human Subjects Research Database, Fiscal Year 1996

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, which also refers to decisions by RERF's IRB.
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 (RERF)

Project Identifier: NAS-90-DEFG0590ER60960

Project Title:

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

Principal Investigator: Dr. Paul Gilman
Principal Investigator's Institution: National Academy of Sciences (NAS)

Project started in: 1990

Fiscal Year 1996 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.

Funding Sources:

DOE: Environment, Safety and Health (EH-63)

Amount: $19,600,000
Comments:

$17,400,000 to RERF from DOE via State Dept; $2,200,000 to NAS via project identifier above. A portion of NAS project funds are for scientific & administrative management activities for RERF.

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 who participated in this project/protocol during FY 1996 (10/1/95 - 9/30/96): 3,658

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For diagnostic research.
• Other use of external ionizing radiation:

  Subjects are atomic bomb survivors or children of exposed survivors.

Collection of Bodily Materials:

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

• 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 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 by the governments of Japan and the United States.

At the time of the renewal of this support 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.

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. The RERF project had 67 active protocols during fiscal year 1996.