National Academy of Sciences

Funding for Human Subjects Research:

DOE: International Health Programs

$14,000,000.00 (Est.) for: Fiscal Year 2006
Percent of funding associated with the use of human subjects: 100

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: National Academy of Sciences
Most recent approval: 06/20/06

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Radiation Effects Research Foundation
Most recent approval: 06/07/06

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4367
Reporting period for number of human subjects: Fiscal Year 2006

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• For diagnostic research
• Other. Explain:

Subjects are atomic-bomb survivors or children of exposed survivors who undergo physical exams in order for the researchers to obtain data for epidemiological analyses.

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 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 RERF, which superseded the Atomic Bomb Casualty Commission in 1975, is funded by the governments of Japan and the United States. Funding is provided via a Cooperative Agreement for the continued support of the National Academy of Sciences (NAS) activities associated with the RERF project.

In 1990, the NAS Committee to Review Human Subjects reviewed the application and determined that the RERF project met the requirements of 45 CFR 46 and gave approval for continued NAS participation. A Standing Institutional Amendment between RERF and NAS was accepted by the Office for Protection from Research Risks on May 20, 1998. The Agreement was added to Multiple Project Assurance file #M-1219 and amends the Assurance to include RERF as a regular performance site for human subject research when the research is conducted or sponsored by the Multiple Project Assured Institution. The RERF IRB is constituted as a separate IRB whose decisions are also reviewed by the NAS IRB. The RERF Federal-wide Assurance number is FWA00001371. The RERF project had 65 active protocols during fiscal year 2006.

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. During the period from 10/1/05 to 9/30/06, a total of 4,367 persons provided samples of blood that were drawn as part of the participants' examinations. 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 aberrations, and 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 lymphocyte response over time and aging. Blood cells are also cryogenically preserved for future epidemiological and biochemical studies. Lymphocytes from 1,000 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. Red blood cells from about 800 families have been collected.

Specific procedures for handling research data in the custody of RERF have been established for safe management and protection of confidentiality of individual information pertaining to atomic bomb survivors.

The procedures are spelled out in four policy directives:
I. Policy and Procedures of Radiation Effects Research Foundation Concerning Request for Use of Research Data in Its Custody
1. Policy and Procedures for Research Data Request from Atomic Bomb Survivors
2. Policy and Procedures for Request to Issue a Certificate Based on Information on A-bomb Deceased in the Custody of RERF in Connection with Enforcement of A-bomb Survivors Relief Law
3. Policy and Procedures for Research Data Request from External Scientific Source

II. Policy and Procedures of Radiation Effects Research Foundation Regarding Use of Its Research Data by Full-time Professional Staff

III. Policy and Procedures of Radiation Effects Research Foundation Regarding Use of Its Research Data by Non-full-time Professional Staff: Consultants, Expert Advisory Panel Members, Visiting Research Fellows, and Visiting Research Associates

IV. Policy and Procedures of Radiation Effects Research Foundation Regarding Use of its Research Data by an Outside Investigator Who Will Participate in an RERF Study