Ms. Molly E. Galvin
News & Public Info Office
National Research Council
2101 Constitution Avenue, NW
Washington, DC 20418
Phone: 202-334-2138
Fax: 202-334-2158
Email: mgalvin@nas.edu
Projects are approved by an IRB located at: RERF under administrative oversight of NAS/NRC.
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: M1219
Number of Human Subjects Projects reported: 1
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. Evan B. Douple
Principal Investigator's Institution: National Academy of Sciences (NAS)
Project started in: 1990
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: -
IRB Review:
Type of Review: Full Board
Most Recent Approval: July 23, 1998
IRB Approval Number: M-219
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 2,985
Type of Human Subjects Involvement:
Subjects are atomic-bomb survivors or children of exposed survivors.
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 RERF, which superseded the Atomic Bomb Casualty Commission in 1975, is funded by the governments of Japan and the United States.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 was changed to a new Cooperative Agreement #DE-FC03-975F21213 in 01/01/97 for the continued support of the 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 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 project had 64 active protocols and 11 inactive protocols during fiscal year 1998.
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 10/1/97 to 9/30/98 a total of 2,985 samples of blood 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 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. 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