Review of Human Subjects Protection Program at the Radiation Effects Research Foundation (RERF) in Japan

Summary

The RERF is a joint DOE and Japanese Ministry of Health, Labor, and Welfare-funded research foundation located in Hiroshima and Nagasaki that focuses on the health impacts of radiation exposure in atomic bomb survivors. On June 26-July 2, 2009, Dr. David Thomassen, Ms. Elizabeth White, and Dr. Peter Kirchner from the Office of Biological and Environmental Research, along with a 6-member bi-national panel of experts, met with officials and staff from the RERF regarding the RERF’s program for the protection of human research subjects. The Office of Biological and Environmental Research in the Office of Science has responsibility for ensuring the protection of human research subjects at DOE laboratories and in research conducted with DOE funds.  During this visit, the external reviewers conducted a formal review of the RERF’s commitment to the protection of human research subjects and compliance with related U.S. Federal and DOE requirements. The review included meetings with senior RERF management, the institutional review board (IRB) Chair and members, principal investigators, tissue registry researchers, and the Chief of the Information Technology Department; as well as a review of RERF records and written policies and procedures. A final report will be issued in August.