The statistics provided below are based on information obtained from a questionnaire that is completed by individual researchers. Due to the nature of the information requested, some subjective interpretations of the questions should be expected.
* 980,483 of the total human subjects (65% of subjects in the database) are from studies conducted at the National Institute for Occupational Safety and Health (NIOSH), mostly in epidemiological studies. This figure has not been included in the chart.
There are 44 research facilities reporting data included in the current database. Thirteen of these research facilities are DOE laboratories, 31 are non-DOE laboratories (such as hospitals and universities) receiving DOE funding or other sites doing studies related to DOE activities. Detailed information can be obtained about most of these research facilities through the above links to their home pages on the World Wide Web.
The DOE-funded or DOE-operated research facilities reported a total of 255 active projects (projects that received funds and/or used human subjects during FY2003) and 46 inactive projects during FY2003, for a total of 301 projects. Of these 77% were conducted at DOE facilities and 23% at non-DOE facilities. Five national laboratories, BNL, LANL, LBNL, LLNL, and ORAU comprised 60% of the active projects while LLNL had the largest number with 48 active projects. Ninety-six of the 255 projects are not currently supported by DOE funds. The reason these projects were listed in the DOE's Human Subjects Research Database was because the research was performed in DOE laboratories or by DOE employees or concerned DOE activities. Projects with current IRB approval have been listed in the database even if they received no funds or reported no current human subject activity. These inactive projects were either formerly active or are new initiatives.
The funding from DOE that was directly associated with tasks or portions of projects involving the use of human subjects was about 45 million dollars during FY2003; funding from other federal and private sources at DOE facilities for human subjects projects was about 9 million. The total funding for human subjects activities was about 55 million. One project, managed by the National Academy of Sciences with the Radiation Effects Research Foundation (RERF) in Hiroshima, Japan, accounted for 25% of the DOE reported funding. Of the NAS funds, ~95% go directly to the RERF.
Over 99% (1,499,102) of the total human subjects in the database are records from registries, questionnaires, surveys and epidemiological studies. Because these studies were included in the database the total number of human subjects reported is not representative of actual people participating but includes a large number of records from human subjects.
A total of 1,503,947 human subjects were reported during FY2003 in DOE-funded, DOE-site, or DOE-related projects. About 29% are reported by DOE facilities and 71% are reported by non-DOE facilities. This year one NIOSH epidemiological study included 600,000 subjects, 40% of the total number of subjects in the database. ORAU (6.8% of reported human subjects) serves as the Epidemiologic Surveillance Data Center for the DOE and most of the subjects from this facility are from records-based studies and registries. The NAS project is also primarily an epidemiological study with some clinical followup. Other epidemiological studies also contribute to the total number of human subjects, making it appear large.
DOE does NOT support any research in which the effect of radiation upon humans per se is the object of study. Of the 301 projects listed in this database approximately 60 involved human exposure to radiation. The number of subjects involved in these studies was 79,771. In all of the studies the radiation used was as a tracer to facilitate imaging (i.e. PET), or for diagnostic (i.e., X-ray) and/or therapeutic reasons.
