Statistical Information on the 2004 Human Subjects Database

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.

Number of Human Subjects	Funds Received from DOE
(Total human subjects: 1,249,568)	(Total DOE funding: $49,991,575)
Number of Projects	Types of Research
(Total active projects: 276)	(Human subjects involvement)

Contributing Research Facilities

There are 46 research facilities reporting data included in the current database. Twelve of these are DOE laboratories and 34 are non-DOE laboratories (such as hospitals and universities) receiving DOE funding or are other sites doing studies related to DOE activities. Detailed information can be obtained about the research facilities through the links to their home pages listed below.

• A total of 1,249,568 human subjects were reported during FY2004 as being involved in DOE-funded, DOE-sited, or DOE-related projects.
• About 24% are reported by DOE facilities and 76% are reported by non-DOE facilities.
• Sixty-nine percent (861,177) of the total number of human subjects in the database are involved in studies conducted at one site, the National Institute for Occupational Safety and Health (NIOSH), mostly in epidemiological studies.
• ORAU (7% of reported human subjects) serves as the Epidemiologic Surveillance Data Center for the DOE, and most of the subjects from this site are in records-based studies and registries.

• Total funding for human subjects activities was nearly 78 million.
• Funding from DOE directly associated with tasks or portions of projects involving the use of human subjects was close to 50 million dollars during FY2004.
• Funding from other federal and private sources for human subjects projects at DOE facilities was about 28 million.
• One project, managed by the National Academy of Sciences for the Radiation Effects Research Foundation (RERF) in Hiroshima, Japan, accounted for 27% of the DOE reported funding.

• DOE-funded or DOE-operated research facilities reported a total of 276 active projects (projects that received funds and/or used human subjects during FY2004) and 51 inactive projects during FY2004.
• Of the total number of projects, 77% were conducted at DOE facilities and 23% at non-DOE facilities.
• Five national laboratories, BNL, LANL, LBNL, LLNL, and ORAU comprised 57% of the active projects while LLNL had the largest number with 48 active projects.
• One hundred five of the 276 projects are not currently supported by DOE funds. The reason these projects were listed in the DOE Human Subjects Research Database was that 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.

• Most studies involving human subjects include questionnaires or surveys or are epidemiological in nature.
• The more "traditional" human studies classified as therapeutic, diagnostic, and clinical account for 19% of research activities.
• The testing of new products, such as computer keyboards and control panels, and the determination of preferences in lighting and climate control in work environments, accounts for 10% of the total human subject involvement.
• Other types of studies make up 24% of the total.

Note:
DOE does NOT support any research in which the effects of external ionizing radiation upon humans per se is the object of study. Of the 327 projects listed in this database (276 active and 51 inactive), 66 projects involved human exposure to radiation. The number of subjects involved in these studies was 81,562. In all of the studies the radiation used was as a radiotracer to facilitate imaging (i.e., PET), or for diagnostic (i.e., X-ray), and/or therapeutic purposes.