Statistical Information on the 2006 Human Subjects Database

The statistics for fiscal year (FY) 2006 are based on information obtained from data submitted by individual researchers. Differences in the use of human subjects compared with FY2005 data are highlighted in the bulleted items below.

Number of Human Subjects	Funding for Human Subjects Research
(Total human subjects: 970,244)	(Total DOE funding: $77,789,944)
Number of Projects	Types of Research
(Total active projects: 290)	(Human subjects involvement)

• The use of human subjects in FY2006 decreased by 5% compared with FY2005.
• A total of 970,244 human subjects were involved in Department of Energy (DOE) funded, site-related, or worker-related projects during FY2006.
• About 78% of the number of human subjects were reported by DOE facilities and 22% were reported by non-DOE facilities.
• Among the 290 active projects and 61 inactive projects reported in FY2006, 46 had no human subjects enrolled to date; 170 were still enrolling subjects, reviewing records, or dispensing research-related interventions; 57 were no longer enrolling subjects but were in long-term follow-up; and 78 studies were completed.
• Fifty-nine percent (576,342) of the total number of human subjects in the database were involved in studies conducted at one site, the Oak Ridge National Laboratory (ORNL).
• The second highest percentage of the total number of human subjects, 14%, was involved in studies at the National Institute for Occupational Safety and Health (NIOSH).
• Lawrence Berkeley National Laboratory (LBNL) and Oak Ridge Associated Universities (ORAU) each accounted for 8% of reported human subjects. ORAU serves as the Illness and Injury Surveillance Data Center for the DOE. In FY2006, data on most of the subjects from this site were in records-based studies and registries.

• Total funding for human subjects activities increased to $112 million in FY2006 from $108 million in FY2005.
• DOE funding directly associated with tasks or portions of projects involving the use of human subjects was $78 million during FY2006, up from $73 million in FY2005, an increase of 7%.
• Funding from other federal sources for human subjects projects at DOE facilities was $34 million.
• One project, managed by the National Academy of Sciences for the Radiation Effects Research Foundation (RERF) in Hiroshima, Japan, accounted for 18% of the DOE-reported funding.
• For both DOE-funded and non-DOE-funded projects, the majority, 34% of DOE-funded and 46% of non-DOE-funded projects, had 100% of their funds allocated to human subject activities.
• The next largest percentage, 31%, for DOE-funded projects corresponds to projects with no funding allocated to direct human subject activities, which means that these projects were either in a start-up phase or in a later stage that included data analysis and reporting functions. The next largest percentage, 25%, for non-DOE-funded projects corresponds to projects with 1% to 20 % of their funds allocated to human subject activities.

• The number of active projects (projects that received funds and/or used human subjects) increased by 2% from a total of 285 in FY2005 to 290 in FY2006.
• DOE-funded, DOE-related, or DOE-operated research facilities reported a total of 290 active projects and 61 inactive projects during FY2006.
• Of the total number of projects, 59% were conducted at DOE facilities and 41% were conducted at non-DOE facilities. This represents a decrease from FY2005 in the portion of projects conducted at DOE facilities.
• Four national laboratories, Lawrence Berkeley, Lawrence Livermore, Brookhaven, and Los Alamos, and one research institute, The MIND Institute, hosted 61% of the active projects. LBNL had the largest number with 45 active projects, followed closely by LLNL with 43 projects.
• Of the 290 active projects, 122 are not currently being supported by DOE funds. The reason these projects are listed in the DOE Human Subjects Research Database is that the research was performed in DOE laboratories, performed by DOE employees, or included current or former members of the DOE work force.
• Projects with IRB approval are listed in the database, even if they have received no funds or reported no current human subject activity. These projects are in later data analysis and reporting stages, were formerly active, or are new initiatives.
• Nineteen projects were reported as being international. The Russian Health Studies Program in the DOE Office of Health Studies and the National Academy of Sciences RERF studies reported the largest number (96%) of foreign subjects. Funding for all international projects was 16% of total project funding.

• The distribution of the types of research in FY2006 involving human subjects was virtually identical to FY2005.
• Most studies involving human subjects (48%) included questionnaires or surveys or were epidemiological in nature.
• The more "traditional" human studies, classified as therapeutic, diagnostic, and clinical, accounted for 19% of the research activities.
• The testing of new (man-machine) products, such as computer keyboards and control panels, and environmental studies, such as the determination of preferences in lighting and climate control, accounted for 8% of total human subject involvement.

Note:
DOE does NOT support any research in which the effects of ionizing radiation from external sources on humans is the object of the study. Of the 351 projects listed in this database (290 active and 61 inactive), 79 projects involved human exposure to radiation. The number of subjects involved in these studies was 78,948. In all of the studies, the radiation used was as a radiotracer to facilitate imaging (e.g., positron emission tomography), diagnostic (e.g., x-ray), and/or therapeutic purposes.

Contributing Research Facilities

There are 47 research facilities that report data included in this year's database. Twelve of these are DOE sites and 35 are non-DOE sites (such as hospitals, universities, or research institutes) receiving DOE funding or other sites conducting studies related to DOE activities. Detailed information about the research facilities can be obtained from their websites (links to their home pages are listed below).