Statistical Information on the 2005 Human Subjects Database

The statistics for 2005 are based on information obtained from data submitted by individual researchers. Differences in the use of human subjects compared with FY2004 data are highlighted in the bulleted items below.

Number of Human Subjects	Funding for Human Subjects Research
(Total human subjects: 1,022,172)	(Total DOE funding: $73,047,706)
Number of Projects	Types of Research
(Total active projects: 285)	(Human subjects involvement)

• The use of human subjects in FY2005 decreased by 18% compared with FY2004.
• A total of 1,022,172 human subjects were involved in Department of Energy (DOE) funded, site-related, or worker-related projects during FY2005.
• About 33% were reported by DOE facilities and 67% were reported by non-DOE facilities.
• Among the 285 active projects and 55 inactive projects reported in FY2005, 53 had no human subjects enrolled to date; 182 were still enrolling subjects, reviewing records, or dispensing research-related interventions; 40 were no longer enrolling subjects but were in long-term follow-up; and 65 studies were completed.
• Fifty-nine percent (602,424) of the total number of human subjects in the database were involved in studies conducted at one site, the National Institute for Occupational Safety and Health (NIOSH), mostly in epidemiological studies.
• The second highest percentage of the total number of human subjects, 19%, were involved in studies at Lawrence Berkeley National Laboratory (LBNL).
• Oak Ridge Associated Universities (ORAU), with 9% of reported human subjects, serves as the Illness and Injury Surveillance Data Center for the DOE. In FY2005, data on most of the subjects from this site were in records-based studies and registries.

• Total funding for human subjects activities increased to nearly $108 million in FY2005 from $78 million in FY2004.
• DOE funding directly associated with tasks or portions of projects involving the use of human subjects was $73 million during FY2005, up from $50 million in FY2004, an increase of 46%.
• Funding from other federal sources for human subjects projects at DOE facilities was almost $35 million.
• One project, managed by the National Academy of Sciences for the Radiation Effects Research Foundation (RERF) in Hiroshima, Japan, accounted for 19% of the DOE-reported funding.
• For both DOE-funded and non-DOE-funded projects, the majority, 39% of DOE-funded and 47% of non-DOE-funded projects, had 100% of their funds allocated to human subject activities.
• The next largest percentages (31% for DOE-funded and 22% for non-DOE-funded projects) correspond 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 number of active projects (projects that received funds and/or used human subjects) increased by 3% from a total of 276 in FY2004 to 285 in FY2005.
• DOE-funded, DOE-related, or DOE-operated research facilities reported a total of 285 active projects and 55 inactive projects during FY2005.
• Of the total number of projects, 72% were conducted at DOE facilities and 28% were conducted at non-DOE facilities.
• Four national laboratories, Lawrence Livermore, Lawrence Berkeley, Brookhaven, and Los Alamos, and one research institute, The MIND Institute, hosted 59% of the active projects. LLNL had the largest number with 44 active projects, followed closely by LBNL with 43 projects.
• One hundred of the 285 active projects 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 current 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.
• At the present time, major international human subject activities include the Russian Health Studies Program in the DOE Office of Health Studies and the National Academy of Sciences RERF studies.

• The distribution of the types of research in FY2005 involving human subjects was virtually identical to FY2004.
• 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 products, such as computer keyboards and control panels, and environmental studies, such as the determination of preferences in lighting and climate control, accounted for 9% 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 340 projects listed in this database (285 active and 55 inactive), 79 projects involved human exposure to radiation. The number of subjects involved in these studies was 78,369. 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 45 research facilities that report data included in this year's database. Twelve of these are DOE sites and 33 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).

*Project was formerly at USW/PACE and PACE alone in FY2004. USW is the United Steel Workers Union and PACE is the Paper, Allied-Industrial, Chemical and Energy Workers International Union.