Statistical Information on the 2007 Human Subjects Database

Statistics for fiscal year (FY) 2007 are based on information obtained from data submitted by principal investigators and researchers. Differences in the use of human subjects compared with FY2006 data are highlighted in the bulleted items below.

Number of Human Subjects	Funding for Human Subjects Research
(Total human subjects: 1,044,569)	(Total DOE funding: $72,215,175)
Number of Projects	Types of Research
(Total active projects: 285)	(Human subjects involvement)

• The use of human subjects in FY2007 increased by 8% compared to FY2006.
• A total of 1,044,569 human subjects were involved in Department of Energy (DOE) funded, site-related, or worker-related projects during FY2007.
• About 80% of the number of human subjects were reported by DOE facilities and 20% were reported by non-DOE facilities.
• Among the 346 projects reported in FY2007, 27 had no human subjects enrolled to date; 171 were still enrolling subjects, reviewing records, dispensing research-related interventions, or in long-term follow-up; 67 were no longer enrolling subjects; and 81 studies were inactive or completed.
• In 2007, 82% of total human subjects in the database were involved in records-based studies at three institutions: the Oak Ridge National Laboratory (ORNL), the National Institute for Occupational Safety and Health (NIOSH), and Oak Ridge Associated Universities (ORAU).

• Funding for human subjects research includes only those projects receiving federal funding. Funding from private sources is not included.
• Total federal funding for human subjects activities increased by 10% to nearly $123 million in FY2007 from $112 million in FY2006.
• DOE funding directly associated with tasks or portions of projects involving the use of human subjects was $72 million during FY2007, down from $78 million in FY2006, a decrease of 8%.
• Funding from other federal sources for human subjects projects at DOE facilities was $51 million in 2007, a sharp 50% increase from $34 million in 2006, driven mainly by an increase of $16 million at the Pacific Northwest National Laboratory (PNNL).
• One project, managed by the National Academy of Sciences for the Radiation Effects Research Foundation (RERF) in Hiroshima, Japan, accounted for 19% of DOE-reported funding.
• Of total projects, including both DOE-funded and non-DOE-funded, the majority (59%) of DOE-funded but only 12% of non-DOE-funded projects had 100% of their funds allocated to human subject activities.
• The opposite situation occurred in the case of funding for human subjects activities in the range of 1% to 20% with 50% of projects being supported by non-DOE funding and only 18% of projects supported by DOE.

• The number of active projects (projects with current IRB approval) was 285 in FY2007. Note that in FY2007, the basis for determining status of active projects changed from projects receiving funding and/or using human subjects (as in all previous years) to those having current fiscal year IRB approval only.
• DOE-funded, DOE-related, or DOE-operated research facilities reported a total of 285 active projects and 61 inactive projects during FY2007, compared to 290 active and 61 inactive projects in 2006.
• Of the total number of projects (346), 79% were conducted at DOE facilities and 21% were conducted at non-DOE facilities.
• Lawrence Livermore National Laboratory (LLNL), with 51, had the largest number active projects, followed by Lawrence Berkeley National Laboratory (LBNL) with 45.
• Of the 237 funded projects, 123 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.
• Thirty-one 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 numbers of foreign subjects. Funding for all international projects was 20% of total project funding.
• 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 could be in later data analysis and reporting stages, or new initiatives.

• The distribution of the types of research conducted in FY2007 involving human subjects was virtually identical to FY2006.
• It is possible for a given project to include multiple types of research activities.
• Most studies involving human subjects (53%) included questionnaires or surveys or were epidemiological in nature.
• The more "traditional" human studies, classified as clinical, diagnostic, and therapeutic, accounted for 18% 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 7% of total human subject involvement.

Radiation Research

Of the 346 projects listed in this database (285 active and 61 inactive), 71 projects involved human exposure to radiation. The number of subjects involved in these studies was 58,252. In many of the studies, the radiation used was as a radiotracer to facilitate imaging (e.g., positron emission tomography), and/or for diagnostic/therapeutic purposes. Other studies involve research on radiation health effects in survivors of the Hiroshima and Nagasaki atomic bombs.

Contributing Research Facilities

There are 45 research facilities that reported data included in this year's database. Thirteen of these are DOE sites and 32 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 included below).