Statistical Information on the 2001 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.

Statistical charts

* 958,855 of the total human subjects (69% 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.

Contributing Research Facilities

There are 46 research facilities reporting data included in the current database. Fourteen of these research facilities are DOE laboratories, 32 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.

Number of Projects:

The DOE-funded or DOE-operated research facilities reported a total of 232 active projects (projects that received funds and/or used human subjects during FY2001) and 62 inactive projects during FY2001, for a total of 294 projects. Of these 71% were conducted at DOE facilities and 29% at non-DOE facilities. Four national laboratories, BNL, LANL, LLNL, and LBNL comprised 48% of the active projects while LLNL had the largest number with 34 active projects. Eighty-six of the 294 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.

Funding for Human Subjects:

The funding from DOE that was directly associated with tasks or portions of projects involving the use of human subjects was about 47 million dollars during FY2001; funding from other federal and private sources at DOE facilities for human subjects projects was about 13 million. The total funding for human subjects activities was about 60 million. One project, managed by the National Academy of Sciences with the Radiation Effects Research Foundation (RERF) in Hiroshima, Japan, accounted for 24% of the DOE reported funding. Of the NAS funds, ~95% go directly to the RERF.

Number of Human Subjects:

About 99% (1,387,885) 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 1,398,245 human subjects were reported during FY2001 in DOE-funded, DOE-site, or DOE-related projects. About 13% are reported by DOE facilities and 87% are reported by non-DOE facilities. This year one NIOSH epidemiological study included 600,000 subjects, 43% of the total number of subjects in the database. ORAU (5.8% 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.

Types of Research:

The pie chart presented above labeled "Types of Research" shows the percent of the total number of protocols for each type of research. A project may have one or more protocols describing different procedures for human subject involvement. Each protocol may include more than one type of research, therefore the percentages add up to more than 100%. The pie chart clearly indicates that the preponderance of human studies, 59% of projects (51% of protocols), include questionnaires, surveys or are epidemiological in nature. The more "traditional" human studies classified as therapeutic, diagnostic and clinical are involved in 27% of the protocols. Other types of studies that include biochemical and biomedical research are included in 19% of the total protocols. 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 13% of the total protocols.

DOE does NOT support any research in which the effect of radiation upon humans per se is the object of study. Of the 294 projects listed in this database approximately 56 involved human exposure to radiation. The number of subjects involved in these studies was 7528. 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.

Activity at HSRD website

The chart below gives an estimate of the number of visits to the DOE Human Subjects Research Database website, broken down by origin of access.

Statistical charts

Please note: The category "Other USA" includes state and local governments, military sites, and sites with an organization (.org) identification. Access from "Commercial" sites includes individuals with personal internet access as well as businesses.



Human Subject Research Database
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