Description of the 2007 Human Subjects Research Database

This database, mandated by DOE Order 443.1 "Protection of Human Subjects", is maintained by the Oak Ridge Institute for Science and Education (ORISE) in Oak Ridge, Tennessee. It contains information on all research projects involving human subjects that were funded by the DOE, conducted in DOE facilities, or performed by DOE personnel including DOE contractor personnel during FY2007. Most projects are domestic, but those that are international in scope are also in the database. The database consists of a detailed description of each research project and a summary for quick referencing of the information. Statistical information from the database is provided, along with a glossary of scientific terms to assist the reader with unfamiliar terminology. Project information is obtained from a questionnaire that is updated by individual researchers. Due to the nature of the information requested, some subjective interpretations of the questions are expected. Therefore, questions relating to individual projects should be directed to the listed public information contact.

DOE supports human subject research projects for a variety of reasons, including its commitment to science and technology research, its legislative mandate to develop new diagnostic and therapeutic applications in the area of nuclear medicine, and its legislative mandate and responsibility as an employer to ensure the health of its work force. By definition, "research involving human subjects" includes a variety of activities ranging from actual experimentation using human volunteers, to gathering information using questionnaires or using existing information such as medical records. Projects involving human subjects may be clinical/diagnostic/therapeutic in nature; include efforts to develop new instrumentation or techniques; involve the use of trace quantities of radioactive material in imaging studies; analyze blood or urine samples from volunteers; or study workers employed at sites that stored or used radioactive materials.

These worker studies are epidemiological in nature and may involve only the analysis of data from occupational and medical records of subjects to identify patterns of illness. Although the total number of human subjects in the database appears large, this total includes workers from these records-based epidemiologic studies and does not reflect persons actively participating in research. By reviewing occupational histories and death certificates, investigators track the health and mortality of current or former DOE workers and DOE contractor workers at DOE sites. Data from this epidemiologic research are available in a separate database, the Comprehensive Epidemiology Data Resource. Information on health studies on former DOE and DOE contractor workers can be obtained at the Former Workers Program Homepage.

All the research involving human subjects that is funded by DOE (or any other federal agency) and/or carried out at DOE facilities must be approved by an Institutional Review Board (IRB) located at the research site. This "local" IRB is the cornerstone of the system of protection of human subjects. No human subject research may be initiated, and no ongoing research may continue in the absence of IRB approval. The IRB is charged with meeting bioethical standards and ensuring that all approved projects are in compliance with the Federal Policy on Protection of Human Subjects (10 CFR Part 745). This policy was drafted with DOE assistance in the 1980s and was adopted by DOE and 16 other federal agencies (including the Department of Health and Human Services) in July 1991. The policy provides uniform guidelines for personnel engaged in federally sponsored research. Responsibility for the protection of human subjects at the DOE resides in the Office of Science. Other agencies also fund research involving human subjects at DOE contractor laboratories, which have a reputation as world class facilities with extensive expertise in biology, medicine, and engineering.

The DOE human subjects research database is compiled annually. To ensure that the database is current, it is updated regularly, both to add new information and to correct existing data if warranted. In addition to this database, other DOE information tools regarding human subject activities are available through the web sites for the DOE and Office of Biological and Environmental Research (OBER).

Comments, questions, or suggestions for improvement of this database are welcome and may be directed to:

Donald R. Watkins, Ph.D.
Human Subjects Database Project Manager
Oak Ridge Institute for Science and Education
ORAU/Mail Stop 50
P.O. Box 117
Oak Ridge, TN 37831-0117
Tel: (865) 241-3744
Fax: (865) 576-7903
Don.Watkins@orise.orau.gov

Questions on the DOE Protection of Human Subjects Program may be directed to:

Human Subjects Research Program
U.S. Department of Energy
Office of Biological and Environmental Research
SC-23.2, Germantown Building
19901 Germantown Road
Germantown, MD 20874-1290

Elizabeth P. White
(301) 903-7693
Elizabeth.White@science.doe.gov

Peter T. Kirchner, M.D.
(301) 903-9106
Peter.Kirchner@science.doe.gov


Human Subject Research Database
Oak Ridge Institute for Science and Education - http://orise.orau.gov/
Webmaster: Bill Estep