Description of the 1996 Human Subjects Research Database
This database, maintained by the Environmental Measurements Laboratory,
contains information on all research projects that involved human subjects and
were funded by the Department of Energy (DOE), or conducted in DOE facilities, or performed
by DOE personnel during FY96. The database consists of a detailed description of each research
project and a section that summarizes the information
for quick referencing. Statistical information concerning the database, along with a
glossary of scientific terms to assist the reader with unfamiliar terminology, are provided. Information on individual projects is available in the
body of the database. This information is obtained from a questionnaire that is completed 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.
By definition, "research involving human subjects" includes a variety of activities ranging from
actual experimentation using human volunteers to gathering information using questionnaires.
Some projects involving human subjects are therapeutic in nature; some include efforts to
develop new instrumentation or techniques; some involve the use of trace quantities of
radioactive material in imaging studies; others involve only the analysis of blood or urine
samples from volunteers; and still others involve follow-up studies on workers previously
employed at sites that stored or used radioactive materials. A few research projects are
epidemiological in nature and involve only the analysis of medical records of subjects to identify
patterns of illness. The total number of
human subjects in the database appears large due to the thousands of anonymous records utilized in these epidemiological studies.
DOE supports a variety of projects for a number of reasons, such as a basic committment to science and technology as well as its legislative mandate to
develop new diagnostic and therapeutic applications in the area of nuclear medicine. Epidemiological studies are funded by DOE as part of its legislative mandate and its
responsibility as an employer to ensure the health of its work force. By reviewing occupational
histories and death certificates, investigators track the health and mortality of current or former
DOE and DOE contractor workers at DOE's sites. Data on this epidemiological research are available on a separate database, the Comprehensive Epidemiology Data Resource.
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. 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 all involved in federally sponsored
research. Responsibility for the protection of human subjects at the DOE resides in the Office of
Energy Research. 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.
This annual DOE human subjects database is a compendium of project information on research involving human
subjects that was conducted in Fiscal Year 1996 (Oct. 1, 1995 - Sept. 30, 1996). To familiarize the reader with the research reported in this database, project summaries
(abstracts) are included. To ensure that the database is current, it will be 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 OBER (Office of Biological and Environmental Research).
Comments, questions, or suggestions for improvement of this database may be directed to:
Richard Larsen
Human Subjects Database Project Manager
United States Department of Energy
Environmental Measurements Laboratory
New York, NY 10014
(212) 620-3524
(212) 620-3600 (fax)
larsenr@eml.doe.gov (e-mail)
Questions on the DOE Protection of Human Subjects Program may be directed to:
Program Manager
Protecting Human Subjects
Life Sciences Research Division (SC 72)
Office of Energy Research
Department of Energy
19901 Germantown Road
Germantown, MD 20874-1290
(301) 903-5037
(301) 903-8521 (fax)
kim.laing@science.doe.gov
Human Subject Research Database
Oak Ridge Institute for Science and Education - http://orise.orau.gov/
Webmaster: Bill Estep