Department of Energy Research Involving Human Subjects Current Activities FY 1994

This Department of Energy database contains descriptions of the methods used in all research projects involving human subjects that are currently funded by the Department of Energy or are performed at DOE facilities with support from others, as reported to DOE by DOE grantees and contractors using the standard "Protecting Human Subjects" form. Summary information on all of the studies has been provided, along with a complete hard copy of the information, which includes a full report on each project.

By definition, "research involving human subjects" includes a variety of activities ranging from actual experimentation to simple questionnaires. Some projects involving human subjects are therapeutic in nature, 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 are epidemiological projects, involving only the analysis of medical records of patients to identify patterns of illness.

Some projects involving human subjects also include efforts to develop new instrumentation or techniques in which human volunteers assist with the evaluation of the instrument. Examples include efforts to develop better methods for identifying individuals photographically (in which volunteers agree to have their pictures taken) or efforts to develop better means for improving indoor air quality (in which a smoker agrees to smoke a cigarette to test the effectiveness of the system for purifying indoor air).

Currently, all research involving human subjects funded by DOE (or any other Federal agency) or carried out at DOE facilities must be approved by a local Institutional Review Board. The Institutional Review Board is charged with ensuring that all approved projects are in full compliance with the Federal Policy on Protection of Human Subjects. This policy was drafted with DOE assistance in the 1980s, was adopted by DOE and 16 other federal agencies (including the Department of Health and Human Services) in July 1991, when the rule-making process was complete.

DOE supports research involving humans for a number of reasons, including its legislative mandate to develop new diagnostic and therapeutic applications in the area of nuclear medicine. An example of addressing this mandate is the DOE support of Brookhaven National Laboratory's use of PET (Positron Emission Tomography) scanning. This gives real-time images of how organs, such as the brain, are functioning. Researchers use the technology in their studies to learn more about drug addiction. Another example is a study at the Memorial Sloan Kettering Cancer Center to develop monoclonal antibodies labeled with a radioactive isotope, so- called "magic bullets," for detecting and treating cancer.

DOE funds epidemiological studies 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, researchers track the health and mortality of current or former DOE and DOE contractor workers at DOE's sites. Data on this epidemiology research have been available on a separate database, the Comprehensive Epidemiology Data Resource.

Other agencies also fund research involving human subjects at DOE Laboratories because the Laboratories are world class facilities, with extensive expertise in biology, medicine, and engineering. Examples are a Lawrence Berkeley Laboratory study of the effects of exercise and diet on cholesterol levels and a Department of Justice/ National Institutes of Justice-funded study at the Sandia National Laboratory of a less-than-lethal "sticky foam" restraint system.

The information contained in this database has been previously available from local sources, and has been maintained for DOE administrative uses. However, the compilation of this information into a single, searchable, electronic database now makes all of this information more readily available and easy to use.

This database is a compendium of in-progress research involving human subjects. To ensure that the database is always current, the information in the database will be updated regularly, both to add new information and to correct existing information, should errors be detected. In addition, project summaries intended to be read by non-specialists will be added over the next few weeks.

This printout represents a "snapshot" of the database as it was first created.

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

Program Manager
Protecting Human Subjects Database
Health Effects and Life Sciences Research Division
Department of Energy
ER-72 GTN
Washington, DC 20585

Phone: (301) 903-5468
Fax:(301) 903-8521
E-mail: kim.laing@oer.doe.gov or joanne.corcoran@oer.doe.gov

Summary Information on Research Involving Human Subjects

• One hundred six projects receive DOE support, 70 at DOE Labs and 36 at other institutions. An additional 69 projects at DOE Laboratories are funded by other agencies, such as the National Institutes of Health.
• DOE annually funds approximately $46 million in projects involving human subjects; other agencies fund an estimated $10 million in such projects at DOE Labs.
• The studies involve a total of about 725,000 individuals in the U.S. Of these, 360,000 are part of two epidemiological studies of current and former DOE and DOE contractor employees. Another 321,000 are involved in a questionnaire study of runners and their health.
• One of the studies is a joint U.S.-Japanese long term follow up study of approximately 138,000 survivors of the atomic bombs detonated at Nagasaki and Hiroshima.
• Forty one projects with 5,056 individuals involve some exposure to radiation, however slight, as part of the research project. Thirty one of these projects, with 3,208 subjects, involve exposure to radiation only in tracer amounts similar to those used in the nuclear medicine tests given in hospitals. Another seven projects with 1,228 subjects are follow-up health studies that include the use of routine diagnostic x-rays, such as chest x-rays. The three remaining projects with 560 subjects involve the use of radiation in the development of new treatments for cancer.
• In Japan, the full set of 138,000 subjects are followed in long-term epidemiological studies. A subset of 12,000 individuals receive more thorough regular medical examinations, including biannual diagnostic chest X-rays, as mandated by the Japanese Atom Bomb Survivors Treatment Law.
• In all of the projects involving radiation, the radiation is used as a tracer to facilitate imaging or other studies or for diagnostic or therapeutic reasons. DOE does not support any projects in which the effect of radiation upon humans per se is the object of study.

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