DOE Human Subjects Research Database: FY 2001 Update

Summary

The FY 2001 update of the DOE Human Subjects Research Database (HSRD) is now on the World Wide Web. The Database, initiated in 1994 and updated annually, contains information on research projects that involve human subjects and that were funded by the Department of Energy (DOE), conducted at DOE facilities or performed by DOE personnel. The annual reporting of human subjects research projects to the HSRD is required by DOE Order O 443.1, Protection of Human Subjects. 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. Many research projects are epidemiological in nature and involve only the analysis of medical records of subjects to identify patterns of illness. The FY 2001 database consists of a total of 294 projects of which 71% were conducted at DOE facilities and 29% at non-DOE facilities (such as hospitals and universities). There are 46 reporting research facilities, 14 are DOE laboratories and 32 are non-DOE facilities. 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 while funding from other federal and private sources at DOE facilities was about 13 million. Registries, questionnaires, surveys and epidemiological studies are included in the database, making the total number of human subjects reported appear large. Thus the number of subjects is not representative of actual people participating, but includes a large number of records.