DOE Human Subjects Protection Program

Background

DOE and its predecessor agencies (the Atomic Energy Commission [AEC]; the Energy Research and Development Administration) have traditionally considered the health of workers in its facilities to be a basic responsibility. From its inception, the U.S. nuclear program measured worker exposures and their impacts on worker health. Post-World War II studies involving active workers were governed by the ethical principles of medical and human research practices as set forth in the internationally accepted Nuremberg Code of 1949.

Paralleling these interests and the continued involvement of workers as research subjects was an increasing concern and interest among the more developed countries in the protection of human subjects from research risks. This trend reflected increasing concerns for human rights and developing technologies that enabled the detection of biological injury or abnormalities at the cellular level in the absence of clinical signs or symptoms and growing capabilities to compile and manipulate large electronic databases.

Accordingly, the AEC initially encouraged, and by 1970 required, its contractors engaged in such work to comply with regulations then being developed by the National Institutes of Health (NIH) to protect human subjects involved in NIH-sponsored research. Contractor institutions set about establishing their own Institutional Review Boards (IRBs) or making arrangements with existing IRBs to provide the necessary reviews of human studies protocols in order to ensure the physical protection and informed consent of research subjects.

There was, however, a growing tendency during the late 1970s and early 1980s for the protocols for such studies to be submitted to the responsible IRB for review as a matter of record. This was a period of rapid development of increasingly sophisticated technologies enabling detection of genetic patterns and aberrations known to be, or suspected of being, associated with existing disease or predictors of disease and others whose clinical significance was unknown or incomplete. With them, new and more complex ethical concerns continued to emerge in the 1990s. These required increased efforts by DOE to maintain an adequate level of monitoring and research human subjects protection. Such efforts resulted in the establishment of a comprehensive policy for the protection of human subjects in research.

Content reviewed: November 12, 2013