DOE Shield DOE Openness: Human Radiation Experiments: Roadmap to the Project
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ACHRE Report

Part II

Chapter 6

Introduction

Origins of the AEC Radioisotope Distribution Program in the Manhattan Project

The AEC Assumes Responsibility for Radioisotope Distribution

Local Oversight: Radioisotope Committees

General Benefits of Radioisotope Research

Conclusion

Chapter 6: Conclusion

At the end of World War II, radioisotopes were regarded as the most promising peacetime application of our new knowledge of the atom. Venturing into new fields carried with it substantial risks: risks due to our ignorance of what lay ahead, and risks due to the lack of training of many would-be explorers. The AEC consistently accepted and acted upon its responsibility to manage this risk. An extensive administrative system was created to oversee the safety of human radiation experiments that used radioisotopes supplied by the AEC. At the heart of the system was the AEC's Subcommittee on Human Applications of the Advisory Committee on Isotopes Distribution Policy. This system regulated the types of uses allowed according to their hazard and the extent of our knowledge of the risks. It required and provided training of those who would use radioisotopes. It required the establishment of local radioisotope committees, which not only reviewed proposals but suggested changes at the local level in experimental design to reduce risk.

While extensive measures were taken to minimize risk, few measures were taken to ensure that all the explorers, subjects as well as researchers, were fully informed and willing members of the expedition. No evidence has yet been found that the standards for documented consent, articulated by AEC General Manager Carroll Wilson in 1947, were applied by the AEC Isotopes Distribution Division. A limited consent requirement was instituted only for the administration of larger-than-usual doses to very sick patients. Only in the late 1950s did a consent requirement for normal volunteers appear in the AEC guidelines.

Based on the records examined by the Advisory Committee, the adjunct system of local radioisotope committees appears to have functioned as planned. The records of local institutions indicate that they established their own local radioisotope committees, as required by the AEC, and that these local committees closely assessed the risks of experiments. At times, this system went beyond what the AEC had planned. Some local committees had jurisdictions that extended to all radiation-related work, not merely to radioisotopes supplied by the AEC. The local committees also provided, probably unintentionally, a ready-made vehicle for administering greater oversight of consent practices, as concern developed in the 1960s. Requirements for consent on a federal level changed only in the late 1960s, as part of a governmentwide concern.

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