Conclusion

Chapter 6: Introduction

The growth in the applications of radioisotopes involved thousands of experiments using radioisotopes. No feasible method was found to review in detail the vast number of individual radioisotope experiments in the Advisory Committee's database. This was due not only to the large number of experiments, but also to the scarcity of information about many of the individual experiments. Both consent and exact dose levels were often not discussed in published work; no federal repository was found that had collected records documenting these aspects of experiments. Given the decentralized structure of American medicine, it is not surprising that the Committee found that records on consent and exact dose, if they exist, would still be held at the local institutions conducting research or perhaps even in the private papers of physicians and scientists. Even when records were found at the local level, there was little documentation about consent.

Thus, for the largest group of human radiation experiments, little documentation remains, and a meaningful examination of all such experiments was not possible. The Committee instead chose to focus its energies in two directions: examining the overall system of oversight created by the federal government and examining small subsets of radioisotope experiments that posed significant ethical issues. The first effort led to this chapter, an overview of the system created by the federal government to monitor radioisotope experiments. The second effort led to the case study on experiments involving children (chapter 7) since those raised questions of both additional biological risk and justification for doing nontherapeutic research on minors.

The AEC's isotope distribution program was faced with three essential ethical questions. The most immediate question concerned the allocation of a scarce resource. Given the likelihood that demand for radioisotopes would exceed supply, how should priorities be set? The question involved not simply the choice among competing proposals for "human uses" (including experimentation, treatment of disease, and diagnosis), but between human uses and other kinds of uses (for example, basic scientific research or industrial uses).

Another immediate question was the safety with which this new material would be used. Since the government was actively promoting the use of radioactive isotopes, it had an obligation to ensure their safe use. Harm to patients, physicians, and others involved could arise from inexperienced and untrained users of radioisotopes. When properly used in trace amounts, radioisotopes posed risks well below those deemed acceptable in occupational settings. Balancing risks versus benefits--and seeking means to decrease risks and increase benefits as the field developed--was a major ethical obligation.

Finally, there was the question of the relationship between researcher and subject--more precisely, the question of the authorization for use in humans and the process of disclosure and consent, if any, to be followed. These uses can be divided into (1) therapeutic/diagnostic uses, (2) therapeutic/diagnostic research, and (3) nontherapeutic research.

As we shall see, great attention was paid initially to the question of resource allocation; but supply soon proved far greater than expected, and the need for this attention evaporated. The control of the risk posed by the use of AEC-provided radioisotopes was also a source of intense focus from the outset and remained so as the program grew. By contrast, notwithstanding the 1947 declarations by AEC General Manager Carroll Wilson on the importance of consent, the matter of consent received only limited attention in the early years of the program.