Lessons from History: Looking to the Future
How this Report is Organized
How This Report is OrganizedThough this report is addressed largely to those who can affect future policy in light of the information the Advisory Committee has gathered, specifically the Human Radiation Interagency Working Group, it has been written in such a way that it should be accessible to a wide range of interested readers.
We begin with an introduction, titled "The Atomic Century," which describes the intersection of several developments: the birth and remarkable growth of radiation science; the parallel changes in medicine and medical research; and the intersection of these changes with government programs that called on medical researchers to play important new roles beyond that involved in the traditional doctor-patient relationship. The introduction concludes with a section titled "The Basics of Radiation Science" for the lay reader.
The remainder of the text is divided into four parts. Each part is preceded by an overview.
Part I, "Ethics of Human Subjects Research: A Historical Perspective," which contains four chapters, explores how both federal government agencies and the medical profession approached human experimentation in the period 1944 through 1974. We begin with the story of the principles stated at midcentury at the highest levels of the Cold War medical research bureaucracies and what we have ascertained about whether these principles were translated into federal rules or requirements. We then turn to the norms and practices engaged in at the time by medical researchers themselves. It is in this chapter that we report the results of our Ethics Oral History Project. In chapter 3, we review the development of formal and public regulations concerning research involving human subjects in the 1960s and 1970s. In the last chapter in part I we present our framework for evaluating the ethics of human radiation experiments, grounded in both history and philosophical analysis.
Part II, "Case Studies," approaches particular experiments from several angles, each of which raises overlapping ethical questions. The chapters on the plutonium injections and total-body irradiation consider the use of sick patients to provide data needed to protect the health of workers engaged in the production of nuclear weapons; the chapter on prisoners considers the use of healthy subjects for this purpose; the chapter on children considers experimentation with particularly vulnerable people; and the chapter on the AEC program of radioisotope distribution considers the institutional safeguards that underlay the conduct of thousands of human radiation experiments. The chapters on intentional releases, atomic veterans, and observational studies consider, in common, situations in which entire groups of people were exposed to risk as a consequence of government-sponsored Cold War programs. The section concludes with a review of the degree to which secrecy impaired, and may still impair, our ability to understand human radiation experiments and intentional releases conducted in the 1944-1974 period.
Part III, "Contemporary Projects," reports the findings of our three inquiries into the present. We begin by describing what we have learned about how the different federal agencies that sponsor human research regulate and oversee this activity. Next, we report the results of our Research Proposal Review Project, followed by the results of our Subject Interview Study. Part III concludes with the Committee's synthesis of the implications of the results of all three of these projects for the current state of human subject research.
Part IV, "Coming to Terms with the Past, Looking Ahead to the Future," reports the Committee's findings and recommendations.