A Final Note

The Committee's Approach

On April 21 and 22, 1994, the Committee held its first meeting, and most of us met each other for the first time. As we listened to opening statements by Cabinet members and members of Congress, as well as the first witness from the general public, it became clear how daunting a task we were undertaking. We realized that our ability to reconstruct the story of past radiation experiments required both the capacity to join with the agencies in the search through thousands of boxes for documents and the intuition to recognize which documents were important. We knew that the ability to tell that story depended on our ability to understand the full range of technically complex, often emotionally charged issues related to human radiation experiments. We could not understand, much less tell, the story until we sought out all who could enhance our understanding, a difficult job because the voices to which we had to listen spoke in the varied languages of medicine, a multiplicity of scientific disciplines, the military, policymakers, philosophers, patients, healthy subjects, family members of former subjects, and individuals in a variety of other roles.

Finally, we were also convinced that an important determinant of our success in keeping faith with the American people would be to understand not only how human subject research was conducted in the past but also how it is being conducted in the present.

Reaching In and Reaching Out

Then we determined to search broadly for those who could contribute to our understanding. We hired a staff with the expertise and experience need for the Committee's myriad tasks. Finally, we sought to make ourselves available to those who wanted to speak to us directly, especially people who felt they or their loved ones were harmed, or might have been harmed, by human radiation-related research or exposure. Each of the Committee's meetings reserved a period for public comment. Since April 1994, the full Committee held sixteen public meetings, each of two to three days' duration. Fifteen of those meetings were held in Washington, D.C., and one was in San Francisco. In addition, subsets of Committee members presided over public forums in Cincinnati, Knoxville, Santa Fe, and Spokane. We traveled to these different cities in order to hear from people who could not come to Washington, D.C., and lived in communities where, or near where, experiments or intentional releases of interest to the Committee had taken place. We further sought to reach out to those who could not attend our meetings. By phone, mail, and personal visit, we and our staff communicated with members of the public, researchers, attorneys, investigative reporters, authors, and representatives of dozens of groups of interested people who shared some aspect of the Committee's concern.

The Records of Our Past: The Search for Documents

We began with documents that were assembled during the 1980s and that provided the basis for the Markey report. But review of those materials confirmed that, even for this relatively well-known group of experiments, basic information was lacking. We found that the Department of Health and Human Services (DHHS), which is the primary government sponsor of research involving human subjects, reported that, as permitted by federal records laws, it had long since discarded files on experiments performed decades ago. Furthermore, the capsule descriptions of research that remained sometimes did not make clear whether the subjects of research had been humans or animals. To complicate matters further, the DHHS also pointed out that much research documentation had originated and been retained only in the files of nonfederal grantee institutions and investigators. Other agencies did provide some lists of experiments; in many cases, however, there was no information on basic questions of concern (for example, who the subjects were and what, if anything, they were told).

What rules or policies, if any, existed to govern federally sponsored experiments in the pre-1974 period? The prevailing assumption was that, with a few notable exceptions, it was not until the mid-1960s that federal agencies began to develop such policies in any significant way. Most scholarship focused on divisions of the (then) Department of Health, Education, and Welfare. Little was known about approaches to human experimentation at the Atomic Energy Commission and the Department of Defense. Yet it was clear from the outset of our inquiry that these agencies, as well as the DHEW, were central to the story of human radiation experiments and that many of the experiments of interest predated by decades the mid-1960s' interest in human subject protections.

As we began our search into the past, we found that it was necessary to reconstruct a vanished world. The Committee and the agencies had to collect information scattered in warehouses throughout the country. At the same time, we had to create and test the framework needed to ensure that there would be a "big picture" into which all the pieces of the puzzle would fit.

After a few months, the outlines of a world that had been almost lost began to reemerge. Working with the Defense Department, we discovered that long-forgotten government entities had played central roles in the planning of midcentury atomic warfare-related medical research and experimentation. These groups, the piecing together of long-lost or forgotten records would show, debated the ethics of human experimentation and discussed possible human radiation experimentation. Similarly, working with the Department of Energy, we pieced together the minutes, and even many transcripts, of the key medical advisory committee to the Atomic Energy Commission. We sought to mine agency histories, when they existed: for example, at the Committee's request, the Defense Nuclear Agency (the heir to the part of the Manhattan Project that was transferred to the Defense Department) made public portions of the more than 500 internal histories that chronicle its story, most of which had previously been available only to those with security clearances.

Despite these successes, it became evident that the records of much of our nation's recent history had been irretrievably lost or simply could not be located. The Department of Energy told the Committee that all the records of the Intelligence Division of its predecessor, the Atomic Energy Commission, had been destroyed--mainly during the 1970s, but in some cases as late as 1989. The CIA explained, as had been previously reported, that records of the program known as MKULTRA, in which unwitting subjects were experimented upon with a variety of substances, had been destroyed during the 1970s, when the program became a widely publicized scandal. Though documents related to the program referred to radiation, the CIA concluded that human experiments using ionizing radiation never took place under that program, based on currently available evidence.

We also turned to nongovernmental archives throughout the country. Cryptic notes and fragments of correspondence located in private and university archives were fitted into our growing outline. For example, a copy of an important 1954 Army surgeon general research policy statement, referenced in Defense Department documents, was found at Yale University among the papers of a Nobel laureate.

By the end of our term, the Committee had received, organized, and reviewed hundreds of thousands of pages of documents from public and private archives. This collection will be available to individuals and scholars who wish to pursue the great many stories that remain to be told, and we view this as one of our most significant contributions.[5]

The Records of Our Past: The Memories of the People

We heard from officials and researchers responsible for human research today and from those who were present at or near the dawn of the Cold War. We heard from individuals who, on their own time, had long been seeking to piece together the story of human radiation experiments and offered to share their findings. We heard from scholars, from members of Congress, and from people who wanted to bear witness for those who could no longer speak. We heard from a woman who, as a high-school student intern decades ago, attended at the bedside while a terminally ill patient was injected with uranium and from a powerfully spoken veteran of the nuclear weapons work force who told of the "body snatching" of dead friends in the name of science.

Most important, we heard from many people who believed that something involving the government and radiation happened to them or their loved ones decades ago; most had been unable to find out exactly what had happened, or why, and now they wanted to know the truth. These witnesses spoke eloquently of their pain, their frustration, and the reasons they do not trust the government. Their very appearance before the Committee testified to a commitment to the country and to the value of the nation's effort to understand its past. We are deeply grateful to all of these witnesses, who overcame the obstacles of geography and emotions to participate in this work.

We combined our public meetings with additional efforts to interview, and record for the nation's archives, those who could shed light on Cold War human radiation experiments and on the ethics of biomedical experimentation. Dozens of interviews were conducted with former government officials responsible for programs that included radiation research, as well as with radiation researchers.

In Mississippi we talked with a retired general who served as a military assistant to secretaries of defense in the 1940s and 1950s; in Berkeley, we talked with the chemist who was one of the discoverers of plutonium; in Rhode Island we talked with the physicist who served as the link between the civilian health and safety agencies and the Cold War military research efforts; in Florida we talked with a pioneer in health physics, a discipline created to provide for the safety of nuclear weapons workers; in San Francisco and Washington, D.C., we talked to the lawyers who advised the Atomic Energy Commission at its postwar creation; in New York we talked with the Navy radiation researcher who was rousted from his Maryland laboratory to respond to the emergency created by the exposure of the Marshall Islanders; in San Diego we talked with a researcher whose own career and massive history of radiation research had covered much of the Committee's territory.

We also launched a special effort, called the Ethics Oral History Project, to learn from eminent physicians who were beginning their careers in academic medicine in the 1940s and 1950s about how research with human subjects was then conducted. The Ethics Oral History Project also included interviews with two people who had been administrators of the National Institutes of Health during the 1950s, since they were intimately involved with ethical and legal aspects of research involving human subjects at the time.

We listened to all these people and more, and through their testimony, this report is informed.

Bounds of Our Inquiry

Similarly, in an occupational setting in which employees are put at risk, it is often difficult to distinguish formal scientific efforts to study effects on the health of employees from routine monitoring of employees' exposure to hazards in the work place for purposes of ensuring worker safety. In the first case, the rules of research ethics apply; in the second they do not. And yet, here too, the worker may discern no difference between the two activities. A further complication for the Committee to consider was the fact that research in occupational settings rarely takes the form of a classic experiment, in which the investigator controls the variable under study and then randomly assigns subjects to be in the "treatment" or "control" group. Instead, most occupational research employs observational and statistical methods, drawing most heavily from the field of epidemiology. These distinctions were unimportant, however, to the representatives of atomic veterans, uranium miners, and residents of the Marshall Islands, who told us of their belief that they, or those they spoke for, were subjects of research.

The Committee struggled with how strictly to define human radiation experiments for purposes of our inquiry. There is no single, clear definition of an experiment that is widely subscribed to by every member of the biomedical community. Even our description above of a classic experiment is open to contest. Today, as well as in the past, the scientific community has rarely employed the term experiment in discussions of biomedical research; other terms, not necessarily synonymous--such as clinical study, clinical investigation, quasi experiment, and case control study--are all used. We concluded that it was not possible to interpret our charge by stipulating an artificial definition of human radiation experiment. Instead, in keeping with the realities of biomedical research, we decided to interpret our charge broadly, as including both research involving human subjects in which the research design called for exposing subjects to ionizing radiation and research designed to study the effects of radiation exposure resulting from nonexperimental activities.

This latter category includes the research involving uranium miners and Marshall Islanders. In these cases we quickly determined that it was in some respects impossible to isolate the ethical questions raised by the research from the ethics of the context in which the research was conducted. A central issue was the exposure of people to risk, regardless of whether they were clearly understood to be subjects of research. This characterization is true, as well, of the experience of atomic veterans. As a consequence, we considered events that might be said to be on the boundary between research and some other activity. Our inquiry underscored the importance for social policy of the need to keep focused on questions of risk and well-being regardless of what side of that boundary the activity producing the risk falls.

Human Experimentation Today

First, we studied how each agency of the federal government that currently conducts or funds research involving human subjects regulates this activity and oversees it. We surveyed what the operative rules are, how they are implemented, and how they are enforced.

Second, from among the very large number of research projects involving human subjects currently supported by the federal government, we randomly selected 125 research projects for scrutiny by the Committee. For each of these projects, we reviewed all available relevant documentation to assess how well it appeared the rights and interests of the subjects participating in these projects were being protected. The success of this review required the cooperation of private research institutions all over the country, on whom we were dependent for access to important documents. We had expected that perhaps no more than half of those asked to cooperate would agree to do so, but with little hesitation, all of the research centers that we approached agreed to cooperate.

Third, to learn from the subjects themselves, the Committee interviewed almost 1,900 patients receiving medical care in outpatient facilities of private and federal hospitals throughout the country. We asked patients about their attitudes toward medical research with human subjects and about the meaning they attach to the different terms used to explain medical research to potential subjects. We ascertained, and attempted to verify, how many of these patients were currently or ever had been subjects of research. Patient-subjects were asked about their reasons for agreeing to join research projects; patients who reported having refused offers to enter research projects were asked why they had decided against participating.

In all three of these projects, we focused not only on human radiation experiments but on human research generally. In critical (but not all) respects, the government regulations that apply to human radiation research do not differ from those that govern other kinds of research involving human subjects. Moreover, the underlying ethical principles that should guide the conduct of research are identical, whether one is considering human radiation research or all research with human subjects. Finally, the Committee hoped to learn whether, in practice, there are any differences between the conduct of radiation and nonradiation experiments.