ACHRE Report



Why the Committee Was Created

The President's Charge

The Committee's Approach

Lessons from History: Looking to the Future

How this Report is Organized

A Final Note

Why the Committee was Created

Past research with human subjects, including human radiation research, has been a source of life-saving knowledge. Research involving human subjects continues to be essential to the progress of medical science, since most advances in medicine must at some point in their development be tested in human subjects. Every one of us who has been either a patient or a loved one of a patient has benefited from knowledge gained through research with human subjects. But medical science, like all science, does not proceed or progress without the taking of risks. In medical research, these risks often fall on the human subject, who sometimes does not stand to benefit personally from the knowledge gained. This is the source of the moral tension at the core of the enterprise of research involving human subjects. In order to secure important collective goods--scientific knowledge and advances in medicine--individuals are put in harm's way. The moral challenge is how to protect the rights and interests of these individuals while enabling and encouraging the advancement of science.

The Committee had its origins when public controversy developed surrounding human radiation experiments that were conducted half a century ago. In November 1993, the Albuquerque Tribune published a series of articles that, for the first time, publicly revealed the names of Americans who had been injected with plutonium, the man-made material that was a key ingredient of the atom bomb. Reporter Eileen Welsome put a human face to what had previously been anonymous data published in official reports and technical journals. As World War II was ending, she wrote, doctors in the United States injected a number of hospitalized patients with plutonium, very likely without their knowledge or consent. The injections were part of a group of experiments to determine how plutonium courses through the human body. The experiments, and the very existence of plutonium, were shrouded in secrecy. They were conducted at the direction of the U.S. government, with the assistance of university researchers in Berkeley, Chicago, and Rochester (New York), with the expectation that the information gained could be used to limit the hazards to the thousands of workers laboring to build the bomb.

On reading the articles, Secretary of Energy Hazel O'Leary expressed shock, first to her staff, and then in response to a question posed at a press conference. She was particularly concerned because the Department of Energy had its earliest origins in the agencies responsible for building the atomic bomb and sponsoring the plutonium experiments. During the Cold War, these agencies had continued to do much of their work in the twilight zone between openness and secrecy. Now, the Cold War was over. The time had come, Secretary O'Leary determined, to make public anything that remained to be told about the plutonium experiments.

Subsequent press reports soon noted that the plutonium injections were not the only human radiation experiments that had been conducted during the war and the decades that followed. In Massachusetts, the press reported that members of the "science club" at the Fernald School for the Retarded had been fed oatmeal containing minute amounts of radioactive material. In Ohio, news articles revived an old controversy about University of Cincinnati researchers who had been funded by the Defense Department to gather data on the effects of "total-body irradiation" on cancer patients. In the Northwest, the papers retold the story of Atomic Energy Commission funding of researchers to irradiate the testicles of inmates in Oregon and Washington prisons in order to gain knowledge for use in government programs. The virtually forgotten 1986 report prepared by a subcommittee headed by U.S. Representative Edward Markey, "American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens," was also recalled to public attention.[1]

Coincidentally, the fact that the environment had also been used as a secret laboratory became a subject of controversy. A November 1993 congressional report uncovered thirteen cases in which government agencies had intentionally released radiation into the environment without notifying the affected populations.[2] At various times, tests were conducted in Tennessee, Utah, New Mexico, and Washington state. This report had been prepared at the request of Senator John Glenn in his capacity as chair of a committee that had undertaken a comprehensive oversight investigation of the nuclear weapons complex. As a young marine in 1945, the senator was in a squadron being trained for possible deployment to Japan when the atomic bomb ended the war; as an astronaut, he had been the subject of constant testing and medical monitoring by space administration flight surgeons; as a senator he was at the center of the country's efforts to understand and control nuclear weapons. Senator Glenn understood the importance of national security, but he found it "inconceivable . . . that, even at the height of the communist threat, some of our scientists and doctors and military and perhaps political leaders approved some of these experiments to be conducted on an unknowing and unwitting public."[3]

In the immediate aftermath of Secretary O'Leary's press conference and the further press reports, thousands of callers flooded the Department of Energy's phone lines to recount their own experiences and those of friends and family members.

Underlying the outrage and concern expressed by government officials and members of the public were many unanswered questions. How many human radiation experiments were conducted? No one knew if the number was closer to 100 or 1,000. Were all the human radiation experiments done in secret, and were any of them still secret? Are any secret or controversial studies still ongoing? Scientists and science journalists pointed out that some of the highly publicized experiments had long ago been the subject of technical journal articles, even press accounts, and were old news; other commentators countered that, for most of the public, articles in technical journals might as well be secret.

How, why, and from what population groups were subjects selected for experiments? Some suspected that subjects were disproportionately chosen from the most vulnerable populations--children, hospitalized patients, the retarded, the poor--those too powerless to resist the government and its researchers.

Did the experiments benefit the American people through the advancement of science and the enhancement of the ability to treat disease?

How many intentional releases took place, and how many people were unknowingly put at risk? The answer here was sketchy; the releases identified in the November 1993 Glenn report had all been performed in secret, and much information about them was still secret.

How great were the risks to which people were exposed? Many pointed out that radiation is not only present in our natural environment, but that, as a result of biomedical research, most people routinely rely on radiation as a means of diagnosing and treating disease. Others noted that while this is so, radiation can be abused, and the potential dangers of low-level exposure are still not well understood.

What did our government and the medical researchers it sponsored do to ensure that the subjects were informed of what would be done to them and that they were given meaningful opportunities to consent? Today, federal government rules require the prior review of proposed experiments, to ensure that the risks and potential benefits have been considered and that subjects will be adequately informed and given the opportunity to consent. But the standards of today, many historians and scholars of medical ethics noted, are not those of yesterday. Others, however, declared that it was self-evident that no one should be experimented upon without his or her voluntary consent. Indeed, it was pointed out that this very principle was proclaimed aloud to the world in 1947, as the plutonium experiments were coming to a close. It was the American judges at the international war crimes trials in Nuremberg, Germany, who invoked the principle in finding doctors guilty of war crimes for their vile experiments on inmates of Nazi concentration camps. How could yesterday's standard have been less strict than that of today? How, moreover, could the standard not have been known by the government that sponsored the experiments and the researchers who conducted them?

Finally, there were questions about how human experiments are conducted today. Insofar as wrong things happened in the past, how confident should we be that they could not happen again? Have practices changed? Do we have the right rules, and are they implemented and enforced?

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