DOE Openness: Human Radiation Experiments: Roadmap to the Project
History of Prison Research Regulation
Chapter 9: History of Prison Research RegulationDr. Paulsen reported in a recent interview that he had "asked a lot of people" in 1963 about the use of prisoners as research subjects. He went on to say that at that time "no one said no" to the use of such subjects in his research. However, Dr. Paulsen explained in the same interview that he had started to sense a shift in public opinion around 1970. In particular, he pointed to comments critical of prison experimentation that he had heard at a New York Academy of Sciences conference, "New Dimensions in Legal and Ethical Concepts for Human Research," which he attended in the spring of 1969. Of course, we cannot rely solely on Dr. Paulsen's recollections to provide historical context for experiments in which he was so intimately involved- - and which have now become controversial. But ample evidence suggests that Dr. Paulsen was essentially correct in his impression that testicular irradiation experiments in Washington and Oregon bridged a transitional period in the history of human experimentation generally and particularly in the history of experimentation in American prisons.
Isolated incidents of prison-based research before World War II formed the foundation for a practice that would become firmly embedded in the structure of American clinical research during World War II. Perhaps the most significant wartime medical research project in which American scientists employed prisoners as research subjects was centered in Illinois's Stateville Prison. Beginning in 1944, hundreds of Illinois prisoners submitted to experimental cases of malaria as researchers attempted to find more effective means to prevent and cure tropical diseases that ravaged Allied forces in the Pacific Theater. In 1947, a committee was established by the governor of Illinois to examine the ethics of using state prisoners as research subjects. The committee was chaired by Andrew Ivy, a prominent University of Illinois physiologist and the chief expert witness on medical ethics for the prosecutors at the Nuremberg Medical Trial, where prison research was a salient topic (see chapter 2). The committee pronounced the wartime experiments at Stateville Prison "ideal" in their conformity with the newly adopted rules of the American Medical Association concerning human experimentation. The AMA rules, which Ivy had played a key role in developing, included provisions stipulating voluntary consent from subjects, prior animal experimentation, and carefully managed research under the authority of properly qualified clinical researchers. Perhaps most significantly, the findings of Ivy's committee were announced to the American medical community when the group's final report was reproduced in the Journal of the American Medical Association. The appearance of this report in the nation's leading medical journal both represented and reinforced the sentiment that prison research was ethically acceptable.
Publicly aired assertions that experimentation on prisoners relied on exploitation or coercion were extremely rare in the United States before the late 1960s. One criticism of medical research behind bars did, however, emerge with some frequency: prisoners who participated in research were somehow escaping from their just measures of punishment. Inmates were usually offered rewards in exchange for their scientific services, ranging from more comfortable surroundings, to cash, to early release. Perhaps the most powerful statement of the concern that convicts should not receive special treatment because they had participated in an experiment came from the AMA. In 1952, this organization formally approved a resolution stating its "disapproval of the participation in scientific experiments of persons convicted of murder, rape, arson, kidnapping, treason, or other heinous crimes." The AMA was alarmed that some such criminals "have not only received citations, but have in some instances been granted parole much sooner than would otherwise have occurred." (In the Oregon testicular irradiation experiments it appears that this recommendation against using inmates accused of "heinous crimes" was not always observed.)
It should be noted that the use of prisoners as research subjects seems to have been a uniquely American practice in the years following World War II. The large-scale successes of prison experimentation during World War II--and the authoritative pronouncement of the Ivy Committee that prison research could be conducted in an ethical fashion--seem to have given the practice a kind of momentum in this country that it did not have elsewhere. In other countries it seems that the first clause of the Nuremberg Code was interpreted to preclude the use of prisoners in experimentation. This clause begins with the assertion that the only acceptable experimental subjects are those who are "so situated as to be able to exercise free power of choice."
It is difficult to overemphasize just how common the practice became in the United States during the postwar years. Researchers employed prisoners as subjects in a multitude of experiments that ranged in purpose from a desire to understand the cause of cancer to a need to test the effects of a new cosmetic. After the Food and Drug Administration's restructuring of drug-testing regulations in 1962, prisoners became almost the exclusive subjects in nonfederally funded Phase I pharmaceutical trials designed to test the toxicity of new drugs. By 1972, FDA officials estimated that more than 90 percent of all investigational drugs were first tested on prisoners.
It appears that throughout the history of medical experimentation on American prisoners many inmates have valued the opportunity to participate in medical research. One must quickly add that such an observation points to the paucity of opportunities open to most prisoners. The common perception among inmates that participating in a medical experiment was a good opportunity has had an important impact on the racial aspects of prison experimentation. Because of the large numbers of African-Americans in prison (and the overt racial exploitation of the notorious Tuskegee syphilis study, in which black men with syphilis were observed but not treated), it might be assumed that minorities predominated as research subjects in prisons. The opposite has generally been true; white prisoners have usually been overrepresented in the "privileged" role of research subject. In most prison studies before and during World War II, it seems that all of the research subjects were white. In 1975, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research carefully examined the racial composition of the research subjects at a prison with a major drug-testing program. The commission found that African-Americans made up only 31 percent of the subject population, while this racial "minority" formed 68 percent of the general prison population.
The shift in public opinion against the use of prisoners as research subjects, which began in the late 1960s, was no doubt tied to many other social and political changes sweeping the country: the civil rights movement, the women's movement, the patients' rights movement, the prisoners' rights movement, and the general questioning of authority associated with the anti-Vietnam War protests. But, as has been common in the history of human experimentation, scandal galvanized public attention, brought official inquiry, and resulted in significant change. A major scandal in prison experimentation came when the New York Times published a front-page article on July 29, 1969, detailing an ethically and scientifically sloppy drug-testing program that a physician had established in the state prisons of Alabama. Even more sensational was Jessica Mitford's January 1973 Atlantic Monthly article. In this article, Mitford portrayed experimentation on prisoners as a practice built on exploitation and coercion of an extremely disadvantaged class. When the article reappeared later in 1973 as a chapter in her widely read book critiquing American prisons, she had come up with an especially provocative and suggestive title for this section of the book: "Cheaper than Chimpanzees." Mitford, and most of the growing number who condemned experimentation on prisoners during the 1970s (and after), offered two arguments against the practice. First, prisoners were identified as incapable of offering voluntary consent because of a belief that most (some argued, all) prisons are inherently coercive environments. Another line of argument was based on a principle of justice that stipulated that one class--especially a disadvantaged class such as prisoners--should not be expected to carry an undue burden of service in the realm of medical research.
A few months after the publication of Mitford's article, Senator Edward M. Kennedy of Massachusetts held hearings to investigate human experimentation. Kennedy was primarily fired into action by the revelations of the Tuskegee syphilis study, which made headlines in 1972, but he devoted one full day of his hearings to the issue of prison experimentation. The chief outcome of Kennedy's hearings was the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which, among other topics, was specifically charged with investigating experimentation on prisoners (see chapter 3).
The eleven commissioners, including Adviory Committee member Patricia King--with the assistance of twenty staff members--gathered a wealth of data on prison medical research, made site visits to prisons, held extensive public hearings, and engaged in long debates among themselves. After their deliberations, the commission concluded that it was "inclined toward protection as the most appropriate expression of respect for prisoners as persons." But the commission did not call for an absolute ban on the use of prisoners in medical research. A steadfast minority on the commission held to a belief that prisoners should not arbitrarily be denied the opportunity to participate in medical research. An excursion to the State Prison of Southern Michigan, where Upjohn and Parke-Davis pharmaceutical companies had cooperatively built and maintained a large Phase I drug-testing facility, served to reinforce the opinions of this contingent. In candid conversations with the visiting commissioners, randomly selected inmates spoke in convincing terms about their support for the drug-testing program in the Michigan prison.
The commission's final report reflected this hesitancy to call for a complete halt to the use of prisoners in nontherapeutic experimentation. The commission recommended that prisoners could be considered ethically acceptable experimental subjects if three requirements were satisfied: (1) "the reasons for involving prisoners in . . . research [were] compelling," (2) "the involvement of [the] prisoners . . . satisfie[d] conditions of equity," and (3) subjects lived in a prison characterized by a great deal of "openness" in which a prisoner could exercise a "high degree of voluntariness." The final requirement involved a detailed prison accreditation scheme intended to ensure the possibility of voluntary consent.
The National Commission derived its primary power from the fact that the secretary of the Department of Health, Education, and Welfare (DHEW) was legally compelled to respond to the commission's findings and to justify the rejection of any commission recommendations. Joseph Califano, DHEW secretary in the Carter administration, spent nearly a year formulating his response regarding the use of prisoners in medical research. Califano explored the possibility of an accreditation scheme as suggested by the commission. However, in a letter to the commission, Califano reported that the American Correctional Association, "the one currently qualified [prison] accrediting organization," had no interest in "accrediting correctional institutions as performance sites for medical research." "On the contrary," Califano went on to explain, the ACA had recently decided it "would not fully accredit any institution which permitted research on prisoners." After his interchange with the ACA, Califano ultimately decided to issue regulations that, for almost all intents and purposes, brought an end to federally funded nontherapeutic medical research in American prisons.
In the interest of uniform federal regulations, Secretary Califano also "directed" the FDA to issue similar rules governing the use of prisoners in "research that the FDA accept[ed] to satisfy its regulatory requirements." The FDA published final rules in the spring of 1980 that were intended, on the planned effective date of June 1, 1981, to eliminate prisons as acceptable sites for nontherapeutic pharmaceutical testing. However, in July of 1980, almost a year before the FDA's regulations were scheduled to take effect, a group of prisoners at the State Prison of Southern Michigan filed suit against the federal government. These inmates claimed that the impending FDA regulations threatened to violate their "right" to choose participation in medical research. The case was settled out of court when FDA attorneys decided to reclassify the agency's prison drug-testing regulations as "indefinitely" stayed. The FDA's regulations still exist in this bureaucratic limbo.
But even before the FDA issued its proposed regulations on the use of prisoners in drug testing, pharmaceutical companies had already largely abandoned a practice that had been so widespread only a few years earlier. Most significantly, pharmaceutical researchers, along with other medical scientists, had discovered that sufficient numbers of experimental subjects could be found beyond prison walls. Students and poor people proved to be especially viable alternative populations from which to draw participants for nontherapeutic experiments--if the cash rewards were sufficient. The growing controversy surrounding the use of prisoners as research subjects, combined with the realization that they could find enough alternate subjects for their needs, led drug companies to make decisions that were based not so much on ethics as expediency. The comments of an administrator associated with an Eli Lilly testing operation at an Indiana prison are revealing and provide a fitting conclusion to this brief historical analysis: "The reason we closed the doggone thing down was that we were getting too much hassle and heat from the press. It just didn't seem worth it."