Institute Charged in Fernald Radiation Experiment Lawsuit

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John Massaria
The Fernald School was the site of the 1946–53 joint experiments by Harvard University and MIT that exposed young male children to tracer doses of radioactive isotopes. Documents obtained in 1994 by the United States Department of Energy revealed the following details:

The experiment was conducted in part by a research fellow sponsored by the Quaker Oats Company.

MIT Professor of Nutrition Robert S. Harris led the experiment, which studied the absorption of calcium and iron.

The boys were encouraged to join a "Science Club", which offered larger portions of food, parties, and trips to Boston Red Sox baseball games.

The 57 club members ate iron-enriched cereals and calcium-enriched milk for breakfast. In order to track absorption, several radioactive calcium tracers were given orally or intravenously.
Radiation levels in stool and blood samples would serve as dependent variables.

In another study, 17 subjects received iron supplement shots containing radioisotopes or iron.
Neither the children nor their parents ever gave adequate informed consent for participation in a scientific study.

The Advisory Committee on Human Radiation Experiments, reporting to the United States Department of Energy in 1994, reported on these experiments:

Under its first resident superintendent, Walter E. Fernald (1859–1924), an advocate of eugenics, the school was viewed as a model educational facility in the field of mental retardation. It was renamed in his honor in 1925, following his death the previous year.

The institution did serve a large population of mentally retarded children, but The Boston Globe estimates that upwards of half of the inmates tested with IQs in the normal range. In the 20th century, living conditions were spartan or worse; approximately 36 children slept in each dormitory room. There were also reports of physical and sexual abuse.[4] This situation changed in the 1970s, when a class action suit, Ricci v. Okin, was filed to upgrade conditions at Fernald and several other state institutions for persons with mental retardation in Massachusetts. U.S. District Court Judge Joseph Louis Tauro, who assumed oversight of the case in 1972, formally disengaged from the case in 1993, declaring that improvements in the care and conditions at the facilities had made them "second to none anywhere in the world." A result for Fernald residents of the class action suit which took effect in 1993 was the provision of "a guaranteed level of care, regardless of cost, to compensate for decades of neglect and abuse.

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Institute Charged in Fernald Radiation Experiment Lawsuit
Issue 49 : Tuesday, October 17, 1995

By Stacey E. Blau
News Editor

The Institute has been charged in a lawsuit over radiation experiments MIT researchers conducted at a home for mentally retarded children during the 1950s.

The lawsuit comes only days after an advisory committee to President Clinton released findings about thousands of human radiation experiments conducted during the Cold War, including the tests done at the Fernald School. The committee concluded that the experiments were wrong and warranted apologies to the test subjects but that only a few should receive monetary compensation.

According to the lawsuit filed by former Fernald Science Club member Ronald Beaulieu, MIT violated the civil rights of at least 54 institutionalized children at the Walter E. Fernald School in Waltham, Mass. The researchers fed children doses of radiation with their breakfast cereal for the purpose of studying the way the body absorbs calcium and iron. The experiments were often performed without the informed consent of the subjects or their families.

The state of Massachusetts, researchers at the Fernald School, and the Quaker Oats Company were also charged in the suit, according to The Boston Globe.

Professor of Physics J. David Litster PhD '65, vice president and dean for research, said that MIT has not yet been served in the Beaulieu complaint.

TESTS WERE "MORALLY TROUBLING'

According to the government report, the Fernald School experiments were "morally troubling" and the government owes the test subjects an apology. But because there was no evidence that the subjects were harmed by exposure to any dangerous levels of radiation, the government is not obliged to monetarily compensate them.

At the Oct. 3 news conference that announced the completion of the committee's nearly 1,000-page report, Clinton made a formal apology to the thousands of subjects of radiation experiments reviewed by the committee.

The report stated that children at the Fernald School were "unfairly burdened" by researchers from MIT and Harvard, who encouraged the children to take part in tests with promises of gifts or trips to Red Sox games.

The researchers also appeared "unwilling to respect" some children's wishes not to participate in experiments, according to the report. The parents of the children involved in the experiments were not told that the tests involved radiation.

The report recommended that the federal government compensate only about 25 tests subjects in three experiments.

The committee also recommended that test subjects who are still unaware that they underwent radiation experiments should not be notified, unless they face more than a 1 in 1,000 cancer risk. Few subjects would qualify for notification, according to the report.

In late 1993, Energy Secretary Hazel O'Leary declassified thousands of documents about government-backed radiation tests, prompting the formation of an advisory committee to investigate the experiments.

The committee's findings stressed the immorality of researchers' failure to obtain consent from test subjects and their families.

UNAUTHORIZED TESTS WERE WRONG

"I was sorry to hear that at least some of the young people who participated in this research and their parents were unaware that the study involved radioactive tracers," said President Charles M. Vest.

A Massachusetts state task force concluded last year that "no significant health effects were incurred by the research subjects as a direct result of the nutritional research studies" at the Fernald School.

"It does seem to me that there was a very wide spectrum of things done, from the truly horrible to the harmless," Litster said. "The state task force did a surprisingly good job of finding out what was done and to whom."

The highest exposure for any subject was 330 millirems, less than the yearly background radiation in Denver. The doses were all below the standards of the time, as well as today's more stringent standards.

"I got quite a dose of x-rays every time my parents took me to the shoe store - far more than the people got who participated in some of these studies 40 years ago. Does someone owe me an apology, and perhaps a monetary settlement?" Litster said.

"In most cases, I think, people were behaving well according to the knowledge and standards of the time," he said.

Rep. Edward J. Markey (D-Mass.), who originally publicized government-sponsored radiation experiments in 1986, plans to introduce a bill in the next few weeks to compensate test subjects.


PDF: V115-N49.pdf
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DOE Openness: Human Radiation Experiments: Roadmap to the Project
ACHRE Report
Chapter 7: The Studies at the Fernald School

Researchers from the Massachusetts Institute of Technology, working in cooperation with senior members of the Fernald staff, carried out nontherapeutic nutritional studies with radioisotopes at the state school in the late 1940s and early 1950s. The subjects of these nutritional research studies were young male residents of Fernald, who were members of the school's "science club." In 1946, one study exposed seventeen subjects to radioactive iron. The second study, which involved a series of seventeen related subexperiments, exposed fifty-seven subjects to radioactive calcium between 1950 and 1953. It is clear that the doses involved were low and that it is extremely unlikely that any of the children who were used as subjects were harmed as a consequence. These studies remain morally troubling, however, for several reasons. First, although parents or guardians were asked for their permission to have their children involved in the research, the available evidence suggests that the information provided was, at best, incomplete. Second, there is the question of the fairness of selecting institutionalized children at all, children whose life circumstances were by any standard already heavily burdened.

Parental Authorization

The Massachusetts Task Force found two letters sent to parents describing the nutrition studies and seeking their permission. The first letter, a form letter signed by the superintendent of the school, is dated November 1949.[83] The letter refers to a project in which children at the school will receive a special diet "rich" in various cereals, iron, and vitamins and for which "it will be necessary to make some blood tests at stated intervals, similar to those to which our patients are already accustomed, and which will cause no discomfort or change in their physical condition other than possibly improvement." The letter makes no mention of any risks or the use of a radioisotope. Parents or guardians are asked to indicate that they have no objection to their son's participation in the project by signing an enclosed form.

The second letter, dated May 1953, we quote in its entirety:

Dear Parent:
In previous years we have done some examinations in connection with the nutritional department of the Massachusetts Institute of Technology, with the purposes of helping to improve the nutrition of our children and to help them in general more efficiently than before.

For the checking up of the children, we occasionally need to take some blood samples, which are then analyzed. The blood samples are taken after one test meal which consists of a special breakfast meal containing a certain amount of calcium. We have asked for volunteers to give a sample of blood once a month for three months, and your son has agreed to volunteer because the boys who belong to the Science Club have many additional privileges. They get a quart of milk daily during that time, and are taken to a baseball game, to the beach and to some outside dinners and they enjoy it greatly.

I hope that you have no objection that your son is voluntarily participating in this study. The first study will start on Monday, June 8th, and if you have not expressed any objections we will assume that your son may participate.

Sincerely yours,

Clemens E. Benda, M.D.

[Fernald] Clinical Director

Approved:_____________________

Malcom J. Farrell, M.D.

[Fernald] Superintendent

Again, there is no mention of any risks or the use of a radioisotope. It was believed then that the risks were minimal, as indeed they appear to have been, and as a consequence, school administrators and the investigators may have thought it unnecessary to raise the issue of risks with the parents. There was no basis, however, for the implication in both letters that the project was intended for the children's benefit or improvement. This was simply not true.

The conclusion of the Massachusetts Task Force was that these experiments were conducted in violation of the fundamental human rights of the subjects. This conclusion is based in part on the task force's assessment of these letters. Specifically, the task force found that

The researchers failed to satisfactorily inform the subjects and their families that the nutritional research studies were non-therapeutic; that is, that the research studies were never intended to benefit the human subjects as individuals but were intended to enhance the body of scientific knowledge concerning nutrition.

The letter in which consent from family members was requested, which was drafted by the former Fernald superintendent, failed to provide information that was reasonably necessary for an informed decision to be made.

Fairness and the Use of Institutionalized Children

The Fernald experiments also raise quite starkly the particular ethical difficulties associated with conducting research on members of institutionalized populations--especially where some of the residents have mental impairments. Living conditions in most of these institutions (including Fernald and Wrentham) have improved considerably in recent years, and sensitivity toward people with cognitive impairments has likewise increased. As Fred Boyce, a subject in one of these experiments has put it, "Fernald is a much better place today, and in no way does it operate like it did then. That's very important to know that."

The Massachusetts Task Force describes conditions in state-operated facilities like Fernald, particularly as they bear on human experimentation, as follows:

Until the 1970s, the buildings were dirty and in disrepair, staff shortages were constant, brutality was often accepted, and programs were inadequate or nonexistent. There were no human rights committees or institutional review boards. If the Superintendent (in those days required to be a medical doctor) "cooperated" in an experiment and allowed residents to be subjects, few knew and no one protested. If nothing concerning the experiments appeared in the residents' medical records, if "request for consent" letters were less than forthright, or if no consent was obtained there was no one in a position of authority to halt or challenge such procedures.

Although public attitudes toward people who are institutionalized are admittedly different today than they were fifty years ago, it is likely that this state of affairs would have been troubling to most Americans even then. Historian Susan Lederer has revealed several episodes of experimentation with institutionalized children in America that caused considerable public outcry even before 1940, presaging the concern generated by Willowbrook when this research became a public issue in the 1960s.

The LMRI staff reported in the early 1960s that the pediatric researchers whom they had gathered agreed in principle that the convenience of conducting research on institutionalized children did not outweigh the moral problems associated with this practice:

Several investigators spoke about the practical advantages of using institutionalized children who are already assembled in one location and living within a standard, controlled environment. But the conferees agreed that there should be no differential recruitment of ward patients rather than private patients, of institutionalized children rather than children living in private homes, or of handicapped rather than healthy children.

A particularly poignant dimension of the unfairness of using institutionalized children as subjects of research is that it permits investigators to secure cooperation by offering as special treats what other, noninstitutionalized children would find far less exceptional. The extra attention of a "science club," a quart of milk, and an occasional outing were for the boys at Fernald extraordinary opportunities. As Mr. Boyce put it:

I won't tell you now about the severe physical and mental abuse, but I can assure you, it was no Boys' Town. The idea of getting consent for experiments under these conditions was not only cruel but hypocritical. They bribed us by offering us special privileges, knowing that we had so little that we would do practically anything for attention; and to say, I quote, "This is their debt to society," end quote, as if we were worth no more than laboratory mice, is unforgivable.

Even when a child was able to resist the offers of special attention and refused to participate in the experiment, the investigators seem to have been unwilling to respect the child's decision. One MIT researcher, Robert S. Harris, explicitly noted that "it seemed to [him] that the three subjects who objected to being included in the study [could] be induced to change their minds." Harris believed that the recalcitrant children could be "induced" to join in the study by emphasizing "the Fernald Science Club angle of our work."

From the perspective of the science, it was considered important to conduct the research in an environment in which the diet of the children-subjects could be easily controlled. From this standpoint, the institutional setting of Fernald was ideal. The institutional settings of the boarding schools in the Boston area, however, would have offered much the same opportunity. Although the risks were small, the "children of the elite" were rarely if ever selected for such research. It is not likely that these children would have been willing to submit to blood tests for extra milk or the chance to go to the beach.

The question of what is ethical in the context of unfair background conditions is always difficult. Perhaps the investigators, who were not responsible for the poor conditions at Fernald, believed that the opportunities provided to the members of the Science Club brightened the lives of these children, if only briefly. Reasoning of this sort, however, can all too easily lead to unjustifiable disregard of the equal worth of all people and to unfair treatment.

Today, fifty years after the Fernald experiments, there are still no federal regulations protecting institutionalized children from unfair treatment in research involving human subjects.[95] The Committee strongly urges the federal government to fill this policy void by providing additional protections for institutionalized children.[96]

Department Of Energy Report