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The state task force on human research concluded Monday that MIT nutritional studies in the 1950s, which used tiny amounts of radioactive tracers, caused "no significant health effects."
The Task Force on Human Subject Research, examining the use of radioactive materials in research between 1943 and 1973 involving residents of the Walter E. Fernald State School and other state residential facilities for youth, issued its report at a news conference at the school in Waltham.
J. David Litster, MIT vice president, dean for research and professor of physics, said in a statement:
"Chairman Fred Misilo, the Rev. Doe West and the entire Task Force on Human Subject Research are to be congratulated for the hard work and thought they have put into completing a difficult mission over the past four months.
"As MIT President Charles M. Vest said in January, MIT has expressed its sorrow that the young people who participated decades ago in the nutritional tracer studies-and their parents-apparently were not informed that the study involved radioactive tracers in very small amounts.
"I am pleased that the Task Force has confirmed MIT's initial impression that no harm was done to the participants in the cereal nutrition studies that were the initial focus of publicity," Professor Litster said.
The Task Force's five principal findings included:
"In the best judgment of the experts whose opinions were sought by the Task Force, no significant health effects were incurred by the research subjects as a direct result of the nutritional research studies in which radioactive calcium and iron tracers were used." The task force consulted with Dr. Joseph L. Lyon, a University of Utah epidemiologist whose testimony in a court case won him favor with the "downwinders," people who lived downwind of nuclear testing in the western United States.
The report stated, "The risk assessment done by Dr. Joseph L. Lyon, an outside epidemiologist with a speciality in radiation medicine, was very reassuring to the the Task Force on these nutritional studies. Dr. Lyon not only concurred with the dosimetry done by Dr. Litster and supported the findings of the other three expert opinions received, but he was also able, as an epidemiologist, to state that `children exposed to ionizing radiation generally manifest the excess risk of leukemia in the first 15 years after the exposure.' Between 40 to 50 years have now passed since these research studies were done, allowing Dr. Lyon to speculate that if the subjects did not exhibit a leukemia between 1961-1970, then it is unlikely that they would suffer this most severe of potential medical risks from either the calcium or iron tracer studies."
The MIT nutrition research used minute amounts (less than one billionth of an ounce) of radioactive iron and calcium to chart the absorption of calcium and iron in the body from eating oatmeal and farina cereals. The exposures to radiation for the youths were between 30% and 99% below the much more stringent standards that are in effect today.
The Task Force has been meeting since January at the request of Philip Campbell, Commissioner of the Department of Mental Health, examining eight human research studies involving the use of radioactive elements carried out at state institutions by state officials, MIT, Harvard University, Boston University, Massachusetts General Hospital and Beth Israel Hospital. The task force submitted to the commissioner its 46-page report and about 250 pages of documentation and appendices in a paper-bound book, "A Report on the Use of Radioactive Materials in Human Subject Research that Involved Residents of State-Operated Facilities within the Commonwealth of Massachusetts from 1943 through 1973."
The task force, in its findings, said the state failed to provide basic protection to the individuals who were subjected to the research, in violation of their human rights. It cited the Fernald superintendent's dual capacity in having the authority both to provide consent on behalf of state wards as well as to plan or approve medical research that would involve those same wards. It said the facility staff and researchers at both Fernald and Wrentham failed to properly enter any information into the permanent medical records of the research subjects. This prevented any knowledge of the research studies to be passed on to future staff, thereby frustrating attempts to study potential long term issues.
At the news conference, the project coordinator, the Rev. Doe West, said that former researchers told task force members it was the belief of the researchers that all the administrative duties were being handled by Fernald officials, and that Fernald had the responsibility for sending out letters to obtain consent. As far as the researchers were aware, they were of the understanding that Fernald had gotten consent, Ms. West said.
She noted that all the residents of Fernald who were participants in the MIT nutrition studies had been identified because MIT graduate students kept records for their doctoral dissertations, which were in MIT's archives.
The report emphasized on the first page that "many of the people who became residents of the Walter E. Fernald School, from its opening in 1848 right through the 1950s, were not admitted with a diagnosis of mental retardation. Societal and cultural norms of the day permitted persons to be admitted to state-operated institutions for a number of reasons. All were labelled mentally retarded just by virtue of having lived within the facility. The Task Force asks that the general public and members of the press take special note that these labels are grossly inaccurate, misleading and simply not true."
The report said laws need to be strengthened to protect persons with mental retardation or who are wards of the state because their families are unable to care for them.
Charles Dyer and Austin LaRocque, both 53, are two members of the task force who were residents at Fernald in 1955 and members of the Fernald School Science Club as potential participants in the MIT nutrition experiments. Mr. LaRocque told the news conference, "I was a normal child as far as I was concerned" but his family couldn't take care of all of their children.
At the news conference, both men criticized the failure of Fernald officials to provide them any schooling. Mr. Dyer said, "Instead of being taught, we were being used, and I don't think that was right."
"I don't have the education that a lot of students have now because of my upbringing here" at Fernald, he said. "I wasn't taught anything, I have trouble reading, I can't spell, I try to get help, and I can't get help."
He said that being a member of the Fernald Science Club meant "to get off the (Fernald) grounds, go to a ball game, go to MIT, Christmas parties with girls and dances. It was something for us to do."
The task force criticized the benefits offered to the 74 members of the MIT Science Club, who were taken to ball games and to functions at MIT in gratitude for their participation in the Fernald nutrition studies. The task force said that "the provision of special rewards and privileges. resulted in the research subjects being unfairly enticed by those conducting the research."
The task force said the research conducted on human subjects at or from the state schools between 1943 and 1973 that involved the introduction of radioactive substances into their bodies "was conducted in violation of the fundamental human rights of the subjects involved." The task force also said the researchers failed to satisfactorily inform the subjects and their families that the nutritional research studies were non-therapeutic; that the Fernald superintendent's letter to family members failed to provide necessary information; and that the researchers delegated the task of obtaining consent to the Fernald superintendent, and failed to ensure that proper informed consent was obtained from family members.
In the thyroid experiments conducted principally by researchers outside of MIT, and in the so-called Cold-war experiment, conducted at the Wrentham State School, that used radioactive iodine, the Task Force said there was a need "for an immediate in-depth study to determine the nature and degree of any possible health risk." A DMR working group, reporting directly to the Commissioner, will continue the analysis on these studies. MIT and Harvard will continue to assist the working group.
The task force recommended that "all participants who were involved in human subject research which used radioactive materials at Massachusetts-operated facilities for persons with mental retardation should be compensated for any and all damage incurred as a result of such research."
It said participants should be entitled to federal benefits for any and all related health-care assessment and follow-up care indicated, and it recommended a federal agency establish a special fund to pay medical benefits for persons involved with these identified studies.
The task force urged passage of "An Act To Require the Informed Consent of Human Subjects as a Condition of Performing Research Involving the Commonwealth's Facilities, Services or Funds" filed by Governor William Weld.
The task force further urged new regulations on informed consent and on record-keeping, and it established guidelines for communicating with former residents of the Fernald School.
A version of this article appeared in the May 11, 1994 issue of MIT Tech Talk (Volume 38, Number 32).