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A report issued at the Walter E. Fernald State School in Waltham, Mass., last month could signal the end of a nightmarish chapter in the history of the University.
The report, which was compiled by state task force, documented numerous experiments during the 1940s, '50s and '60s in which Harvard researchers fed unwitting retarded children radioactive isotopes. The task force concluded that the tests violated the "fundamental human rights" of the experiment subjects. But the night mare may not be completely over.
As revelations continue about those and other government-supported experiments in which Harvard researchers participated, questions have been raised about whether such tests could happen again today.
A Frightening Chronology
Harvard Medical School instructor Dr. Clemens E. Benda, who died in 1975, supervised a series of experiments at the Fernald School from the mid-1940s to the mid-1950s.
In the tests, MIT scientists fed scores of retarded children radioactive isotopes in their breakfast cereal.
In 1953, Benda, who was a Harvard faculty member until the late 1960s, wrote Fernald parents seeking permission to include their sons in the experiments. One letter says the children had "volunteered" to participate in the tests. In another, Benda says the absence of consent by parents or guardians would be taken as an assumption that permission had been granted.
Benda never mentioned that radioactivity would be used in the tests.
Then, in 1957, Harvard Medical School and Beth Israel Hospital researchers studied the thyroid function of 21 students and seven parents at Fernald using doses of radioactive tracer high enough to cause "serious concern," according to the state task force report.
And at a state school for the retarded in Wrentham, Mass., two Harvard scientists used children as young as one year old in a 1961-62 experiment to determine the human threshold for nuclear fallout.
In addition to its condemnation of the experiments, the state task force recommended that test subjects be compensated for their participation but did not say who should bear that cost.
Harvard is still reviewing the state's report. Acting Vice President for Government, Community and Public Affairs Jane H. Corlette says Harvard's own committee to review human subject research, established by Provost Jerry R. Green in February, is currently evaluating the document.
"Each committee member is going through the report with his or her perspective of expertise," Corlette says. Harvard's in-house review committee is expected to present its report next fall.
Meanwhile, the state task force continues its work, digging for more information about the most troubling set of tests-the nuclear fallout experiments conducted at Wrentham.
Who Should Pay?
But the question of who should compensate the test subjects remains unanswered. Both Harvard officials and task force members have declined to discuss the matter.
Some advocates for the retarded are calling for Harvard and MIT to pay up. The research institutions, however, may look to the deep pockets of the federal government, which licensed the radioactive material used in some of the experiments.
One way Harvard may try to avoid compensating victims is to argue that it is not responsible for the actions of its researchers. That argument may strain credibility because documents show that University scientists were listing their Harvard titles in correspondence regarding the experiments.
Stewart L. Udall Secretary of the Interior under President Jimmy Carter and author of a book on Cold War radiation experiments says Harvard bears "a serious responsibility that can't be disavowed."
"I was surprised when I read that institutions of the caliber of Harvard and MIT would have been involved," Udall says. "The ethical violations are egregious."
"The people who are saying 'don't judge what they did then by the standard of today'...I think that's outrageous because the medical ethics of the 1940s on this subject were no different than the medical ethics of today," says Udall, who is 74. "The Nuremburg trial of the Nazi doctors received widespread publicity- I remember it well."
David H. Dockham '58 an advocate for the retarded, says the experiments with radiation conducted on retarded children at Fernald and Wrentham violated the standards of the 1947 Nuremburg Code, which established the notion of "informed consent."
The code states that "voluntary consent of the human subject [of experimentation] is essential."
In a letter sent last week to President Neil L. Rudenstine and the Harvard Corporation, Dockham requests an "unconditional and constructive apology for Harvard's involvement in deception and consequent failure to achieve fully informed consent."
"We executed something like 17 people over these issues," says Dockham, in reference to the Nuremburg trials. "The least we can do is take them seriously ourselves."
Udall, too, believes an apology is in order.
"I would think an apology would be the bare minimum thing that could be done," says Udall, who has represented test subjects in lawsuits against the federal government.
Could It Happen Again?
Most recently, questions have surfaced about Harvard's current regulations concerning human subject research and whether violations similar to those occurred at the state schools could happen in 1994.
The policy, adopted by the Corporation in 1981, says a committee on human subject research may waive the requirement of informed consent under certain circumstances.
"This loophole is an opening big enough for a Mac truck hauling both Fernald and Wrentham School," Dockham says. "This would allow for the very same thing to occur again."
The policy says: "The Standing Committee may waive these requirements only when persuaded that the research cannot otherwise be done that its potential value outweighs the indignity to the subject, and that the subject risks no other harm in participating."
Dockham's letter to Rudenstine and the Corporation calls for the University to delete this provision.
The alumnus appears to have already made an important convert. Associate Dean of the Faculty Richard G. Leahy, who as a member of the faculty's institutional review board oversees proposed human subject research, met with Dockham last week. He now says Harvard's policy needs to be clarified.
"In my experience on the FAS human subject research review committee, we've never had anything that's come close for us to even considering waiving the requirements," Leahy says. "I can't think of an instance where we would want to do that. But the fact that two of us can't think of an instance where this could happen still suggests that it ought to be clarified."
The 13-year-old policy has drawn verbal fire from medical ethicists and human rights experts across the country.
Dr. B. Lachlan Forrow, an instructor, in medicine at the Medical School who has reviewed the policy, criticizes the regulation as "poorly worded" and says its intent is unclear.
"It sounds like someone could receive harm," Forrow says. "This needs to be clarified. This calls out for more clarity because the intent is unclear."
"The muddiness of language...needs to be clarified from a 1990s perspective," he adds.
C.K. Gunsalus, the chair of the American Association for the Advancement of Science's research review committee, says Harvard's guidelines are not unique. She says the question of whether they should be revised is a national, not a local one.
"Harvard's regulations mirror the language of the federal regulations, so Harvard is not alone is this," says Gunsalus a professor and member of the research review board at the University of Illinois. "Nationally this is a question people are looking at. Harvard is not at a special vulnerability."
Gunsalus says she does not think Fernald-type experiments could occur under Harvard's current policy because of a "changed consciousness" concerning human subject research.
Dr. Joan P. Porter of the National Institutes of Health Office for Protection from Research Risks, the agency which established the federal guidelines on which Harvard's Policy is modeled, says the University's regulations "are adequate if they are applied properly and there is very careful institutional review board review."
Still, she says, there is always a risk.
"Ultimately there is potential for abuse of any kind of rules if they don't follow them in the spirit in which they are intended," Porter says.
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