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Cold War Radiation Tests On Children Haunt Harvard

"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."

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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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