Research Policy May Be Changed

A Harvard alumnus has convinced at least one high-level University official that a 13-year-old research regulation allowing scientists to test human subjects without obtaining informed consent needs to be reconsidered.

David H. Dockham '58 is raising the issue in the wake of a state report condemning "human rights violations" by Harvard researchers who used retarded children in experiments with radiation without their consent during the Cold War.

The policy, adopted by the President and Fellows of Harvard College in late 1981, says a committee on human subject research may waive the requirement of informed consent under certain circumstances.

The policy says: "The Standing Committee may waive these requirements only when persuaded that the research cannot otherwise by done, that its potential value outweighs the indignity to the subject, and that the subject risks no other harm in participating."

Dockham says that policy is, in effect, a loophole which could permit the same human rights violations criticized by the Massachusetts government to happen again.

"This loophole is an opening big enough for a Mack truck hauling both Fernald and Wrentham School," Dockham said in an interview, referring to two state schools for the retarded at which Harvard faculty used radioactive tracers in experiments on children. "This would allow for the very same thing to occur again."

Associate Dean of the Faculty of Arts and Sciences (FAS) Richard G. Leahy, a member of the Faculty's institutional review board, met with Dockham last week. He said he now agrees with the alumnus that Harvard's policy needs to be clarified.

"In my experience on the FAS human subject research review committee we'venever had anything that's come close for us toeven considering waiving the requirements," Leahysaid. "I can't think of an instance where we wouldwant to do that. But the fact that two of us can'tthink of an instance where this could happen tillsuggests that it ought to be clarified."

Dockham sent letters last week to PresidentNeil L. Rudenstine and all the members of theHarvard Corporation asking them to delete theprovision from the FAS research guidelines .

In his letter, Dockham said he is especiallyconcerned in light of recent revelations about theradiation experiments.

But Leahy said there was no possibility thosekinds to test would ever be approved by theFaculty.

"It's inconceivable that anything like thatcould happen at this point," he said.

Dean of the Faculty Jeremy R. Knowles said in atelephone interview that any ambiguities inHarvard's research policy should be clarified.

"If there is ambiguity or lack of clarity inthe Faculty guidelines, we should certainly lookat them," Knowles said.

One possible reason why the policy seems tohave been left open is to accommodate "deceptionresearch," or tests dependent on deceivingsubjects. Such research is commonly used by socialand behavioral scientists, research experts say.

In spite of any potential used for the escapeclause, Dr. B. Lachlan for row, an instructor inmedicine at the Medical School who has reviewedthe policy, criticized the regulation as "poorlyworded" and said that its intent is unclear.

"It sounds like someone could receive harm,"Forrow said. "This needs to be clarified. Thiscalls out for more clarity because the intent isunclear."

Leahy suggested that the age of the guidelines,which were established 13 years ago and draftedfrom policies older than that, might be the reasonfor the lack of clarity.

"These were set up quite a long time ago,"Leahy said. "I'm not that familiar how they wereestablished."

Professor of social Psychology RobertRosenthal, who serves on the University's humansubject review committee, said Harvard's specificguidelines matter less than the vigilance of thereview board itself.

"The heart of the matter is the sincerity andhow hard working the particular institutionalreview board is," Rosenthal said. "We are very,very sensitive to providing potential subjectswith all the information they would need."

And C. K. Gunsalus, the chair of the AmericanAssociation for the Advancement of Science'sresearch review committee, said Harvard'sguidelines are consistent with regulationsestablished by the federal government.

"Harvard's regulations mirror the language ofthe federal regulations, so Harvard is not alonein this," said Gunsalus, a professor and member ofthe research review board at the University ofIllinois. "Nationally this is a question peopleare looking at. Harvard is not at a specialvulnerability."

Gunsalus said she does not think Harvard'spolicy would allow for radiation testing becauseof a "changed consciousness" concerning humansubject research.

Dr. Joan P. Porter of the National Institutesof Health Office for Protection form ReearchRisks--the office which established the federalguidelines on which Harvard's policy ismodeled--said Harvard's regulations "are adequateif they are applied properly and there is verycareful institutional review board review."

But Dockham said the policy sets a bad examplefor other colleges and universities.

"Someone else might use Harvard's reputation tosell that kind of exception, in both principle andpractice, to other research institutions," hisletter to Rudenstine and the Corporation says

Dockham sent letters last week to PresidentNeil L. Rudenstine and all the members of theHarvard Corporation asking them to delete theprovision from the FAS research guidelines .

In his letter, Dockham said he is especiallyconcerned in light of recent revelations about theradiation experiments.

But Leahy said there was no possibility thosekinds to test would ever be approved by theFaculty.

"It's inconceivable that anything like thatcould happen at this point," he said.

Dean of the Faculty Jeremy R. Knowles said in atelephone interview that any ambiguities inHarvard's research policy should be clarified.

"If there is ambiguity or lack of clarity inthe Faculty guidelines, we should certainly lookat them," Knowles said.

One possible reason why the policy seems tohave been left open is to accommodate "deceptionresearch," or tests dependent on deceivingsubjects. Such research is commonly used by socialand behavioral scientists, research experts say.

In spite of any potential used for the escapeclause, Dr. B. Lachlan for row, an instructor inmedicine at the Medical School who has reviewedthe policy, criticized the regulation as "poorlyworded" and said that its intent is unclear.

"It sounds like someone could receive harm,"Forrow said. "This needs to be clarified. Thiscalls out for more clarity because the intent isunclear."

Leahy suggested that the age of the guidelines,which were established 13 years ago and draftedfrom policies older than that, might be the reasonfor the lack of clarity.

"These were set up quite a long time ago,"Leahy said. "I'm not that familiar how they wereestablished."

Professor of social Psychology RobertRosenthal, who serves on the University's humansubject review committee, said Harvard's specificguidelines matter less than the vigilance of thereview board itself.

"The heart of the matter is the sincerity andhow hard working the particular institutionalreview board is," Rosenthal said. "We are very,very sensitive to providing potential subjectswith all the information they would need."

And C. K. Gunsalus, the chair of the AmericanAssociation for the Advancement of Science'sresearch review committee, said Harvard'sguidelines are consistent with regulationsestablished by the federal government.

"Harvard's regulations mirror the language ofthe federal regulations, so Harvard is not alonein this," said Gunsalus, a professor and member ofthe research review board at the University ofIllinois. "Nationally this is a question peopleare looking at. Harvard is not at a specialvulnerability."

Gunsalus said she does not think Harvard'spolicy would allow for radiation testing becauseof a "changed consciousness" concerning humansubject research.

Dr. Joan P. Porter of the National Institutesof Health Office for Protection form ReearchRisks--the office which established the federalguidelines on which Harvard's policy ismodeled--said Harvard's regulations "are adequateif they are applied properly and there is verycareful institutional review board review."

But Dockham said the policy sets a bad examplefor other colleges and universities.

"Someone else might use Harvard's reputation tosell that kind of exception, in both principle andpractice, to other research institutions," hisletter to Rudenstine and the Corporation says