Legislators Blast UCI’s Fertility Center Role : Hearing: Lack of oversight on research called ‘astounding.’ Officials defend university, vow search for truth.

Members of an Assembly committee and other legislators blasted UC Irvine officials Tuesday for what one called an “astounding” lack of oversight of university research programs and failure to promptly correct what should have been obvious problems at the school’s troubled fertility clinic.

During the first in what is expected to be a series of legislative sessions on the fertility clinic scandal, the chairwoman of the Assembly Higher Education Committee and guest panelist Sen. Tom Hayden (D-Santa Monica) wondered aloud how UCI could have failed to notice the Center for Reproductive Health’s failings for so long.

“If the whistle-blowers had not whistled, how would you ever have found out about problems with the center?” demanded an exasperated chairwoman Marguerite Archie-Hudson (D-Los Angeles).

During the two-hour session, called to explore the controversy’s larger implications, committee members grilled two UCI officials on their supervision of human-subject researchers and suggested that profit-making ventures on campus may encourage institutions to turn a blind eye to their practices.

University Executive Vice Chancellor Sidney Golub, one of two UCI officials to testify Tuesday, said that arriving at the truth and protecting patients have been the university’s priorities from the outset. He blamed the clinic’s doctors for hampering UCI’s investigations and the media for distorting the facts of the case.

“I think we all agree that . . . the situation we are discussing today is fraught with sadness,” Golub said in conciliatory opening remarks. “The stakes are very high. At risk is the credibility of an important new field of medicine. . . . At risk are careers of successful doctors and the reputation of an outstanding research university. At risk is the public trust. . . . We believe that the truth must prevail.”

The scandal erupted three weeks ago when the university abruptly cut its ties to the clinic and put three of its doctors--Ricardo H. Asch, Jose P. Balmaceda and Sergio Stone--on leave from the faculty. In an unusual lawsuit, the university later accused them of transplanting eggs without permission and using patients in research without their approval, among other things.

UCI officials say eggs have been stolen from women in at least two cases, and perhaps as many as five.

The doctors have denied knowingly committing any wrongdoing.

The National Institutes of Health, which has threatened to pull $14 million in federal research grants from UCI, contends that in at least six studies at the Center for Reproductive Health, doctors did not obtain necessary approval for human research.

Golub and Frederic Wan, UCI vice chancellor for research, adamantly insisted Tuesday that the fertility center’s improprieties are not symptomatic of a larger disease and that UCI moved quickly to address problems as soon as they arose.

“We do not believe this is a widespread problem,” said Golub, his voice at times trembling during his testimony. “I’m convinced that the faculty in general knows the importance of integrity in research.”

But during a tense exchange with Archie-Hudson, another university official admitted that UCI might not have caught the research improprieties because its review panel for human subjects cannot force researchers who receive no outside funding to submit their plans for approval.

The center’s case “exposed a loophole in our system,” said Wan.

“I’d like to [make] a point right there,” Archie-Hudson interjected sharply. “What you call a ‘loophole’ to us is the crux of the argument. . . . Because there was no extramural funding, these doctors could have been doing anything--anything.”

While Wan tried to explain that university policy requires reviews but researchers may not always comply, she termed the university’s hands-off approach “astounding.”

Both Golub and Wan said that UCI is now requiring researchers to submit regular reports on all research projects they are working on.

Bill Dommell, a senior policy adviser with NIH who also testified at the hearing, commended UCI for its prompt response and reforms since the agency’s Office for Protection From Research Risks visited the campus in January and pointed out UCI’s flaws. “We think the university moved with the utmost of speed,” he said.

But Hayden, chairman of the Senate Select Committee on Higher Education, suggested that UCI only moved quickly when it became clear that millions of dollars in research funding were at risk. The Assembly committee’s staff report said that in addition to the $14 million in federal research dollars that could be lost, another $35 million of private funds are in jeopardy.

“Would you say, in conclusion, that this all would have come out without your interest or would you say you were a trigger on the university’s response?” Hayden asked Dommell.

Dommell said he believes that his agency “triggered a rapid response” but that the university was aware and working on the problem before the NIH became involved.

Golub, however, said UCI was aware of other problems at the clinic but not the deficiencies in research oversight until the NIH pointed them out.

Reese Jones, chairman of the Committee on Human Research at UC San Francisco, told the committee that allegations of wrongdoing such as those made at UCI do not point to systemic failures but rather seem to be isolated.

“I can’t imagine something like this happening” at UC San Francisco, he said.

But Golub said playing by the rules depends to a certain extent on personal integrity, and “some rules will be flouted because there will be those who flout the rules for personal gain.” After the hearing ended, Golub hurried from the room amid a cluster of reporters, refusing to elaborate on questions his testimony raised. He said he had to catch a plane.

But Hayden and Archie-Hudson stayed behind to voice concerns about whether UCI’s problems point to a larger dilemma raised when profit-making enterprises are permitted on the grounds of a public research institution.

“Something’s very, very wrong here,” said Hayden, whose committee plans to hold a more intensive inquiry on the scandal next week. “There’s no doubt about that.”