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UCI Tightens Oversight Policy on Research


IRVINE — Pledging to keep a closer eye on research that involves people as its subjects, officials at UC Irvine on Monday announced a variety of measures designed to prevent the kind of scandal that besmirched its reputation in reproductive medicine.

Describing its efforts as ways of tightening and ensuring in-house "oversight," the university unveiled the final recommendations of a seven-member task force, which sought to examine more aggressive ways of policing a broad range of medical and scientific research--all involving humans.

"These new administrative structures reflect UCI's commitment to ensuring that human-subjects research is conducted in compliance with all university, state and federal regulations," UCI Research Vice Chancellor Frederic Wan said Monday.

However, at least one of the attorneys representing just some of the plaintiffs in the more than 70 lawsuits now pending against UCI and three once-elite fertility specialists was skeptical of Monday's developments.

"It's like closing the barn door after the horses have run out," said Melanie Blum, who has filed 25 lawsuits on behalf of clients who claimed to have been wronged by doctors at UCI. "Sure, it's nice they're trying to do something, but what about the hundreds of people already victimized by the university. What are they doing about them?"

Blum, who noted that seven "live births" have resulted from misappropriated eggs and embryos affecting only her clients, said the university has yet to settle or litigate a single lawsuit connected with the scandal.

"I don't have a real strong indication that the university is looking at these cases and assuming responsibility," she said. "They're doing everything they can to get out of responsibility. OK, so now, they're trying to tighten up regulations that will oversee people who had nothing to do with this scandal. Great. That's real nice."

UCI's long-anticipated oversight measures come in the wake of the scandal, which led to the ouster of Dr. Ricardo H. Asch, former director of the school's now-defunct Center for Reproductive Health, and two of his colleagues, all of whom were world renowned in fertility circles.

Along with Drs. Jose P. Balmaceda and Sergio C. Stone, Asch is accused by the university of stealing the eggs and embryos of scores of women and implanting them in others or using them in research. The doctors also are accused of pocketing hundreds of thousands of dollars in university money, engaging in research misconduct and committing insurance fraud.

The three deny any deliberate wrongdoing. An Orange County Grand Jury recently indicted Stone, alleging mail fraud.

In response to the scandal, UCI appointed the Human Subjects Research Task Force, which then began studying ways of improving and safeguarding the integrity of human-subjects research.

The task force met nine times between mid-April and late July of last year, looking at human-subjects research in detail and setting up various committees in response.

Although some oversight procedures were put in place months ago, Monday's report, according to UCI spokeswoman Fran Tardiff, "is the result of meetings and interviews and deliberations conducted over a period of time."

Tardiff also noted that, although the task force was instituted after the school's fertility scandal, its recommendations apply to all human-subjects research and not just reproductive medicine.

The UCI fertility scandal has also led to a flurry of proposed legislation. Assemblywoman Jackie Speier (D-Burlingame) has introduced a bill that establishes a more rigorous procedure for obtaining patients' consent to donate human eggs or embryos for implantation in other women.

Another Speier bill--sponsored by the University of California--would expand an existing law, allowing the university to prosecute acts of fraud more easily. And state Sen. Tom Hayden (D-Santa Monica) has introduced a bill that would make it a felony to misappropriate human eggs or embryos.

In conjunction with those efforts, UCI announced the following on Monday:

* A satellite Office of Research Administration at UCI Medical Center will assist medical faculty in conducting human subjects research.

* A new Research Conduct Administration will consolidate the activities of several committees overseeing human subject and animal research, biosafety and conflict-of-interest matters. This division also is designed to police the enforcement of all federal and state regulations regarding the research conduct of faculty.

* The Research Conduct Policy Committee will provide ongoing faculty review of research policy and procedures. Headed by James McGaugh, director of the Center for the Neurobiology of Learning and Memory, this committee will review all human subjects research policy and coordinate with other campus regulatory activities.


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