UC Irvine Unveils Plan for Closer Policing of Research on Humans
Pledging to keep a closer eye on research that involves people, 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 to tighten and ensure 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.
“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,” said Research Vice Chancellor Frederic Wan.
However, at least one of the attorneys representing some of the plaintiffs in the more than 70 lawsuits now pending against UC Irvine and three fertility specialists was skeptical.
“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 UC Irvine. “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 her clients, said the university has yet to settle or litigate any lawsuit connected with the scandal.
“I don’t have a real strong indication,” she said, “that the university is looking at these cases and assuming responsibility.”
The school’s long-anticipated oversight measures are a result of the scandal that 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.
Along with Drs. Jose P. Balmaceda and Sergio 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, UC Irvine appointed the Human Subjects Research Task Force, which began studying ways of improving and safeguarding the integrity of research.
School spokeswoman Fran Tardiff 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 recommendations include the following:
* A satellite Office of Research Administration at the school’s 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. Led 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.
