Wednesday, May 17, 1995

MICHELLE NICOLOSI; SUSAN KELLEHER
THE ORANGE COUNTY REGISTER

Doctors at UCI's fertility clinic performed unnecessary surgery on women as part of an unapproved study to test fertility procedures, a doctor at the clinic acknowledged Tuesday.

The doctors, world renowned specialists who ran the University of California, Irvine, Center for Reproductive Health, admit they did at least four studies of human subjects without either university approval or written consent from patients.

Federal regulations require university approval, while state law and UCI policy say study subjects must give written consent. But researchers Dr. Jose P. Balmaceda, Dr. Sergio Stone and Dr. Jane Frederick said they did not realize the studies they were conducting required any approval.

"We wouldn't consider it research, we considered it treatment," said Balmaceda. "We were not getting away with anything."

Balmaceda said some women who did not need surgery got it anyway in a study he conducted comparing implanting an embryo into the fallopian tube to a less invasive procedure. Balmaceda said 60 percent to 70 percent of the women would have had surgery anyway.

Dr. David Olive, director of Yale University's fertility clinic, said researchers who do unapproved research put all research at risk, because they harm the public's trust that everything is being done properly.

"It's terrible," said Olive. "(Oversight) is not just paperwork. It's not just a game. It's a safeguard that's well-established in this country."

Balmaceda said all patients in his study were fully informed about the procedures: They knew that by being involved in the study, some who wanted surgery might get another procedure instead, and some who might have gotten the less invasive procedure would get surgery.

People who did not want to take part were not included, he said.

But Balmaceda said he did not get written consent for research as required because he didn't realize his study required it.

"At no time did I or anybody in our team misrepresent to the patients the procedures that were going to be performed," Balmaceda said.

"We were not getting away with anything," he said. "I didn't hide in a closet and laugh and say, `I got away with this,' I published it openly."

The clinic is the target of at least five separate investigations into its financial, clinical and research practices. On Monday, UCI Medical Center severed its relationship with the clinic, which has treated hundreds of women. The clinic will close June 2.

Stone said he realizes now that his study comparing two commonly used fertility drugs was research that required board approval and written patient consent, but didn't realize until it was pointed out to him.

"This has not been clear in my mind, which publications require approval," said Stone. "It was not clearly in my mind at all."

Stone and Balmaceda said the rules regarding consent and approval have gotten stricter recently, and they and other researchers aren't as familiar with the changes as they should be. University policy states "all UCI research involving human subjects must receive approval."

"We receive notices but don't pay much attention to them," said Stone. "There has been no effort to educate us."

Frederick said she, too, was "suprised" to learn she should have gotten approval for a study she would not discuss.

But Dr. Hoda Anton-Culver, a prominent researcher studying breast cancer at UCI, said in her department every study involving human subjects is passed through the board.

"If it involves a human subject, whether you're drawing blood or looking back at records, all of those should go to the review board," said Anton-Culver.

"Every single little project that's done should have approval. That protects the investigator as well as the institution."

To reach Michelle Nicolosi, Kim Christensen or Susan Kelleher, call (714) 953-7967.