ORANGE — A federal audit conducted in March found eight cases in which a research team at Children's Hospital of Orange County failed to follow procedure in obtaining consent from patients or their families for experimental treatments, according to a report obtained by The Times.
In two of the cases, characterized by experts as the most serious, treatment started before consent forms were signed, and in one of those consent was obtained over the phone rather than in person.
In a third case, the audit found, the person involved appeared "incompetent to sign informed consent."
The audit of 62 patients' records was conducted by a multi-agency team that included the Children's Cancer Group, the National Cancer Institute and the Office of Research Integrity, which fall under the National Institutes of Health, and the U.S. Food and Drug Administration.
Investigators reviewed government-supported medical research that was supervised by Dr. Mitchell Cairo, the oncologist known for attempting an experimental transplant last year to save the daughter of baseball Hall of Famer Rod Carew. And the final report on their findings, completed in late April, resulted in Cairo being suspended for six months as the hospital's head investigator for the Children's Cancer Group, a national research collaborative.
The audit report indicates that investigators found what they considered "only a few deficiencies" in the area of informed consent, but it noted that investigators had not focused on that area.
Children's Hospital Medical Director Robert L. Manniello said he could not comment on specific cases reviewed by the audit. However, he said a special committee of the hospital's Institutional Review Board is reviewing the entire consent process in an effort to improve it.
The committee is looking at all research performed at Children's Hospital, not just those studies conducted as part of the Children's Cancer Group, Manniello said. He would not comment on whether problems have been identified that go beyond the scope of the audit.
"The [board] is actively looking at the issues brought forth by the . . . special audit," Manniello said. "They are looking at each individual record and looking at our entire process of informed consent, not only for [Children's Cancer Group] studies but for all research carried out at the institution."
Children's Hospital treats many of Orange County's sickest children, including those with terminal illnesses for whom experimental treatment might be the only hope.
