UC Seeks to Ease Curbs on Patient Research

The University of California and several health groups are lobbying the Legislature for more leeway to enroll incapacitated patients in research studies.

But patient activists say the UC system doesn’t deserve this new authority because of its previous lapses in protecting human research subjects in medical experiments. And bioethicists worry that the legislation could place patients at risk for exploitation.

The bill, which passed the Assembly and is headed to the Senate as early as today, would allow certain relatives, from spouses to the closest available family member, to approve studies involving patients unable to give consent. Such patients might include victims of strokes or Alzheimer’s disease, or those in comas.

The university, along with such groups as the American Heart Assn. and California chapters of the Alzheimer’s Assn., said more flexibility is needed to advance treatment of life-threatening diseases and injuries.

The bill’s advocates also seek greater clarity: The consent laws are open to interpretation.

Federal law allows any “legally appointed representative” to give consent on behalf of an incapacitated patient, leaving interpretation of that term to individual states. California law is more restrictive, giving authority only to those appointed by the courts or legally approved by the patients before incapacitation. The state’s definition may or may not include close relatives.

The situation is “a bit of a mess,” said Regis Kelly, executive vice chancellor of UC San Francisco.

Individual UC campuses and other research institutions interpret the laws in various ways. In April, acting on legal advice, UCLA issued a moratorium that bars researchers from enrolling patients in studies if they cannot give consent. But other UC campuses allow such research if a relative consents.

Questions about the precise meaning of the law have arisen as research institutions nationwide have come under fire in recent years for controversial studies, some of which have led to deaths.

The California bill would create a list of relatives who could give consent for a patient who is incapacitated.

“If we could make somebody better or give them relief, why wouldn’t we want to do that?” asked Assemblywoman Dion Aroner (D-Berkeley), who co-authored the bill.

But Aroner, whose mother had Alzheimer’s disease, said after conferring with patient advocates that “there are some issues here that need to be dealt with still. It’s not a black-and-white issue.”

Some patient advocates are suspicious. “This is like a grab for more power” by UC, said Vera Hassner Sharav, president of the Alliance for Human Research Protection. “In fact, they haven’t earned it at all. They haven’t complied with the existing regulations and law.”

She and other critics said the UC system has a history of violating the rights of patients involved in research.

In 1994, UCLA was reprimanded by federal officials for failing to get proper informed consent from patients enrolled in a clinical trial of a new anti-schizophrenia drug. One patient committed suicide.

The next year, three doctors at UC Irvine were accused of taking the eggs and embryos of patients without their consent and implanting them in other women, some of whom gave birth.

Since June 2001, the U.S. Office of Human Research Protections has criticized UCLA, UC Irvine and UC San Francisco for minor instances of failing to inform subjects of their risks in experiments.

UC officials said they have made every attempt to rectify past problems, and the federal office has expressed satisfaction with each campus’ efforts.

“If you go back a few years anywhere in the country, [the protections] would not meet the standards of today,” said William Parker, vice chancellor for research at UC Irvine. “We’ve made improvements since then.”

Sandra Fried, a UC lobbyist and analyst in Sacramento, said the university and other sponsors of the legislation have tried to address opponents’ concerns. They have made several changes, including eliminating patients involuntarily committed to mental hospitals as research subjects.

With opponents who remain, she said, “I think we’ve gotten down to a philosophical difference as to whether human beings should be involved in this kind of research at all.”

The American Stroke Assn. is a strong advocate of the bill, saying that the ability to get patients the most up-to-date treatment is urgently needed.

“When a patient presents at the emergency room, the most appropriate treatment for that patient is often still in an experimental state,” said Marc Burgat, a legislative advocate for the stroke association in Sacramento.

“We would like to have the law very specifically clarified,” Burgat said.

But Bob Aller, whose son participated in the schizophrenia study at UCLA in 1990, said he still doesn’t trust UC researchers. During the study, Aller’s son Greg, who had been taken off antipsychotic medication without his knowledge, came to believe voices in his head that ordered him to kill the former president, Aller has said.

“The lessons learned and the integrity for the individual ... don’t seem to be taken to heart really,” said Aller, who with his son is suing the university for not properly advising Greg Aller of potential risks in the research.

The case, closely watched by researchers, is set for trial in January.

Bioethicists said it is premature to change the California law. So far, they said, studies have shown that family members and doctors are poor predictors of what treatments patients actually want.

“What gives me pause is that there has not been any real public discussion of whether this is something that society wants to sanction or not,” said Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia Medical School.

Another bioethicist, George Annas of the Boston University School of Public Health, would insist upon a host of changes in the proposed law.

One would be that every incapacitated patient have an independent physician who agreed that the study would not cause harm.

And the legislation should prevent relatives from being paid “to volunteer somebody else for an experiment,” Annas said.

Bioethicists said UC is not the only university system to be criticized for research protections.

Alleging serious violations, the federal government in the last three years temporarily suspended all research involving humans at several schools, including Duke University and Johns Hopkins.

“Some of the most advanced research centers seem to have the worst problems, probably because they have some of the most aggressive researchers going after diseases,” said USC bioethicist Alexander Capron.