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UCLA didn't ask schizophrenic patients' consent for experiment

Published Mar. 11, 1994|Updated Oct. 6, 2005

A federal agency has ruled that the University of California at Los Angeles failed to get proper consent from schizophrenic patients in an experiment in which they were taken off their medication and allowed to suffer severe relapses.

Experts on medical ethics said the study and others like it raised fundamental questions about the system for protecting patients in medical experiments.

The system depends heavily on ethical review committees at individual institutions, which make decisions on an ad-hoc basis.

Although Congress has mandated general guidelines on informed consent procedures, ethicists say they are too loose and are insufficient to prevent the lapses that occurred in the UCLA case.

Experts who are familiar with the agency's ruling say they hope it will lead to a change in national policy on informed consent, especially for so-called vulnerable populations like the mentally ill.

The experts say the university's study raises two basic questions: How much are doctors required to tell the subjects of an experiment about the risks they face? And should any experimenter be permitted to allow patients to get worse in hopes of learning more about illness?

In the UCLA study, which began in 1983 and is still going on, 23 of 50 patients under treatment for schizophrenia suffered severe relapses after their medicine was stopped. Several of the patients had more than one severe relapse, including hallucinations and paranoia.

Researchers in the study, the UCLA schizophrenic disorders research project, say they are trying to find out if some schizophrenics might do better without medication.

All of the patients signed "informed consent" documents stating that they understood that in the experiment their conditions might "improve, worsen or remain unchanged."

But they were not told how severe their relapses might be, including the possibility of suffering increasingly severe symptoms with each recurrence, according to the federal agency, the Office of Protection from Research Risks.

Families of two of the patients filed complaints about the experiment with the federal government. One of the patients, Antonio Lamadrid, a former UCLA student, committed suicide. The other, Gregory Aller, dropped out of college and threatened to kill his parents.

In its final report, the office on research risks at the National Institutes of Health said the experiment "failed to comply with the requirements of HHS regulations" by not telling patients the extent of the risks they would be asked to take and not telling them that ordinary treatment would be safer for most of them.

The report, which has not been released publicly, was obtained from a person involved in the inquiry.

The researchers denied in interviews that they had done anything unethical.

Several ethicists said in interviews that the university's experiment was improper because those directing it did not tell patients enough about the risks. Some of the ethicists also said the experiment probably was unethical even if proper consent had been given because it was expected that many of the patients would suffer severe mental relapses.

But Dr. Michael Gitlin, who is leading the UCLA study with Dr. Keith Nuechterlein, said, "The patient's best interest is always placed first." He said the researchers did not intentionally drive patients to severe relapses.

Gitlin says it is important to find out if schizophrenic patients can do well without medication because antipsychotic drugs can cause an irreversible condition in which patients have involuntary tremors.

Families of four patients in the UCLA study said in interviews that if they had been told about the expected harm, they never would have allowed participation. They said they had been led to believe that the program was intended to offer high-quality treatment as well as research.

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