In a decision that has forced the cancellation of at least 10 research projects, a New York state appeals court has found the state's rules governing psychiatric experiments on children and the mentally ill to be unconstitutional.
The court found that the rules did not adequately protect people who, because of age or illness, cannot give informed consent to taking part in drug tests or other experiments.
The decision focused particularly on experiments that might pose a health risk without providing any direct benefit to the patient. For example, one study that has been halted involved spinal taps on suicidal adolescents to monitor the levels of chemicals in their nervous systems.
The unanimous decision was issued Dec. 5 in Manhattan by the First Department of the Appellate Division of state Supreme Court. It upheld a 1995 ruling by Justice Edward Greenfield.
Authorities said it would affect 10 to 15 of the 400 state and privately financed psychiatric research projects in the state. The ruling did not affect federally financed research, which is governed by stricter federal rules, but the court agreed to reconsider that question at the request of the plaintiffs.
While the decision does not set a precedent outside New York, experts said it could have wide effect because other states have similar rules, and some are in the process of rewriting them.
"This could be a landmark case," said Jonathan Mareno, an ethicist at the State University of New York's Downstate Medical Center in Brooklyn, "and it will raise a lot of eyebrows in other states. It is the first big case in which mental-health officers are taken to task for rushing ahead with experiments at the expense of patients' rights."
Researchers, however, defended the rules, saying that the only way to test drugs intended for treatment of severe mental illness or Alzheimer's disease is on patients with those disorders, many of whom lack the capacity to consent.
They expressed fear that more stringent rules on obtaining consent from parents or guardians could seriously hamper research efforts.
Dr. John Oldham, director of the New York State Psychiatric Institute, said that if the court's view of consent was allowed to stand, many vital experiments "simply won't be able to be done" because the time and trouble it would take to get consent, possibly through a court hearing, would be too great.
Under the rules that were struck down, researchers could use mental patients in such experiments with the approval of what the court described as "surrogates" like friends or family members. The rules did not require that the surrogate be the legal guardian of the patient.
Similar rules applied to children. The rules permitted researchers to use children in experiments that posed a possible health risk but no direct benefit, with consent from a family member. The rules did not require that the family member be a parent or guardian.
In both situations, the court found the rules violated the due process provisions of the state and federal constitutions.
The court forbade all such experiments on children. In an opinion written by Justice David Ross, it declared: "We are not dealing here with parental choice among reasonable alternatives but with a decision to subject the child to nontherapeutic treatments and procedures that may cause harmful permanent or fatal side effects.
It follows therefore that a parent or guardian, let alone another adult who may be a member of a child's family, may not consent to have a child submit to painful and/or potentially life-threatening research procedures that hold no prospect of benefit for the child."
Different states and the federal government have different rules about experiments on children and incapable adults. Lynda Schuler, a lawyer for the Bazelon Center for Mental Health Law in Washington, said that many states -- including California, Connecticut, Massachusetts and Illinois -- flatly prohibit research with risks but no benefits whenthe patient cannot give consent.
Federal rules are also stricter than the New York rules. For example, under the federal rules, only a court-appointed surrogate can give consent, not any relative or friend.
Moreover, for experiments on children with substantial risk and no direct benefit to the child, the federal rules require parental consent, consent of the secretary of health and human services, approval by an expert panel, and public notice and comment. The New York rules require only the consent of a relative.
Officials at the New York State Office of Mental Health, which wrote the rules, declined comment and said they had not decided whether to appeal. Officials at the Department of Health, which oversees the Office of Mental Health, also refused to comment.
The case began five years ago, when the state set out to update rules governing psychiatric experiments conducted with private or state money, to make it easier for medical researchers to recruit patients, while strengthening safeguards to protect patients, officials said.
Both sides said that many provisions of the new rules were improvements on the sketchy, loose rules they replaced. But patient advocates found fault with the rules governing people who cannot give consent, and they filed suit on behalf of six mental patients who had been committed and treated by court order without their consent and who the advocates said feared that they would also become subjects of experiments without their consent.
The case was brought by Cliff Zucker of Disability Advocates in Albany and Ruth Lowenkron of New York Lawyers for the Public Interest in New York City.
Patient advocates say that experiments should be carried out only on those who can give or withhold consent, not children and incapable adults. In the worst cases, they say, patients who can't give consent are put into experiments that have considerable risks and no likely benefits to them.
Oldham said several experiments at the New York State Psychiatric Institute had been halted because of the ruling, including the study -- involving spinal taps -- of mentally ill adolescents and suicide. The experiment, he said, had been under way for more than a year and had enrolled hundreds of adolescents, with their parents' permission.
"That experiment has been greatly compromised," he said. "We may not be able to do it any other way."
In neuroscience and brain studies, Oldham said, "We have a special situation because some of the diseases we are talking about do impair reasoning and cognitive capacity in severe cases. But we need to work with patients with severe illness."
He said one example of the progress made with this type of experimentation was the new schizophrenia drug Clozapine. "This is the only new medicine to come along in recent memory that is effective in schizophrenia," he said. "My opinion is that the Clozapine experiments just wouldn't have been done, and the drug wouldn't have come to market in the U.S." under the court's ruling.
Patients' advocates disagreed. Zucker said that at early stages of a drug experiment, it was true that incapable adults probably could not be used, because it would be unclear what benefit, if any, the drug offers. But in later phases when benefits are known, it is possible to get surrogates' consent.
Also, he said, in many illnesses like schizophrenia, patients often cycle between lucid and delusional states. Consent may be obtained when the patients are capable of giving it, he said.
Oldham said he hoped that new rules could be worked out, even if researchers had to get court permission for some experiments. "It is just crucially important that this work go on," he said. In addition to New York State Psychiatric Institute, which is affiliated with Columbia University, institutions where experiments have been halted include the Pilgrim Psychiatric Center in Brentwood and the Nathan S. Kline Institute at Rockland Psychiatric Center in Orangeburg.
The case is part of a trend across the United States to re-examine the relations between experimenters and their subjects. Texas and Maryland are currently considering new rules, said Dr. Adil Shamoo of the University of Maryland, an expert in ethics and psychiatric experiments. In both states the proposals would prohibit risky, nonbeneficial experiments on those who cannot consent.
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