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The highest court in New York State has shut the door on a lawsuit that would have halted almost all psychiatric research with patients as subjects in the state. In a move that brought a sigh of relief from psychiatrists, researchers, and advocates for the mentally ill, the New York State Court of Appeals dismissed a suit challenging the ability of scientists to conduct federally funded research that involved individuals under age 18 or adults who were incompetent to understand what they were consenting to when they agreed to become research subjects.
These same plaintiffs had notched a victory when lower courts prohibited such psychiatric research when funded from state coffers, but those rulings, as devastating as they were to research centers in New York, where some of the world's leading psychiatric researchers work, stopped short of extending the restrictions to projects with federal funding (Psychiatric News, January 17, 1997). Faced with this additional area of litigation, however, the appeals court ruled that since criteria for federally funded research were not part of the original lawsuit, and since the plaintiffs succeeded in the trial court in their suit regarding state-funded studies, they had no legal standing on which to challenge federally funded projects at this level of appeal.
The legal challenge brought by six patients-who were not research study subjects but were being treated in state psychiatric facilities-and three public interest law firms sought to nullify rules governing enrollment of research subjects promulgated in 1990 by the New York State Office of Mental Health (OMH). Their suit specifically challenged 10 research studies, though it put the fate of dozens of others under way in state psychiatric facilities in serious jeopardy. It was also likely that a decision in favor of the plaintiffs would affect state-funded research in general hospital psychiatric units.
The suit has been working its way through state courts for about seven years, forcing much of the state's research establishment into a legal limbo. To the dismay of researchers and advocates for the mentally ill, in December 1996 the state's Supreme Court, which is one level down from the Court of Appeals, ruled that all nontherapeutic research and much therapeutic research involving incompetent subjects or mentally ill youngsters had to be ended. It allowed only a limited amount of state-funded "possibly therapeutic" research to proceed-that in which the risk was no more than "minimal." That court defined therapeutic research as that from which subjects will derive a direct benefit or were to receive treatment regimens only available via the research protocol; it was labeled nontherapeutic if benefits would accrue to future patients or only after there had been follow-up studies. The court did not subscribe to the argument that benefits to future patients could be substantial in these studies and thus should not be saddled with the nontherapeutic label. All state-funded studies in which the risk of harm to subjects was more than "minimal" was to be halted.
The state's regulations did not permit the unfettered enrollment of incapable subjects, but instead restricted it to studies that could be conducted only with the participation of such patients and focused on specific psychiatric disorders from which they suffered. Also mandatory was agreement by psychiatrists and others treating the potential subject that the research protocol was consistent with the treatment plan they had decided would best benefit the ill and incompetent patient.
The New York Supreme Court's ruling applied only to subjects in psychiatric facilities that receive state funding for their research, but appeared also to apply to brain-imaging studies using patients with Alzheimer's disease or brain-injury as subjects, for example, since the court views such tests as nontherapeutic. The justices said that the OMH's regulations about research-subject selection gave too little heed to the possibly harmful effects of research procedures on mentally incompetent subjects "who are incapable of speaking for themselves" in the pursuit of the "worthwhile goal of fostering the development of better methods to diagnose, treat, and otherwise care for these same individuals."
One key section of the regulations that came under assault in the lawsuit permitted mentally incompetent subjects to participate in research studies if permission was given by surrogates such as family members or friends who did not have to be the subject patient's legal guardian (the latter usually applied to studies involving AIDS patients, who often did not have or communicate with families). The same requirement for family-member approval governed subjects under age 18 in state facilities.
The state Supreme Court, however, even restricted the ability of researchers to assess the competency of potential patient-subjects for therapeutic studies, insisting that a clinician not affiliated with the research project must evaluate the competency of patients prior to enrollment in any state-funded study.
The justices ruled as well that they were negating most of the regulations because developing such criteria should have been the province of the state's Department of Health and not its chief mental health agency.
That court's ruling was "clearly predicated on the belief that standard treatments are safe and effective for all and the belief that psychiatric research exposes participants to huge risk of grievous harm, while providing them with little or no prospect of benefit," according to John Oldham, M.D., OMH's chief medical officer, OMH attorney Stephan Haimowitz, and Susan Delano of the Albany-based Research Foundation for Mental Hygiene. Writing in the November-December 1997 Hastings Center Report, they note, "Few would dispute that treatments for psychiatric conditions involve risks to patients. . . . Medications for serious mental illness involve risks of side effects, whether provided as part of standard treatment or as part of a research protocol." They emphasize, however, that "[i]n many cases the likelihood or magnitude of the risks from a medication under investigation may be less than those associated with standard treatments." And as for the risks of failing to advance the science of mental illness treatment, they are "apallingly high."
Thus, the Court of Appeals' dismissal of the plaintiffs' challenge to the continuation of federally funded psychiatric research "has to be looked at as an extremely good decision," Oldham told Psychiatric News. "This will allow a thoughtful, reasonable process to go forward that hopefully will lead to appropriate safeguards for vulnerable populations while permitting critical research work to continue."
Oldham is also director of the New York State Psychiatric Institute, a leading research center affiliated with Columbia University.
The process to which Oldham was referring was the just-completed work of a task force under the auspices of the Department of Health chaired by psychiatrist Herbert Pardes, M.D., dean of Columbia's medical school, former APA president, and former head of the National Institute of Mental Health. The task force's charge was to develop a new set of recommendations for enrolling incompetent adults and minors in research studies. A draft of such recommendations was to be finalized in mid-March and submitted to the commissioner of the Department of Health. It will then be made available for public comment prior to implementation. Until that time, Oldham said, an "informal agreement" is in effect in which no new state-funded psychiatric research involving mentally incompetent subjects is being initiated.