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In a setback to publicly funded mental illness research in New York, the New York State Supreme Court has ruled that the law specifying the criteria that state mental health officials must use to enroll mentally incompetent patients as research subjects violates both the state and federal constitutions' due process guarantees.
By shutting down "nontherapeutic" and some "possibly therapeutic" state-funded research in which mentally incompetent children or adults serve as the subjects and the risk is more than "minimal," the December 9 ruling may resolve the legal limbo in which mental health researchers have lived since the law was challenged five years ago. (The New York State Supreme Court is not the state's highest court. Its decisions may be appealed to the New York State Court of Appeals.)
For purposes of this case, possibly therapeutic research was defined as holding out the prospect that subjects will experience a direct benefit and offers a treatment regimen available only through the research protocol. Nontherapeutic research encompasses everything else.
The court's ruling deals directly only with subjects who are patients in psychiatric facilities, but the judges' reasoning appears to extend the ruling to subjects in any type of medical research when those individuals are incapable of providing informed consent about their participation. The potential impact on investigations in such areas as head injury, stroke, and Alzheimer's disease, among others, "could be enormous," said psychiatrist John Oldham, M.D., chief medical officer for the New York State Office of Mental Health.
Among the obvious casualties may be studies involving technological breakthroughs such as those in brain imaging. PET scans, for example, are immensely valuable but don't fit the court's definition of therapeutic and are thus likely to be off limits, Oldham told Psychiatric News.
Also threatened, he added, are studies where the patient's illness entails some risk of negative outcome. At the New York State Psychiatric Institute, of which Oldham is the director, a potentially valuable study of adolescents at extremely high risk of suicide--an understudied but increasing critical problem--may have to be terminated because researchers cannot guarantee the project as risk free. The study requires subjects to undergo lumbar punctures and has a "nontherapeutic component," he explained.
The case arose in 1991 when six patients who had been declared incapable of giving informed consent to participate as research subjects and who were being medicated over their objections--joined by advocates for several patient and public interest legal groups--sued the New York State Office of Mental Health (OMH) to block implementation of regulations the agency had designed "to ensure the protection of patients who participate in research while, at the same time, facilitating research into the very disorders from which they suffer. . . ."
The court ruled, however, that despite its stated intention, the OMH failed to balance its responsibility "to protect individuals who--because of mental illness, age, birth defect, other disease, or some combination of these factors--are incapable of speaking for themselves, from needless pain, indignity, and abuse, against its worthwhile goal of fostering the development of better methods to diagnose, treat, and otherwise care for these same individuals through cooperation with the medical community and private industry."
The regulations under challenge apply to nonfederally funded research in state facilities that involves "more than minimal risk" to the patients. Such studies could investigate antipsychotic medications that had received FDA approval as well as those that had not done so. Among the studies coming under the regulations were placebo-controlled research in which subjects responding positively to a drug could be taken off it before the experimental medication is reintroduced, an interval during which, the court decision points out, "they may relapse and suffer the adverse symptoms of their particular illnesses or disorders."
The regulations also permitted mentally incompetent adults to participate if surrogates such as friends or family members, not necessarily legal guardians, gave researchers their approval. A similar requirement governed children's participation in psychiatric research; a family member's consent was necessary, but that individual did not have to be the child's parent or legal guardian.
The court acknowledged that abuses had justifiably led the OMH to develop the regulations at issue, but stressed that "however laudable the ends," their insufficient safeguards for protecting subjects unable to consent or object to the protocols potentially exposes them "to pain and suffering" and thus violates their constitutional right to due process. "The alternative of allowing such experiments to continue, without proper consent and in violation of the rights of the incapable individuals who participate, is clearly unacceptable," the ruling states.
Of the approximately 400 state-funded psychiatric studies involving "more than minimal risk" that were underway when the suit was filed, 10 were part of the original challenge. The court ruling cancels only the four that are nonfederally funded. (Researchers using federal dollars must comply with human research subject standards set by the U.S. Department of Health and Human Services and are thus exempt from meeting standards set by the state law. This case does not address the constitutionality of such federal regulations.) The restriction on the state's research mission may be more severe than that indicated by the court ruling, however, since it did not address the studies underway in psychiatric units of general hospitals, pointed out attorney John Tauriello, the OMH's deputy commissioner and counsel.
The six-year chronicle of the legal challenge has seen a series of injunctions, appeals, temporary restraining orders, and modifications of most of them. The state agency continued all of the challenged studies during this time (Psychiatric News, April 5, 1996; April 7, 1995).
In addition to finding constitutional due process violations in the state law, the New York Supreme Court also ruled that the state legislature had never granted the mental health agency the statutory authority to develop regulations governing human subject research.
The responsibility to oversee all such research and "to protect the rights of individuals who may be the subjects of that research" is part of the "mission" of the Department of Health and not of the mental health agency, the court declared. The latter agency's charge to "foster research" into the prevention, diagnosis, and treatment of mental illness stops short of the authority to promulgate or enforce criteria for protecting research subjects, even in mental illness oriented studies, according to the ruling.
As of January 2, OMH officials had not decided whether to appeal the ruling to the New York State Court of Appeals, the state's highest appellate court, attorney Tauriello told Psychiatric News.
(Psychiatric News, January 17, 1997)